[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33260-33301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16173]
[[Page 33259]]
_______________________________________________________________________
Part VII
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 152 and 156
Pesticides and Ground Water State Management Plan Regulation; Proposed
Rule
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 /
Proposed Rules
[[Page 33260]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 152 and 156
[OPP-36190; FRL-4981-9]
RIN 2070-AC46
Pesticides and Ground Water State Management Plan Regulation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking.
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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
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State Governments States Developing Pesticide
SMPs
Industry Pesticide registrants;
farmers and other commercial
pesticide users
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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 suggest possible associations between triazine exposure and
various human health effects, including ovarian cancer, non-Hodgkins
lymphoma, and birth defects. All of the studies, however, had
significant limitations, and the Agency does not consider any of the
suggested health-effect associations to be established by currently
available information.
Alachlor was classified as a B2 (probable human) carcinogen by
virtue of positive results in studies of both rats and mice. At this
time, however, alachlor is considered to be not classified under the
current agency system pending further review of scientific issues
raised by the registrant. Metolachlor has limited evidence of liver
carcinogenicity in animals.
The cancer classifications cited here are likely to change in the
future for several reasons. First, EPA has recently proposed to revise
its guidelines for the assessment of cancer risks. The new proposed
guidelines were made available on April 16, 1996, for a 120-day public
comment period. The issues raised during the comment period will then
be presented to the Agency's Science Advisory Board. New guidelines are
likely to become final in 1997. Among other things, the new guidelines
may change the way the Agency weighs the various kinds of laboratory
evidence used to identify carcinogenic potential.
In addition to changing guidelines, the registrants of the triazine
and acetanilide herbicides have recently submitted new data which they
believe should reduce concerns about human cancer risks for these
compounds. It is not clear at this time how this new evidence will
affect the Agency's risk assessment for these compounds, or how the
evidence will be evaluated under the new guidelines. In any case, human
cancer risk is not the only basis for the Agency's concern about these
chemicals.
b. Ground Water Reference Points. Table 2 of this Unit displays the
relevant summary toxicological data for these five compounds. The
derivation of the Ground Water Reference Points shown in Table 2 is
discussed below.
The Ground Water Reference Point for a compound is a representation
of the compound's toxicity, expressed in units corresponding to
environmental exposure. The Reference Point provides a means to assess
the significance of known or anticipated concentrations that occur in
ground water. As described in Unit II. of this preamble, the Agency
normally will use MCLs established under the Safe Drinking Water Act
(SDWA) as reference points. MCLs are derived from Maximum Contaminant
Level Goals (MCLGs), which is that concentration, ``... at which no
known or anticipated adverse effects on the health of persons occur and
which allows an adequate margin of safety'' (SDWA section 1412(b)(4)).
In most cases an MCLG is based on the Reference Dose (RfD) for the
compound, to which standard conversion and uncertainty factors have
been applied to account for anticipated drinking water exposure. For
compounds classified as Group C carcinogens, EPA also applies a 10-fold
uncertainty factor to provide for an additional margin of safety. The
enforceable MCL, set simultaneously with the MCLG, is set ``as close to
the [MCLG] as is feasible'' (Ibid). In the case of B2 carcinogens,
Agency policy has been to set the MCLG at zero. The corresponding MCL
is then set at a finite level by evaluating the performance of feasible
water treatment and analytic technology. More information on EPA's
methodology for setting MCLs and MCLGs is available in the final rule
which established MCLs for atrazine and alachlor (56 FR 3526, January
30, 1991).
The following Table 2 is a summary of the human health risk posed
by these five chemicals:
Table 2.--Summary of Human Health Risk
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ground Water
Reference Reference Dose
Point Source (MCL, HAL, (RfD) (g/ Study/Endpoint\1\ Cancer Category Q1* (1/mg/kg/d)
(g/ or other) kg/d)
l)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Atrazine......................... 3 Final MCL 35\2\ Chronic Animal C 0.22
Study decreased
body wt. gain;
cardio-
developmental
toxicity
Simazine......................... 4 Final MCL 5 Chronic Rodent C 0.12
Study (decreased
body wt. gain
hematological
changes)
[[Page 33277]]
Cyanazine........................ 1 HA 2 Chronic Animal C 1.00
Study (decreased
body wt. gain)
Alachlor......................... 2 Final MCL 10 Sub-Chronic Dog * 0.08
Study (hematology)
Metolachlor...................... 70 HA 100 Chronic Rodent C 0.009
Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This column refers to the study or toxicological endpoint which serves as the basis for the RFD listed in the column immediately to the left.
\2\ The RfD for atrazine was revised in December 1992; the previous RfD (of 5 micrograms per kilogram per day) served as the basis for the current MCL
displayed at left.
In the absence of MCLs, EPA will use a Health Advisory (HA) to
establish Ground Water Reference Points. HA levels are established
using the same methodology used for non-zero MCLGs. MCLs have been
established for atrazine, simazine, and alachlor, and these are Ground
Water Reference Points for these compounds. The Reference Points for
cyanazine and metolachlor are based on HA levels.
In summary, the Agency feels that there is sufficient evidence to
concluded that each of the five compounds addressed in today's rule may
cause serious, irreversible adverse effects to the health of persons,
if any of the compounds were present in drinking water at or above
particular concentrations or at other concentrations for a prolonged
period of time. In fact EPA has set drinking water standards for three
of the compounds in this proposed rule, in order to prevent the onset
of such effects as a result of drinking water in Public Water Systems
(PWSs). The Agency has set Health Advisories for the other two
compounds, in order to allow PWSs to evaluate and avert potential
adverse effects to human health should these compounds be encountered.
MCLs for these two compounds may also be developed at a later date.
2. Environmental effects. In addition to their potential for
adverse human health effects, EPA is also concerned about the potential
adverse effects of these compounds: (1) On specific non-target plants
and animals, including the potential economic impact associated with
adverse effects on both commercial crops and animals; and (2) on
ecosystems as a whole.
EPA has far less specific data on the potential adverse ecological
effects of these five compounds than for adverse health effects.
However, both the chloro-triazines and the acetanilides inhibit
photosynthesis in plants and may have phytotoxic effects to terrestrial
and aquatic plants.
Of these chemicals, atrazine has been the most fully studied and
characterized for environmental effects. In comparative laboratory
acute toxicity testing, atrazine exhibits moderate toxicity to birds,
mammals, fish, or aquatic invertebrates. Studies representing simulated
field conditions have also been conducted. For aquatic plants,
available information indicates that short-term exposure to relatively
low levels of atrazine (for example, concentrations of approximately 20
g/l) can produce phytotoxic effects from which plant
populations will not recover. Information on simazine and cyanzine
indicate that longer-term exposure at even lower levels, in the range
of about 5 g/l, can also inhibit plant reproduction.
Substantial risks can be anticipated from continuing off-target
movement of these five compounds and consequent exposure of aquatic
organisms and ecosystems. Contamination of ground water can be a
mechanism of transport for these compounds to surface water, since
ground water provides a significant source of recharge for many bodies
of surface water. While it is difficult to segregate potential risks
from the presence of these compounds in ground water from those that
might result from other means of environmental transport such as
runoff, the risks are real enough to be of concern.
In addition, there is a considerable body of monitoring data
available on these five pesticides, primarily in the mid-western
``corn-belt'' States where they are most heavily used. These data
demonstrate that residues of these five pesticides can be detected in
both ground and surface waters in areas of heavy use, at levels which
frequently approach, and sometimes exceed, the MCLs or HAs. (Data for
ground-water occurrence are discussed in more detail below).
Thus, the Agency feels that there is sufficient evidence to infer
that present environmental levels of these herbicides from various
environmental transport mechanisms, including leaching to ground water,
pose substantial risks to aquatic plant life, both in the form of
outright phytotoxicity and in the longer-term and more subtle effect of
inhibiting plant reproduction. If such effects occur in an aquatic
environment, the effects on the ecosystem could be profound. Complete
loss of habitats may occur. Even partial loss of food supply or
protective cover can result in significant impacts on other aquatic
organisms. Herbicides in the aquatic environment could destroy the food
source for higher organisms, which may then starve. Herbicides may also
reduce the amount of vegetation available for protective cover and the
laying of eggs by aquatic species. Submerged aquatic vegetation is the
nursery for commercial and recreational species. As such, drastic loss
of submerged aquatic vegetation in rivers or estuaries is a serious
environmental concern. Some experts believe that herbicide related
ecosystem damage may already be occurring in locations such as the
Chesapeake Bay and parts of the Mississippi delta.
EPA has drafted a Water Quality Criteria document for atrazine that
proposes to establish a fish-protection level of 22.7 g/l
(measured as a 4-day average concentration over a 3-year period), below
which ``freshwater aquatic animals and their uses should not be
affected unacceptably ...,'' adding a peak 1-hour concentration limit
of 571.9 g/l (not to be exceeded more than an average of once
in a 3-year period). For the protection of freshwater aquatic plants,
atrazine concentrations should not exceed 2.0 g/l for any 4-
day period within a 3-year period.
The total risks of these five pesticides to aquatic ecosystems are
beyond the scope of the regulatory action being proposed today. These
ecological risks involve, in addition to contamination of ground water,
contamination of surface water through many alternative routes, such as
runoff through the unsaturated zone to a nearby water body.
Ground water SMPs cannot be expected to address all of these
potential routes to surface water contamination that may occur as a
result of the legal use of these five pesticides. However, certain use
management measures implemented by States as part
[[Page 33278]]
of their ground-water Plans may provide some ancillary protection
against such surface-water contamination. At a minimum, no SMP will be
approved that contains a preventive measure that will clearly increase
the likelihood that surface water will be adversely affected as a
consequence (see Unit III.C.7. of this preamble, and Guidance, pp 3-15-
6, Ref. 18).
3. Ground water contamination potential-- a. Persistence and
mobility. EPA requires that all pesticide registrants submit data on
the physical and chemical characteristics of a pesticide in order to
characterize its environmental fate. These data are generated through a
battery of basic laboratory tests and limited field studies as
specified in 40 CFR 158.290, otherwise known as the ``Subpart N''
Guidelines. Two important factors, known as persistence and mobility,
are particularly relevant in predicting whether a substance has the
potential to reach ground water.
Persistence refers to a substance's relative resistance to
environmental processes which tend to break that substance down, and
thus to the length of time that substance can exist in the environment.
Persistence is generally measured as a half-life (t1/2 or
t50), or the length of time in which 50 percent of an
environmental concentration disappears as a result of transport or
degradation. Mobility refers to the potential for an ingredient to move
away from the point of application, and is typically represented by a
substance's resistance to binding to soil or soil constituents.
Measures such as the soil-water partition coefficient (kd) or the
carbon-referenced sorption coefficient (Koc) are used to indicate a
substance's binding potential.
A pesticide that is relatively persistent and mobile would tend to
remain in the subsurface environment, be present at substantial
fractions of the original environmental residue, and reach underlying
aquifers relatively quickly. Together, persistence and mobility are
referred to as a pesticide's leaching potential.
(i) Parent compounds. Table 3 of this Unit contains a summary of
the persistence and mobility characteristics for the five pesticides
subject to today's proposed rule. The Table shows chemical-specific
values for the seven parameters that EPA uses to evaluate a pesticide's
propensity to reach ground water. These values, generated from the
combination of laboratory and field studies EPA requires for
registration, are compared against the values (displayed in the Table)
that EPA regards as indicative of leaching potential.
EPA proposed these values in a previous proposed rulemaking (see 56
FR 22076, May 13, 1991) as criteria indicating a reasonable potential
for reaching ground water on a widespread basis, for purposes of
considering a pesticide for restricted use classification. While EPA is
not proposing to apply these criteria to determine whether a pesticide
needs to be subject to an SMP, the Agency provides the information as
evidence of the pesticides' leaching potential. As indicated in Table
3, all five pesticides display persistence and mobility characteristics
exceeding the values EPA considers evidence of a propensity to leach.
In the event EPA were to classify the pesticides for conventional
restricted use independently of the regulatory action referred to
above, the Agency believes that this evidence, combined with the
detections of the parent compounds in ground water to date, would not
only meet the EPA's final criteria for restricted use for ground-water
concerns, it would establish that these pesticides could pose a serious
hazard to the environment in the absence of the mitigation provided by
restricted use classifications. Such evidence would be sufficient for
EPA to propose restricted use classification for simazine and
metolachlor, the two pesticides subject to today's proposed rule not
now classified as such, under the existing regulations for restricted
use classification (c.f., 40 CFR 152.170(d)).
As shown in Table 3 below, all five pesticides are resistant to
chemical hydrolysis, indicating their likely environmental persistence.
The term ``stable'' as used in Table 3 means the compound was observed
to degrade more slowly than the rate of degradation specified as the
critical value in the criteria column, i.e., a decrease of 10 percent
or more in the tested concentration of a substance over 30 days
duration of a hydrolysis test.
Table 3.-- Persistence and Mobility
(A value exceeding a criterion shown in Italic)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Parameter Criteria Atrazine Simazine Cyanazine Alachlor Metolachlor
--------------------------------------------------------------------------------------------------------------------------------------------------------
Persistence.................. Field > 21 days (3 60-120 days 44-231 days 6-181 days 11 days 7-292 days
........................... Lab-derived > 21 days (3 146 days 110 days 17 days 2-3 weeks 67 days
aerobic soil wks), or
metabolism half-
life
........................... Hydrolysis half- < 10% in 30 stable (pH stable (pH 148 days (pH stable (pH stable (pH
life days, or 5,7,9) 5,7,9) 5), stable (pH 3,6,9) 5,7,9)
7,9)
........................... Photolysis half- < 10% in 30 days > 30 days > 30 days 6 days NA 8 days
life (soil)
Mobility..................... Soil adsorption: 5 ml/ 0.20 (sand) 4.31 (clay) 0.28-2.3 1.87 (clay)
Kd g, or
......................... 0.73 (loam) 0.65 (sand) 2.16 (sandy
loam)
......................... 0.79 (sandy 1.27 (sandy 0.62-8.13 0.108 (sand)
loam) loam)
......................... 2.45 (clay) 0.48 (loam) 0.77 (loam)
........................... Soil adsorption 500 38 - 152 103 - 152 40 - 84 190 (est)\1\ 22 - 110
Koc ml/g, or
[[Page 33279]]
........................... Depth of 75 cm NA\2\ NA\2\ 45 cm 122 cm 122
leaching in cm
field
dissipation
study
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ est = estimate.
\2\ NA = Not Available (either not reported by the registrant or not required - waived - by EPA).
(ii) Degradates. In the case of all five of these pesticides, the
leaching potential of metabolites and/or degradates are an additional
concern. For example, since the 1980s investigators have reported
detections of triazine degradates as well as the parent compounds in
both ground and surface water. Alachlor and metolachlor also have
various degradation products which may be mobile and persistent enough
to leach.
b. Occurrence of ground water contamination. Registrants, States,
the United States Geological Survey (USGS), and EPA's National
Pesticide Survey are all sources of ground-water monitoring data (Refs.
10 and 14). In reviewing monitoring data, EPA's Office of Pesticide
Programs (OPP) records occurrence in ground water as the number of
discrete locations where a pesticide ingredient was detected at least
once. Multiple detections at the same well over an interval of time
from repeat sampling are not counted as separate detections in the main
data collections cited below. EPA recognizes that this procedure could
function to put wells with only a single detection from repeated
sampling on an equal footing with wells in which occurrence is
regularly found. Specified detection limits are a measure of the
sensitivity of the analyses. Such sites are typically water-supply
wells or, to a lesser extent, ground-water monitoring wells. OPP uses
the term ``wells'' to refer to occurrence sites.
EPA's sources of ground-water data include: (1) The Pesticides in
Ground Water Data Base (PGWDB), a data base containing the information
described above, and periodically up-dated by OPP (Ref. 15); (2) EPA's
National Pesticide Survey (NPS; Refs. 10 and 14), a statistically
designed one-time survey of existing wells, including both community
wells and rural domestic wells nationwide, (data not included in the
PGWDB); (3) Monsanto's National Alachlor Well Water Survey (NAWWS)
(Ref. 3)-this survey was limited to alachlor use areas, and sampling
was limited to private rural domestic wells; (4) Ciba-Geigy (now Ciba
Plant Protection) performed a Large-Scale Retrospective Ground-Water
Study for Metolachlor in Four Areas of the U.S. (Ref. 2) with high
metolachlor use and/or high vulnerability to contamination of ground
water by pesticides; and (5) a number of State-initiated ground water
monitoring programs. All of these information sources are described in
greater detail in the ``Water Resources Impact Analysis for the
Triazine Herbicides'' (Ref. 20). Tables 4 through 8 of this Unit
summarize information developed from those sources.
