33260 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 152 and 156

[OPP–36190; FRL–4981–9]

RIN 2070–AC46

Pesticides and Ground Water State

Management Plan Regulation

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of proposed rulemaking.

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 EPAapproved 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: oppdocket@epamail.epa.gov. 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:

calvert.arden@epamail.epa.gov.

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

Category Examples of Regulated 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
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 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 groundwater 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 crosspurposes.

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 riskmitigation 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 groundwater 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 groundwater 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 groundwater 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
33262 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

result in an efficient regulation of

pesticide use that will satisfy the preeminent 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 startup 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 EPAapproved 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
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 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 groundwater 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 groundwater 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-ofevidence 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 byproducts, 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 GroundWater 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
33264 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

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 groundwater monitoring sites. For ground

water, models are not sufficiently

reliable to predict future contamination.

Second, any contamination of groundwater 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 groundwater 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
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33265

Table 1.—Currently-Registered Pesticides Considered for SMPs Because of Their Detection in Ground

Water—Continued

Selected Not selected at this

time

Metolachlor Carbofuran

Simazine DCPA (Dacthal)

Dicamba

Diazinon

Lindane

Picloram

Methomyl

Metribuzin

Oxamyl

Promoton

1,3-D (Telone II)

2,4-D

The five pesticides selected for this

proposed rule, stand apart in the

breadth, frequency, and magnitude of

ground-water contamination. While

Unit IV. of this preamble goes into the

evidence in greater detail, each has been

detected hundreds of times in many

States. Each has been detected at levels

exceeding their corresponding reference

points in multiple locations or times,

clearly exhibiting a capacity to

contaminate ground water at

concentrations exceeding health-based

standards. All five are also associated

with serious and irreversible

toxicological effects, including

carcinogenicity. One (alachlor) was

classified as a B2 (probable human)

carcinogen by EPA, but is now

considered to be not classified pending

further review of scientific issues; the

remaining four have been classified as C

(possible human) carcinogens. These

classifications are under review, as

discussed later in this document.

All five are broad-spectrum herbicides

with extensive agricultural uses. These

similarities of use suggest that these five

can be regulated together as a cluster.

Since all raise significant ground-water

concerns, dealing with them together

also helps prevent creating unintended

incentives to substitute ones under

State-management constraints for those

less stringently regulated. Analytic

methods for ground-water monitoring of

these compounds are available and in

widespread use around the country.

This fact, combined with the

commonalities of use practices, will

make it easier for States to develop

coordinated monitoring programs for

these five as a group.

Among the other candidates, several

are known to have occurred in

concentrations exceeding an MCL or

Health Advisory Levels, but not as

frequently as the pesticides selected.

Furthermore, previous regulatory

restrictions on use can be considered to

have significantly reduced the risks of

ground-water contamination for some of

these candidates. One example is

carbofuran, which has been detected

over 4,100 times from 1980-1990 in 11

States, with 73 of those detections at

levels over the current MCL of 40

micrograms per liter (μg/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,’’
33266 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

‘‘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 EPAapproved State Management Plan (SMP) for

ground-water protection. Sale and use are

prohibited in States that do not have an EPAapproved 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 § 152.187

provides that a State may submit a

proposed Plan at any time, § 152.187

prohibits use of a pesticide or pesticides

in question in States without an EPAapproved 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 groundwater 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
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33267

circumstances. In delegating approval

authority to the Regional Administrator,

EPA anticipates that only a limited

Agency Headquarters role will be

necessary. Headquarters will help

assure overall national consistency

among Regions by providing a forum to,

for example, air issues which Regions

believe may need additional

clarification. It is EPA’s assumption that

such consultation will be particularly

helpful in the beginning of SMP

development and implementation;

therefore, the Agency has established a

regular schedule of regional/HQ

consultation to facilitate regional review

of initial Generic and pesticide-specific

SMPs. After promulgation of the rule,

Headquarters will continue to provide

specific national policy guidance and

technical assistance as the regions

require.

The Guidance, in Appendix A

(Chapters 2-4), envisions a two-step

process for EPA review and approval or

disapproval of proposed State Plans.

The first step, a completeness review, is

to ensure that the State has addressed

all 12 components of an SMP, pursuant

to the requirements set forth in

§ 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, § 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 previouslyapproved SMPs (see § 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 § 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 § 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
33268 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

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 groundwater 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 longterm 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

§ 152.190.

1. State’s philosophy and goals

toward protecting ground water.

Proposed § 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
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 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

§ 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

§ 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

§ 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 sideby-side comparison of SMP

requirements as described in proposed

§ 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 § 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

§ 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 § 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 groundwater 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 groundwater sensitivity must involve ‘‘subcounty’’ 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 subcounty 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
33270 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

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 subcounty 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/decisionmakers 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 groundwater 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-callin authorities under FIFRA section

3(c)(2)(B)) for additional ground-water

monitoring from the registrants of these

five pesticides. Such concurrent datagathering 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 groundwater 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 § 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
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 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 § 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 groundwater 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

§ 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,
33272 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

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

§ 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 § 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 § 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 groundwater 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 § 152.191), by

updating the SMP (per proposed

§ 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 EPAidentified 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
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 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 § 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 EPAapproved State Management Plan (SMP) for

ground-water protection. Sale and use are

prohibited in States that do not have an EPAapproved 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

§ 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 § 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 § 156.10 each describe one of nine

specific components of a pesticide

product label. EPA proposes that the

last two paragraphs of § 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 § 156.10; (2)

redesignating paragraph (i) as two new

sections, § § 156.120 and 156.121,

within this new subpart G; and (3)

creating new § § 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

§ 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
33274 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

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 preventionprogram 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 riskreduction 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

§ 152.198. A State would be free to

specify in its Plan an array of riskmanagement 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

§ 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

§ 152.190(h) to require SMP responseprogram 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 riskmanagement 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 groundwater 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 nationallevel 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
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 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 broadspectrum 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-thanoffsetting 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,
33276 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

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 healtheffect 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

Point (μg/l)

Source (MCL,

HAL, or other)

Reference

Dose (RfD)

(μg/kg/d)

Study/Endpoint1 Cancer

Category

Q1

* (1/

mg/kg/d)

Atrazine .... 3 Final MCL 352 Chronic Animal Study decreased body wt. gain; cardiodevelopmental toxicityC 0.22

Simazine 4 Final MCL 5 Chronic Rodent Study (decreased body wt. gain

hematological changes)

C 0.12
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33277

TABLE 2.—SUMMARY OF HUMAN HEALTH RISK—Continued

Ground

Water Reference

Point (μg/l)

Source (MCL,

HAL, or other)

Reference

Dose (RfD)

(μg/kg/d)

Study/Endpoint1 Cancer

Category

Q1

* (1/

mg/kg/d)

Cyanazine 1 HA 2 Chronic Animal Study (decreased body wt. gain) C 1.00

Alachlor .... 2 Final MCL 10 Sub-Chronic Dog Study (hematology) * 0.08

Metolachlor 70 HA 100 Chronic Rodent Study C 0.009

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 nontarget 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 chlorotriazines 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 μg/

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 μg/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 longerterm 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 μg/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 μg/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 μg/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
33278 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

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 carbonreferenced 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 dissipation

half-life

> 21 days

(3 wks),

or

60-120 days 44-231 days 6-181 days 11 days 7-292 days

............... Lab-derived aerobic

soil metabolism

half-life

> 21 days

(3 wks),

or

146 days 110 days 17 days 2-3 weeks 67 days

............... Hydrolysis half-life < 10% in 30

days, or

stable (pH

5,7,9)

stable (pH 5,7,9) 148 days (pH 5),

stable (pH 7,9)

stable (pH

3,6,9)

stable (pH 5,7,9)

............... Photolysis half-life

(soil)

< 10% in 30

days

> 30 days > 30 days 6 days NA 8 days

Mobility ....... Soil adsorption: Kd ≤ 5 ml/g, or 0.20 (sand) 4.31 (clay) 0.28-2.3 1.87 (clay)

............ 0.73 (loam) 0.65 (sand) 2.16 (sandy

loam)

............ 0.79 (sandy

loam)

1.27 (sandy

loam)

0.62-8.13 0.108 (sand)

............ 2.45 (clay) 0.48 (loam) 0.77 (loam)

............... Soil adsorption ≤

Koc

≤ 500 ml/g,

or

38 - 152 103 - 152 40 - 84 190 (est)1 22 - 110
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33279

TABLE 3.— PERSISTENCE AND MOBILITY—Continued

(A value exceeding a criterion shown in Italic)

Parameter Criteria Atrazine Simazine Cyanazine Alachlor Metolachlor

............... Depth of leaching in

field dissipation

study

75 cm NA2 NA2 45 cm 122 cm ≥ 122 cm

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 μg/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 μg/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 μg/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 μg/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
33280 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

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 μg/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 μg/l whereas

the likely MCL for cyanazine is 1 μg/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 μg/l;

whereas the detection limit for the other

4 analytes was 0.03 μg/l. This higher

detection limit undoubtedly reduced the

number of observed positives. No

estimate was given for cyanazine

concentrations that exceed 1 μg/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 μg/l

(or 10 percent of its reference point) in

more than 350 wells in 21 States.

