Pesticides and Ground Water State Management Plan Regulation

SUMMARY: This proposed rule implements a key component of the Agency's

1991 Pesticides and Ground Water Strategy, and reflects many years of

discussions and input from States and other stakeholders. Through the

development and use of State Management Plans (SMPs), EPA is proposing

to restrict the use of certain pesticides by providing States with the

flexibility to protect the ground water in the most appropriate way for

local conditions. This approach capitalizes on the most effective and

efficient roles for State and Federal governments to collaborate in the

protection of the nation's ground water resources. In this proposed

rule, using the proposed SMP approach, EPA is proposing to restrict the

legal sale and use of five pesticides that have been identified as

either ``probable'' or ``possible'' human carcinogens--alachlor,

atrazine, cyanazine, metolachlor, and simazine. Because of their

potential to contaminate ground water, EPA has determined that these

pesticides may cause unreasonable adverse effects on the environment in

the absence of effective management measures provided by an SMP. The

labels of these pesticides would be changed to require use in

accordance with an EPA-approved SMP, after a period allowed for

development and approval of these State plans. Incidentally, this

proposed rule will also revise existing pesticide labeling regulations,

in order to clarify general labeling requirements.

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

ADDRESSES: Submit written comments, bearing the docket control number

``OPP-36190'' by mail to: Public Response and Program Resources Branch,

Field Operations Division (7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

Comments may be submitted by facsimile to (703) 305-5558. In person,

bring comments to: Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA 22202.

Comments and data may also be submitted electronically by sending

electronic mail (e-mail) to: [email protected]. Electronic

comments must be submitted as an ASCII file avoiding the use of special

characters and any form of encryption. Comments and data will also be

accepted on disks in WordPerfect in 5.1 file format or ASCII file

format. All comments and data in electronic form must be identified by

the docket number ``OPP-36190.'' No Confidential Business Information

(CBI) should be submitted through e-mail. Electronic comments on this

document may be filed online at many Federal Depository Libraries.

Additional information on electronic submissions can be found in Unit

V. of this document.

Information submitted as a comment concerning this document may be

claimed confidential by marking any part or all of that information as

CBI. Information so marked will not be disclosed except in accordance

with procedures set forth in 40 CFR part 2. A copy of the comment that

does not contain CBI must be submitted for inclusion in the public

record. Information not marked confidential may be disclosed publicly

by EPA without prior notice. All written comments will be available for

public inspection in Rm. 1132 at the Virginia address given above from

8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Arden Calvert, Policy and Special

Projects Staff (7501C), Office of Pesticide Programs, Environmental

Protection Agency, 401 M St., SW., Washington, DC 20460. Office

location and telephone number: Rm. 1113, Crystal Mall #2, 1921

Jefferson Davis Hwy., Arlington, VA, Telephone: (703) 305-7099, Fax:

(703) 305-6244, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: This document is organized into eight units.

Unit I. describes the background and statutory basis for this proposed

regulatory action. Unit II. describes the general considerations by

which the Agency will decide to classify specific pesticides to be

subject to State Management Plans (SMPs). Unit III. describes the

content of SMPs as an ``other regulatory restriction'' pursuant to the

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section

3(d). Unit IV. provides the risk and benefit determinations that are

the basis for today's proposed rule, summarizing data on human health

and environmental risks, ground-water contamination potential and

benefits of the five pesticides subject to today's proposal. Unit V.

provides further information on the public docket established for this

proposed rule. Unit VI. describes referral to the U.S. Department of

Agriculture and the Pesticides Scientific Advisory Panel. Unit VII.

provides a list of references cited in today's proposal. Unit VIII.

provides information on the Regulatory Impact Analysis provided for

this proposed rule and other requirements.

Regulated Entities

------------------------------------------------------------------------

Examples of Regulated

Category Entities

------------------------------------------------------------------------

State Governments States Developing Pesticide

SMPs

Industry Pesticide registrants;

farmers and other commercial

pesticide users

------------------------------------------------------------------------

This table is not exhaustive, but is a guide to the entities EPA

believes would be regulated by this action. Read carefully the contents

of the rule to determine whether this rule applies to you.