(i) Atrazine and triazine metabolites-- (a) Atrazine parent. The
evidence of atrazine occurrence is summarized in Table 4 of this
preamble. Atrazine was the third most often detected of all currently
registered pesticides in OPP's Pesticides in Ground Water Data Base,
after aldicarb (and its metabolites) and carbofuran (and also after two
banned pesticides, EDB and DBCP).
Atrazine was found in the National Pesticide Survey, as shown in
Table 4, and in the Monsanto NAWWS Survey. In particular, in the
latter, atrazine was the most frequently found pesticide, estimated to
be present in 12 percent of wells in the alachlor use area. The study
estimated that concentrations will exceed the MCL of 3 g/l in
0.1 percent of the wells in the alachlor use area.
(b) Chloro-triazine degradates and other triazine occurrence. There
are fewer data on degradates in ground water than for the parent
triazines; cyanazine and simazine degradates in particular are rarely
looked for. The Pesticides in Ground Water Data Base contains
detections of two chloro degradates of atrazine at concentrations of
0.05 to 2.86 g/l. The NPS analyzed for only one degradation
product of atrazine (desethyl atrazine) and the detection limit for
that product was relatively high (2.2 g/l); the NAWWS did not
analyze samples for degradation products of atrazine or the other
triazines at all. Two of the three major chloro-triazine degradates of
atrazine were analytes in Iowa's SWRL study, the results of which are
shown in Table 4. The Wisconsin Rural Well Study provided significant
information on the occurrence of atrazine degradates. Almost 92 percent
of wells that were resampled in phase 2 of the study contained a
combination of parent and degradate residues. Overall, degradates found
in the Wisconsin Rural Well Survey accounted for 67 percent of total
triazine residues.
Results of a recent USGS study of herbicides and nitrates in near-
surface aquifers in the mid-continent United States (Kolpin, et. al.,
1994) reported that desethyl atrazine was the most frequently reported
compound (18.1 percent of wells), followed by atrazine (17.4 percent),
and desisopropyl atrazine (5.7 percent). The detection of total
residues was 25 percent more than the detection of atrazine alone. This
study differs from the NPS and NAWWS studies in that it sampled ambient
ground water, not just ground water used as a source of drinking water.
Finally, the advent of new analytic techniques such as the rapid,
highly sensitive and relatively cheap detection methods based on
enzyme-linked immunosorbant assay (ELISA), has allowed monitoring
studies of ``total triazine'' levels. While typically employed as a
``screen,'' with detections subsequently analyzed by conventional
methods to identify and quantitate specific compounds, the PGWDB
contains reports of one State's findings of undifferentiated ``total
triazine'' occurrence. In 1990, Ohio reported monitoring at 863 sites,
with 48 detections at concentrations ranging from 0.1 to 5 g/l
(Baker, et. al., ``Nitrate and Pesticides in Private Wells of Ohio: A
State Atlas,'' Heidelberg College, (Ongoing)).
(ii) Simazine. The evidence of simazine occurrence in ground water
is summarized in Table 5 of this preamble. Simazine was the eighth most
often detected pesticide in OPP's Pesticides in Ground Water Data Base
and the sixth most frequently detected of the currently registered
analytes. In Kolpin, et. al. (1994) simazine residues were detected in
1.0 percent of the wells sampled in the mid-continental U.S.
(iii) Cyanazine. Less monitoring data exist for cyanazine in ground
water than for atrazine and simazine. Table 6
[[Page 33280]]
summarizes data on monitoring results for cyanazine. Cyanazine was the
15th most often detected pesticide in OPP's Pesticides in Ground Water
Data Base, with detections in 15 out of 27 States in which samples were
collected. Additionally, cyanazine has been reported to be found at
concentrations greater than 0.1 g/l (or 10 percent of its reference
point of 1 g/l) in more than 80 additional wells in 12 States.
No detections were reported in the NPS; however, the minimum
detection limit in that study was 2.4 g/l whereas the likely
MCL for cyanazine is 1 g/l. NAWWS estimates that detectable
levels of cyanazine are expected to occur in 0.3 percent of rural
domestic wells in counties where alachlor is used. As is the case for
simazine, this may not be a good national estimate of cyanazine
occurrence because the use areas of cyanazine and alachlor may not
closely coincide. The detection limit for cyanazine in this study was
0.1 g/l; whereas the detection limit for the other 4 analytes
was 0.03 g/l. This higher detection limit undoubtedly reduced
the number of observed positives. No estimate was given for cyanazine
concentrations that exceed 1 g/l. NAWWS did not analyze water
samples for degradation products of cyanazine. Cyanazine was not an
analyte in the Ciba-Geigy Large-Scale Retrospective Ground-Water Study.
As regards State surveys, cyanazine was the 5th most frequently
detected pesticide in Iowa's SWRL study (of the 27 pesticide analytes).
Cyanazine was not an analyte in the Wisconsin study and no confirmed
detections of cyanazine are reported in the California database.
Cyanazine was detected in 0.7 percent of the wells sampled in the USGS
study by Kolpin et. al. (1994).
(iv) Alachlor (and metabolites). Table 7 of this preamble
summarizes the information available to the Agency regarding alachlor
occurrence in ground water. Alachlor is the seventh most often found
pesticide in the Pesticides in Ground Water Database, with only
aldicarb (and its metabolites), carbofuran, atrazine and oxamyl among
the currently registered pesticides detected more often. In addition,
alachlor has been reported to be found at concentrations greater than
0.2 g/l (or 10 percent of its reference point) in more than
350 wells in 21 States.
The NPS estimated that 3,140 (or <0.1 percent) rural domestic wells
contained alachlor at levels above the Reference Point of 2 g/
l. There were no detections of alachlor in community water system
wells. The NAWWS estimated that alachlor occurs in approximately 1
percent of rural wells throughout its use area. Less than half of these
detections are at levels exceeding 0.2 g/l (or 10 percent of
the MCL). Alachlor is estimated to occur at levels exceeding its 2
g/l MCL in 0.02 percent (or approximately 1200 wells) of the 6
million rural wells in the alachlor use area. There were no degradation
products analyzed in either the NPS or the NAWWS. Alachlor residues
were detected in 1.7 percent of the wells sampled by USGS (c.f.,
Kolpin, 1994). The State survey results are summarized in Table 7. In
addition, several investigators (including USGS) have reported finding
a major metabolite of alachlor, t-sulfonic acid in ground-water samples
(c.f., Ref. 3).
(v) Metolachlor. Metolachlor was the 12th most often found
pesticide in the OPP Pesticides in Ground Water Database (see Table 8).
Metolachlor was also reportedly found at concentrations exceeding 7
g/l (or 10 percent of its reference point) in 19 wells across
6 States. NAWWS estimates that metolachlor has a detection frequency
near 1 percent in the surveyed ``alachlor use area.'' Less than half of
the metolachlor detections are at levels exceeding 0.2 g/L.
The average detection limit was 0.03 g/L.
Results from the Ciba large-scale retrospective study of
metolachlor indicate that metolachlor was detected in 89 of 920 samples
(or 10 percent), and 39 of 240 wells (or 16 percent). The screening
level was 0.1 g/l. Detections ranged from 0.1 to 88
g/l with half of these detections at concentrations of 0.1 to
0.5 g/l. None of the detections in this study exceeded the
Health Advisory (HA) of 70 g/l. USGS (Kolpin, 1994) reported
that 2.7 percent of the wells sampled in the mid-continental United
States contained metolachlor residues. The following five tables
(Tables 4 through 8) summarize the data on occurrence for each of the
five pesticides.
Table 4.--Atrazine Occurrence in Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Source
-----------------------------------------------------------------------------------------------------------------------
Atrazine (Rf. Pt. = 3 g/ State Surveys
l) PGWDB NPS NAWWS -----------------------------------------------------------
IA: SWRL WI: RWS CA: WID
--------------------------------------------------------------------------------------------------------------------------------------------------------
# of Wells Sampled............. 26,909 (in 40 1,349 (566 PWS, 1,430 (in 89 686 2,200/236 6286 (in 53
Frequency & Distribution of 1,512 (in 32 NA 166 NA 603/200 (143- 111 (in 21
Detections (# of wells). states)\2\ 208)\1\,\2\ counties)
Frequency & Distribution of 172 (in 22 states) NA 2 NA NA/15 (56)\1\,\2\ 0
Wells > Rf. Pt..
Range of Detected Concentrations trace-1500 trace - 7.0 0.1 - 0.13 - 6.61 0.10 - 16.0 0.1 - 0.19
(in g/l). 6.72
Estimated Occurrence Rate NA Among CSWs: 1.7% 12% 4.4%(2.8-5.9) NA NA
(Statistical Surveys only; (0.5-2.9%); 3.5% \3\..........
Confidence interval ranges in Private wells: 3.5%\4\...........
parens). 0.7% (0.1-2.0%)
Estimated Number of Wells with NA Among CSWs: 1570 720,000 NA NA NA
measurable residues (420-2710);
(Statistical Surveys only; Private wells:
Confidence interval ranges in 70,800 (13,300-
parens). 214,000)
[[Page 33281]]
Estimated Occurrence Rates & # NA < 0.1% Private 0.1%; 8,400 NA NA 0
of wells with concentrations > wells < 9,450 private wells
Rf. Pt. (Statistical Surveys Private wells
only).
Detection Limit (g/l).. Various 0.12 0.025 0.13 0.1 Various
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Results of both Phase I and II Studies shown; Phase I (immunoassay) results shown first, separatefrom Phase II with a slash (/).
\2\ There are additional chloro-metabolite detections reported in PGWDB, but the majority of samples and detections occur within the IA:SWRL study. Des-
ethyl atrazine reported in 27 sites in Indiana and Iowa; des-isopropyl atrazine reported in 24 sites in Indiana and Iowa.
\3\ Desethyl atrazine (a chloro-metabolite).
\4\ Desisopropyl atrazine (a chlorinated metabolite).
Table 5.--Simazine Occurrence in Ground Water
----------------------------------------------------------------------------------------------------------------
DATA SOURCE
-------------------------------------------------------------------------------
Simazine(Rf. Pt. = 4 g/ State Surveys
l) PGWDB NPS NAWWS -------------------
CA: WID
----------------------------------------------------------------------------------------------------------------
# of Wells Sampled.............. 22,374 (30 states) * * 6,752 (55
Frequency & Distribution of 486 in 19 states NA 23 308 (9 counties)
Detections ( of wells).
Frequency & Distribution of 36 in 12 states NA 1 0
wells > Rf. Pt..
Range of Detected Concentrations trace - 67 trace - 1 < 0.15 - 8.36 0.1-2.4
(g/l).
Estimated Occurrence Rate NA For CSWs: 1.1% Private wells:
(Statistical Surveys only). (0.4-2.7%) 1.6%
private wells:
0.2% (< 0.1 -
1.3%)
Estimated Number of Wells with NA For PWSs: 1,080 96,000 private
measurable residues (350 - 2540) wells
(Statistical Surveys only). private wells:
25,100 (590 -
141,000)
Estimated Occurrence Rates & # NA < 0.1 % NA
of Wells with concentrations < 9,450 private
Rf. Pt. wells.
(Statistical Surveys only).
Detection Limit (g/l).. Various 0.38 0.025 Various
----------------------------------------------------------------------------------------------------------------
[[Page 33282]]
Table 6.--Cyanazine Occurrence in Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
DATA SOURCE
--------------------------------------------------------------------------------------------------------------------
Cyanazine (Rf. Pt. = 1 g/ State Surveys
l) PGWDB NPS NAWWS ---------------------------------------------
IA: SWRL CA: WID
--------------------------------------------------------------------------------------------------------------------------------------------------------
# of Wells Sampled................. 7,468 (in 27 states) * * 686 871 (in 24 counties)
#Frequency & Distribution of 155 in 15 states NA NA NA 0
Detections ( of Wells).
Frequency & Distribution of Wells 22 in 9 states NA 0 0 0
Rf. Pt..
Range of Detected Concentrations trace -29.0 0 < 0.45 0.14 - 0.84 0
(g/l).
Estimated Occurrence Rate NA < 0.1% 0.3% (private wells) 1.2% (private wells) NA
(Statistical Surveys only).
Estimated Number of Wells with NA < 9,450 private wells 18,000 private wells NA NA
measurable residues (Statistical
Surveys only).
Estimated Occurrence Rates & # of NA < 0.1% 0 NA NA
Wells with concentrations > Rf.
Pt. (Statistical Surveys only).
Detection Limit (g/l)..... Various 2.4 0.1 0.12 Various
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 7.--Alachlor Occurrence in Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
DATA SOURCE
--------------------------------------------------------------------------------------------------------------------
Alachlor (Rf. Pt. = 2 g/l) State Surveys
PGWDB NPS NAWWS ---------------------------------------------
IA: SWRL CA: WID
--------------------------------------------------------------------------------------------------------------------------------------------------------
# of Wells Sampled................. 26,856 (in 35 states) * * 686 2,009 (34 counties)
Frequency & Distribution of 543 (in 25 states) * 28 NA 1
Detections ( of Wells).
Frequency & Distribution of Wells > 101 (in 16 states) * NA 1
Rf. Pt..
Range of Detection Concentrations trace - 3,000 4.2 < 0.15 - 6.19 0.02 - 4.76 9.0
(g/l).
Estimated Occurrence Rate NA < 0.1% (< 0.1 - 1.0%) - 0.8% - private wells 1.2% (0.4 - 2.0%) NA
(Statistical Surveys only). private wells
Estimated Number of Wells with NA 3,140 (1 - 101,000) 48,000 private wells NA
measurable residues (Statistical private wells
Surveys only).
Estimated Occurrence Rates & # of NA < 0.1% (<0.1 - 1.0%); 0.02%; 1200 private Various
Wells with concentrations Rf. Pt. (Statistical Surveys private wells
only).
Detection Limit (g/l)..... Various 0.50 0.025 0.02
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 33283]]
Table 8.--Metolachlor Occurrence in Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
DATA SOURCE
--------------------------------------------------------------------------------------------------------------------
Metolachlor (Rf. Pt. = 70 g/l) PGWDB NPS NAWWS ---------------------------------------------
IA: SWRL CA: WID
--------------------------------------------------------------------------------------------------------------------------------------------------------
# of Wells Sampled................. 22,255 (in 29 states) * 240 (in 4 states) 686 107 (10 counties)
Frequency & Distribution of 213 (in 20 states) * 39 (in 4 states) NA 0
Detections (# of Wells).
Frequency & Distribution of Wells > 3 (in 3 states) 0 0 NA 0
Rf. Pt..
Range of Detection Concentrations 0 - 157 0.20 - 3.81 0.1 - 88.0 0.04 -9.00 0
(g/l).
Estimated Occurrence Rate NA 1.0% (private wells) 16% (private wells) 1.5% (0.6- 2.4%)- NA
(Statistical Surveys only). private wells
Estimated Number of Wells with NA 60,000 private wells NA NA NA
measurable residues (Statistical
Surveys only).
Detection Limit (g/l)..... Various 0.025 0.1 0.04 Various
--------------------------------------------------------------------------------------------------------------------------------------------------------
Legend (for Tables 4-8) Data in Tables include data on
identifiable metabolites, shown in italics. Specific degradate
compounds identified by footnote. Numbers in parentheses in rows
displaying estimates for statistical surveys are 95% confidence
intervals for a given estimate. Studies, surveys, and reports
containing the information summarized in Table, denoted by
abbreviations as explained below:
PGWDB = Pesticides in Ground Water Data Base (as summarized in
Ref. 15), which also includes the data reported in the ``state
surveys'' in this Table - thus, ``detections'' as reported in each
column are not additive (although the PGWDB does not include the
detections from the NPS, NAWWS or Ciba statistical studies).
NPS = National Pesticide Survey, Phase I Report (Ref. 10); also
Phase II Report (Ref. 14). Data may be displayed reporting separate
results for community-supply wells (CSWs), serving public community
water systems and rural, private wells. The two categories were
selected for sampling according to different stratification schemes.
NAWWS = National Alachlor Well Water Survey (as summarized in
Refs. 3 and 4); note that estimates of occurrence rates listed in
the Table under the ``NAWWS'' column apply only to rural private
water wells in the ``alachlor use area'' as defined in the NAWWS
design; ascribing Study's occurrence rates nationally would
overstate prospective occurrence. However, the projected number of
wells and/or population exposed take that limitation into account.
Ciba = Large-scale Retrospective G.W. Monitoring Study (for
metolachlor only; Ref. 2).
IA: SWRL= Iowa State-Wide Rural Water Survey (1990); note that
specified occurrence rates in the Table apply to estimated
occurrence in the State of Iowa only.