The NPS estimated that 3,140 (or <0.1

percent) rural domestic wells contained

alachlor at levels above the Reference

Point of 2 μg/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 μg/l (or 10

percent of the MCL). Alachlor is

estimated to occur at levels exceeding

its 2 μg/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 μg/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 μg/L. The average

detection limit was 0.03 μg/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 μg/l. Detections

ranged from 0.1 to 88 μg/l with half of

these detections at concentrations of 0.1

to 0.5 μg/l. None of the detections in

this study exceeded the Health Advisory

(HA) of 70 μg/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

Atrazine (Rf. Pt. = 3 μg/l)

Data Source

PGWDB NPS NAWWS

State Surveys

IA: SWRL WI: RWS CA: WID

# of Wells Sampled ................... 26,909 (in 40

states)

1,349 (566 PWS,

783 private)

1,430 (in 89

counties)

686 2,200/236 6286 (in 53

counties)

Frequency & Distribution of Detections (# of wells).1,512 (in 32

states)2

NA 166 NA 603/200 (143-

208)1,2

111 (in 21

counties)

Frequency & Distribution of

Wells > Rf. Pt..

172 (in 22

states)

NA 2 NA NA/15 (56)1,2 0

Range of Detected Concentrations (in μg/l).trace-1500 trace - 7.0 ≤0.1 - 6.72 0.13 - 6.61 0.10 - 16.0 0.1 - 0.19

Estimated Occurrence Rate

(Statistical Surveys only; Confidence interval ranges in

parens).

NA Among CSWs:

1.7% (0.5-2.9%);

Private wells:

0.7% (0.1-2.0%)

12% 4.4%(2.8-5.9)

3.5% 3 ..........

3.5%4 ............

NA NA

Estimated Number of Wells with

measurable residues (Statistical Surveys only; Confidence

interval ranges in parens).

NA Among CSWs:

1570 (420-2710);

Private wells:

70,800 (13,300-

214,000)

720,000 NA NA NA
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33281

TABLE 4.—ATRAZINE OCCURRENCE IN GROUND WATER—Continued

Atrazine (Rf. Pt. = 3 μg/l)

Data Source

PGWDB NPS NAWWS

State Surveys

IA: SWRL WI: RWS CA: WID

Estimated Occurrence Rates &

# of wells with concentrations

> Rf. Pt. (Statistical Surveys

only).

NA < 0.1% Private

wells < 9,450 Private wells

0.1%; 8,400 private wellsNA NA 0

Detection Limit (μg/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

Simazine(Rf. Pt. = 4 μg/l)

DATA SOURCE

PGWDB NPS NAWWS

State Surveys

CA: WID

# of Wells Sampled .......................................... 22,374 (30 states) * * 6,752 (55 counties)

Frequency & Distribution of Detections (ι of

wells).

486 in 19 states NA 23 308 (9 counties)

Frequency & Distribution of wells > Rf. Pt. ..... 36 in 12 states NA 1 0

Range of Detected Concentrations (μg/l) ........ trace - 67 trace - 1 < 0.15 - 8.36 0.1-2.4

Estimated Occurrence Rate (Statistical Surveys only).NA For CSWs: 1.1% (0.4-

2.7%) private wells:

0.2% (< 0.1 - 1.3%)

Private wells: 1.6%

Estimated Number of Wells with measurable

residues (Statistical Surveys only).

NA For PWSs: 1,080 (350 -

2540) private wells:

25,100 (590 - 141,000)

96,000 private wells

Estimated Occurrence Rates & # of Wells with

concentrations ≤ Rf. Pt. (Statistical Surveys

only).

NA < 0.1 %

< 9,450 private wells .........

NA

Detection Limit (μg/l) ........................................ Various 0.38 0.025 Various
33282 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

TABLE 6.—CYANAZINE OCCURRENCE IN GROUND WATER

Cyanazine (Rf. Pt. = 1 μg/l)

DATA SOURCE

PGWDB NPS NAWWS

State Surveys

IA: SWRL CA: WID

# of Wells Sampled ............................ 7,468 (in 27

states)

* * 686 871 (in 24 counties)

Frequency & Distribution of Detections (ι of Wells).155 in 15 states NA NA NA 0

Frequency & Distribution of Wells ≤

Rf. Pt..

22 in 9 states NA 0 0 0

Range of Detected Concentrations

(μg/l).

trace -29.0 0 < 0.45 0.14 - 0.84 0

Estimated Occurrence Rate (Statistical Surveys only).NA < 0.1% 0.3% (private

wells)

1.2% (private

wells)

NA

Estimated Number of Wells with

measurable residues (Statistical

Surveys only).

NA < 9,450 private wells 18,000 private

wells

NA NA

Estimated Occurrence Rates & # of

Wells with concentrations > Rf. Pt.

(Statistical Surveys only).

NA < 0.1% 0 NA NA

Detection Limit (μg/l) .......................... Various 2.4 0.1 0.12 Various

TABLE 7.—ALACHLOR OCCURRENCE IN GROUND WATER

Alachlor (Rf. Pt. = 2 μg/l)

DATA SOURCE

PGWDB NPS NAWWS

State Surveys

IA: SWRL CA: WID

# of Wells Sampled ......................... 26,856 (in 35 states) * * 686 2,009 (34 counties)

Frequency & Distribution of Detections (ι of Wells).543 (in 25 states) * 28 NA 1

Frequency & Distribution of Wells >

Rf. Pt..

101 (in 16 states) * NA 1

Range of Detection Concentrations

(μg/l).

trace - 3,000 4.2 < 0.15 - 6.19 0.02 - 4.76 9.0

Estimated Occurrence Rate (Statistical Surveys only).NA < 0.1% (<

0.1 - 1.0%)

- private

wells

0.8% - private wells 1.2% (0.4 -

2.0%)

NA

Estimated Number of Wells with

measurable residues (Statistical

Surveys only).

NA 3,140 (1 -

101,000)

private

wells

48,000 private wells NA

Estimated Occurrence Rates & # of

Wells with concentrations ≤ Rf.

Pt. (Statistical Surveys only).

NA < 0.1% (<0.1

- 1.0%);

3,140 (1 -

101,000)

private

wells

0.02%; 1200 private wells Various

Detection Limit (μg/l) ....................... Various 0.50 0.025 0.02
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33283

TABLE 8.—METOLACHLOR OCCURRENCE IN GROUND WATER

Metolachlor (Rf. Pt. = 70 μg/l)

DATA SOURCE

PGWDB NPS NAWWS

State Surveys

IA: SWRL CA: WID

# of Wells Sampled ............................. 22,255 (in 29

states)

* 240 (in 4 states) 686 107 (10 counties)

Frequency & Distribution of Detections (# of Wells).213 (in 20 states) * 39 (in 4 states) NA 0

Frequency & Distribution of Wells >

Rf. Pt..

3 (in 3 states) 0 0 NA 0

Range of Detection Concentrations

(μg/l).

0 - 157 0.20 - 3.81 0.1 - 88.0 0.04 -9.00 0

Estimated Occurrence Rate (Statistical Surveys only).NA 1.0% (private wells) 16% (private

wells)

1.5% (0.6-

2.4%)-private

wells

NA

Estimated Number of Wells with

measurable residues (Statistical

Surveys only).

NA 60,000 private wells NA NA NA

Detection Limit (μg/l) ........................... Various 0.025 0.1 0.04 Various

Legend (for Tables 4-8) Data in Tables

include data on identifiable metabolites,

shown in italics. Specific degradate

compounds identified by footnote. Numbers

in parentheses in rows displaying estimates

for statistical surveys are 95% confidence

intervals for a given estimate. Studies,

surveys, and reports containing the

information summarized in Table, denoted

by abbreviations as explained below:

PGWDB = Pesticides in Ground Water Data

Base (as summarized in Ref. 15), which also

includes the data reported in the ‘‘state

surveys’’ in this Table - thus, ‘‘detections’’ as

reported in each column are not additive

(although the PGWDB does not include the

detections from the NPS, NAWWS or Ciba

statistical studies).

NPS = National Pesticide Survey, Phase I

Report (Ref. 10); also Phase II Report (Ref.

14). Data may be displayed reporting separate

results for community-supply wells (CSWs),

serving public community water systems and

rural, private wells. The two categories were

selected for sampling according to different

stratification schemes.

NAWWS = National Alachlor Well Water

Survey (as summarized in Refs. 3 and 4); note

that estimates of occurrence rates listed in

the Table under the ‘‘NAWWS’’ column

apply only to rural private water wells in the

‘‘alachlor use area’’ as defined in the

NAWWS design; ascribing Study’s

occurrence rates nationally would overstate

prospective occurrence. However, the

projected number of wells and/or population

exposed take that limitation into account.

Ciba = Large-scale Retrospective G.W.

Monitoring Study (for metolachlor only; Ref.

2).

IA: SWRL= Iowa State-Wide Rural Water

Survey (1990); note that specified occurrence

rates in the Table apply to estimated

occurrence in the State of Iowa only.

WI: RWS = Wisconsin Rural Well Survey

(1990).

CA: WID = California Well Inventory

Database (annual reports; data contained in

Ref. 15).

NA = Not applicable or unavailable.

Trace = Detection below a specified

detection limit.