I. Basis for Regulatory Action

A. Background

Ground-water resources are of vital importance to the United

States. The quality of these resources affects the health of its

citizens, the integrity of many of its ecosystems, and the vigor of its

economy. Ironically, the variety of human activities made possible by

healthy ecosystems and abundant clean water also threatens the

continued viability of these resources.

Consequently, ground-water protection is a significant

responsibility for EPA. In July 1991, the Agency set forth its ground-

water protection goals and guiding principles in ``Protecting

[[Page 33261]]

the Nation's Ground Water: EPA's Strategy for the 1990's'' (Ref. 11).

The centerpiece of Agency ground-water protection efforts is

development of Comprehensive State Ground Water Protection Programs

(CSGWPPs). These programs are designed to integrate all State and

Federal efforts to protect ground water, increasing the efficiency and

effectiveness of State and Federal resources. The CSGWPPs also mark a

new direction in Federal/State cooperation: EPA supports voluntary

State initiatives to harmonize diverse ground-water protection

activities. Since the use of pesticides contributes significantly to

the problem of ground-water contamination, one of the Agency's first

efforts in developing CSGWPPs is the establishment of State Management

Plans (SMPs) for certain pesticides.

A State Management Plan consists of 12 components that together:

(a) Describe the State's ground-water protection philosophy and

goals, its authority and its organizational and resource basis for

fulfilling its commitment to manage the pesticide's use.

(b) Detail the manner in which the State intends to carry out this

commitment, using such measures as ground-water vulnerability

assessments, ground-water monitoring, and direct management of

pesticide use.

(c) Establish the State's commitments to develop and implement

these provisions through a process of public participation, to make

pesticide users aware of State management measures and to monitor the

effectiveness of the Plan through the development of meaningful

measurements of environmental results.

A pesticide State Management Plan is envisioned to be developed and

implemented in the context of a State's CSGWPP, which outlines the

State's overall ground-water protection approach. The additional

benefits of coordinated implementation of a State's CSGWPP and its SMPs

include: (1) More effective and consistent protection of the resource;

(2) increased State control to target efforts towards highest priority

protection; (3) more efficient use of limited program resources; and

(4) reduced potential for ground-water protection activities to be at

cross-purposes.

While EPA regards the creation of SMPs as a significant step in

protecting ground water from pesticides, EPA will continue to act to

reduce the risk of ground-water contamination in its ongoing national

pesticide registration and reregistration efforts. EPA will continue to

consider specific label provisions for individual pesticide products as

it screens both new and existing uses of pesticides. These may include

general advisory language (warning users of a pesticide's potential to

contaminate ground water and advising caution in the circumstances of

its use) or more specific constraints on the conditions of use, as the

evidence of contamination potential warrants. It may also include

classifying pesticides for use only by or under the supervision of a

certified applicator, under ``conventional'' restricted-use

classification authority (see section D. of this Unit). These

alternative risk-mitigation measures are also part of EPA's

consideration in proposing pesticides for SMPs (see Unit II. of this

preamble).

The concept and development of pesticide SMPs is the direct

outgrowth of extensive, collaborative work to produce a strategy for

achieving ground-water protection by using and integrating all Federal

and State pesticide regulatory authorities and resources. Beginning in

1986, with major public workshops EPA created an interactive process

with other Federal agencies, State agricultural, environment and health

agencies, the private sector, environmentalists, farmers and other

pesticide users, and ground-water experts. The States in particular

have taken an active and constructive role in addressing pesticide and

ground-water issues and have moved ahead with many of the management

approaches ultimately endorsed by the final Agency strategy for

pesticides and ground water.

The Pesticides and Ground-Water Strategy (hereafter referred to as

``the Strategy'') was issued October 31, 1991 (Ref. 12). The Strategy

describes the Agency's goals, policies, management programs, and

regulatory approaches for protecting the nation's ground-water

resources from risks of contamination by pesticides. The Strategy, and

the 1988 proposed Strategy, characterize the breadth and seriousness of

the potential problem of pesticides in ground water and the need for

coordinated regulatory and nonregulatory initiatives to protect the

resource (Ref. 7). Those interested in a more detailed discussion of

the history, purpose, objectives, and policy are referred to the

Strategy itself.