WI: RWS = Wisconsin Rural Well Survey (1990).
CA: WID = California Well Inventory Database (annual reports;
data contained in Ref. 15).
NA = Not applicable or unavailable.
Trace = Detection below a specified detection limit.
* = See Table 4.
c. Conclusions--Ground water contamination potential. The five
pesticides selected in today's proposed rule exhibit persistence and
mobility characteristics that suggest the capacity to reach ground
water on a widespread basis. This potential is confirmed by the record
of occurrence produced from ground-water monitoring efforts. Each of
the five has been detected hundreds of times in many States, indicating
the breadth and magnitude of ground-water contamination potential.
Moreover, each has been detected at concentrations exceeding its
respective reference point in multiple locations, in different States,
and across a variety of hydrologic and geologic conditions. This, and
the fact that many more detected concentrations of each are within one
order of magnitude (i.e., 10 percent or more) of each reference point,
confirms that each pesticide exhibits the capacity to reach ground
water at concentrations exceeding health-based standards. To EPA's
knowledge, point sources do not explain the range and number of these
occurrences. All five can be reasonably expected to contaminate ground
water at or above their respective reference points. EPA has reached
the tentative conclusion from this data that continued use of these
pesticides without further controls and protective measures constitutes
a clear risk of continued ground-water contamination.
4. Risk conclusions. In summary, EPA concludes that exposure from
these pesticides may present the potential for adverse human health and
environmental effects associated with exposure from these five
pesticides.
These five, while they may differ among themselves in the frequency
and severity of prior detections in ground water, entail a significant
number of detections in multiple States. Among currently registered
pesticides, only these five and aldicarb, which is being addressed by
other regulatory means, have been detected above their respective
reference points in three States or more. Second, these five share a
substantial overlap in use sites and crops, such that each pesticide
could represent a significant alternative to the use of one or more of
the others. This latter circumstance plays a significant role in EPA's
decision to subject all five to SMPs. Leaving one or more of these free
from State management measures might constitute an incentive for users
to substitute that pesticide for one of those subject to SMPs. EPA's
analysis of the contamination potential of these pesticides suggests
that such a course might only increase the occurrence of the excluded
pesticide(s) to a frequency and severity that would rival that observed
for atrazine and alachlor. The practical effect of such an exclusion
might be to worsen the overall quality of the ground-water resource.
EPA has also considered the potential impact associated with the
increased use of substitute pesticides that may result from reduced use
of the five under consideration here. This issue includes two separate
considerations. The first is the possibility that increased ground-
water contamination will result from increased use of substitute
[[Page 33284]]
pesticides not subject to SMPs. EPA acknowledges that there is a
likelihood that other pesticides will be used in substitution for these
five in cases where State measures constrain triazine and acetanilide
use. EPA has analyzed the likelihood for such substitutions in its
Regulatory Impact Analysis (see Unit VIII. of this preamble); in this
analysis the Agency has identified the likely substitute pesticides for
a substantial variety of crops and other uses. Only a few of the
prospective substitutes exhibit similar persistence and mobility
characteristics; upon closer examination, moreover, it is unlikely that
any of the prospective substitutes exhibit as severe a potential for
ground-water contamination as these five candidates. None of the
prospective substitutes have been detected in ground water to the
extent and frequency as these five. Given the substantial evidence
summarized in here that these five are the largest ground-water
contamination risks of any pesticides in current use, EPA concludes
that it is has no reason to anticipate that increased use of
substitutes will result in a greater risk to ground water for the
foreseeable future.
The other consideration is that the increased use of substitutes
might indirectly increase net risks, because of greater risks through
other routes of exposure, such as dietary and worker exposures. This is
a considerably more complex question. EPA believes that these risks
will not measurably rise because of the use of anticipated substitutes.
EPA reaches this conclusion, considering: (1) There will be
comparatively little substitution of use of these pesticides with
potentially more dangerous alternatives (at least compared to an
outright cancellation), since EPA's analysis of impacts concludes that
State measures will permit substantial continuing use of the five
pesticides in question; and (2) none of the anticipated substitutes
pose particularly elevated risks for these other exposure routes at
reasonably expected increased levels of use. EPA has confidence that
none of the substitutes are particularly more toxic, overall and in
relation to particular endpoints, than the five pesticides in question.
For example, none of the prospective substitutes are in Special Review,
for health concerns as the triazines are.
a. Metabolites. At this time EPA does not intend to require that
State Plans provide for monitoring degradates of these five pesticides.
However, EPA would like comments on: (1) Whether it should require
State submissions to address selected metabolites of toxicological
concern; (2) what specific metabolites should be addressed by SMPs; and
(3) what specific SMP provisions should apply to the metabolites.
The Agency notes that relatively inexpensive screening methods are
available for all five of the parent compounds, and for many of their
metabolites. Thus, a State may choose to include degradates in their
monitoring plan, as some already do. Moreover, if additional
information about some or all of these degradates raises concerns in
the future, EPA may revisit this issue. The availability of practical
analytical methods would be an important consideration in asking States
to include degradates in their monitoring plan.
C. Costs and Benefits
The following section completes EPA's proposed determination that
the five pesticides may present an unreasonable risk to the environment
without additional management measures to reduce the chances of their
contamination of ground-water resources, by evaluating the risks
represented by that contamination potential in light of the social and
economic costs that SMPs represent. Costs and benefits under
consideration are conceived on the broadest, most inclusive fashion
(i.e., beyond the direct costs of the SMPs envisioned by this proposed
rule and the benefits of averting human health risks represented by
ground-water contamination). The remainder of this section summarizes
the data, analysis and conclusions contained in the Agency's draft
Regulatory Impact Analysis (RIA) prepared for this rule pursuant to
Executive Order 12866 (see Unit VIII. of this preamble). Those
interested in a more detailed analysis of costs and benefits should
refer to that document.
The assessment of risks and benefits associated with the decision
to make these five pesticides subject to SMPs as a regulatory
requirement takes into account the Agency's policy objective of
prevention, i.e., to act in order to avert reasonably expected adverse
effects to human health or the environment before they may occur. EPA
must exercise its judgement on the basis of an analysis of the
respective costs and benefits of regulatory action in a manner that
takes into account the considerable uncertainty surrounding both. This
entails acting on the basis of less tangible evidence of risk and
considerable degree of uncertainty about both existing and future
ground water contamination and its consequences, and taking
considerable allowance of these uncertainties. It also entails weighing
a detailed and quantified analysis of costs against an array of
prospective benefits, many of which are difficult to describe in
quantitative terms. Such a comparison, between what appear to be
tangible costs and more intangible benefits, presents well-recognized
analytic difficulties. Care must be taken not to let the quantified
factors override consideration of important qualitative factors. In
other words, SMPs will be justified based on a reasoned determination
that the benefits (generally conceived and including elements difficult
to quantify) justify the cost impacts associated with SMPs.
In developing the Strategy (Ref. 12) EPA evaluated a range of
available regulatory options in addition to the State Management Plan
approach. Specifically, EPA compared three general approaches in a
companion document to the Strategy, the ``Pesticides and Ground-Water
Strategy: A Survey of Potential Benefits'' (February 1991; Ref. 13).
This analysis is discussed in Unit IV.D., of this preamble.
In the interests of presenting as full and honest a
characterization of risk and benefit as possible, the Agency will also
point out: (1) The relative magnitude of uncertainty regarding the true
value of a quantity or attribute that EPA is estimating in its
analysis; and (2) the reasons for believing that any specific estimate
or characterization may overstate or understate the true value of such
a quantity or attribute.
1. Costs. EPA identifies four general areas where some level of
adverse economic impact (i.e., both direct and indirect costs) could
result from regulatory action in response to ground water concerns.
Federal program costs are the attributable costs of developing and
justifying regulatory action regarding ground-water protection,
including the assembly and evaluation of ground-water risk data, as
well as expenditures relating to implementation of protection measures.
Current expenditures include the cost of ongoing regulatory and risk
assessment activities pertaining to ground-water protection in the
pesticides program and grants to State pesticide programs to help
sustain the cost of ground-water protection activities and, in
particular, the development of ``generic'' SMPs.
EPA program costs are subdivided into headquarters (HQ) program
costs and regional costs. As should be evident from the description in
Unit II. of this preamble, the larger portion of EPA's effort will
reside with the Regions. EPA estimated its regional-program costs by
estimating a per-SMP average level of
[[Page 33285]]
effort and multiplying by the expected number of State Plans that are
currently anticipated for these five pesticides. EPA's analysis is
calculated on the expectation that 236 Plans will be submitted. This
translates into an annualized cost of $1.1 million for regional
activities. EPA estimates its annual HQ program costs will range
approximately from $413,300 to $437,000 (in current dollars) for the
first 3 years after promulgating this rule, with costs decreasing to an
average of $160,600 annually thereafter.
The margin of uncertainty for EPA's estimate is relatively small
(mostly reflecting the relatively small dollar estimate) and relatively
insignificant with regard to its potential impact on EPA's decision. It
is difficult to determine whether EPA's estimate tends to understate or
overstate the likely actual value of Federal costs, in part since a
substantial proportion of the costs are part of ongoing regulatory
activities. However, any error in EPA's estimate (because of these
uncertainties) is probably more likely to understate the estimate
slightly.
State program costs are the estimated State expenditures for
implementing Federal ground-water protection actions. These include the
costs of developing five pesticide-specific SMPs and of implementing
and enforcing elements of approved Plans and represent a substantial
level of expenditure.
Because the scale of State Management Plans is contingent upon
pesticide usage and aquifer sensitivity-- which will vary not only
between States but also within a given State--the costs of developing,
implementing, and enforcing SMPs are particularly difficult to
generalize. In calculating the costs of SMPs, it is reasonable to
assume that costs will vary directly with the scale of a State's plan.
Finally, several additional factors will influence the eventual costs
of a State's plan. These include: the risk mitigation options available
to State planners; the role of coordination between State agencies and
other governmental bodies; the shifting of costs to registrants; and
technological innovations that may lead to decreasing costs over time.
States have reported (in the process of developing ``generic'' SMPs) a
broad range of anticipated costs (from as little as $17,000, to write a
generic plan to over $1 million, counting in full the conduct of
vulnerability assessments, ground-water monitoring and data base
management), corroborating the assumption of variable State costs.
EPA made some critical simplifying assumptions in developing its
cost estimates: (1) That ``States'' (including territories and some
Indian tribal authorities) would develop and submit State Plans for all
or most of the five pesticides in question before the effective date of
the rule; (2) that the Plans would represent an adequate level of
protection, i.e., would be approved by EPA; (3) that some States would
be obliged to develop SMPs that entailed extensive protection programs
for one or more of the five pesticides, that others would have to
develop Plans with some additional protection and that still others
would have to do little more than minor amendments to their ``generic''
SMPs to provide for future use of any of the five chemicals (based on
an analysis of the current use patterns of the five pesticides); (4)
that virtually all States would submit Plans that would consolidate the
activities related to any and all pesticides as much as possible, so
that substantial costs in ground-water vulnerability assessment and
monitoring, for example, would be shared and not duplicated among
individual-pesticide proposals - a reasonable assumption in this case,
considering in particular the common use areas among these five
candidates and their concentration in areas of high-intensity field-
crop agriculture that would otherwise be of high State concern in any
case; and (5) that the mix of ``extensive'' and less-extensive State
Plans would entail a level of effort that could be estimated on the
basis of a ``model'' SMP activity, that could in turn be extrapolated
from analysis of existing State programs, ``generic'' SMP submissions
and the requirements of pesticide-specific SMPs embodied here in
today's proposed rule and in the Agency's Guidance. The Agency regards
this last assumption as particularly conservative, since the Agency
expects that a significant number of actual Plans will turn out to be
of the less-extensive variety. Pricing every Plan on the basis of a
``model'' Plan will significantly overstate the true costs, since the
Agency constructed the ``model'' to represent a relatively extensive
level of effort.
EPA developed its aggregate State-cost estimate by means of using
an existing State plan (Wisconsin's) as a model or surrogate for
individual State plans. Wisconsin's program was chosen as
representative for several reasons; its ability and readiness to share
its data on program development and costs; and its exemplary nature (in
terms of level and extent of commitment and exercise of risk-management
measures). Furthermore, Wisconsin falls into the range of moderate
vulnerability as measured by several macro-level ground-water
vulnerability indices. However, this latter circumstance is in itself
not the consummate proof of Wisconsin's representativeness (or even
adequate characterization of Wisconsin's relative ground-water
sensitivity), since State situations in terms of vulnerability are so
diverse as to preclude the classification of any State as ``average.''
Finally, EPA did not view the Wisconsin program as the maximum effort a
State might have to exert: not only has the program dealt primarily
with a few, particular pesticides, but it terms of general ground-water
contamination risk, Wisconsin may not represent the greatest degree of
vulnerability.
EPA, in its analysis, took into account both the one-time costs of
a Wisconsin-type program (annualized over either a 5- or 10-year
period) and estimated annual incremental costs to arrive at a range of
estimated annual State expenditures. One reason for using Wisconsin's
experience as a model is the fact that it has performed some of the
initial activities necessary to implement an SMP, enabling the Agency
to model such activities as the establishment of pesticide usage
surveys, vulnerability assessment, soil susceptibility mapping, other
data base creation, monitoring (establishing and sampling sites),
maintenance of records, personnel, public awareness and education, and
other miscellaneous costs of plan development.
EPA estimates State programs on the average may annually cost in
the range of $250,000 to $750,000 during the first several years of
implementation, with $500,000 as the average annual cost. Successive
SMPs required by the Agency will undoubtedly require less new effort by
the States, so that incremental costs would be expected to decline over
the long run. EPA took this expectation into account in its estimate of
State program costs, projecting that each State, in developing multiple
SMPs for these five pesticides, would incur some economies by
developing Plans with common elements. Therefore, national costs were
calculated by positing one per-SMP cost estimate ($500,000) for a
single Plan, and fractional estimates for accompanying Plans.
Calculated on this basis, if States and territories were to implement a
total of 236 SMPs (EPA's current estimate of States' intentions), their
total annual cost of implementing this regulation would be $ 59.9
million.
The Agency wishes to emphasize that the use of a ``model'' level of
effort, based largely on one State's experience, is for purposes of
estimating the costs
[[Page 33286]]
and benefits of this proposed rule. The analysis is not meant to
represent pre-conceptions about the contents of State submissions.
State Plans could depart substantially from the details presented in
the ``model.'' Such differences could be caused by the State's
particular situation (varying in size, ground-water vulnerability, and
pesticide use patterns from the model) or by an innovative approach
that EPA has not anticipated. These Plans would be found adequate to
the extent States could demonstrate to the satisfaction of the
reviewing Region that they assure adequate protection. At the same
time, the Agency believes that it has projected the particulars of the
``model'' Plan in a manner that depicts the kind of effort necessary to
meet the objectives of this proposed rule. To that extent, EPA offers
the State-cost analysis as a reasonable basis for evaluating the cost
and benefit of this rule.
Moreover, the Agency wishes to emphasize that the estimate of $59.9
million is the annual average of aggregate State costs over a 10-year
period. As such, it represents: (1) The amortization of high one-time
costs, such as drilling monitoring wells or performing baseline
vulnerability assessments; and (2) several years of operation of fully-
developed, mature State programs. Under no circumstances should the
figure be construed to be the immediate, first- (or even second-) year
costs the States will incur. As stated in Unit III. of this proposed
rule, EPA anticipates that States can be expected to have to phase in
``capital'' elements of an SMP (e.g., the development of monitoring and
vulnerability assessment activities).
EPA's assumption of broad State participation (that all States will
develop Plans for most of the five pesticides, and that many will
develop Plans for all five) may appear to be particularly tenuous,
since there is no compulsion on the States to develop such Plans,
beyond the loss of the legal use of a pesticide within the State. The
consequences of error in this assumption are two-fold with respect to
estimating costs: (1) EPA's estimate of State costs may overestimate
actual State costs, because the Agency has over-estimated State
participation; but (2) in that event, EPA's estimate of user impacts
might be low. Since the absence of an acceptable SMP would result in
prohibition of a pesticide's use in a State, more user impacts may
result than EPA has estimated. The fact that the effects of error in
this assumption are at least potentially offsetting reduces the
Agency's concern.
EPA has confidence in the validity of assuming maximum State
participation, however. First, the Agency believes the States have
strong incentive to avoid these increased impacts to its own users by
developing Plans. This belief is bolstered by the strong evidence of
the States' interest in assuming the responsibility for managing
pesticide use to protect ground water (for example, the near-universal
acceptance of grants and development of ``generic'' SMPs). At the same
time, EPA has little alternative to such an assumption. EPA does not
have any basis for estimating which or how many States might fail to
implement plans, beyond current informal communications between EPA
regions and the States. Finally, it seems reasonable to assume the
States least likely to participate are those with the least incentive
to do so (i.e., those with little or no current or projected use of the
pesticides), so that their non-participation would have comparatively
little effect on current use (and consequently little user impact).