* = See Table 4.

c. Conclusions—Ground water

contamination potential. The five

pesticides selected in today’s proposed

rule exhibit persistence and mobility

characteristics that suggest the capacity

to reach ground water on a widespread

basis. This potential is confirmed by the

record of occurrence produced from

ground-water monitoring efforts. Each of

the five has been detected hundreds of

times in many States, indicating the

breadth and magnitude of ground-water

contamination potential. Moreover, each

has been detected at concentrations

exceeding its respective reference point

in multiple locations, in different States,

and across a variety of hydrologic and

geologic conditions. This, and the fact

that many more detected concentrations

of each are within one order of

magnitude (i.e., 10 percent or more) of

each reference point, confirms that each

pesticide exhibits the capacity to reach

ground water at concentrations

exceeding health-based standards. To

EPA’s knowledge, point sources do not

explain the range and number of these

occurrences. All five can be reasonably

expected to contaminate ground water

at or above their respective reference

points. EPA has reached the tentative

conclusion from this data that

continued use of these pesticides

without further controls and protective

measures constitutes a clear risk of

continued ground-water contamination.

4. Risk conclusions. In summary, EPA

concludes that exposure from these

pesticides may present the potential for

adverse human health and

environmental effects associated with

exposure from these five pesticides.

These five, while they may differ

among themselves in the frequency and

severity of prior detections in ground

water, entail a significant number of

detections in multiple States. Among

currently registered pesticides, only

these five and aldicarb, which is being

addressed by other regulatory means,

have been detected above their

respective reference points in three

States or more. Second, these five share

a substantial overlap in use sites and

crops, such that each pesticide could

represent a significant alternative to the

use of one or more of the others. This

latter circumstance plays a significant

role in EPA’s decision to subject all five

to SMPs. Leaving one or more of these

free from State management measures

might constitute an incentive for users

to substitute that pesticide for one of

those subject to SMPs. EPA’s analysis of

the contamination potential of these

pesticides suggests that such a course

might only increase the occurrence of

the excluded pesticide(s) to a frequency

and severity that would rival that

observed for atrazine and alachlor. The

practical effect of such an exclusion

might be to worsen the overall quality

of the ground-water resource.

EPA has also considered the potential

impact associated with the increased

use of substitute pesticides that may

result from reduced use of the five

under consideration here. This issue

includes two separate considerations.

The first is the possibility that increased

ground-water contamination will result

from increased use of substitute
33284 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

pesticides not subject to SMPs. EPA

acknowledges that there is a likelihood

that other pesticides will be used in

substitution for these five in cases

where State measures constrain triazine

and acetanilide use. EPA has analyzed

the likelihood for such substitutions in

its Regulatory Impact Analysis (see Unit

VIII. of this preamble); in this analysis

the Agency has identified the likely

substitute pesticides for a substantial

variety of crops and other uses. Only a

few of the prospective substitutes

exhibit similar persistence and mobility

characteristics; upon closer

examination, moreover, it is unlikely

that any of the prospective substitutes

exhibit as severe a potential for groundwater contamination as these five

candidates. None of the prospective

substitutes have been detected in

ground water to the extent and

frequency as these five. Given the

substantial evidence summarized in

here that these five are the largest

ground-water contamination risks of any

pesticides in current use, EPA

concludes that it is has no reason to

anticipate that increased use of

substitutes will result in a greater risk to

ground water for the foreseeable future.

The other consideration is that the

increased use of substitutes might

indirectly increase net risks, because of

greater risks through other routes of

exposure, such as dietary and worker

exposures. This is a considerably more

complex question. EPA believes that

these risks will not measurably rise

because of the use of anticipated

substitutes. EPA reaches this

conclusion, considering: (1) There will

be comparatively little substitution of

use of these pesticides with potentially

more dangerous alternatives (at least

compared to an outright cancellation),

since EPA’s analysis of impacts

concludes that State measures will

permit substantial continuing use of the

five pesticides in question; and (2) none

of the anticipated substitutes pose

particularly elevated risks for these

other exposure routes at reasonably

expected increased levels of use. EPA

has confidence that none of the

substitutes are particularly more toxic,

overall and in relation to particular

endpoints, than the five pesticides in

question. For example, none of the

prospective substitutes are in Special

Review, for health concerns as the

triazines are.

a. Metabolites. At this time EPA does

not intend to require that State Plans

provide for monitoring degradates of

these five pesticides. However, EPA

would like comments on: (1) Whether it

should require State submissions to

address selected metabolites of

toxicological concern; (2) what specific

metabolites should be addressed by

SMPs; and (3) what specific SMP

provisions should apply to the

metabolites.

The Agency notes that relatively

inexpensive screening methods are

available for all five of the parent

compounds, and for many of their

metabolites. Thus, a State may choose to

include degradates in their monitoring

plan, as some already do. Moreover, if

additional information about some or all

of these degradates raises concerns in

the future, EPA may revisit this issue.

The availability of practical analytical

methods would be an important

consideration in asking States to include

degradates in their monitoring plan.

C. Costs and Benefits

The following section completes

EPA’s proposed determination that the

five pesticides may present an

unreasonable risk to the environment

without additional management

measures to reduce the chances of their

contamination of ground-water

resources, by evaluating the risks

represented by that contamination

potential in light of the social and

economic costs that SMPs represent.

Costs and benefits under consideration

are conceived on the broadest, most

inclusive fashion (i.e., beyond the direct

costs of the SMPs envisioned by this

proposed rule and the benefits of

averting human health risks represented

by ground-water contamination). The

remainder of this section summarizes

the data, analysis and conclusions

contained in the Agency’s draft

Regulatory Impact Analysis (RIA)

prepared for this rule pursuant to

Executive Order 12866 (see Unit VIII. of

this preamble). Those interested in a

more detailed analysis of costs and

benefits should refer to that document.

The assessment of risks and benefits

associated with the decision to make

these five pesticides subject to SMPs as

a regulatory requirement takes into

account the Agency’s policy objective of

prevention, i.e., to act in order to avert

reasonably expected adverse effects to

human health or the environment before

they may occur. EPA must exercise its

judgement on the basis of an analysis of

the respective costs and benefits of

regulatory action in a manner that takes

into account the considerable

uncertainty surrounding both. This

entails acting on the basis of less

tangible evidence of risk and

considerable degree of uncertainty about

both existing and future ground water

contamination and its consequences,

and taking considerable allowance of

these uncertainties. It also entails

weighing a detailed and quantified

analysis of costs against an array of

prospective benefits, many of which are

difficult to describe in quantitative

terms. Such a comparison, between

what appear to be tangible costs and

more intangible benefits, presents wellrecognized analytic difficulties. Care

must be taken not to let the quantified

factors override consideration of

important qualitative factors. In other

words, SMPs will be justified based on

a reasoned determination that the

benefits (generally conceived and

including elements difficult to quantify)

justify the cost impacts associated with

SMPs.

In developing the Strategy (Ref. 12)

EPA evaluated a range of available

regulatory options in addition to the

State Management Plan approach.

Specifically, EPA compared three

general approaches in a companion

document to the Strategy, the

‘‘Pesticides and Ground-Water Strategy:

A Survey of Potential Benefits’’

(February 1991; Ref. 13). This analysis

is discussed in Unit IV.D., of this

preamble.

In the interests of presenting as full

and honest a characterization of risk and

benefit as possible, the Agency will also

point out: (1) The relative magnitude of

uncertainty regarding the true value of

a quantity or attribute that EPA is

estimating in its analysis; and (2) the

reasons for believing that any specific

estimate or characterization may

overstate or understate the true value of

such a quantity or attribute.

1. Costs. EPA identifies four general

areas where some level of adverse

economic impact (i.e., both direct and

indirect costs) could result from

regulatory action in response to ground

water concerns. Federal program costs

are the attributable costs of developing

and justifying regulatory action

regarding ground-water protection,

including the assembly and evaluation

of ground-water risk data, as well as

expenditures relating to implementation

of protection measures. Current

expenditures include the cost of

ongoing regulatory and risk assessment

activities pertaining to ground-water

protection in the pesticides program and

grants to State pesticide programs to

help sustain the cost of ground-water

protection activities and, in particular,

the development of ‘‘generic’’ SMPs.

EPA program costs are subdivided

into headquarters (HQ) program costs

and regional costs. As should be evident

from the description in Unit II. of this

preamble, the larger portion of EPA’s

effort will reside with the Regions. EPA

estimated its regional-program costs by

estimating a per-SMP average level of
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33285

effort and multiplying by the expected

number of State Plans that are currently

anticipated for these five pesticides.

EPA’s analysis is calculated on the

expectation that 236 Plans will be

submitted. This translates into an

annualized cost of $1.1 million for

regional activities. EPA estimates its

annual HQ program costs will range

approximately from $413,300 to

$437,000 (in current dollars) for the first

3 years after promulgating this rule,

with costs decreasing to an average of

$160,600 annually thereafter.

The margin of uncertainty for EPA’s

estimate is relatively small (mostly

reflecting the relatively small dollar

estimate) and relatively insignificant

with regard to its potential impact on

EPA’s decision. It is difficult to

determine whether EPA’s estimate tends

to understate or overstate the likely

actual value of Federal costs, in part

since a substantial proportion of the

costs are part of ongoing regulatory

activities. However, any error in EPA’s

estimate (because of these uncertainties)

is probably more likely to understate the

estimate slightly.