B. Goal

The Strategy articulated the Agency's goal for pesticides and

ground water. In summary, the goal:

is to prevent contamination of ground water resources resulting

from the normal, registered use of pesticides that would cause

unreasonable risks to human health and the environment by taking

appropriate actions where such risks may occur. (Ref. 12, p 9, see

also pp ES 6-7; emphasis added)

This goal highlights two important elements of EPA's pesticide and

ground-water policy: pollution prevention and local action.

Delaying action until ground-water contamination occurs at

significant levels and with a frequency sufficient to cause immediate

concern is costly, and ultimately counterproductive. ``[G]round-water

cleanup is extremely costly, and usually difficult and in some cases

impossible to achieve and demonstrate'' (Ref. 12, p. 10; also, Ref. 11,

p 5). In some cases, actual ground-water contamination may be virtually

irreversible. Allowing contamination to reach a level that presents an

immediate threat to human health or the environment forecloses

prevention and necessitates remediation. Remediation is more costly, as

well as more dangerous, than prudent action to anticipate and prevent

harm.

The second element of the Agency goal is local action. Taking

action locally, ``where such risks may occur,'' takes into account the

highly variable factors affecting the potential for ground-water

contamination. ``Ground water is a uniquely local resource due to the

ease with which small sources can affect it, and the impact that use

and hydrologic characteristics can have on its quality'' (Ref. 11).

There are several factors which generally influence whether

pesticides will contaminate ground water: (1) The properties of the

chemical itself (e.g., solubility in water, persistence, and mobility

in the subsurface environment); (2) the characteristics of the site of

use (e.g., soil type, depth to ground water, temperature, rainfall, and

site-specific hydrological factors collectively denoted by the term,

``sensitivity''); (3) application practices, (e.g., the amount of

pesticide per application, the frequency and method of applications);

and (4) other agronomic practices associated with the pesticide use

(e.g., irrigation or tillage practices).

The Agency believes that, as a general matter, the best method for

addressing differences in sensitivity throughout the country is to

tailor prevention measures in a given area to reflect the vulnerability

of local ground water to contamination. This approach minimizes the

complementary risks of over-regulating where ground water is not

particularly vulnerable to contamination and of underprotecting highly

vulnerable areas which might result from a solely ``national''

regulatory approach. It is expected to

[[Page 33262]]

result in an efficient regulation of pesticide use that will satisfy

the pre-eminent objective of reducing or eliminating unreasonable risk

with respect to ground water.

The Agency has further concluded that for pesticides which may pose

an unreasonable risk, the States can appropriately take the lead in

preventing unreasonable risk and protecting ground water through the

management of pesticide use. State management of use can be based on

local relative vulnerability of the ground-water resource, and where

necessary, its use and value. A lead role for the States, consistent

with overall Agency ground-water protection principles, acknowledges

the traditional primacy of States in the management and protection of

ground water as a natural resource; makes best use of expertise at the

State level in local hydrogeology, soils, agronomic practices, climate,

and pesticide use; and takes advantage of State and local understanding

of population and land use trends that help to define the future use of

ground-water resources.

C. SMP Start-up

State participation in pesticide-use management is a significant

new step for many States, requiring substantial preparation. EPA has

assisted this start-up in several ways, described more fully in the

Strategy.

1. Since 1990, EPA has provided funds to States to help develop

``generic'' SMPs. In these ``generic'' SMPs, States prepare for

development of pesticide-specific requirements by providing basic,

generalized information for each of the required components of a

pesticide-specific SMP. Generic SMPs give States an early opportunity

to consider how they will design Plan components and build the capacity

to implement them. Since Generic Plans have no legal force, EPA does

not ``approve'' them, in the sense of conferring legal authority upon

them; rather, States will submit Generic SMPs for review, comment and

concurrence. Fifty-seven States and territories with primary

enforcement authority for FIFRA use violations, as well as two Indian

tribal authorities, have received funds and are proceeding with

development of the generic SMPs. EPA has provided $35 million in grants

for this purpose in the Fiscal Years 1990 to 1996. By June 1995, all 50

States had developed and submitted draft Generic Plans to EPA regions

for early review and comment.

2. EPA published a Guidance for Pesticides and Ground Water State

Management Plans with two appendices in December 1993 (Ref. 18,

hereafter referred to as the Guidance). It provides practical

instruction on how to develop both Generic and pesticide-specific SMPs.