Among the other sources of EPA's uncertainty of its estimate are
the inherent variation in the size and level of agricultural activity
across States, and the anticipated variation in State approaches,
ground-water protection objectives and the like. EPA does not believe
the margin of uncertainty in its estimate exceeds the magnitude of the
estimates. Among the reasons for believing EPA's estimate
underestimates the true impact of regulatory action are unanticipated
difficulties or obstacles in State implementation of its requirements
(such as unanticipated non-compliance, necessitating substantially more
enforcement activities), as well as those considerations described
above. In addition, EPA has not taken into account potential increased
costs of Federal-State enforcement of sale/use prohibitions for those
States that fail to develop Plans. For the reasons explained above in
describing the assumptions, EPA does not anticipate many States will
not develop approveable Plans for all five pesticides. For those few
cases that may arise it is EPA's expectation that enforcement and
compliance costs will be minimal, since part of the reason for State
disinterest in developing SMPs for these pesticides will be their
insignificant use in the State. Among the reasons for anticipating that
EPA's estimate overstates the true level of State expenditures would be
the deliberate conservatism in pricing aggregate State costs on the
basis of a ``model'' Plan that represents substantial effort, limiting
the estimate of economies-of-scale achieved by developing multiple SMPs
and the possibilities for innovations in ground-water assessment and
monitoring techniques (particularly the latter).
Registrant (or pesticide-industry) impacts are those that would be
the direct result of regulatory action, apart from any anticipated loss
of income from reduced use of the products attributable to regulatory
restriction. Attributable costs would include: (1) The lost revenue
associated with decreased use of the products, caused by State risk-
management measures; (2) the costs of increased technical assistance
(such as ground-water monitoring) and outreach to users that the
registrants might provide, to help them ascertain and follow the new,
applicable State management measures or other safeguards on the
chemicals' continued use; and (3) the direct costs of relabeling and
compliance with the administrative provisions of this proposed rule.
The first category, lost revenue, was calculated as a function of
likely State actions, which in turn are represented as three scenarios
of differing regulatory stringency. Projected annual lost revenues for
a ``medium impact'' scenario was calculated to be $33.6 million. Using
current sales figures from the major registrants of these five
pesticides, this figure represents an estimated 0.06 percent decrease
in total sales, and a 0.48 percent decrease in pesticide-product sales
for these registrants. The estimated costs in the second category are
those that are incremental to ongoing ground-water monitoring,
technical assistance or outreach efforts the registrants now perform
with regards to ground-water protection. They are estimated to be in
the range of $3.1 to 12.7 million annually, conceived as substantial
new ground-water monitoring activities performed in addition to State
efforts. These costs can also be attributed to the possible new ground-
water monitoring requirements that EPA may prescribe on registrants
concurrently with State development of SMPs (see Unit III. of this
preamble). While EPA has not committed to the development of such
requirements at this time, the Agency nevertheless includes a cost
estimate for the activity in the interests of not underestimating
costs. Uncertainties include EPA's actual specification of those
requirements, the level of effort represented by that specification,
the identification of further technical-assistance activities and their
delineation from ongoing regulatory efforts.
By far the most substantial impact (in terms of relative magnitude)
is anticipated to be impacts on agricultural
[[Page 33287]]
and non-agricultural users, and associated indirect impacts of reduced
consumer benefits. These impacts pertain to the changes caused by
regulatory restrictions in use of pesticides and the consequent changes
in agricultural (and other economic) productivity and expenditures. In
addition to being the largest component of cost, its magnitude is the
most uncertain and difficult to estimate. Estimating these impacts
entails an econometric analysis with consideration of a multitude of
cascading secondary effects across geographic regions and economic
sectors and with estimated impacts expressed through a variety of
economic measures. These difficulties are compounded by the necessary
consideration of the combined behavior changes of perhaps a million
affected farmers and other users, the normal uncertainties in the
agricultural sector (the effect of weather, etc.) and the like.
EPA attempted to anticipate as many of these interactions and
uncertainties as possible by using a widely used multi-sector, multi-
regional econometric computer simulation model called AGSIM. The
analysis was performed to take into account not only regional
variations in commodity supply and production (i.e., varying responses
to changes in per-acre yields, variable costs, and prices) but also the
present and projected influences of farm policy elements (e.g., Federal
price-support and conservation programs, Federal monetary policy, etc).
These measures aggregate into separate (and additive) dollar estimates
of the combined impact to the agricultural-production sectors
(expressed as the change in net agricultural production and income) and
the consequent decrease in domestic-consumer benefits (sometimes
referred to as ``surplus value,'' or the amount of additional consumer
expenditures to maintain the same standard of living as reflected in
the ``baseline'' conditions, prior to a regulatory action).
In order to estimate impacts it is necessary to estimate certain
effects of the SMPs and use these as inputs to the econometric model.
Specifically, a critical task was to estimate how State risk-management
measures would influence: (1) The acreage where these five pesticides
are used; (2) yield impacts; and (3) input (i.e., pesticide-chemical)
cost impacts. Thus, SMP impacts on users are estimated by a matrix of
combinations of these three factors (taking the availability of non-SMP
pesticide substitutes into account) and the consequent change in crop
yield and price. The critical measure of impact is the reduced treated
acreage associated with State risk-management measures. These values
must be regarded as a proxy for the variety of potential effects that
SMPs may have on agricultural practices. They are not intended to
represent a forecast of actual State practices, but rather a surrogate
measure of their potential effect on agricultural practices.
These estimates were made by consultation with a variety of
sources. Affected acreage was identified by the use of a Ground-water
Vulnerability Index for Pesticides designed by Robert Kellogg of USDA's
Soil Conservation Service. A percentage of these affected acres was
assumed to be subject to either restricted or prohibited use under
State Management Plans; this percentage varied according to impact
scenario and was based upon the 1992 Wisconsin Atrazine Rule. EPA tried
to account for the considerable uncertainty about the impact of State
management measures by positing a variety of reduced-use scenarios
across the principal use areas of these five pesticides. EPA believes
the most-likely estimate of user impacts rests with its medium-impact
scenario, but has provided companion low- and high-impact scenarios for
comparison. The Regulatory Impact Analysis accompanying this proposal
provides a fuller explanation of EPA's estimates and the methodology
used to derive them. The SMP-use restrictions have the anticipated
effect of lowering expected yields and pesticide input costs.
Restrictions on application rates lower pesticide input costs since
total usage declines; use prohibitions also lower costs since the cost
of alternative pesticides are less than that of the SMP pesticides.
Crop producers are actually expected to be better off in terms of net
crop revenues as a result of such restrictions, due to the combination
of increased prices obtained for affected commodities and reduced input
costs. Increased commodity prices are predicted due to reduced acreage
planted, which in turn, decreases the total supply of a particular
commodity. However, increased prices resulting from reduced supply are
a net negative impact to the economy overall, in the form of reduced
consumer surplus value.
At the same time, increased feed crop (corn, soybean, sorghum)
prices raise input costs for livestock producers. Coupled with stagnant
or declining demand for livestock products, increased input costs
negatively impact livestock returns in this analysis by reducing
livestock revenues. Because the reduction in livestock returns is
estimated to be greater than the increase in crop returns, net impacts
to the U.S. agricultural sector are negative, but relatively minor (-$1
million to -$11 million, across the three scenarios).
Correspondingly, indirect impacts, in the form of reduced consumer
benefits, are estimated to be in the range of $242 to $254 million.
While the absolute magnitude of such impacts appear to be
substantial, in relative terms such impacts are moderate. Relative to
the economic value of U.S. field corn production ($16 to $23 billion),
such impacts are small. For example, the SMP-use restrictions are
anticipated to lower U.S. field corn production by about 1 percent,
leading to a potential 1.1 percent increase in market prices. Such
impacts would have a de minimis effect on the Gross Domestic Product.
Average annual consumer expenditures and food prices would change less
than $1.00 per person (from $0.94 to $0.98) as a result of these
impacts. Individual farmer income in the aggregate would also change
little, but regional effects of greater magnitudes (both positive and
negative) could occur.
This range of projected impacts compares to impacts of $ 3.6
billion or more in combined user costs and reduced consumer benefits,
associated with either outright cancellation of the five pesticides
(plus aldicarb, which had minimal costs associated with its management)
or more stringent, nationwide use restrictions, as estimated by Taylor,
et al. in 1991, using a similar econometric approach.
EPA's method for estimating user impacts, like its projection of
State-program costs, relies on some key simplifying assumptions: (1) A
degree of regulatory restriction will translate into a discrete (and
predictable) level of decreased (or alternative) pesticide use,
resulting in predictable adverse effects to agricultural production and
the other relevant economic effects summarized above; and (2) the
scenarios vary (predictably) in the degree of regulatory restriction
they represent, and this difference can be expressed in terms of the
cropped acreage subject to reduced, substituted or eliminated pesticide
use. Among the reasons for anticipating that EPA's estimate understates
the true potential impact of ground-water protection measures are: (1)
That the analysis pertains only to uses on field crops (which, however,
represent over 90 percent of the combined current use of these five),
overlooking the potential impact on fruit and vegetable crops; and (2)
that EPA assumes all States will participate, so that no greater
restrictions on use will ensue from the fact that State inaction causes
a
[[Page 33288]]
complete curb on use. However, EPA has equal or greater reason to
believe its estimate overstates the actual potential impact; chief
among these is faith in the States' ability to develop a variety of
innovative management measures that will minimize the disruption in
crop production caused by ground-water safeguards. State
resourcefulness in developing new approaches will undoubtedly outrun
the Agency's present expectations. It is already clear, for instance,
that States will emphasize measures that will enhance the
sustainability of agricultural production simultaneously with ground-
water protection, preserving much of the necessary use of the
pesticides in question. Also, inevitable improvements in ground-water
monitoring and vulnerability-assessment techniques will enable states
to ``fine-tune'' necessary restrictions to a degree EPA cannot yet
anticipate in its estimate. In addition, in developing its estimates of
crop yield losses, EPA did not take into account the considerable
promise that is subsequently emerging in the areas of integrated pest
management and other reduced-use strategies.
In summary, it needs to be stated that in distinguishing the
various costs that may be attributable to Federal regulatory action for
purposes of weighing the costs and benefits of any action, EPA did not
attempt to assess the reasonable likelihood that a particular category
of parties would actually incur the costs. For example, the boundaries
between ``State'' and ``registrant'' costs may be considerably more
blurred than our analysis would suggest. A variety of activities
attributed to the States in managing the use of a pesticide subject to
an SMP rule (including those involving substantial levels of effort,
such as ground-water monitoring or user education and outreach), for
example, could in practice be either performed (in part or in whole) or
paid for (either directly or through State imposition of fees) by the
registrants. Likewise, some of the activities identified by EPA as
``registrant costs,'' e.g., the provision of increased user training
and technical assistance, could be expected to be performed often at
the behest of State agencies pursuant to their Plans. Accrual of
expenditures accurately to the various parties was of less importance
to EPA in making this analysis than was concern for the projection of
overall level of effort and expenditure attributable to this rule.
2. Benefits. Chapter 7 of the RIA contains the Agency's appraisal
of the potential benefits associated with establishing SMPs for these
five pesticides. This appraisal begins by cataloging the different
kinds of values associated with protecting ground water as a natural
resource. These values are categorized in terms of their various
services as a resource. This categorization follows a recent Agency
conceptual framework for assessing the economic value of ground-water
protection in evaluating regulatory impacts (Ref. 19). Each of these
service values, (associated with two general functions of ground water:
both as a source of water stock and as a discharge to surface water
supplies) may be subject to a variety of economic valuation techniques.
Since these categories generally involve the value of the resource in
terms of its economic use, other categories of value recognized by
natural-resources economists must also be acknowledged: the so-called
altruistic, bequest, and existence values (sometimes referred
collectively as ``non-use value'') associated with protecting a natural
resource per se.
In general, however, the benefits of SMPs will accrue from the
reduced levels of ground-water contamination, by substances associated
with adverse human and/or environmental effects, that result from the
regulatory safeguards required by the individual Plans. It is the
presence of this contamination that jeopardizes any and all of the use
and non-use values under consideration.
In order to perform a reasonable quantitative analysis of benefits,
accurate and reliable estimation of exposure levels (both existing and
projected, and in the case of the latter, projected for a number of
different regulatory options) are critical. Unfortunately, reliable
estimation of ground-water contamination occurrence is among the most
difficult and uncertain issues with regards to ground-water concerns.
Past and current efforts at ground-water monitoring have not been of a
sufficient level and frequency to give adequate assurance that the
Agency knows the levels of occurrence of pesticide contamination of
ground water, either of the specific pesticides addressed in this
proposed rule or of pesticides in general.
The United States Department of Interior, in comments submitted to
EPA regarding the proposed Ground Water Restricted Use Rule (in 56 FR
22076, referred to in Unit I. of this preamble), characterized the
state of knowledge associated with the nation's ground-water monitoring
efforts as follows: ``Given shortcomings in national ground-water
monitoring efforts, it is highly unlikely that all locations of all
contaminants in ground water have been determined.'' [July 5, 1991
letter from Jonathan P. Deason, Director, Office of Environmental
Affairs; exhibit 7 in OPP comment file no. 36172]. While not
necessarily reflecting the views of EPA, these comments are testimony
to the limitations associated with the evidence of contamination from
current ground-water monitoring results, particularly the substantial
likelihood of under-estimating the present and future level of
exposure. Other methods of estimating prospective occurrence, such as
projections from data on the leaching potential, volume and location of
use of a pesticide or projections using environmental-fate-and-
transport models, have even greater limitations (see, for example,
National Resource Council, ``Ground Water Vulnerability Assessment,''
NAS Press, 1993, for a fuller description of the strengths and
weaknesses of various ground-water analytic techniques).
The consequences of this potential under-measurement of present
ground-water contamination has another dimension. Since known ground-
water contamination is particularly localized, it is characterized by
the incidence of limited ``hot spots'' of high concentrations.
Occurrence of ground-water contamination is unevenly distributed, due
to the variety of hydrologic and topographic factors. Locations of high
concentrations of pesticides (and a corresponding high risk of
potential adverse effects) in ground water are dispersed unevenly
across the country. The overall profile of the risks associated with
pesticides in ground water, then is one of large numbers of people at
relatively low risk, punctuated with ``hot spots'' of higher risk. The
risk concentrated in these ``hot spots'' are likely to exceed national
average risks, but are difficult to characterize using aggregate
occurrence estimates. This unevenness in the distribution of risk
levels raises concerns regarding ``environmental equity,'' to the
extent that effects are disproportionately high and adverse, which the
Agency is committed to take into account as a matter of policy.
Finally, it should be noted that taking the next step of
quantifying human health risk by combining population exposure figures
with some benchmark of toxicity associated with a unit quantity of
exposure, is hampered by limited methodologies for quantifying hazard.
At present, the Agency customarily confines hazard quantification to
carcinogenicity (e.g., projecting ``number of cancer cases avoided''),
while the possible consequences of other toxicological endpoints cannot
usually be presented with the same appearance of precision.
[[Page 33289]]
Despite the limitations on available evidence and methodologies
discussed above, as a matter of illustration the Agency has presented
in the RIA a number of different estimates of nationwide human exposure
to these five pesticides in drinking water using ground-water sources.
These alternatives represent different data sources and estimation
methods. Three of these data sources have been referenced earlier in
Unit IV. of this preamble: the Pesticides in Ground Water Data Base,
the National Pesticide Survey and the National Alachlor Water Well
Survey. Another estimate is based on the application of a modeling
procedure, i.e., the application of an environmental-fate model using
assumed values for prevailing hydrogeological conditions across all
local areas where corn pesticides are used. This estimate is provided
in a yet-unpublished Agency analysis of the cumulative risks and
benefits of a host of pesticides frequently used on corn, a so-called
``corn cluster'' analysis. A copy of this analysis is available in the
public docket for this rule-making.
The Agency presents these alternative estimates without making a
judgement that one estimate is superior to another, or that any (or
all, considered collectively) can be considered a reliable estimate of
nationwide exposure and hence, national risk. Three of the four
analyses provide estimates of both: (1) the number of individuals
exposed to any measurable concentration of these five pesticides (or,
in the case of the NPS, a surrogate estimate of ``total pesticide''
exposure); and (2) the number of individuals exposed to concentrations
at or above health-based ground water reference points. The model-based
estimate also estimates total population with any exposure, but offers
a calculation of baseline cancer and non-cancer risk in place of the
number of individuals exposed above reference points.