State program costs are the estimated

State expenditures for implementing

Federal ground-water protection

actions. These include the costs of

developing five pesticide-specific SMPs

and of implementing and enforcing

elements of approved Plans and

represent a substantial level of

expenditure.

Because the scale of State

Management Plans is contingent upon

pesticide usage and aquifer sensitivity—

which will vary not only between States

but also within a given State—the costs

of developing, implementing, and

enforcing SMPs are particularly difficult

to generalize. In calculating the costs of

SMPs, it is reasonable to assume that

costs will vary directly with the scale of

a State’s plan. Finally, several

additional factors will influence the

eventual costs of a State’s plan. These

include: the risk mitigation options

available to State planners; the role of

coordination between State agencies

and other governmental bodies; the

shifting of costs to registrants; and

technological innovations that may lead

to decreasing costs over time. States

have reported (in the process of

developing ‘‘generic’’ SMPs) a broad

range of anticipated costs (from as little

as $17,000, to write a generic plan to

over $1 million, counting in full the

conduct of vulnerability assessments,

ground-water monitoring and data base

management), corroborating the

assumption of variable State costs.

EPA made some critical simplifying

assumptions in developing its cost

estimates: (1) That ‘‘States’’ (including

territories and some Indian tribal

authorities) would develop and submit

State Plans for all or most of the five

pesticides in question before the

effective date of the rule; (2) that the

Plans would represent an adequate level

of protection, i.e., would be approved by

EPA; (3) that some States would be

obliged to develop SMPs that entailed

extensive protection programs for one or

more of the five pesticides, that others

would have to develop Plans with some

additional protection and that still

others would have to do little more than

minor amendments to their ‘‘generic’’

SMPs to provide for future use of any

of the five chemicals (based on an

analysis of the current use patterns of

the five pesticides); (4) that virtually all

States would submit Plans that would

consolidate the activities related to any

and all pesticides as much as possible,

so that substantial costs in ground-water

vulnerability assessment and

monitoring, for example, would be

shared and not duplicated among

individual-pesticide proposals - a

reasonable assumption in this case,

considering in particular the common

use areas among these five candidates

and their concentration in areas of highintensity field-crop agriculture that

would otherwise be of high State

concern in any case; and (5) that the mix

of ‘‘extensive’’ and less-extensive State

Plans would entail a level of effort that

could be estimated on the basis of a

‘‘model’’ SMP activity, that could in

turn be extrapolated from analysis of

existing State programs, ‘‘generic’’ SMP

submissions and the requirements of

pesticide-specific SMPs embodied here

in today’s proposed rule and in the

Agency’s Guidance. The Agency regards

this last assumption as particularly

conservative, since the Agency expects

that a significant number of actual Plans

will turn out to be of the less-extensive

variety. Pricing every Plan on the basis

of a ‘‘model’’ Plan will significantly

overstate the true costs, since the

Agency constructed the ‘‘model’’ to

represent a relatively extensive level of

effort.

EPA developed its aggregate State-cost

estimate by means of using an existing

State plan (Wisconsin’s) as a model or

surrogate for individual State plans.

Wisconsin’s program was chosen as

representative for several reasons; its

ability and readiness to share its data on

program development and costs; and its

exemplary nature (in terms of level and

extent of commitment and exercise of

risk-management measures).

Furthermore, Wisconsin falls into the

range of moderate vulnerability as

measured by several macro-level

ground-water vulnerability indices.

However, this latter circumstance is in

itself not the consummate proof of

Wisconsin’s representativeness (or even

adequate characterization of

Wisconsin’s relative ground-water

sensitivity), since State situations in

terms of vulnerability are so diverse as

to preclude the classification of any

State as ‘‘average.’’ Finally, EPA did not

view the Wisconsin program as the

maximum effort a State might have to

exert: not only has the program dealt

primarily with a few, particular

pesticides, but it terms of general

ground-water contamination risk,

Wisconsin may not represent the

greatest degree of vulnerability.

EPA, in its analysis, took into account

both the one-time costs of a Wisconsintype program (annualized over either a

5– or 10–year period) and estimated

annual incremental costs to arrive at a

range of estimated annual State

expenditures. One reason for using

Wisconsin’s experience as a model is

the fact that it has performed some of

the initial activities necessary to

implement an SMP, enabling the

Agency to model such activities as the

establishment of pesticide usage

surveys, vulnerability assessment, soil

susceptibility mapping, other data base

creation, monitoring (establishing and

sampling sites), maintenance of records,

personnel, public awareness and

education, and other miscellaneous

costs of plan development.

EPA estimates State programs on the

average may annually cost in the range

of $250,000 to $750,000 during the first

several years of implementation, with

$500,000 as the average annual cost.

Successive SMPs required by the

Agency will undoubtedly require less

new effort by the States, so that

incremental costs would be expected to

decline over the long run. EPA took this

expectation into account in its estimate

of State program costs, projecting that

each State, in developing multiple SMPs

for these five pesticides, would incur

some economies by developing Plans

with common elements. Therefore,

national costs were calculated by

positing one per-SMP cost estimate

($500,000) for a single Plan, and

fractional estimates for accompanying

Plans. Calculated on this basis, if States

and territories were to implement a total

of 236 SMPs (EPA’s current estimate of

States’ intentions), their total annual

cost of implementing this regulation

would be $ 59.9 million.

The Agency wishes to emphasize that

the use of a ‘‘model’’ level of effort,

based largely on one State’s experience,

is for purposes of estimating the costs
33286 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

and benefits of this proposed rule. The

analysis is not meant to represent preconceptions about the contents of State

submissions. State Plans could depart

substantially from the details presented

in the ‘‘model.’’ Such differences could

be caused by the State’s particular

situation (varying in size, ground-water

vulnerability, and pesticide use patterns

from the model) or by an innovative

approach that EPA has not anticipated.

These Plans would be found adequate to

the extent States could demonstrate to

the satisfaction of the reviewing Region

that they assure adequate protection. At

the same time, the Agency believes that

it has projected the particulars of the

‘‘model’’ Plan in a manner that depicts

the kind of effort necessary to meet the

objectives of this proposed rule. To that

extent, EPA offers the State-cost analysis

as a reasonable basis for evaluating the

cost and benefit of this rule.

Moreover, the Agency wishes to

emphasize that the estimate of $59.9

million is the annual average of

aggregate State costs over a 10–year

period. As such, it represents: (1) The

amortization of high one-time costs,

such as drilling monitoring wells or

performing baseline vulnerability

assessments; and (2) several years of

operation of fully-developed, mature

State programs. Under no circumstances

should the figure be construed to be the

immediate, first- (or even second-) year

costs the States will incur. As stated in

Unit III. of this proposed rule, EPA

anticipates that States can be expected

to have to phase in ‘‘capital’’ elements

of an SMP (e.g., the development of

monitoring and vulnerability

assessment activities).

EPA’s assumption of broad State

participation (that all States will

develop Plans for most of the five

pesticides, and that many will develop

Plans for all five) may appear to be

particularly tenuous, since there is no

compulsion on the States to develop

such Plans, beyond the loss of the legal

use of a pesticide within the State. The

consequences of error in this

assumption are two-fold with respect to

estimating costs: (1) EPA’s estimate of

State costs may overestimate actual

State costs, because the Agency has

over-estimated State participation; but

(2) in that event, EPA’s estimate of user

impacts might be low. Since the absence

of an acceptable SMP would result in

prohibition of a pesticide’s use in a

State, more user impacts may result

than EPA has estimated. The fact that

the effects of error in this assumption

are at least potentially offsetting reduces

the Agency’s concern.

EPA has confidence in the validity of

assuming maximum State participation,

however. First, the Agency believes the

States have strong incentive to avoid

these increased impacts to its own users

by developing Plans. This belief is

bolstered by the strong evidence of the

States’ interest in assuming the

responsibility for managing pesticide

use to protect ground water (for

example, the near-universal acceptance

of grants and development of ‘‘generic’’

SMPs). At the same time, EPA has little

alternative to such an assumption. EPA

does not have any basis for estimating

which or how many States might fail to

implement plans, beyond current

informal communications between EPA

regions and the States. Finally, it seems

reasonable to assume the States least

likely to participate are those with the

least incentive to do so (i.e., those with

little or no current or projected use of

the pesticides), so that their nonparticipation would have comparatively

little effect on current use (and

consequently little user impact).

Among the other sources of EPA’s

uncertainty of its estimate are the

inherent variation in the size and level

of agricultural activity across States, and

the anticipated variation in State

approaches, ground-water protection

objectives and the like. EPA does not

believe the margin of uncertainty in its

estimate exceeds the magnitude of the

estimates. Among the reasons for

believing EPA’s estimate underestimates

the true impact of regulatory action are

unanticipated difficulties or obstacles in

State implementation of its

requirements (such as unanticipated

non-compliance, necessitating

substantially more enforcement

activities), as well as those

considerations described above. In

addition, EPA has not taken into

account potential increased costs of

Federal-State enforcement of sale/use

prohibitions for those States that fail to

develop Plans. For the reasons

explained above in describing the

assumptions, EPA does not anticipate

many States will not develop

approveable Plans for all five pesticides.