Much of the contents of the Guidance and the first Appendix anticipates

the contents of today's proposed rule (see Unit II.C. of this

preamble). These documents should be referred to for a more complete

description of how EPA envisions SMPs will be developed, and what EPA

envisions the level of protection will be.

3. As mentioned at the outset of this Unit, pesticide-specific SMPs

are intended to operate as an integral part of CSGWPPs. Likewise,

pesticide and ground-water protection measures tie into other EPA

programs and grants dedicated to ground-water protection. Among the

many related activities are: (a) The non-point source program under

section 319 of the Clean Water Act; (b) Coastal Zone non-point source

measures mandated by the Coastal Zone Management Act as amended in

1990; (c) the emerging ``watershed protection approach'' for

implementing the Agency's Clean Water Act activities; (d) Wellhead

Protection Programs and other drinking-water source-protection

initiatives under the Safe Drinking Water Act (SDWA); and (e) Public

Water System regulatory programs under SDWA, in particular, the

establishment of Maximum Contaminant Levels (MCLs) and monitoring

requirements for a variety of contaminants (including the five

pesticides subject to today's proposed rule). For example, an SMP

designed to deal with pesticide contamination risks could be integrated

with a Well Head Protection Program in a rural community where

pesticide use in nearby agricultural areas posed a threat to well field

re-charge areas. The SMP would provide Federal and State authorities

for pesticide regulation to complement and interact with the State's

other water quality protection authorities to help achieve the goal of

the Well Head Protection Program. A more detailed description of the

variety of interlocking programs is provided in an October 1992

document prepared by EPA's Office of Pesticide Programs (OPP),

``Integrating EPA's Agriculture and Water Grant Programs.''

In addition, the Strategy detailed a variety of related Federal

non-regulatory activities, including U.S. Department of Agriculture

(USDA) research and the ongoing activities of the U.S. Geological

Survey (USGS), as well as the connection between ground-water

protection and the Agency's ongoing pesticide regulatory initiatives,

such as encouraging the development of reduced-risk pesticides.

D. Statutory Authority

As a general matter, pesticides may not be sold, distributed, or

used in the United States unless they are registered by EPA [FIFRA

section 3(a)]. The standard for granting and maintaining a registration

is found in FIFRA section 3(c)(5). Among other things, this section

requires that the pesticide will perform its intended function without

causing unreasonable adverse effects on the environment and that, when

used in accordance with widespread and commonly recognized practice,

will not cause unreasonable effects on the environment.

Further, FIFRA section 3(d) gives EPA authority to classify a

pesticide for restricted use if EPA finds its use may cause

unreasonable adverse effects on the environment. Specifically, FIFRA

section 3 (d)(1)(C) [7 U.S.C. 136a(d)(1)(C)], provides:

If the Administrator determines that the pesticide, when applied

in accordance with its directions for use, warnings and cautions and

for the uses for which it is registered, or for one or more such

uses, or in accordance with widespread and commonly accepted

practice, may generally cause, without additional regulatory

restrictions, unreasonable adverse effects on the environment,

including injury to the applicator, he shall classify the pesticide,

or particular use or uses to which the determination applies, for

restricted use.

In the event the Administrator makes such a determination, ``the

pesticide shall be applied ... only by or under the direct supervision

of a certified applicator, or subject to such other restrictions as the

Administrator may provide by regulation'' (FIFRA section

3(d)(1)(C)(ii); emphasis added). An EPA-approved SMP would be such an

``other restriction.''

The basis for determining whether a pesticide warrants the

``additional regulatory restrictions'' referred to in section

3(d)(1)(C), is finding that the pesticide ``may generally cause ...

unreasonable adverse effects ...'' without such additional

restrictions. FIFRA section 2(bb) defines unreasonable adverse effects

as ``any unreasonable risk to man or the environment, taking into

account the economic, social and environmental costs and benefits of

the use of any pesticide.'' Thus, one of the critical aspects of

determining whether additional regulatory restrictions are necessary is

an evaluation of the risks and benefits of the pesticide use. However,

in finding a pesticide may cause unreasonable adverse effects, EPA will

consider these risks and benefits in a manner that takes into account

the considerable uncertainty surrounding both. Unit IV. of this

preamble, as well

[[Page 33263]]

as the Regulatory Impact Analysis prepared for this proposed rule,

describes the relative risks and benefits associated with the five

pesticides proposed to be subject to SMPs, as well as the costs and

benefits of State Management Plans as a regulatory measure.