It is notable that when viewed together, there is a wide variation
in central-tendency estimates of population exposed among the studies,
as well as considerable uncertainty surrounding each estimate, taken
individually and together. For example, best estimates derived from the
available statistically-based studies of total population exposed to
any concentration of the five pesticides, from domestic wells alone,
range from a few hundred thousand to as many as 5 million. Estimates
from the non-statistically based Pesticides in Ground Water Data Base,
which does not differentiate private and public well occurrence, range
to more than 20 million. More importantly, the estimated numbers
exposed to high concentrations range from nearly none to one-half
million people or more; taking estimates of random error into account,
the number exposed above health-based standards could theoretically
also be as high as 20 million. Estimates from the Data Base for this
subset run as high as 2.84 million people.
In addition, each of the four estimations discussed has specific
shortcomings which need to be recognized before relying on any
estimate, considered either individually or together, as a credible
basis for estimating the benefits of the rule. Some of the problems to
be aware of with these studies are: (1) Most fail to account for the
entire nationwide exposure potential, leaving out parts of the total
exposed population (e.g., those drinking from community water systems);
(2) not every data source addresses precisely the five pesticides in
question; (3) most are based on limited and imperfect monitoring data
(i.e., data from surveys with design flaws, or data that are not
statistically based), and the modeling exercise is not based on
monitoring results at all; (4) all of them measure or estimate the
frequency and concentration of well contamination and not human
exposure per se, which means that certain unverified assumptions were
made regarding the numbers of people drinking well water to produce
population-exposure estimates; and (5) they all produce estimates that
are highly uncertain, for example, with the potential for random error
(among the statistically designed studies) represented by 95 percent
confidence intervals ranging from zero to the hundreds of thousands.
One method (based on the PGWDB) is based on a larger amount of well
water sampling, but such sampling is not statistically based, so no
estimate of the degree of expected random error in the estimate is
possible.
Given the wide range of divergent estimates, and the significant
limitations on their reliability, the Agency cannot reasonably identify
a single ``best estimate'' of prevailing exposure to the SMP pesticides
in ground water. The Agency believes that the evidence of substantial
contamination of ground-water-based drinking water supplies, indicated
by the data summarized in Unit IV. of this preamble, provides reason to
believe: (1) That many individuals (running up to the thousands, or
even hundreds of thousands) are or will be consuming ground water
contaminated by one or more of these pesticides at levels above health-
based standards, in the absence of effective, localized risk-reduction
measures as envisioned in SMPs; and (2) that many more individuals
(running into the millions) are or will be consuming ground water with
at least detectable levels of contamination. While concern tends to
focus on the former subset, SMPs can be expected to substantially
reduce the exposure to the larger population as well. The Agency
further believes that the potential health risk represented by this
magnitude of occurrence/exposure bears a reasonable relation to the
magnitude of the economic impacts discussed in the section above.
The uncertainty surrounding the actual levels of individual
exposure makes it very difficult to take the next step, that is,
combining indications of toxicological potency with the estimates of
exposure to obtain an estimate of human health risk. Where the
particular study cited presents no estimates of population risk
associated with the estimated exposure, the Agency has not developed
any subsequent estimates. However, one of the studies (the modeling-
based analysis associated with the Corn Cluster) offers both estimates
of cancer and non-cancer population risks. The analysis suggests that
these five pesticides together represent about 0.4 excess cancer cases
per year, given a 3-meter depth of ground water as a drinking water
source. The preponderance of this risk comes from one chemical alone,
atrazine. The analysis arrives at an estimate of maximum individual
cancer risk at this depth of 2 x 10-4. To put the magnitude of
this risk into perspective, as a measure of risk in hotspots, is to
note that it is roughly twice as great as the incremental lifetime risk
that this analysis estimates for the dietary pathway, about 8 x
10-5 for an individual of average exposure. A less conservative
assumption that a 1 meter depth is representative of ground water
recharge leads to an estimate of about 5 statistical cancers a year,
with a corresponding estimate of maximum individual cancer risk of 3
x 10-3, or nearly 40 times the average dietary estimate stated
earlier. However, given that neither estimate can be regarded as a
direct representation of ground-water exposure (since the model only
simulates the loading to ground water via percolation through crop root
zones), the Agency regards neither estimate as authoritative. In
particular, the Agency has reason to believe the 3 meter estimate
understates ground-water occurrence, based on the Agency's
[[Page 33290]]
experience with controlled field-scale studies, and describes this
experience in Chapter 7 of the RIA. In addition, it is very likely that
the cluster analysis underestimates the risk posed by pesticides other
than atrazine. Specifically, risks presented by alachlor and simazine
should be only slightly less than that of atrazine, based on the
monitoring record.
The Agency is not attempting to authoritatively quantify the risks
of ground-water contamination by these five pesticides, nor to monetize
the value of avoiding these risks. The Agency believes such estimates
are difficult to support scientifically, under these circumstances. The
Agency solicits comment on the reliability of risk estimates that may
be developed from these exposure estimates cited above, or from other
sources.
Beyond the difficulties of characterizing the magnitude of
potential human exposure to these pesticides in drinking water, absent
the risk reduction afforded by SMPs, there remains the question of how
effective SMPs will be in reducing that risk. The main impediment to
the evaluation of SMPs' prospective effectiveness is the fact that
individual SMP provisions remain to be set. However, even making some
assumptions as to the general features of future SMPs, there remains
the problem of estimating ground-water contamination occurrences. As
mentioned earlier, present levels of ground-water monitoring are
inadequate to gauge the levels of overall ground-water contamination
with confidence. Alternatives to monitoring, e.g., environmental fate
models, are not yet developed to provide an adequate substitute to
monitoring results.
However, what little evidence is available to the Agency appears to
support the conclusion that the risk-management measures contained in
SMPs are likely to be effective in reducing the occurrence of ground-
water contamination. The most reasonable approach to assessing the
prospective effectiveness of SMPs is to consider the closest existing
analogue to SMPs, i.e., the performance of existing State-imposed
localized risk-reduction measures. Very few such analogues presently
exist, but there is recent information that the Wisconsin atrazine use
restrictions referred to earlier have resulted in an overall reduction
in atrazine concentrations in contaminated wells.
In 1995, the Wisconsin Department of Agriculture, Trade and
Consumer Protection (DATCP) conducted an extensive analysis of atrazine
and its metabolites in drinking water wells located within risk-
management areas imposed by the Department beginning in 1992, which had
been previously monitored (Ref. 22). Seventy-six (84 percent) of 90
wells sampled in 1995 declined in total atrazine concentration, and 16
percent increased. For the 76 wells that decreased in concentration,
levels decreased an average of 2.5 parts per billion (ppb). While the
re-sampling of these wells generally occurred in one time period, from
June to September 1995, the study compares these results to a baseline
sampling frame that varies for each well. Each well was sampled with
varying frequency across a period that spans from March 1990 to
September 1994. Relative to the State standard, 57 percent of a
slightly larger universe of 111 wells (encompassing the 90 cited above)
are now below 3 ppb (with an average concentration of 1.4 ppb). The 43
percent of wells still above the 3 ppb standard had an average
concentration of 5.9 ppb. The overall average concentration for the 111
wells is 3.3 ppb. While the report attributes the reductions in
contamination to the use reductions, it was less able to explain the
reasons for the occasional increases. However, the report mentions
several plausible reasons, including the possibility that these wells
are deeper (and so experienced higher levels of contamination from pre-
controlled atrazine use later than the norm), or are located in more
recently designated areas, or were affected by continued illegal use or
spills near the wells. These are in addition to the common-sense
explanations, i.e., the natural variability in sample results over time
and/or metabolite contributions from non-prohibited triazine use in the
areas (because atrazine, simazine, and cyanazine have some common
degradation by-products that will be detected by first-round analytic
methods). These data provide some evidence that state risk-reduction
measures seem to have a beneficial effect, reducing both the number of
occurrences of pesticide contamination in affected areas and the level
of that contamination.
In addition to health effects, the Agency believes that the
possibility of resource effects need to be acknowledged and considered
in the decision whether to exact further regulatory protection for
these pesticides. There are two major considerations. First is the
adverse effect to ecosystems linked to ground-water sources. The
scientific basis for estimating such things as the location, frequency,
and duration of sensitive-ecosystem exposure to such ground-water
contamination is less developed than even the limited information
discussed above for human exposure. At the same time, the risk of
ecological adverse effects is certainly a real possibility, and should
not be discounted merely out of lack of currently available scientific
means of ascertaining it. Second, there is an even more inestimable,
but nonetheless relevant, concern over the intrinsic or future value of
ground water as a resource, as free of man-made pollution as may be
practicable. Studies that estimate ``willingness to pay'' based on
survey methodologies have suggested proxy values of substantial
magnitude, which if extrapolated to national scale, amount to billions
of dollars, but the estimates from this controversial approach have
uncertain applicability. One can hypothesize a threshold willingness to
pay commensurate to the estimated costs of this proposed rule, which
would compare favorably to the results of previous studies.
Specifically, if an estimated 5 to 8 million potentially-affected
households (an estimated 15 to 20 million potentially exposed
individuals divided by the national-average per household population of
2.64) were willing to spend between $47 to $63 annually, these sums
would be commensurate with the $356 million projected cost of the SMP
rule. EPA believes that these estimates are well within the range of
expectations, but only a carefully conducted survey, expressly
clarifying the expected risk-reductions specifically associated with
SMPs, could confirm these expectations. Likewise, prevention is a value
that EPA subscribes to because the costs of prevention can be expected
to be much lower than the costs of remediating contaminated ground
water when and if it occurs.
The fact that the dimensions of risk and the effect of risk-
reduction efforts are both highly uncertain dictates a policy to
proceed cautiously and with maximum flexibility. The Agency believes
the prudent course in the face of the uncertainties presented by
pesticidal ground-water contamination is to take positive action that
avoids irrevocable national policy courses at the outset that might
lead to programmatic dead-ends. The Agency believes this is the essence
of the SMP approach, and that this is the most practical policy course
from among the regulatory alternatives.
EPA therefore recognizes the lack of information necessary to
calculate quantifiable benefits that may be associated with the SMP
approach. However, the States, in electing to participate, will have
made a practical
[[Page 33291]]
evaluation of both the real and intangible benefits of ground-water
protection measures, and their participation will represent the choice
for prevention over remediation. These States will have evaluated the
benefits of participating relative to their respective environmental
policy philosophy and goals and on the State economies depending upon
pesticide use.
D. Risk-Benefit Conclusions
Based on the information currently available, it is EPA's reasoned
determination that the benefits of preventing ground-water
contamination by these five pesticides justify the expected costs of
implementing preventive measures through the SMP approach, and further,
that the SMP approach appears to be the most cost-effective of the
means available for protecting ground water.
EPA believes that the level and nature of protection to be afforded
by SMPs is appropriate to the magnitude and character of contamination
potential indicated by the evidence. In developing the SMP approach in
cooperation with a broad spectrum of interested parties from the public
and private sectors, there was much discussion of the alternative
approach of having EPA impose national-level risk-reduction measures,
such as labeling or use restricted to certified applicators. That
alternative is discussed in Unit III. of this preamble and is being
offered for comment in this proposal. The Agency wishes to point out,
however, several factors which led EPA to propose the SMP approach
rather than the national-level restrictions approach.
The main issue is whether label changes alone, or in combination
with restricted use classification, and perhaps additional requirements
placed on the registrants would be sufficient to address the risks of
ground-water contamination. The evidence of each of the five
pesticides' ground-water contamination risks suggests no particular,
specific circumstances causing such contamination. The evidence of
present ground-water contamination is so broad and general that it is
unlikely that a pesticide user could readily identify a specific
condition that would, to a high degree of certainty, cause the
pesticide to contaminate ground water. Consequently, it seems
questionable whether clear and simple label instructions could be
developed that would adequately identify conditions for a user to avoid
such that ground water risks would be significantly reduced or
eliminated. Many ground water experts, including EPA staff, believe
that reliable neutralization of the risks requires a knowledge of
technical, site-specific factors that most pesticide users cannot
reasonably be expected to possess. Furthermore, as a matter of policy,
EPA believes that the users of pesticide products should not be given
the burden of interpreting label instructions that are either
unreasonably complex or technical, or are uncertain to achieve their
purpose. The training associated with classification for restricted use
may alleviate some of this concern, but would not address the issue of
whether label restrictions would actually work.
If this alternative approach were to include monitoring
requirements to demonstrate effectiveness, and use prohibitions if
specific detection triggers were met, then this approach might well end
up being substantially more onerous to both users and registrants than
SMPs. The Agency is requesting detailed comments on this alternative
from all potentially affected parties.
In considering the issue of national-level labeling measures, EPA
has taken into consideration the fact that new risk-reduction measures
have recently been in effect for atrazine (since 1992) which are
intended to reduce the pesticide's contamination potential for both
surface and ground water. These measures include label changes
providing for the deletion of certain non-crop uses including highway
and railroad rights-of-way, reduction of the rates of application for
remaining crop uses and the imposition of set-backs (non-application
zones) for wells and bodies of water, prohibiting use and mixing/
loading within specified distances from surface waters and drinking
water wells. These measures have not been in place long enough for EPA
to discern any positive effect on the ground-water contamination
potential of this pesticide. However, when EPA agreed to these risk-
reduction proposals (which were voluntary measures proposed by the
registrant), it made clear that additional measures would have to be
considered. Furthermore, the Agency is taking into account the
voluntary phase-out and eventual cancellation of cyanazine, announced
in August 1995 (see 1., below). Finally, EPA is anticipating that all
the pesticides ultimately subject to SMPs will also be classified for
``conventional'' restricted use, that is, restricted to use by or under
the direct supervision of a certified applicator.
In the Strategy EPA committed to considering existing State and
local measures in making its regulatory decisions about pesticides with
ground-water concerns. To EPA's knowledge, a total of 10 States have or
are working on some kind of independent restriction for one or more
pesticides with ground-water concerns. However, not all of these apply
to the five pesticides discussed here. Another 12 States have some
authority to impose such restrictions, but have heretofore not employed
it. From a national perspective, this level of effort appears to be
inadequate to address the extent and character of ground-water
contamination potential associated with these five pesticides. It
appears that, in the main, States are anticipating that this proposed
rule requiring pesticide-specific SMPs will serve as the framework for
their own efforts in this regard.
Finally, it is EPA's belief and expectation that SMPs should
sufficiently reduce the risks associated with the ground-water
contamination potential of these five pesticides, so that full
cancellation of use based on ground-water concerns alone is not likely
to be necessary. While the potential risks represented by these five
are substantial and warrant the imposition of effective preventive
measures, the measures to be taken by the States should be adequate to
mitigate the risks.
A remaining issue is whether the risks associated with ground water
may combine with other routes of exposure for any of these five
pesticides to constitute an unreasonable risk and thus warrant
cancellation. EPA customarily uses the Special Review procedure to
determine whether the combination of different routes of exposures
represents unreasonable risks. Alachlor and cyanazine have been subject
to Special Reviews in the past, and the three triazine active
ingredients (atrazine, simazine, and cyanazine) have just recently
begun Special Review. Any or all of these five may be subject to this
further consideration in the future. In such Special Reviews, EPA will
take into account the level of risk-reduction expected to be afforded
by SMPs in making an evaluation of the pesticides' overall risk to
human health and the environment.
1. Cyanazine special review. The recent agreement between the
Agency and DuPont Agricultural Products, the principal registrant of
cyanazine in the United States, to phase out and eventually terminate
sale and use of cyanazine, affects this proposed rule. On August 4,
1995, DuPont signed an agreement with EPA whereby DuPont will amend its
registration to: (1) Reduce the maximum use rates on cyanazine labels
in four increments,
[[Page 33292]]
from 1997 to 1999; (2) cease production and sale at the end of 1999;
and (3) prohibit all uses of cyanazine by the end of the year 2002.
This arrangement will resolve the Agency's concerns with respect to
cyanazine in its Special Review of the three triazines. EPA will soon
publish its termination of the cyanazine Special Review. However, EPA
will proceed with proposing cyanazine to be subject to SMPs in this
rule, for several reasons. First, until the Special Review is
officially terminated and the registrant's voluntary actions go into
effect, the ground-water risks enumerated in this notice will remain,
warranting at least proposed regulatory action. Second, even when the
agreement is implemented, the phase-out schedule provides for a brief
interval during which cyanazine may be used in States that would need
SMPs. Third, the Agency is concerned with the possibility that
cyanazine could be registered at some future date as a completely new
pesticide. In that event, it is the Agency's judgement at this time
that the present evidence of the pesticide's severe contamination
potential requires that any such future use needs to be subject to
SMPs.