For those few cases that may arise it is

EPA’s expectation that enforcement and

compliance costs will be minimal, since

part of the reason for State disinterest in

developing SMPs for these pesticides

will be their insignificant use in the

State. Among the reasons for

anticipating that EPA’s estimate

overstates the true level of State

expenditures would be the deliberate

conservatism in pricing aggregate State

costs on the basis of a ‘‘model’’ Plan that

represents substantial effort, limiting the

estimate of economies-of-scale achieved

by developing multiple SMPs and the

possibilities for innovations in groundwater assessment and monitoring

techniques (particularly the latter).

Registrant (or pesticide-industry)

impacts are those that would be the

direct result of regulatory action, apart

from any anticipated loss of income

from reduced use of the products

attributable to regulatory restriction.

Attributable costs would include: (1)

The lost revenue associated with

decreased use of the products, caused

by State risk-management measures; (2)

the costs of increased technical

assistance (such as ground-water

monitoring) and outreach to users that

the registrants might provide, to help

them ascertain and follow the new,

applicable State management measures

or other safeguards on the chemicals’

continued use; and (3) the direct costs

of relabeling and compliance with the

administrative provisions of this

proposed rule. The first category, lost

revenue, was calculated as a function of

likely State actions, which in turn are

represented as three scenarios of

differing regulatory stringency.

Projected annual lost revenues for a

‘‘medium impact’’ scenario was

calculated to be $33.6 million. Using

current sales figures from the major

registrants of these five pesticides, this

figure represents an estimated 0.06

percent decrease in total sales, and a

0.48 percent decrease in pesticideproduct sales for these registrants. The

estimated costs in the second category

are those that are incremental to

ongoing ground-water monitoring,

technical assistance or outreach efforts

the registrants now perform with

regards to ground-water protection.

They are estimated to be in the range of

$3.1 to 12.7 million annually, conceived

as substantial new ground-water

monitoring activities performed in

addition to State efforts. These costs can

also be attributed to the possible new

ground-water monitoring requirements

that EPA may prescribe on registrants

concurrently with State development of

SMPs (see Unit III. of this preamble).

While EPA has not committed to the

development of such requirements at

this time, the Agency nevertheless

includes a cost estimate for the activity

in the interests of not underestimating

costs. Uncertainties include EPA’s

actual specification of those

requirements, the level of effort

represented by that specification, the

identification of further technicalassistance activities and their

delineation from ongoing regulatory

efforts.

By far the most substantial impact (in

terms of relative magnitude) is

anticipated to be impacts on agricultural
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33287

and non-agricultural users, and

associated indirect impacts of reduced

consumer benefits. These impacts

pertain to the changes caused by

regulatory restrictions in use of

pesticides and the consequent changes

in agricultural (and other economic)

productivity and expenditures. In

addition to being the largest component

of cost, its magnitude is the most

uncertain and difficult to estimate.

Estimating these impacts entails an

econometric analysis with consideration

of a multitude of cascading secondary

effects across geographic regions and

economic sectors and with estimated

impacts expressed through a variety of

economic measures. These difficulties

are compounded by the necessary

consideration of the combined behavior

changes of perhaps a million affected

farmers and other users, the normal

uncertainties in the agricultural sector

(the effect of weather, etc.) and the like.

EPA attempted to anticipate as many

of these interactions and uncertainties

as possible by using a widely used

multi-sector, multi-regional econometric

computer simulation model called

AGSIM. The analysis was performed to

take into account not only regional

variations in commodity supply and

production (i.e., varying responses to

changes in per-acre yields, variable

costs, and prices) but also the present

and projected influences of farm policy

elements (e.g., Federal price-support

and conservation programs, Federal

monetary policy, etc). These measures

aggregate into separate (and additive)

dollar estimates of the combined impact

to the agricultural-production sectors

(expressed as the change in net

agricultural production and income)

and the consequent decrease in

domestic-consumer benefits (sometimes

referred to as ‘‘surplus value,’’ or the

amount of additional consumer

expenditures to maintain the same

standard of living as reflected in the

‘‘baseline’’ conditions, prior to a

regulatory action).

In order to estimate impacts it is

necessary to estimate certain effects of

the SMPs and use these as inputs to the

econometric model. Specifically, a

critical task was to estimate how State

risk-management measures would

influence: (1) The acreage where these

five pesticides are used; (2) yield

impacts; and (3) input (i.e., pesticidechemical) cost impacts. Thus, SMP

impacts on users are estimated by a

matrix of combinations of these three

factors (taking the availability of nonSMP pesticide substitutes into account)

and the consequent change in crop yield

and price. The critical measure of

impact is the reduced treated acreage

associated with State risk-management

measures. These values must be

regarded as a proxy for the variety of

potential effects that SMPs may have on

agricultural practices. They are not

intended to represent a forecast of actual

State practices, but rather a surrogate

measure of their potential effect on

agricultural practices.

These estimates were made by

consultation with a variety of sources.

Affected acreage was identified by the

use of a Ground-water Vulnerability

Index for Pesticides designed by Robert

Kellogg of USDA’s Soil Conservation

Service. A percentage of these affected

acres was assumed to be subject to

either restricted or prohibited use under

State Management Plans; this

percentage varied according to impact

scenario and was based upon the 1992

Wisconsin Atrazine Rule. EPA tried to

account for the considerable uncertainty

about the impact of State management

measures by positing a variety of

reduced-use scenarios across the

principal use areas of these five

pesticides. EPA believes the most-likely

estimate of user impacts rests with its

medium-impact scenario, but has

provided companion low- and highimpact scenarios for comparison. The

Regulatory Impact Analysis

accompanying this proposal provides a

fuller explanation of EPA’s estimates

and the methodology used to derive

them. The SMP-use restrictions have the

anticipated effect of lowering expected

yields and pesticide input costs.

Restrictions on application rates lower

pesticide input costs since total usage

declines; use prohibitions also lower

costs since the cost of alternative

pesticides are less than that of the SMP

pesticides. Crop producers are actually

expected to be better off in terms of net

crop revenues as a result of such

restrictions, due to the combination of

increased prices obtained for affected

commodities and reduced input costs.

Increased commodity prices are

predicted due to reduced acreage

planted, which in turn, decreases the

total supply of a particular commodity.

However, increased prices resulting

from reduced supply are a net negative

impact to the economy overall, in the

form of reduced consumer surplus

value.

At the same time, increased feed crop

(corn, soybean, sorghum) prices raise

input costs for livestock producers.

Coupled with stagnant or declining

demand for livestock products,

increased input costs negatively impact

livestock returns in this analysis by

reducing livestock revenues. Because

the reduction in livestock returns is

estimated to be greater than the increase

in crop returns, net impacts to the U.S.

agricultural sector are negative, but

relatively minor (-$1 million to -$11

million, across the three scenarios).

Correspondingly, indirect impacts, in

the form of reduced consumer benefits,

are estimated to be in the range of $242

to $254 million.

While the absolute magnitude of such

impacts appear to be substantial, in

relative terms such impacts are

moderate. Relative to the economic

value of U.S. field corn production ($16

to $23 billion), such impacts are small.

For example, the SMP-use restrictions

are anticipated to lower U.S. field corn

production by about 1 percent, leading

to a potential 1.1 percent increase in

market prices. Such impacts would have

a de minimis effect on the Gross

Domestic Product. Average annual

consumer expenditures and food prices

would change less than $1.00 per

person (from $0.94 to $0.98) as a result

of these impacts. Individual farmer

income in the aggregate would also

change little, but regional effects of

greater magnitudes (both positive and

negative) could occur.

This range of projected impacts

compares to impacts of $ 3.6 billion or

more in combined user costs and

reduced consumer benefits, associated

with either outright cancellation of the

five pesticides (plus aldicarb, which had

minimal costs associated with its

management) or more stringent,

nationwide use restrictions, as

estimated by Taylor, et al. in 1991, using

a similar econometric approach.

EPA’s method for estimating user

impacts, like its projection of Stateprogram costs, relies on some key

simplifying assumptions: (1) A degree of

regulatory restriction will translate into

a discrete (and predictable) level of

decreased (or alternative) pesticide use,

resulting in predictable adverse effects

to agricultural production and the other

relevant economic effects summarized

above; and (2) the scenarios vary

(predictably) in the degree of regulatory

restriction they represent, and this

difference can be expressed in terms of

the cropped acreage subject to reduced,

substituted or eliminated pesticide use.

Among the reasons for anticipating that

EPA’s estimate understates the true

potential impact of ground-water

protection measures are: (1) That the

analysis pertains only to uses on field

crops (which, however, represent over

90 percent of the combined current use

of these five), overlooking the potential

impact on fruit and vegetable crops; and

(2) that EPA assumes all States will

participate, so that no greater

restrictions on use will ensue from the

fact that State inaction causes a
33288 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

complete curb on use. However, EPA

has equal or greater reason to believe its

estimate overstates the actual potential

impact; chief among these is faith in the

States’ ability to develop a variety of

innovative management measures that

will minimize the disruption in crop

production caused by ground-water

safeguards. State resourcefulness in

developing new approaches will

undoubtedly outrun the Agency’s

present expectations. It is already clear,

for instance, that States will emphasize

measures that will enhance the

sustainability of agricultural production

simultaneously with ground-water

protection, preserving much of the

necessary use of the pesticides in

question. Also, inevitable improvements

in ground-water monitoring and

vulnerability-assessment techniques

will enable states to ‘‘fine-tune’’

necessary restrictions to a degree EPA

cannot yet anticipate in its estimate. In

addition, in developing its estimates of

crop yield losses, EPA did not take into

account the considerable promise that is

subsequently emerging in the areas of

integrated pest management and other

reduced-use strategies.