Any restrictions imposed under FIFRA section 3(d) authority are

fully enforceable under FIFRA. Section 12 (a)(2) of FIFRA specifically

provides that it shall be unlawful (in subparagraph (F)):

to distribute or sell, or make available for use, or to use, any

registered pesticide classified for restricted use for some or all

purposes other than in accordance with section 3(d) and any

regulations thereunder.

Thus, once this rulemaking is final and EPA has approved the

requirements and specifications that constitute a SMP, that SMP will be

fully enforceable by Federal authorities. EPA will also require

registrants to incorporate the restriction to use a pesticide according

to the provisions of an EPA-approved State Plan as part of that

pesticide's labeling. Thus SMP requirements would also be federally

enforceable pursuant to section 12 (a)(2)(G), which makes it illegal

``to use any registered pesticide in a manner inconsistent with its

labeling.''

II. Process for Selecting Pesticides for Restriction under SMPs

A. Determining Potential to Contaminate Ground Water

As described in Unit I. of this preamble, the Agency's goal for

ground-water protection is to prevent contamination that would cause

unreasonable risks. Prevention entails the need to act in anticipation

of future environmental harm to ensure that this harm does not occur.

There are many uncertainties that limit the ability to quantify

risks and benefits to any reasonable degree of accuracy. These stem in

part from the circumstances pertaining to ground-water risks, and are

discussed further in Unit IV. of this preamble. These and other

impediments to national-level risk-benefit analysis were addressed in

the development of the Strategy, and in fact were instrumental in the

decision to favor the SMP approach in addressing serious pesticide

ground-water risks. Prescribing SMPs for individual pesticides fits

under EPA's regulatory authority to regulate beneficial but potentially

risky substances well before the onset of unreasonable adverse effects.

It also accommodates the uncertainties and variations which

characterize groundwater risk assessment.

This judgement will be made consistent with the Agency's current

regulatory procedures for classifying pesticides for restricted use.

These procedures are contained in 40 CFR part 152, subpart I. They

provide for EPA to impose restrictions other than limiting use to

certified applicators if the Agency determines that:

(a) Without such restrictions, the product when used in

accordance with warnings, cautions and directions for use or in

accordance with widespread and commonly recognized practices of use

may cause unreasonable adverse effects on the environment; and

(b) The decrease in risks as a result of restricted use would

exceed the decrease in benefits as a result of restricted use. (40

CFR 152.171)

Subpart I also provides for restricting use to certified applicators

and for other types of future restrictions, as authorized by FIFRA

section 3(d)(1)(C). Unit III. of this preamble explains in further

detail the distinction between such new ``other regulatory

restrictions'' as this SMP requirement and the conventional restricted

use of application only by or under the supervision of a certified

applicator.

EPA will make such a determination to subject a pesticide to the

requirements of an SMP through a weight of evidence analysis, taking

into account the economic, social and environmental costs and benefits

of the pesticide's use.

The first step in this weight-of-evidence approach is to

characterize a pesticide's potential to contaminate ground water.

Direct evidence of a pesticide's contamination potential includes its

physical-chemical properties (e.g., leaching potential) and the

circumstances, frequency and concentrations of known occurrence in

ground water. In addition to the direct evidence of contamination

potential, EPA will take into account information about use patterns

and practices which may supplement the more direct evidence of

contamination potential. Specifically, EPA will also consider: (a) The

crops and sites on which a pesticide is registered for use; (b) the

volume of pesticide used (on specific sites or crops, or in total) and

the extent of the pesticide's use (in terms of rates and/or number of

acres treated); and (c) the methods, timing, and rates of application

of a pesticide.

EPA will also take into account the potential of any of a

pesticide's by-products, metabolites or degradates, or any other

component of a product associated with the pesticide, to reach ground

water or to cause an adverse effect thereby, to the extent such

substances have been identified and information about their potentials

are known.