It may be EPA's judgement in considering a final SMP rule that
cyanazine's eventual cancellation will be sufficient to address the
Agency's ground-water concerns; if so, it may choose to issue a final
rule for only four of the pesticides proposed today. In any event, the
Agency wishes to emphasize that the fact that cyanazine use will
terminate soon after the effective date of the SMP restriction will be
taken into account when EPA evaluates State submissions. EPA does not
anticipate that State Plans for cyanazine will have to be as extensive
or detailed as for pesticides whose uses are expected to continue
indefinitely.
2. Alachlor Special Review. In 1985, EPA initiated a Special Review
of Alachlor (50 FR 1115, January 9, 1985). As noted above, alachlor was
classified as a B2 (probable human) carcinogen, and the
carcinogenicity potential has been quantified, although the
classification is now under review. EPA concluded the Special Review of
alachlor (52 FR 49480, December 31, 1987), after taking the following
actions to reduce risk for workers: EPA classified alachlor for
restricted use by certified applicators; prohibited aerial application
using human flaggers; and required persons applying alachlor to 300 or
more acres per year to use mechanical transfer systems for mixing and
loading alachlor. In addition to these regulatory actions, however, EPA
deferred action on whether the risks posed from alachlor in drinking
water from contamination of ground water required regulatory action.
EPA concluded that the further evaluation of the ground-water risks
would offer an appropriate occasion to revisit the overall risks and
benefits of alachlor (including dietary risks) on a crop-by-crop basis
to determine whether the risk benefit balance had changed to a degree
requiring regulatory action.
Since 1987, Monsanto has submitted the National Alachlor Well Water
Survey (NAWWS) and review has been completed. EPA's concerns with
respect to continuing ground-water risks are evident in its proposal to
classify alachlor for SMPs in this proposed rule. In addition, EPA has
reviewed recent trends in usage and percent of crop treated with
alachlor and determined it is not necessary to revisit the risk/benefit
determination of alachlor on a crop-by-crop basis. The dietary risks
posed by alachlor were in the 10-6 range at the time the Special
Review was concluded and have declined further since then.
EPA has determined that the remaining Special Review concern about
alachlor in ground-water is adequately addressed by the actions
proposed in today's document. Thus, EPA concludes that the concerns
deferred by the Special Review will have been addressed with
promulgation of this proposed rule and no further action related to the
Special Review of alachlor will be necessary upon this proposed rule's
promulgation. In a separate notice, EPA will announce the cessation of
the alachlor special review.
E . Analysis of Regulatory Options
In developing the Strategy EPA evaluated a range of available
regulatory options in addition to the SMP approach. Specifically, EPA
compared three general approaches in a companion document to the
Strategy, the ``Pesticides and Ground-Water Strategy: A Survey of
Potential Benefits'' (Ref. 13). In supporting the comparative
advantages of the SMP approach, this document compared it to the option
of a projected extension of current national-level risk-reduction
measures, and another of full cancellation of a problem pesticide. Both
options were regarded as establishing the extremes of potentially
effective and reasonably feasible alternatives to the SMP approach.
The first alternative to SMPs was construed to permit significant
levels of ground-water contamination before milder forms of regulatory
action (e.g., label changes or restricted use) would be considered. In
other words, the option constituted a non-prevention-oriented approach
that, although contrary to Agency policy, constituted a conceivable
approach to the problem of pesticide contamination of ground water. The
option relied to a considerable degree upon remediation of projected
contamination sites to address the problem; as such, it was tantamount
to addressing the problem of pesticides in ground water through other
environmental statutes, especially the Safe Drinking Water and
Superfund (CERCLA) Acts. Consequently, the costs of remediation, and,
by extension, the costs associated with degradation of ground water as
a natural resource, were construed to be a larger component of this
option's cost impacts than any other. While these impacts were not
directly monetized in EPA's 1991 analysis (for the same considerations
discussed in Unit IV.C. of this preamble), by indirect analysis EPA
concluded that the ``status quo'' option would bear considerably higher
societal-cost impacts than the SMP approach. Moreover, such an approach
would be unacceptable on policy grounds, representing insufficient
commitment to a preventive approach. This policy preference, of course,
in part reflects EPA's discomfort about the ability to correct (much
less correctly estimate the price of) ground-water contamination once
it occurs. EPA's view is that such ground-water contamination may be in
many circumstances practically irreversible, based in part on the
economics of remedial action (where millions of dollars can be spent
for uncertain results at a single site).
Likewise, outright cancellation of one or more pesticides that
might represent a substantial risk via ground water stands to entail
far higher societal costs than other regulatory alternatives, such as
SMPs. As the Taylor analysis (Ref. 5) indicates, the magnitude of user
and consumer impacts associated with cancellation of these five
pesticides dwarf those that might be associated with SMPs. Taking into
account the additional administrative and technical program costs
associated with the SMP approach (that would not be necessary if the
pesticides were canceled instead), the SMP approach still appears to
represent the most cost-effective approach. While absolute cancellation
may provide a degree of greater surety that ground-water contamination
will be averted (and in that way affords greater benefits), it is
unlikely that the incremental gain in surety justifies the enormous
difference in economic impact between the two options.
[[Page 33293]]
F. Request for Comments
EPA is interested in receiving comments on its determination of the
risks and benefits associated with its proposal to classify these five
pesticides as subject to SMPs. EPA in particular invites all interested
persons to submit further information concerning the risks and benefits
(with respect to ground-water contamination, its prevention and any
ancillary issues) associated with the use of atrazine, simazine,
cyanazine, alachlor, and metolachlor, as discussed in this proposed
rule. EPA would like comments on its estimate of the economic impacts
of the proposed rule. For instance, has the Agency sufficiently
addressed the indirect costs, such as those associated with minor use
sites (e.g., fruits, nuts, and turf)? Of particular interest would be
suggestions for how to improve both: (1) The estimate of present/future
risks posed by these five pesticides in ground water absent further
risk-reduction measures like SMPs; and (2) the estimate of
environmental results likely to be achieved by SMPs.
V. Public Docket
A record has been established for this rulemaking under docket
number OPP-36190 (including comments and data submitted electronically
as described below). A public version of this record, including
printed, paper versions of electronic comments, which does not include
any information claimed as CBI, is available for inspection from 8 a.m.
to 4:30 p.m., Monday through Friday, excluding legal holidays. The
public record is located in Room 1132 of the Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
VI. Notification to Secretary of Agriculture and the Scientific
Advisory Panel
As provided in 40 CFR 153.31(b), EPA has transmitted copies of this
Notice and the Regulatory Impact Analysis, to the Secretary of
Agriculture and the Scientific Advisory Panel for comment, prior to
today's publication. In the process of reviewing the proposed
regulation USDA has raised a number of concerns that the Agency has
addressed in the text of the proposal. Among those concerns are the
effects on minor uses, the potential for de facto cancellations with
the States' failure to have an approved Plan, possible costs incurred
by USDA programs, the need for an appropriate balancing of risks and
benefits in the development and approval of SMPs, and the most
appropriate statutory authority for taking regulatory action. USDA
looks forward to a full public consideration of these and other
critical issues in the promulgation of the final regulation. In
particular, USDA urges the Agency to adopt a streamlined process which
examines a broad range of possible alternatives for efficiently
mitigating the environmental impacts while preserving sound
agricultural production. The Panel had no written comments.
VII. References
1. Baker, David B., et.al., ``Immunoassay Screens for Alachlor
in Rural Wells: False Positives and an Alachlor Soil Metabolite,''
Environmental Science Technology., 1993, 27, 562-4.
2. Roux, Paul R., Large-Scale Retrospective Ground-Water Study
for Metolachlor in Four Areas of the U.S., [Ciba-Geigy, Corp.],
1989.
3. Holden, L.R., and Graham, J.A., ``Project Summary of the
National Alachlor Well Water Survey,'' (Project Summary and 6
Volumes), Monsanto Agricultural Co., St. Louis, MO, February 1990.
4. ``Review of the Monsanto Company National Alachlor Well Water
Survey,'' Phase II Report prepared for EPA by ICF, Inc., March 29,
1991.
5. Taylor, C. Robert, et. al., ``Economic Impacts of Chemical
Use Reduction in the South,'' Southern Journal of Agricultural
Economics, July 1991.
6. USEPA-OPTS, 1987a: ``Agricultural Chemicals in Ground Water:
Summary Minutes from the 1987 Pesticide Strategy Workshop,'' October
1987.
7. USEPA-OPTS, 1987b: ``Agricultural Chemicals in Ground Water:
Proposed Pesticide Strategy,'' December 1987.
8. USEPA-OPTS, 1988a: ``Summary of State Commissioners Meeting
on EPA Proposed Strategy on Agricultural Chemicals in Ground
Water,'' August 1988.
9. USEPA-OPTS, 1988b: ``Pesticides in Ground Water Data-Base
1988 Interim Report,'' December 1988.
10. USEPA, 1990: National Survey of Pesticides in Drinking Water
Wells: Phase I Report, EPA 570/9-90-015, November 1990.
11. USEPA 1991a, Protecting the Nation's Ground Water: EPA's
Strategy for the 1990s (The Final Report of the EPA Ground-Water
Task Force), 21Z-1020, July 1991.
12. USEPA 1991b, Pesticides and Ground-Water Strategy, 21T-1022,
October 1991.
13. USEPA, 1991c; USEPA, Office of Pesticide Programs,
Biological and Economic Analysis Division (Economic Analysis
Branch), ``Pesticides and Ground-Water Strategy: A Survey of
Potential Benefits,'' February 1991.
14. USEPA, 1992a, National Survey of Pesticides in Drinking
Water Wells: Phase II Report, EPA 570/9-91-021, Winter 1992.
15. USEPA, 1992b, Pesticides in Ground Water Database: A
Compilation of Monitoring Studies: 1971 - 1991 (11 volumes: a
National Summary and 10 Regional Summaries), EPA 734-123-92-001,
September 1992.
16. USEPA, 1992c, ``EPA Definition of `Pollution Prevention',''
Memorandum to all EPA personnel from F. Henry Habicht, Deputy
Administrator, May 28, 1992.
17. USEPA, 1992d, Final Comprehensive State Ground Water
Protection Program Guidance, EPA 100-R-93-001, December 1992.
18. USEPA, 1993; USEPA-OPPTS, Guidance for Pesticides and Ground
Water State Management Plans: Implementation Document for the
Pesticides and Ground Water Strategy, EPA 735-B-93-005a, December,
1993; and two Appendices (EPA 735-B-93-005b, and EPA 735-B-93-005c).
19. USEPA, 1995, ``A Framework for Measuring the Economic
Benefits of Ground Water,'' EPA 230-B-95-003, October 1995.
20 USEPA, 1996, ``Water Resources Impact Analysis for the
Triazine Herbicides,'' [unpublished]
21. Nowak, Peter, Wolfe, Steven, et. al., ``Assessment of 1992
Wisconsin Atrazine Rule (Ag 30),'' Final Report - University of
Wisconsin College of Agricultural and Life Sciences, May 1993).
22. WDATCP, 1996: Wisconsin Department of Agriculture, Trade and
Consumer Protectiion (Postle, Jeff), ``Resampling Wells that
Previously Exceeded a Pesticide Enforcement Standard,'' Final Report
- February 1996.
VIII. Regulatory Assessment Requirements
A. Executive Order 12866
Pursuant to Executive Order 12866 (58 FR 51735, October 4, 1993),
it has been determined that this is a ``significant regulatory action''
because it may result in an annual effect of $100 million or more. This
action was therefore submitted to the Office of Management and Budget
(OMB) for review, and any comments or changes made during that review
have been documented in the public record.
[[Page 33294]]
In addition, the Agency has conducted an economic analysis of the
potential impacts associated with this proposed action, which is
included in a Regulatory Impact Analysis' document prepared for this
regulation. A copy of this analysis, which is discussed in Unit IV. of
this preamble, is also included in the public record.
B. Regulatory Flexibility Act
Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.),
EPA has determined that this regulatory action does not impose any
adverse economic impacts on small entities.
An analysis of the prospective impacts of this proposed rule on
small States, pesticide distributors, and agricultural producers was
prepared as part of the Agency's economic analysis for this proposed
action, which is summarized in Unit IV. of this preamble. This analysis
is included in a Regulatory Impact Analysis' document, a copy of which
is included in the public record for this action. This information is
also being forwarded to the Chief Counsel for Advocacy of the Small
Business Administration. Any comments regarding the economic impacts
that this proposed regulatory action may impose on small entities
should be submitted to the Agency at the address listed above.
C. Paperwork Reduction Act
The information collection requirements in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.
An Information Collection Request (ICR) document has been prepared by
EPA (EPA ICR No. 1771.01) and a copy may be obtained from Sandy Farmer,
OPPE Regulatory Information Division; U.S. Environmental Protection
Agency (2136); 401 M St., SW.; Washington, DC 20460, by calling (202)
260-2740, or by sending an e-mail request to:
[email protected].
For PRA purposes, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
Development and implementation of pesticide SMPs entails the
collection of various sorts of information. In particular, States will
need to create and/or gather information to conduct ground water
vulnerability assessments, including data on agronomic practices (e.g.,
pesticide use, cropping patterns) and aquifer sensitivity; the States
will either gather the data themselves or require third parties (users
and/or pesticide registrants) to report the data. States will then use
this data to assess the vulnerability of ground water to the pesticides
requiring Pesticide SMPs. In addition, States may need to develop and/
or maintain ground-water monitoring efforts, or expand their existing
efforts to gather chemical, physical, geological, biological, and other
environmental data. This data will be necessary to support Pesticide
SMP activities such as determining ground water levels, analyzing the
existence and extent of contamination, and evaluating the effectiveness
of management measures. Furthermore, once Pesticide SMPs are approved
by EPA, States will need to submit an SMP Biennial Report every 2 years
beginning 2 years from the EPA approval date and continuing every 2
years thereafter. The SMP Biennial Report will provide a basis for
measuring States' progress toward protection of ground water resources
from pesticide contamination. The commitment to develop and report such
information is a mandatory component of SMPs.
The total annual burden for the information collection related
activities associated with this proposed action is estimated to average
412,560 hours per year for all respondents, including State (and
territorial) government, and private parties. The per respondent burden
(i.e., burden for each State, territory, or private party divided by
the number of States, territories and tribal authorities expected to
submit SMPs) is expected to average 7,367 hours per year. First year
burden is estimated to be a total of 673,083 hours, with 12,1019 hours
per respondent. The total annual costs for the information collection
related activities associated with this proposed action is estimated to
average $18,043,080 per year for all respondents, with an annual
estimated cost of $322,198 per year for each respondent. First year
start-up costs are expected to be $22,395,865, with an estimated
$399,926 cost per respondent.
An Agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
Comments are requested on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested
methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments on the ICR to the
Director, OPPE Regulatory Information Division, U.S. Environmental
Protection Agency (2136), 401 M St., SW., Washington, DC 20460, and to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th St., NW., Washington, DC 20503, marked
``Attention: Desk Officer for EPA.'' Include the ICR number in any
correspondence. Comments related to these estimates may be submitted to
the address listed in the ADDRESSES unit anytime during the comment
period for the proposed action. However, since OMB is required to make
a decision concerning the proposed collection between 30 and 60 days
after June 26, 1996, a comment to OMB is best assured of having its
full effect if OMB receives it by July 26, 1996. The final rule will
respond to any OMB or public comments on the information collection
requirements contained in this proposal.
D. Unfunded Mandates Reform Act and Executive Order 12875
Pursuant to Title II of the Unfunded Mandates Reform Act (UMRA) of
1995 (Pub. L. 104-4), EPA has determined that this regulatory action
contains a Federal mandate that may result in expenditures of $100
million or more for State, local and tribal governments, in the
aggregate, or to the private sector in any 1-year. Accordingly, EPA has
prepared the following description of the intergovernmental
consultation under UMRA, and Executive Order 12875 (58 FR 58093,
October 28, 1993), entitled ``Enhancing the Intergovernmental
Partnership.'' The basis for EPA's determination is contained in the
economic analysis accompanying this rule, which is included in the
public record for this action and summarized in Unit IV. of this
preamble.