In summary, it needs to be stated that

in distinguishing the various costs that

may be attributable to Federal regulatory

action for purposes of weighing the

costs and benefits of any action, EPA

did not attempt to assess the reasonable

likelihood that a particular category of

parties would actually incur the costs.

For example, the boundaries between

‘‘State’’ and ‘‘registrant’’ costs may be

considerably more blurred than our

analysis would suggest. A variety of

activities attributed to the States in

managing the use of a pesticide subject

to an SMP rule (including those

involving substantial levels of effort,

such as ground-water monitoring or user

education and outreach), for example,

could in practice be either performed (in

part or in whole) or paid for (either

directly or through State imposition of

fees) by the registrants. Likewise, some

of the activities identified by EPA as

‘‘registrant costs,’’ e.g., the provision of

increased user training and technical

assistance, could be expected to be

performed often at the behest of State

agencies pursuant to their Plans.

Accrual of expenditures accurately to

the various parties was of less

importance to EPA in making this

analysis than was concern for the

projection of overall level of effort and

expenditure attributable to this rule.

2. Benefits. Chapter 7 of the RIA

contains the Agency’s appraisal of the

potential benefits associated with

establishing SMPs for these five

pesticides. This appraisal begins by

cataloging the different kinds of values

associated with protecting ground water

as a natural resource. These values are

categorized in terms of their various

services as a resource. This

categorization follows a recent Agency

conceptual framework for assessing the

economic value of ground-water

protection in evaluating regulatory

impacts (Ref. 19). Each of these service

values, (associated with two general

functions of ground water: both as a

source of water stock and as a discharge

to surface water supplies) may be

subject to a variety of economic

valuation techniques. Since these

categories generally involve the value of

the resource in terms of its economic

use, other categories of value recognized

by natural-resources economists must

also be acknowledged: the so-called

altruistic, bequest, and existence values

(sometimes referred collectively as

‘‘non-use value’’) associated with

protecting a natural resource per se.

In general, however, the benefits of

SMPs will accrue from the reduced

levels of ground-water contamination,

by substances associated with adverse

human and/or environmental effects,

that result from the regulatory

safeguards required by the individual

Plans. It is the presence of this

contamination that jeopardizes any and

all of the use and non-use values under

consideration.

In order to perform a reasonable

quantitative analysis of benefits,

accurate and reliable estimation of

exposure levels (both existing and

projected, and in the case of the latter,

projected for a number of different

regulatory options) are critical.

Unfortunately, reliable estimation of

ground-water contamination occurrence

is among the most difficult and

uncertain issues with regards to groundwater concerns. Past and current efforts

at ground-water monitoring have not

been of a sufficient level and frequency

to give adequate assurance that the

Agency knows the levels of occurrence

of pesticide contamination of ground

water, either of the specific pesticides

addressed in this proposed rule or of

pesticides in general.

The United States Department of

Interior, in comments submitted to EPA

regarding the proposed Ground Water

Restricted Use Rule (in 56 FR 22076,

referred to in Unit I. of this preamble),

characterized the state of knowledge

associated with the nation’s groundwater monitoring efforts as follows:

‘‘Given shortcomings in national

ground-water monitoring efforts, it is

highly unlikely that all locations of all

contaminants in ground water have

been determined.’’ [July 5, 1991 letter

from Jonathan P. Deason, Director,

Office of Environmental Affairs; exhibit

7 in OPP comment file no. 36172].

While not necessarily reflecting the

views of EPA, these comments are

testimony to the limitations associated

with the evidence of contamination

from current ground-water monitoring

results, particularly the substantial

likelihood of under-estimating the

present and future level of exposure.

Other methods of estimating prospective

occurrence, such as projections from

data on the leaching potential, volume

and location of use of a pesticide or

projections using environmental-fateand-transport models, have even greater

limitations (see, for example, National

Resource Council, ‘‘Ground Water

Vulnerability Assessment,’’ NAS Press,

1993, for a fuller description of the

strengths and weaknesses of various

ground-water analytic techniques).

The consequences of this potential

under-measurement of present groundwater contamination has another

dimension. Since known ground-water

contamination is particularly localized,

it is characterized by the incidence of

limited ‘‘hot spots’’ of high

concentrations. Occurrence of groundwater contamination is unevenly

distributed, due to the variety of

hydrologic and topographic factors.

Locations of high concentrations of

pesticides (and a corresponding high

risk of potential adverse effects) in

ground water are dispersed unevenly

across the country. The overall profile of

the risks associated with pesticides in

ground water, then is one of large

numbers of people at relatively low risk,

punctuated with ‘‘hot spots’’ of higher

risk. The risk concentrated in these ‘‘hot

spots’’ are likely to exceed national

average risks, but are difficult to

characterize using aggregate occurrence

estimates. This unevenness in the

distribution of risk levels raises

concerns regarding ‘‘environmental

equity,’’ to the extent that effects are

disproportionately high and adverse,

which the Agency is committed to take

into account as a matter of policy.

Finally, it should be noted that taking

the next step of quantifying human

health risk by combining population

exposure figures with some benchmark

of toxicity associated with a unit

quantity of exposure, is hampered by

limited methodologies for quantifying

hazard. At present, the Agency

customarily confines hazard

quantification to carcinogenicity (e.g.,

projecting ‘‘number of cancer cases

avoided’’), while the possible

consequences of other toxicological

endpoints cannot usually be presented

with the same appearance of precision.
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33289

Despite the limitations on available

evidence and methodologies discussed

above, as a matter of illustration the

Agency has presented in the RIA a

number of different estimates of

nationwide human exposure to these

five pesticides in drinking water using

ground-water sources. These

alternatives represent different data

sources and estimation methods. Three

of these data sources have been

referenced earlier in Unit IV. of this

preamble: the Pesticides in Ground

Water Data Base, the National Pesticide

Survey and the National Alachlor Water

Well Survey. Another estimate is based

on the application of a modeling

procedure, i.e., the application of an

environmental-fate model using

assumed values for prevailing

hydrogeological conditions across all

local areas where corn pesticides are

used. This estimate is provided in a yetunpublished Agency analysis of the

cumulative risks and benefits of a host

of pesticides frequently used on corn, a

so-called ‘‘corn cluster’’ analysis. A

copy of this analysis is available in the

public docket for this rule-making.

The Agency presents these alternative

estimates without making a judgement

that one estimate is superior to another,

or that any (or all, considered

collectively) can be considered a

reliable estimate of nationwide exposure

and hence, national risk. Three of the

four analyses provide estimates of both:

(1) the number of individuals exposed

to any measurable concentration of

these five pesticides (or, in the case of

the NPS, a surrogate estimate of ‘‘total

pesticide’’ exposure); and (2) the

number of individuals exposed to

concentrations at or above health-based

ground water reference points. The

model-based estimate also estimates

total population with any exposure, but

offers a calculation of baseline cancer

and non-cancer risk in place of the

number of individuals exposed above

reference points.

It is notable that when viewed

together, there is a wide variation in

central-tendency estimates of

population exposed among the studies,

as well as considerable uncertainty

surrounding each estimate, taken

individually and together. For example,

best estimates derived from the

available statistically-based studies of

total population exposed to any

concentration of the five pesticides,

from domestic wells alone, range from

a few hundred thousand to as many as

5 million. Estimates from the nonstatistically based Pesticides in Ground

Water Data Base, which does not

differentiate private and public well

occurrence, range to more than 20

million. More importantly, the

estimated numbers exposed to high

concentrations range from nearly none

to one-half million people or more;

taking estimates of random error into

account, the number exposed above

health-based standards could

theoretically also be as high as 20

million. Estimates from the Data Base

for this subset run as high as 2.84

million people.

In addition, each of the four

estimations discussed has specific

shortcomings which need to be

recognized before relying on any

estimate, considered either individually

or together, as a credible basis for

estimating the benefits of the rule. Some

of the problems to be aware of with

these studies are: (1) Most fail to

account for the entire nationwide

exposure potential, leaving out parts of

the total exposed population (e.g., those

drinking from community water

systems); (2) not every data source

addresses precisely the five pesticides

in question; (3) most are based on

limited and imperfect monitoring data

(i.e., data from surveys with design

flaws, or data that are not statistically

based), and the modeling exercise is not

based on monitoring results at all; (4) all

of them measure or estimate the

frequency and concentration of well

contamination and not human exposure

per se, which means that certain

unverified assumptions were made

regarding the numbers of people

drinking well water to produce

population-exposure estimates; and (5)

they all produce estimates that are

highly uncertain, for example, with the

potential for random error (among the

statistically designed studies)

represented by 95 percent confidence

intervals ranging from zero to the

hundreds of thousands. One method

(based on the PGWDB) is based on a

larger amount of well water sampling,

but such sampling is not statistically

based, so no estimate of the degree of

expected random error in the estimate is

possible.