B. Determining Potential Risk

The second step is to compare the pesticide's potential to

contaminate ground water to an indicator of unreasonable risk. In

theory, a pesticide may have a ``potential to contaminate ground

water'' but not an associated significant ``potential to cause adverse

effects.'' The Ground-Water Reference Point is an important tool in

determining whether this association exists. Ground-Water Reference

Points are numerical indicators of the toxicity of a substance

established by EPA, based on test data and other reliable health

effects information. The concept of Ground-Water Reference Points was

explicated in the July 1991 Protecting the Nation's Ground Water: EPA's

Strategy for the 1990's (Ref. 11; in Part D, ``Agency Policy on EPA's

Use of Quality Standards in Ground-Water Prevention and Remediation

Activities'') and echoed in the Strategy (Ref. 12). Pursuant to these

policies, EPA will use as reference points for specific substances any

of the following: (1) Maximum Contaminant Levels (MCLs) established

under the Safe Drinking Water Act, or (2) Health Advisories (where MCLs

are not available for a substance), or (3) Water Quality Standards

(where the concern is adverse effects to ecosystems affected by closely

hydrologically linked surface waters) under the Clean Water Act. If

such numbers are not available, reference points may be derived from

the health effects literature where appropriate. In certain cases, the

Agency policy (cited above) provides that Maximum Contaminant Level

Goals (MCLGs) under the Safe Drinking Water Act may be used in order to

comply with Federal statutory requirements; however, MCLGs are unlikely

to be used in the context of any regulatory action the Agency might

take under FIFRA.

In protecting ground water, the Agency takes the reference point as

a benchmark that defines the failure of currently-implemented

preventive measures (c.f., Ref. 11, p. 31: ``Reaching the ...

appropriate reference point would be considered a failure of

prevention.''). In the context of pesticides and ground water, a

detection at or above the level established as the appropriate Ground-

Water Reference Point for a pesticide ingredient would be considered a

failure of measures to prevent unreasonable risk to human health or the

environment associated with that ingredient. Known

[[Page 33264]]

or predicted levels of contamination can be compared to these reference

points in order to gauge the relative risk of adverse effects.

Reference points provide a means by which the Agency may assess and

take into account the toxicity of ground-water contaminants, and

thereby the implicit level of hazard and risk posed by particular

contamination levels. Given the uncertainties regarding: (1) The actual

level and extent of pesticide contamination in ground water; (2) the

nature and degree of human exposure associated with such contamination;

(3) either the levels or the mechanisms of pesticide occurrence that

may affect ecosystems, habitats, or non-target biological organisms;

and (4) the anticipated future levels of occurrence, exposure and

associated hazard, it is problematic to make direct estimates of

exposure, and hence estimates of risk, with satisfactory accuracy.

Therefore, use of reference points to gauge the relative seriousness of

detected pesticide contamination serves as a useful surrogate to direct

estimates of exposure and risk.

It is theoretically possible to determine that a pesticide has the

potential to contaminate ground water, but that it is unlikely to cause

adverse effects. In practice, however, this distinction can often be

difficult to sustain with reasonable certainty. First, there is often

significant uncertainty about the levels and extent of current

contamination. Ground water is not systematically monitored across the

country. Ground waters susceptible to contamination by pesticides vary

significantly in character, limiting the ability to generalize beyond

ground-water monitoring sites. For ground water, models are not

sufficiently reliable to predict future contamination. Second, any

contamination of ground-water resources represents some tangible damage

to its value as a resource to present, and especially future,

generations. The Agency's pollution prevention philosophy clearly

states the Agency's interest in protecting the resource from

impairment. Hence, the Agency included in its Reference Point policy

that, as a matter of policy (Ref. 11):

Detection of a percentage of the reference point at an

appropriate monitoring location would then be used to trigger

consideration of additional action (e.g., additional monitoring,

restricting, limiting use or banning the use of a pesticide).

As a matter of prudence, therefore, the Agency considers the ability to

reach ground water, as indicated by physical and chemical properties,

and detections at any level to be evidence of some potential to reach

ground water at an unacceptable level.