UMRA requires that such a rule be accompanied by a statement that,
among other things, documents that the rule is the least costly, most
cost-effective or least burdensome alternative that achieves the
regulatory objective. In the absence of such documentation, UMRA
[[Page 33295]]
provides that the head of the promulgating Agency may otherwise provide
in the statement an explanation of why the least burdensome approach
was not adopted or is inconsistent with law. The discussion in part E
of Unit IV of this preamble describes the Agency's analysis of
regulatory options. As this discussion, and the earlier analysis cited
therein (c.f., Ref. 13) indicates, the Agency believes that this
proposed action is the most cost-effective and least burdensome
alternative to the alternatives considered in the development of the
Pesticides and Ground-Water Strategy (Ref. 12), developed as the
groundwork for today's proposed rule. A particularly advantageous
feature of the chosen option is that it allows States to determine the
most appropriate approach for preventing unreasonable adverse effects
within their individual States. The practical alternatives are a choice
between different kinds of Federally mandated restrictions, either
national standards and/or risk-reduction measures (principally in the
form of label changes) or outright cancellations of use. The principal
disadvantage of both is that they can not take State specific issues
into consideration, and so can be anticipated to increase the loss of
economic benefits associated with the pesticides' use, relative to the
impacts of SMPs. National-level measures are potentially less certain
of meeting the regulatory objective, that is, of achieving the goal of
preventing unreasonable levels of ground-water contamination. This
greater uncertainty is caused by the relative inability to tailor risk-
management measures, proceeding instead on a ``lowest common
denominator'' approach. Still another conceivable (but unanalyzed)
option is doing nothing at the Federal level, leaving the potential for
ground-water contamination to be addressed, if at all, by voluntary
action and/or independent State action. This alternative was not
analyzed because it clearly failed to meet the regulatory objective.
Such an option that freely permits contamination would entail no direct
regulatory costs, but the far larger reduction in the value of the
resource must be compared to the more conventional economic impacts.
The statement required by UMRA also requires a summary description
of State/local/Tribal governmental input in the rule's development.
Prior consultation with State and Tribal authorities has been
extensive. The Pesticides and Ground Water Strategy development process
began with a major public workshop held in 1986 in Coolfont, West
Virginia. State Agriculture, Environment and Health agencies were among
the participants. A second public workshop was held at Coolfont during
the summer of 1987, also with similar participation. Beyond the
Strategy, State regulatory officials were involved in the development
of the subsequent Guidance beginning in 1989, when EPA sponsored
working sessions to determine how best to guide the process of managing
pesticide use to protect the ground water resource. Two week long
sessions were held in Fredericksburg, Virginia during October and
November of 1989. These sessions were actual working sessions to
develop the document that today is the SMP guidance document. Between
five and seven States participated in each session. Drafts of the
guidance document were shared with all 50 State Lead Agencies for
Pesticides, EPA Regional Offices, and other Federal agencies.
During development of the proposed rule, many issues were discussed
with the Water Quality Working Committee Group of the State FIFRA
Issues Research and Evaluation Group (SFIREG) on which eight State Lead
Agencies sit. This group meets three times per year with OPP to discuss
water quality issues and this forum was used extensively in the early
stages of development of the proposed rule.
The proposed regulation itself has been provided as an initial
draft twice to EPA's 10 regional offices and all 50 states for review
and comment, in addition to the SFIREG Water Quality Committee and to
SFIREG's parent body, the American Association of Pesticide Control
Officials (AAPCO). The first round of review in fall 1994 elicited 38
written comments from State and Tribal agencies; the second round in
spring 1995 elicited 18 further comments. As a result of each round of
review, the draft proposed rule was modified. These written comments
are in the public record and were considered in the development of the
proposed rule. Virtually all of the principal State comments and
concerns are reflected in the discussion in Unit III of this preamble,
and in the request for comments accompanying that Unit.
All other UMRA requirements for the accompanying statement to a
``significant regulatory action,'' e.g., descriptions of statutory
authority, anticipated costs and benefits, compliance costs, are
contained throughout this preamble, in the appropriate headings.
E. Executive Order 12898
Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994),
the Agency has considered environmental justice related issues with
regard to the potential impacts of this action on the environmental and
health conditions in low-income and minority communities. As related
throughout this document, the approach the Agency is proposing to
address the problem of pesticides in ground water is based on a full
appreciation of the localized nature of the problem, and this approach
strives to be the most effective strategy for localized protection of
the ground-water resource. As the Strategy highlights, alternatives to
effective local-level risk reduction measures (e.g., national-level
regulation or no regulatory protection) are considered likely to either
over-regulate pesticide use (causing undue economic hardship to
affected parties) or under-protect (increasing the risk of various
adverse health and environmental effects to specific parties).
List of Subjects
40 CFR Part 152
Environmental protection, Administrative practice and procedure,
Pesticides and pest, Reporting and recordkeeping requirements.
40 CFR Part 156
Environmental protection, Labeling, Occupational safety and health,
Pesticides and pest, Reporting and recordkeeping requirements.
Dated: June 19, 1996.
Carol M. Browner,
Administrator.
Therefore, 40 CFR chapter I, is proposed to be amended as follows:
1. In Part 152:
PART 152 --[AMENDED]
a. The authority citation for part 152 would continue to read as
follows:
Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31
U.S.C. 9701.
b. By adding a new subpart J to part 152, to read as follows:
Subpart J--Ground-Water State Management Plans
Sec.
152.180 Applicability.
152.183 Definitions.
152.185 Restriction.
152.187 Submission and approval of ground-water State Management
Plans.
152.190 Specifications and requirements of a ground-water State
Management Plan.
152.191 Evaluation of State Management Plan Implementation.
152.193 Amendment of State Management Plans.
[[Page 33296]]
152.195 Withdrawal of approval of a State Management Plan.
152.198 Pesticides classified for restricted use subject to a
ground water State Management Plan.
Subpart J--Ground-Water State Management Plans
Sec. 152.180 Applicability.
This subpart applies to any pesticide or pesticide product
designated to be subject to the requirements and provisions of ground-
water State Management Plans by means of a Restricted Use
Classification.
Sec. 152.183 Definitions.
In addition to the definitions in Sec. 152.3, the following terms
also apply to this subpart:
Ground Water Reference Point means an environmental concentration
of a pesticide ingredient based on 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 ingredient poses adverse
effects to ecosystems affected by closely hydrologically linked surface
waters) under the Clean Water Act.
Plan means a State Management Plan developed for the purpose of
managing the use of a pesticide in order to prevent unreasonable risks
of ground water contamination.
State means each of the 50 States, Puerto Rico, the U.S. Virgin
Islands, the District of Columbia, Guam, American Samoa and other
Pacific Island Territories of the United States, as well as Indian
Lands under Tribal jurisdiction.
Sec. 152.185 Restriction.
(a) Restriction. A pesticide or pesticide product classified for
restricted use subject to a State Management Plan may be used only in
accordance with the provisions and requirements of an Agency-approved
State Management Plan, after a date 33 months from the date the
pesticide or product is so classified. Such a pesticide or pesticide
product may not be sold or used after that date within the boundaries
of a State without an Agency-approved State Management Plan.
(b) Labeling. (1) Upon classification of a pesticide for restricted
use, subject to ground-water State Management Plans, each registrant of
a product subject to that classification shall, within 12 months after
the date of that classification by final Agency rule, submit for such
product:
(i) A copy of the labeling amended to include the statement
specified in Sec. 156.137(a)(2)(ii) of this chapter.
(ii) A statement that the registrant will comply with the labeling
requirements prescribed by the Agency by the effective date of this
rule. The Agency will regard such statement to be a report under the
Act. The Agency may deny registration or initiate cancellation
proceedings if a registrant fails to comply with the timetables
established in this section.
(2) A product whose labeling bears directions for end use and that
has been classified as subject to ground-water State Management Plans
must be labeled in accordance with the requirements of Sec. 156.10 of
this chapter after the effective date of the restriction.
(c) Distribution and sale of classified products. No product with a
use classified for restricted use, subject to ground-water State
Management Plans, may be distributed or sold by a retailer or other
person after the effective date of the restriction, unless the product
bears a label or labeling which contains the terms of the
classification and otherwise complies with paragraph (b)(2) of this
section.
Sec. 152.187 Submission and approval of ground-water State Management
Plans.
If any State, at any time after the classification of a pesticide
or pesticide product to be subject to State Management Plans by final
rule, wishes to establish a ground-water State Management Plan for such
a pesticide or pesticide product, that State shall submit a proposed
Plan for that purpose to the Administrator. The Administrator will
approve the Plan submitted by any State if, in the Administrator's
judgement, the Plan meets the requirements of Sec. 152.190.
(a) Schedule. A State that wishes to implement a Plan on the
effective date of the State Management Plan restriction shall submit a
proposed Plan, along with the administrative record accompanying
development of the proposed Plan to the appropriate EPA region under 40
CFR 1.7, before a date 24 months from the date a pesticide or product
is classified. The submission shall include an electronic file in
Wordperfect 5.1 or higher or ASCII for all material. The Administrator
will review such submittals and approve or disapprove Plans within 9
months of receipt of a complete submittal.
(b) Review. Upon receipt of a proposed State Plan submitted for EPA
approval, the Administrator or a designee will first review the
proposed Plan to determine that all requirements as provided in
Sec. 152.190 have been addressed. Upon completion of this review, the
Administrator will notify the State in writing of the initial
determination of the completeness of the submission. In the event that
the Administrator determines that the submission fails to address all
requirements, the Administrator will request the State revise its
submission to provide the missing components. Once the Administrator is
satisfied that the submission is complete, full evaluation of the
submission will proceed.
(c) Approval. Upon completion of the review of the submission, if
the Administrator finds that the Plan meets the requirements of
Sec. 152.190, then the Administrator will publish a Notice of Approval
in the Federal Register and a letter of notification to the State
official designated as State Liaison, pursuant to Sec. 152.190(b),
informing of the approval.
(d) Disapproval. If, after completion of the review of the
submission, the Administrator finds that the submission fails to meet
the requirements of Sec. 152.190, the Administrator shall notify the
State Liaison by letter that EPA will not approve the Plan as
submitted, and specifying the deficiencies in the Plan that prevent its
approval. If, after further consultation, the Administrator still finds
that the submission fails to meet the requirements, the Administrator
will publish a notice in the Federal Register announcing the
disapproval of the Plan and including the reasons for finding the Plan
inadequate pursuant to Sec. 152.190. In this event, sale or use in the
State of the pesticide that is the subject of the Plan shall be
prohibited 33 months after the promulgation of a rule classifying the
pesticide as subject to a ground-water State Management Plan.
Sec. 152.190 Specifications and requirements of a ground-water State
Management Plan.
The Administrator shall approve the State Management Plan submitted
by any State, or any modification thereof, if in the Administrator's
judgement, the Plan fulfills the following requirements.
(a) State's philosophy and goals toward protecting ground water. An
acceptable Plan must, to the satisfaction of the Administrator, contain
a description of the State's ground-water protection philosophy and
goals regarding pesticide management, including an explanation how its
philosophy and goals will be no less protective than EPA's goal of
preventing adverse effects to human health and the environment and
protecting the environmental integrity of the nation's ground water.
[[Page 33297]]
(b) Roles and responsibilities of State agencies. An acceptable
Plan must, to the satisfaction of the Administrator:
(1) Identify and describe both the general responsibility of, and
the specific technical and administrative tasks to be performed by,
each participating agency responsible for the development and
implementation (including enforcement) of the Plan, including a
description of how the State agencies intend to use the programs and
expertise of Federal agencies in carrying out the Plan.
(2) Identify a Liaison who will serve as a single contact point for
all formal communications concerning the Plan process between EPA and
the State, including responsibility for the transmittal and receipt of
official correspondence and information.
(3) Describe the coordination mechanisms between all participating
State agencies, local entities, and appropriate Federal agencies.
(4) Describe how local governments are included in activities under
the Plan. When local governments have authority to address State
ground-water-related objectives and priorities, the State must
demonstrate that program coordination, guidance, or oversight is
provided.
(5) Contain official concurrences from the directors of all State
agencies with responsibilities under the Plan stating their agreement
with the Plan, and their commitment to carry out their responsibilities
under the Plan.
(6) Discuss any relevant inter-State multi-jurisdictional
coordination, including how any multi-jurisdictional issues will be
resolved for purposes of implementing the Plan.
(c) Legal authority. An acceptable Plan must, to the satisfaction
of the Administrator:
(1) Contain regulatory authorities that are sufficient to
accomplish the objectives of the Plan, established in paragraph (a) of
this section.
(2) Specify the legal authorities of the State to implement the
Plan successfully and specify the State's authority to impose
preventive measures, its remedial action authority and its compliance
and enforcement authorities, citing all relevant State laws and
regulations and including Federal legislation, regulations and program
delegation, available to the State.
(3) Identify the specific authorities that will be used to carry
out the specific commitments made in the Plan. The State must
specifically identify the authority to conduct or require others to
conduct monitoring, prohibit use in specific areas, close public wells,
or supply or require others to supply alternative sources of water,
where such actions are elements of the Plan, must be identified.
(d) Resources. An acceptable Plan must, to the satisfaction of the
Administrator, demonstrate there are adequate resources available to
implement and enforce the program. Resources include technical
expertise and personnel, physical and operational capabilities, and
funding. The Plan must demonstrate there is an adequate match between
revenues and proposed expenditures and that the necessary expertise is
available.
(e) Basis for assessment and planning. An acceptable Plan must, to
the satisfaction of the Administrator, specify the State's approach and
activities to assess vulnerability for the geographic area in which the
State intends to allow pesticide use, identifying the sources of all
such data. The State shall specifically describe the State's available
pesticide use data (e.g., geographic use and application rates) and how
it will be factored into assessing vulnerability.
(f) Monitoring. An acceptable Plan must, to the satisfaction of the
Administrator, demonstrate that monitoring activities (including
ground-water monitoring) performed pursuant to the Plan are appropriate
for the purposes of the Plan, with assurances that the activities will
be carried out adequately. Specifically, an acceptable Plan must
identify and describe key elements of the monitoring program, including
the scope and objective (in relation to the purposes of the Plan) of
such monitoring, design and justification (including the number of
sites to be sampled, the number of samples to be taken and the
frequency of sampling) of such monitoring, monitoring protocols,
quality assurance/quality control, sampling methodology, analytical
methods, and analytes. Such description must make clear how the
placement of monitoring sites relates to the State's priorities for
protecting ground water, and will allow evaluation of the effectiveness
of prevention and response measures specified in paragraphs (g) and (h)
of this section. Monitoring performed for the purpose of fulfilling
this requirement must be performed in accordance with an EPA-approved
Quality Assurance Project Plan (as described in Chapter 5.4.2 of
Appendix B, ``Assessment, Prevention, Monitoring and Response
Components of State Management Plans,'' to the Guidance for Pesticides
and State Management Plans (EPA 735-B-93-005c, February 1994). This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the Public Response and Program Resources Branch,
Field Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Copies may be inspected at the above address or at the Office of the
Federal Register, 800 North Capitol St., NW., suite 700, Washington,
DC. Good Laboratory Practice Standards (40 CFR part 160) do not apply
to monitoring performed for the purpose of fulfilling this requirement.
(g) Prevention actions. An acceptable Plan must, to the
satisfaction of the Administrator, specify the actions a State will
take to manage the use of the pesticide classified for use subject to
the Plan, to fulfill the State's goals and principles enunciated
pursuant to paragraph (a) of this section and will otherwise prevent
unreasonable adverse effects to human health and protect the
environmental integrity of the nation's ground-water resources.
(h) Response to detections of pesticides. An acceptable Plan must,
in the judgement of the Administrator, adequately specify the measures
that the State will take (and the circumstances under which the State
will take them) to respond to contamination so that Ground Water
Reference Points are not reached, and specify the actions the State
will take in the event Reference Points are met or exceeded. This
description must be presented in the form of a general corrective
response scheme, illustrating the State's capacity for timely,
coordinated response to contamination.
(i) Enforcement mechanisms. An acceptable Plan must, to the
satisfaction of the Administrator, demonstrate that the State's
enforcement authorities and capabilities are adequate to implement and
to monitor compliance with the specific measures included in the Plan,
describing authorities and capabilities that are intended to protect
ground water from contamination and response actions where
contamination has already occurred. Enforcement authority must be
identified by the State, and the roles and responsibilities of each
State agency must be defined, including how coordination of enforcement
capabilities within agencies will work to prevent and respond to
contamination.
(j) Public awareness and participation. An acceptable Plan must, to
the satisfaction of the Administrator, demonstrate that there is notice
and opportunity for public comment within the process of Plan
development, and will be informed of significant Plan
[[Page 33298]]
implementation activities. This demonstration must:
(1) Describe the public role regarding development of the Plan and
decision-making in implementing the Plan, and identify or describe
existing legal requirements within the State that would ensure public
participation in the process (i.e., an Administrative Procedure Act
requiring notice and comment, etc.). If no such legal requirements
exist within the State, the Plan must describe any other public
participation process that the State uses in the development of the
Plan.