Given the wide range of divergent

estimates, and the significant limitations

on their reliability, the Agency cannot

reasonably identify a single ‘‘best

estimate’’ of prevailing exposure to the

SMP pesticides in ground water. The

Agency believes that the evidence of

substantial contamination of groundwater-based drinking water supplies,

indicated by the data summarized in

Unit IV. of this preamble, provides

reason to believe: (1) That many

individuals (running up to the

thousands, or even hundreds of

thousands) are or will be consuming

ground water contaminated by one or

more of these pesticides at levels above

health-based standards, in the absence

of effective, localized risk-reduction

measures as envisioned in SMPs; and

(2) that many more individuals (running

into the millions) are or will be

consuming ground water with at least

detectable levels of contamination.

While concern tends to focus on the

former subset, SMPs can be expected to

substantially reduce the exposure to the

larger population as well. The Agency

further believes that the potential health

risk represented by this magnitude of

occurrence/exposure bears a reasonable

relation to the magnitude of the

economic impacts discussed in the

section above.

The uncertainty surrounding the

actual levels of individual exposure

makes it very difficult to take the next

step, that is, combining indications of

toxicological potency with the estimates

of exposure to obtain an estimate of

human health risk. Where the particular

study cited presents no estimates of

population risk associated with the

estimated exposure, the Agency has not

developed any subsequent estimates.

However, one of the studies (the

modeling-based analysis associated with

the Corn Cluster) offers both estimates

of cancer and non-cancer population

risks. The analysis suggests that these

five pesticides together represent about

0.4 excess cancer cases per year, given

a 3–meter depth of ground water as a

drinking water source. The

preponderance of this risk comes from

one chemical alone, atrazine. The

analysis arrives at an estimate of

maximum individual cancer risk at this

depth of 2 × 10-4. To put the magnitude

of this risk into perspective, as a

measure of risk in hotspots, is to note

that it is roughly twice as great as the

incremental lifetime risk that this

analysis estimates for the dietary

pathway, about 8 × 10-5 for an

individual of average exposure. A less

conservative assumption that a 1 meter

depth is representative of ground water

recharge leads to an estimate of about 5

statistical cancers a year, with a

corresponding estimate of maximum

individual cancer risk of 3 × 10-3, or

nearly 40 times the average dietary

estimate stated earlier. However, given

that neither estimate can be regarded as

a direct representation of ground-water

exposure (since the model only

simulates the loading to ground water

via percolation through crop root

zones), the Agency regards neither

estimate as authoritative. In particular,

the Agency has reason to believe the 3

meter estimate understates groundwater occurrence, based on the Agency’s
33290 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

experience with controlled field-scale

studies, and describes this experience in

Chapter 7 of the RIA. In addition, it is

very likely that the cluster analysis

underestimates the risk posed by

pesticides other than atrazine.

Specifically, risks presented by alachlor

and simazine should be only slightly

less than that of atrazine, based on the

monitoring record.

The Agency is not attempting to

authoritatively quantify the risks of

ground-water contamination by these

five pesticides, nor to monetize the

value of avoiding these risks. The

Agency believes such estimates are

difficult to support scientifically, under

these circumstances. The Agency

solicits comment on the reliability of

risk estimates that may be developed

from these exposure estimates cited

above, or from other sources.

Beyond the difficulties of

characterizing the magnitude of

potential human exposure to these

pesticides in drinking water, absent the

risk reduction afforded by SMPs, there

remains the question of how effective

SMPs will be in reducing that risk. The

main impediment to the evaluation of

SMPs’ prospective effectiveness is the

fact that individual SMP provisions

remain to be set. However, even making

some assumptions as to the general

features of future SMPs, there remains

the problem of estimating ground-water

contamination occurrences. As

mentioned earlier, present levels of

ground-water monitoring are inadequate

to gauge the levels of overall groundwater contamination with confidence.

Alternatives to monitoring, e.g.,

environmental fate models, are not yet

developed to provide an adequate

substitute to monitoring results.

However, what little evidence is

available to the Agency appears to

support the conclusion that the riskmanagement measures contained in

SMPs are likely to be effective in

reducing the occurrence of groundwater contamination. The most

reasonable approach to assessing the

prospective effectiveness of SMPs is to

consider the closest existing analogue to

SMPs, i.e., the performance of existing

State-imposed localized risk-reduction

measures. Very few such analogues

presently exist, but there is recent

information that the Wisconsin atrazine

use restrictions referred to earlier have

resulted in an overall reduction in

atrazine concentrations in contaminated

wells.

In 1995, the Wisconsin Department of

Agriculture, Trade and Consumer

Protection (DATCP) conducted an

extensive analysis of atrazine and its

metabolites in drinking water wells

located within risk-management areas

imposed by the Department beginning

in 1992, which had been previously

monitored (Ref. 22). Seventy-six (84

percent) of 90 wells sampled in 1995

declined in total atrazine concentration,

and 16 percent increased. For the 76

wells that decreased in concentration,

levels decreased an average of 2.5 parts

per billion (ppb). While the re-sampling

of these wells generally occurred in one

time period, from June to September

1995, the study compares these results

to a baseline sampling frame that varies

for each well. Each well was sampled

with varying frequency across a period

that spans from March 1990 to

September 1994. Relative to the State

standard, 57 percent of a slightly larger

universe of 111 wells (encompassing the

90 cited above) are now below 3 ppb

(with an average concentration of 1.4

ppb). The 43 percent of wells still above

the 3 ppb standard had an average

concentration of 5.9 ppb. The overall

average concentration for the 111 wells

is 3.3 ppb. While the report attributes

the reductions in contamination to the

use reductions, it was less able to

explain the reasons for the occasional

increases. However, the report mentions

several plausible reasons, including the

possibility that these wells are deeper

(and so experienced higher levels of

contamination from pre-controlled

atrazine use later than the norm), or are

located in more recently designated

areas, or were affected by continued

illegal use or spills near the wells. These

are in addition to the common-sense

explanations, i.e., the natural variability

in sample results over time and/or

metabolite contributions from nonprohibited triazine use in the areas

(because atrazine, simazine, and

cyanazine have some common

degradation by-products that will be

detected by first-round analytic

methods). These data provide some

evidence that state risk-reduction

measures seem to have a beneficial

effect, reducing both the number of

occurrences of pesticide contamination

in affected areas and the level of that

contamination.

In addition to health effects, the

Agency believes that the possibility of

resource effects need to be

acknowledged and considered in the

decision whether to exact further

regulatory protection for these

pesticides. There are two major

considerations. First is the adverse

effect to ecosystems linked to groundwater sources. The scientific basis for

estimating such things as the location,

frequency, and duration of sensitiveecosystem exposure to such groundwater contamination is less developed

than even the limited information

discussed above for human exposure. At

the same time, the risk of ecological

adverse effects is certainly a real

possibility, and should not be

discounted merely out of lack of

currently available scientific means of

ascertaining it. Second, there is an even

more inestimable, but nonetheless

relevant, concern over the intrinsic or

future value of ground water as a

resource, as free of man-made pollution

as may be practicable. Studies that

estimate ‘‘willingness to pay’’ based on

survey methodologies have suggested

proxy values of substantial magnitude,

which if extrapolated to national scale,

amount to billions of dollars, but the

estimates from this controversial

approach have uncertain applicability.

One can hypothesize a threshold

willingness to pay commensurate to the

estimated costs of this proposed rule,

which would compare favorably to the

results of previous studies. Specifically,

if an estimated 5 to 8 million

potentially-affected households (an

estimated 15 to 20 million potentially

exposed individuals divided by the

national-average per household

population of 2.64) were willing to

spend between $47 to $63 annually,

these sums would be commensurate

with the $356 million projected cost of

the SMP rule. EPA believes that these

estimates are well within the range of

expectations, but only a carefully

conducted survey, expressly clarifying

the expected risk-reductions specifically

associated with SMPs, could confirm

these expectations. Likewise, prevention

is a value that EPA subscribes to

because the costs of prevention can be

expected to be much lower than the

costs of remediating contaminated

ground water when and if it occurs.

The fact that the dimensions of risk

and the effect of risk-reduction efforts

are both highly uncertain dictates a

policy to proceed cautiously and with

maximum flexibility. The Agency

believes the prudent course in the face

of the uncertainties presented by

pesticidal ground-water contamination

is to take positive action that avoids

irrevocable national policy courses at

the outset that might lead to

programmatic dead-ends. The Agency

believes this is the essence of the SMP

approach, and that this is the most

practical policy course from among the

regulatory alternatives.

EPA therefore recognizes the lack of

information necessary to calculate

quantifiable benefits that may be

associated with the SMP approach.

However, the States, in electing to

participate, will have made a practical
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33291

evaluation of both the real and

intangible benefits of ground-water

protection measures, and their

participation will represent the choice

for prevention over remediation. These

States will have evaluated the benefits

of participating relative to their

respective environmental policy

philosophy and goals and on the State

economies depending upon pesticide

use.

D. Risk-Benefit Conclusions

Based on the information currently

available, it is EPA’s reasoned

determination that the benefits of

preventing ground-water contamination

by these five pesticides justify the

expected costs of implementing

preventive measures through the SMP

approach, and further, that the SMP

approach appears to be the most costeffective of the means available for

protecting ground water.

EPA believes that the level and nature

of protection to be afforded by SMPs is

appropriate to the magnitude and

character of contamination potential

indicated by the evidence. In

developing the SMP approach in

cooperation with a broad spectrum of

interested parties from the public and

private sectors, there was much

discussion of the alternative approach of

having EPA impose national-level riskreduction measures, such as labeling or

use restricted to certified applicators.