C. Determining Appropriate Regulatory Action

After characterizing the pesticide's ground-water contamination

potential and its associated health and environmental risk, EPA next

considers the adequacy of current labeling safeguards. The Strategy

describes this step (Ref. 12):

If EPA has reasonable assurance from the evidence of a

particular chemical's contamination potential that it would not

cause `unreasonable adverse effects on the environment' if used in

accordance with the requirements of the label or under the

conditions of restricted use [to certified applicators], then

...those national-level management measures [would be] the only

measures necessary.

However, if EPA cannot conclude from the available evidence that

these measures would sufficiently reduce the risk of ground-water

contamination, it could pursue either an approved SMP, ... or

national cancellation if State Management Plans would not be

adequate to prevent risks.

A judgement on the need for State management measures depends on the

Agency's confidence in the effectiveness and efficacy of these uniform

national labeling instructions relative to the protection anticipated

from SMPs, present use practices and patterns, existing State risk-

mitigation measures and other prospective Federal regulatory actions,

including label changes and restricting use to certified applicators.

When EPA has adequate confidence in the efficacy of such measures, it

will conclude SMPs are unnecessary. The decision to prescribe SMPs is a

judgement that national labeling limitations likely will not prevent

the realization of a pesticide's ground-water contamination potential.

In considering whether to prescribe an SMP for a pesticide, EPA

evaluates the benefits of continued pesticide use under the provisions

of an SMP. The assessment of whether the reduced risk of ground-water

contamination might justify the social and economic costs of the SMP is

documented in a Regulatory Impact Assessment. The costs considered

include both the expense of developing and implementing SMPs (e.g.,

direct costs) as well as the costs of foregone benefits (e.g., indirect

costs). Indirect costs may include more expensive pest-control

substitutes and the economic loss associated with less pest control.

The Agency decides to establish the SMP restriction upon a reasoned

determination that the benefits of regulatory action justify its costs,

recognizing that some costs and benefits are difficult to quantify.

Finally, EPA also considers whether it is likely to take other,

more stringent regulatory action such as cancellation of major products

and/or uses of a particular pesticide. For instance, the Agency might

conclude that a pesticide in Special Review poses an unreasonable risk

for reasons different from and in addition to ground-water concerns, so

that only cancellation of major products and/or uses would be

appropriate. In that case, EPA would be inclined not to require the

States to develop SMPs to manage uses that will soon be prohibited. On

the other hand, EPA may both start a Special Review of a pesticide and

propose the same pesticide for SMPs via rule making. There may be a

need to provide the increased level of ground-water protection afforded

by State Plans while the Special Review is conducted. As the Strategy

explained, EPA may also use its cancellation authorities under FIFRA

section 6 to establish SMPs. There are many possible outcomes of a

Special Review besides the more stringent measure of cancellation. For

example, the Agency is addressing the ground-water contamination

potential of the pesticide aldicarb through a Special Review instituted

in 1984, and thus is not including it in this proposed rule. EPA sees

no inconsistency in pursuing both this proposed rule and the new

Special Review for the triazines, initiated in November 1994.

D. Selection of Pesticides for Today's Rule

The Agency has selected five pesticides for regulation under SMPs:

atrazine, simazine, cyanazine, alachlor and metolachlor. In selecting

these five, the Agency evaluated the ground-water contamination

potentials, hazards and uses of 20 currently registered pesticides that

have been reported to occur most frequently in ground water, according

to the available data compiled by EPA's Office of Pesticide Programs

(Ref. 15) (see Table 1). This included the pesticide aldicarb, which

was not considered for this proposed rule in light of its ongoing

Special Review.

Table 1.--Currently-Registered Pesticides Considered for SMPs Because of

Their Detection in Ground Water

------------------------------------------------------------------------

Selected Not selected at this time

------------------------------------------------------------------------

Alachlor Aldicarb

Atrazine Bentazon

Cyanazine Bromacil

[[Page 33265]]

Metolachlor Carbofuran

Simazine DCPA (Dacthal)

Dicamba

Diazinon

Lindane

Picloram

Methomyl

Metribuzin

Oxamyl

Promoton

1,3-D (Telone II)

2,4-D

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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,''

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``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

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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- 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 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 wells 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 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% ( 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 g/l).

Estimated Occurrence Rate NA Rf.

Pt. (Statistica

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