(2) The Plan must also specify the level of detection in ground
water that is considered by the State to be of such significance that
the State will inform the public. Indicate how, when, and by whom the
public will be informed of detections in ground water that are
considered significant, providing for, at a minimum:
(i) The notification of any well owner of any detections in ground
water; and
(ii) The notification of all users of any detections above the
reference point.
(3) 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 Plan.
(k) Information dissemination. An adequate Plan must, to the
satisfaction of the Administrator, describe the means by which measures
prescribed pursuant to the Plan will be communicated to pesticide users
and all other interested parties. A plan must:
(1) Describe how information regarding prevention measures (e.g.,
use limitations and precautions) will be relayed to the appropriate
audiences.
(2) Describe how pesticide users will be trained or educated in how
to comply with requirements of applying a pesticide where use is
governed by the Plan.
(3) Identify the targeted parties and discuss how information will
be relayed.
(4) Explain why the information dissemination approach is
appropriate for the type of contamination prevention actions being
employed, and the education and/or awareness of the targeted audience
is required.
(5) Describe how information will be updated as requirements
change. Such discussion should include the form these updates will take
and the distribution methods. The Plan should also discuss any existing
mechanisms (i.e., Memoranda of Understanding, cooperative agreements,
etc.) between the State and other entities that will be involved in
this effort.
(l) Records and reporting. An adequate Plan must, to the
satisfaction of the Administrator:
(1) Include a commitment by the State to maintain essential records
relating to Plan implementation for a period of at least 6 years. The
information maintained must include, but is not limited to, records on
any monitoring or sampling conducted, results of analyses, issuance of
permits, types and numbers of enforcement actions taken, records of any
site-specific regulatory actions, and administrative actions. The State
must commit to promptly make available to the Agency, upon request,
records related to the development or implementation of the Plan.
(2) Commit to developing and submitting to the appropriate Regional
Office a Plan Biennial Report, as described in Sec. 152.191(a), and to
report any significant findings to the appropriate Agency Regional
Office.
(3) Commit to submitting with each report to EPA a signed
certification, worded as follows:
I certify under penalty of law that I have personally examined
and am familiar with the information submitted herein and based on
my inquiry of those individuals immediately responsible for
obtaining the information, I believe the submitted information is
true, accurate and complete. I am aware that there are significant
penalties for submitting false information, including the
possibility of fine and imprisonment. See 18 U.S.C. section 1001 and
7 U.S.C. section 136).
Sec. 152.191 Evaluation of State Management Plan Implementation.
Any State Management Plan approved under Sec. 152.190 shall be
subject to periodic evaluations of its implementation by the Agency, in
order to assure implementation of the Plan consistent with its goals
and commitments, to determine the environmental effectiveness and the
level of ground-water protection provided by the Plan, and to ensure a
minimum level of national consistency.
(a) Biennial Report. A Biennial Report, as described in
Sec. 152.190 (l)(2), must be developed and submitted by the State in
order to maintain Agency approval, and will be used by the Agency and
by State officials to evaluate a State's effectiveness in protecting
its ground-water resources from pesticide contamination. The State
shall prepare the Biennial Report according to the provisions of
Chapter 5 of Appendix A, ``Review, Approval and Evaluation of State
Plans,'' to the Guidance for Pesticides and State Management Plans (EPA
735-B-93-005b, February 1994).
(b) Evaluation reporting requirements. The Biennial Report must be
approved by State officials directing the key State agencies that play
a role in implementing the Plan. The Biennial Report must be submitted
in October of alternate years, starting in October [of the year 4 years
after date of publication of the final rule] to the appropriate Agency
Regional Office. The State may submit a single Biennial Report in the
event it implements Plans for more than one classified pesticide. In
that event, the report must include programmatic and environmental
evaluations addressing each approved Plan. States will also submit a
programmatic and an environmental evaluation that addresses any
progress made in implementing the Plan.
Sec. 152.193 Amendment of State Management Plans.
(a) The State will amend an approved Plan as part of the Biennial
Report required under Sec. 152.191(a) when:
(1) The evaluation performed pursuant to Sec. 152.191 demonstrates
that the provisions in the Plan do not adequately protect the ground-
water resource from pesticide contamination.
(2) A change in the legal (statutory or regulatory) and enforcement
framework for Plan development and implementation necessitates a change
in the Plan.
(3) A State, through experience, finds more effective ways to
assess ground-water contamination, to prevent and respond to
contamination, and to educate affected parties or disseminate
information.
(4) Changes in pesticide management measures or approaches become
necessary as a result of significant changes in crops or crop
production systems and technologies within the State.
(5) Roles and responsibilities of State agencies involved in the
implementation of the Plan change so as to necessitate a change in the
Plan.
(b) If a State is aware that an amendment is needed, then that
amendment should be submitted as part of the Plan Biennial Report. In
addition, if the Regional Office that is the recipient of that Report
determines through the evaluation process that the Plan needs to be
updated, then the Regional Administrator of that region, or a designee,
can initiate the updating process by requesting that the State submit a
Plan Update Report. In every case, the Update Report must include:
(1) A description of the proposed changes in the Plan.
(2) An explanation of why the changes are necessary.
(3) An analysis of the impact the changes will have on the other
[[Page 33299]]
components of the Plan, the implementation of the Plan and the
protection of the resource.
(4) If changes will affect pesticide users, a description of how
users will be alerted to the changes in the Plan.
(5) Concurrences by all officials directing the key State agencies.
(6) If changes are significant, a description of how the State
received public input on changes to the Plan, and the administrative
record developed in the course of changing the Plan. Amendments to
Plans must be concurred or approved by the Regional Administrator.
Sec. 152.195 Withdrawal of approval of a State Management Plan.
(a) If, in the judgement of the Administrator or a designee,
either:
(1) A State fails to demonstrate that it is satisfactorily
implementing the Plan; or
(2) A State's Plan is not protecting ground water from
contamination at or above ground water reference points (as specified
in Sec. 152.198); or
(3) A State fails to address deficiencies identified by the Plan
evaluation through updating the Plan and/or improving implementation of
the Plan; or
(4) A State fails to submit a biennial report;
he or she shall notify the designated State Liaison, named pursuant to
Sec. 152.190(b), and relevant State administrators of the Agency's
concerns. In that event, the State will have 90 days to respond to
these deficiencies in its Pesticide Plans, either through the Plan
updating process or by demonstrating to the Region that the Plan is
being satisfactorily implemented.
(b)(1) If the Administrator determines that the State has failed to
address the deficiencies identified by the Agency or has failed to
correct the deficiencies, the Administrator shall notify the officials
directing the key State agencies involved in implementing the Plan and
the designated State Liaison by letter that withdrawal of Agency
approval is being considered. The notice will include:
(i) A statement concerning the potential withdrawal of Agency
approval of the Plan.
(ii) A listing of the deficiencies of the Plan or a description of
the failure of the Plan or its implementation to protect ground water.
(iii) A brief summary of the events that led to the withdrawal
notice.
(iv) Dates by which the State can respond to the deficiencies to
stop the withdrawal process.
(2) The State must respond to the notice within 30 days of receipt
of the notice in writing with a commitment to address the deficiencies
in the Plan itself or in its implementation. If the State disagrees
with the judgement or the findings of the Administrator in the initial
notice described in paragraph (b) of this section, the State may
request to meet with the Administrator within 60 calendar days from the
time the EPA Administrator sends the letter of potential withdrawal to
the Administrators of the key State agencies.
(3) If, in the Administrator's judgement, continued use of the
pesticide within the State presents unreasonable adverse effects on the
environment because of the deficiencies cited pursuant to paragraph
(b)(1) of this section, the Administrator may prohibit further sale and
use of the pesticide in the State until the Agency and the State reach
an agreement on how to address the Plan's deficiencies. Such a
prohibition shall be published in a Federal Register notice describing
the basis for the Administrator's findings, and soliciting comment
thereon. After addressing any public comment, the Administrator may
take final action temporarily prohibiting use of the pesticide in the
State.
(c) If the State does not respond to the notice that withdrawal of
approval is being considered or fails to address the deficiencies
identified in the notice to the satisfaction of the Administrator, the
Administrator will send a formal letter to the officials directing the
key State agencies and the State Liaison indicating that EPA is
publishing a Federal Register Notice proposing to withdraw the
Pesticide Plan. In the event the State does not respond to this notice,
the Administrator will publish a Federal Register Notice to provide an
opportunity for public comment on withdrawal of the Plan. After
addressing any public comments, the Region will publish a Notice of
Withdrawal in the Federal Register and prohibit the sale and use of the
pesticide in the State.
(d) Upon publication of the final Notice of Withdrawal in the
Federal Register, sale and use of the pesticide within the boundaries
of the State will be prohibited.
Sec. 152.198 Pesticides classified for restricted use subject to a
ground water State Management Plan.
Pesticide products containing the active ingredients listed in the
table to this section, with the corresponding Ground Water Reference
Points specified are classified for restricted use, to be subject to
the provisions and requirements of an EPA-approved State Management
Plan.
------------------------------------------------------------------------
Ground Water
Active Ingredient CAS Number Reference Point
------------------------------------------------------------------------
Alachlor 15972-60-8 2 g/l
Atrazine 1912-24-9 3 g/l
Cyanazine 21725-46-2 1 g/l
Metolachlor 51218-45-2 70 g/l
Simazine 122-34-9 4 g/l
------------------------------------------------------------------------
2. In Part 156:
PART 156--[AMENDED]
a. The authority citation for part 156 continues to read as
follows:
Authority: 7 U.S.C. 136-136y.
b. In Sec. 156.10, by revising paragraphs (a)(1)(viii) and
(a)(1)(ix) and removing paragraph (i) to read as follows:
Sec. 156.10 Labeling Requirements
(a) * * *
(1) * * *
(viii) The directions for use as prescribed in subpart G of this
part; and
(ix) The use classification(s) as prescribed in subpart G of this
part.
* * * * *
c. By adding a new subpart G to part 156 to read as follows:
Subpart G--Directions for Use
Sec.
156.120 General requirements.
156.121 Contents of directions for use.
156.135 Statements of use classification.
156.136 General use statements. [Reserved]
156.137 Restricted use statements.
[[Page 33300]]
Subpart G--Directions for Use
156.120 General requirements.
(a) Adequacy and clarity of directions. Directions for use must be
stated in terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide. When
followed, directions must be adequate to protect the public from fraud
and from personal injury and to prevent unreasonable adverse effects on
the environment.
(b) Placement of directions for use. Directions may appear on any
portion of the label provided that they are conspicuous enough to be
easily read by the user of the pesticide product. Directions for use
may appear on printed or graphic matter which accompanies the pesticide
provided that:
(1) If required by the Agency, such printed or graphic matter is
securely attached to each package of the pesticide, or placed within
the outside wrapper or bag.
(2) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as ``See directions in the
enclosed circular.''
(3) The Administrator determines that it is not necessary for such
directions to appear on the label.
(c) Exceptions to requirement for direction for use--(1) Detailed
directions for use may be omitted from labeling of pesticides which are
intended for use only by manufacturers of products other than pesticide
products in their regular manufacturing processes, provided that:
(i) The label clearly shows that the product is intended for use
only in manufacturing processes and specifies the type(s) of products
involved.
(ii) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of product
involved and its proper use in manufacturing processes.
(iii) The product will not come into the hands of the general
public except after incorporation into finished products.
(iv) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Detailed directions for use may be omitted from the labeling of
pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(i) The label clearly states that the product is for use only by
physicians or veterinarians.
(ii) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(iii) The product is also a drug and regulated under the provisions
of the Federal Food, Drug and Cosmetic Act.
(3) Detailed directions for use may be omitted from the labeling of
pesticide products which are intended for use only by formulators in
preparing pesticides for sale to the public, provided that:
(i) There is information readily available to the formulators on
the composition, toxicity, methods of use, applicable restrictions or
limitations, and effectiveness of the product for pesticide purposes.
(ii) The label clearly states that the product is intended for use
only in manufacturing, formulating, mixing, or repacking for use as a
pesticide and specifies the type(s) of pesticide products involved.
(iii) The product as finally manufactured, formulated, mixed, or
repackaged is registered.
(iv) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
156.121 Contents of directions of general use.
The directions for use shall include the following, under the
headings ``Directions for Use'':
(a) The statement of use classification as prescribed in paragraph
(j) of this section immediately under the heading ``Directions for
Use.''
(b) Immediately below the statement of use classification, the
statement ``It is a violation of Federal law to use this product in a
manner inconsistent with its labeling.''
(c) The site(s) of application, as for example the crops, animals,
areas, or objects to be treated.
(d) The target pest(s) associated with each site.
(e) The dosage rate associated with each site and pest.
(f) The method of application, including instructions for dilution,
if required, and type(s) of application apparatus or equipment
required.
(g) The frequency and timing of applications necessary to obtain
effective results without causing unreasonable adverse effects on the
environment.
(h) Worker protection statements meeting the requirements of
subpart K of this part.
(i) Specific directions concerning the storage and disposal of the
pesticide and its container, meeting the requirements of 40 CFR part
165. These instructions shall be grouped and appear under the heading
``Storage and Disposal.'' This heading must be set in type of the same
minimum sizes as required for the child hazard warning. (See Table in
Sec. 162.10(h)(1)(iv))
(j) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(1) Required intervals between application and harvest of food or
feed crops.
(2) Rotational crop restrictions.
(3) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(4) [Reserved]
(5) For restricted use pesticides, a statement that the pesticide
may be applied under the direct supervision of a certified applicator
who is not physically present at the site of application but
nonetheless available to the person applying the pesticide, unless the
Agency has determined that the pesticide may only be applied under the
direct supervision of a certified applicator who is physically present.
(6) Other pertinent information which the Administrator determines
to be necessary for the protection of man and the environment.
Sec. 156.135 Statements of use classification.
(a) Requirement. Each product bearing one or more uses that has
been classified for restricted use must bear a classification statement
on the label of the product, and also in any supplemental labeling that
accompanies the product in sale or distribution. A product that bears
only unclassified uses as described in Sec. 152.160 or uses classified
for general use is not required to bear any classification statement.
Restricted use statements are set out in Sec. 156.137.
(b) Products bearing mixed classified uses. A product for which
some uses are not classified, and other uses are classified for general
use or for restricted use must have a separate registration for uses
that are restricted, except that a product bearing restricted uses may
also bear unclassified or general uses in addition to the restricted
uses. A product bearing mixed restricted uses and other uses is
considered a restricted use product.
(c) Placement of classification statements. (1) Statements of
restricted use classification must be located at the top of the front
panel of the label (the ``Restricted Use'' area), and in a similarly
prominent location in supplemental labeling. No other label statements
shall appear above the restricted use statements, and no other
statements than those prescribed by the
[[Page 33301]]
Agency shall appear in the restricted use area of the label.
(2) The restricted use statements shall be distinguished from
surrounding label text by suitable means, such as white space or a box
around the statements. The words ``Restricted Use Pesticide'' shall
appear in a type size at least that of the signal word prescribed by
Sec. 156.10(h)(1)(iv).
Sec. 156.136 General use statements. [Reserved]
Sec. 156.137 Restricted use statements.
(a) A product that is classified for restricted use must bear, on
the front panel in accordance with Sec. 156.135(c), the statements in
paragraphs (a)(1) and (a)(2) of this section.
(1) The phrase, ``Restricted Use Pesticide.''
(2) Immediately below the phrase ``Restricted Use Pesticide,'' a
statement of the reason for the restricted use classification. This
statement will describe the characteristic of the pesticide, its
formulation, or its use pattern, that is the basis for the
classification. These characteristics include acute or chronic
toxicity, environmental fate (biodegradability, leaching potential,
etc.), or non-target organism toxicity. The Agency will prescribe the
nature and wording of the statement.
(i) A product that is restricted to use by certified applicators
(for example, pesticides and uses listed in Sec. 152.170) must bear the
statement, ``For retail sale to and use only by Certified Applicators
or persons under their direct supervision and only for those uses
covered by the Certified Applicator's certification.''
(ii) A product that is classified for restricted use subject to a
ground-water State Management Plan (SMP) under subpart J of part 152 of
this chapter must bear the statement, ``For use only in accordance with
an EPA-approved State Management Plan for ground-water protection. Sale
and use are prohibited in States that do not have an EPA-approved State
Management Plan.''
(b) The Agency may develop and require a label statement different
from, or in addition to, those described in paragraphs (b)(1) and
(b)(2) of this section, for any product classified for ``restricted
use.''
[FR Doc. 96-16173 Filed 6-25-96; 8:45 am]
BILLING CODE 6560-50-F