That alternative is discussed in Unit III.

of this preamble and is being offered for

comment in this proposal. The Agency

wishes to point out, however, several

factors which led EPA to propose the

SMP approach rather than the nationallevel restrictions approach.

The main issue is whether label

changes alone, or in combination with

restricted use classification, and

perhaps additional requirements placed

on the registrants would be sufficient to

address the risks of ground-water

contamination. The evidence of each of

the five pesticides’ ground-water

contamination risks suggests no

particular, specific circumstances

causing such contamination. The

evidence of present ground-water

contamination is so broad and general

that it is unlikely that a pesticide user

could readily identify a specific

condition that would, to a high degree

of certainty, cause the pesticide to

contaminate ground water.

Consequently, it seems questionable

whether clear and simple label

instructions could be developed that

would adequately identify conditions

for a user to avoid such that ground

water risks would be significantly

reduced or eliminated. Many ground

water experts, including EPA staff,

believe that reliable neutralization of the

risks requires a knowledge of technical,

site-specific factors that most pesticide

users cannot reasonably be expected to

possess. Furthermore, as a matter of

policy, EPA believes that the users of

pesticide products should not be given

the burden of interpreting label

instructions that are either unreasonably

complex or technical, or are uncertain to

achieve their purpose. The training

associated with classification for

restricted use may alleviate some of this

concern, but would not address the

issue of whether label restrictions

would actually work.

If this alternative approach were to

include monitoring requirements to

demonstrate effectiveness, and use

prohibitions if specific detection triggers

were met, then this approach might well

end up being substantially more

onerous to both users and registrants

than SMPs. The Agency is requesting

detailed comments on this alternative

from all potentially affected parties.

In considering the issue of nationallevel labeling measures, EPA has taken

into consideration the fact that new riskreduction measures have recently been

in effect for atrazine (since 1992) which

are intended to reduce the pesticide’s

contamination potential for both surface

and ground water. These measures

include label changes providing for the

deletion of certain non-crop uses

including highway and railroad rightsof-way, reduction of the rates of

application for remaining crop uses and

the imposition of set-backs (nonapplication zones) for wells and bodies

of water, prohibiting use and mixing/

loading within specified distances from

surface waters and drinking water wells.

These measures have not been in place

long enough for EPA to discern any

positive effect on the ground-water

contamination potential of this

pesticide. However, when EPA agreed to

these risk-reduction proposals (which

were voluntary measures proposed by

the registrant), it made clear that

additional measures would have to be

considered. Furthermore, the Agency is

taking into account the voluntary phaseout and eventual cancellation of

cyanazine, announced in August 1995

(see 1., below). Finally, EPA is

anticipating that all the pesticides

ultimately subject to SMPs will also be

classified for ‘‘conventional’’ restricted

use, that is, restricted to use by or under

the direct supervision of a certified

applicator.

In the Strategy EPA committed to

considering existing State and local

measures in making its regulatory

decisions about pesticides with groundwater concerns. To EPA’s knowledge, a

total of 10 States have or are working on

some kind of independent restriction for

one or more pesticides with groundwater concerns. However, not all of

these apply to the five pesticides

discussed here. Another 12 States have

some authority to impose such

restrictions, but have heretofore not

employed it. From a national

perspective, this level of effort appears

to be inadequate to address the extent

and character of ground-water

contamination potential associated with

these five pesticides. It appears that, in

the main, States are anticipating that

this proposed rule requiring pesticidespecific SMPs will serve as the

framework for their own efforts in this

regard.

Finally, it is EPA’s belief and

expectation that SMPs should

sufficiently reduce the risks associated

with the ground-water contamination

potential of these five pesticides, so that

full cancellation of use based on

ground-water concerns alone is not

likely to be necessary. While the

potential risks represented by these five

are substantial and warrant the

imposition of effective preventive

measures, the measures to be taken by

the States should be adequate to

mitigate the risks.

A remaining issue is whether the risks

associated with ground water may

combine with other routes of exposure

for any of these five pesticides to

constitute an unreasonable risk and thus

warrant cancellation. EPA customarily

uses the Special Review procedure to

determine whether the combination of

different routes of exposures represents

unreasonable risks. Alachlor and

cyanazine have been subject to Special

Reviews in the past, and the three

triazine active ingredients (atrazine,

simazine, and cyanazine) have just

recently begun Special Review. Any or

all of these five may be subject to this

further consideration in the future. In

such Special Reviews, EPA will take

into account the level of risk-reduction

expected to be afforded by SMPs in

making an evaluation of the pesticides’

overall risk to human health and the

environment.

1. Cyanazine special review. The

recent agreement between the Agency

and DuPont Agricultural Products, the

principal registrant of cyanazine in the

United States, to phase out and

eventually terminate sale and use of

cyanazine, affects this proposed rule.

On August 4, 1995, DuPont signed an

agreement with EPA whereby DuPont

will amend its registration to: (1)

Reduce the maximum use rates on

cyanazine labels in four increments,
33292 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

from 1997 to 1999; (2) cease production

and sale at the end of 1999; and (3)

prohibit all uses of cyanazine by the end

of the year 2002. This arrangement will

resolve the Agency’s concerns with

respect to cyanazine in its Special

Review of the three triazines. EPA will

soon publish its termination of the

cyanazine Special Review. However,

EPA will proceed with proposing

cyanazine to be subject to SMPs in this

rule, for several reasons. First, until the

Special Review is officially terminated

and the registrant’s voluntary actions go

into effect, the ground-water risks

enumerated in this notice will remain,

warranting at least proposed regulatory

action. Second, even when the

agreement is implemented, the phaseout schedule provides for a brief

interval during which cyanazine may be

used in States that would need SMPs.

Third, the Agency is concerned with the

possibility that cyanazine could be

registered at some future date as a

completely new pesticide. In that event,

it is the Agency’s judgement at this time

that the present evidence of the

pesticide’s severe contamination

potential requires that any such future

use needs to be subject to SMPs.

It may be EPA’s judgement in

considering a final SMP rule that

cyanazine’s eventual cancellation will

be sufficient to address the Agency’s

ground-water concerns; if so, it may

choose to issue a final rule for only four

of the pesticides proposed today. In any

event, the Agency wishes to emphasize

that the fact that cyanazine use will

terminate soon after the effective date of

the SMP restriction will be taken into

account when EPA evaluates State

submissions. EPA does not anticipate

that State Plans for cyanazine will have

to be as extensive or detailed as for

pesticides whose uses are expected to

continue indefinitely.

2. Alachlor Special Review. In 1985,

EPA initiated a Special Review of

Alachlor (50 FR 1115, January 9, 1985).

As noted above, alachlor was classified

as a B2 (probable human) carcinogen,

and the carcinogenicity potential has

been quantified, although the

classification is now under review. EPA

concluded the Special Review of

alachlor (52 FR 49480, December 31,

1987), after taking the following actions

to reduce risk for workers: EPA

classified alachlor for restricted use by

certified applicators; prohibited aerial

application using human flaggers; and

required persons applying alachlor to

300 or more acres per year to use

mechanical transfer systems for mixing

and loading alachlor. In addition to

these regulatory actions, however, EPA

deferred action on whether the risks

posed from alachlor in drinking water

from contamination of ground water

required regulatory action. EPA

concluded that the further evaluation of

the ground-water risks would offer an

appropriate occasion to revisit the

overall risks and benefits of alachlor

(including dietary risks) on a crop-bycrop basis to determine whether the risk

benefit balance had changed to a degree

requiring regulatory action.

Since 1987, Monsanto has submitted

the National Alachlor Well Water

Survey (NAWWS) and review has been

completed. EPA’s concerns with respect

to continuing ground-water risks are

evident in its proposal to classify

alachlor for SMPs in this proposed rule.

In addition, EPA has reviewed recent

trends in usage and percent of crop

treated with alachlor and determined it

is not necessary to revisit the risk/

benefit determination of alachlor on a

crop-by-crop basis. The dietary risks

posed by alachlor were in the 10-6 range

at the time the Special Review was

concluded and have declined further

since then.

EPA has determined that the

remaining Special Review concern

about alachlor in ground-water is

adequately addressed by the actions

proposed in today’s document. Thus,

EPA concludes that the concerns

deferred by the Special Review will

have been addressed with promulgation

of this proposed rule and no further

action related to the Special Review of

alachlor will be necessary upon this

proposed rule’s promulgation. In a

separate notice, EPA will announce the

cessation of the alachlor special review.

E . Analysis of Regulatory Options

In developing the Strategy EPA

evaluated a range of available regulatory

options in addition to the SMP

approach. Specifically, EPA compared

three general approaches in a

companion document to the Strategy,

the ‘‘Pesticides and Ground-Water

Strategy: A Survey of Potential Benefits’’

(Ref. 13). In supporting the comparative

advantages of the SMP approach, this

document compared it to the option of

a projected extension of current

national-level risk-reduction measures,

and another of full cancellation of a

problem pesticide. Both options were

regarded as establishing the extremes of

potentially effective and reasonably

feasible alternatives to the SMP

approach.

The first alternative to SMPs was

construed to permit significant levels of

ground-water contamination before

milder forms of regulatory action (e.g.,

label changes or restricted use) would

be considered. In other words, the

option constituted a non-preventionoriented approach that, although

contrary to Agency policy, constituted a

conceivable approach to the problem of

pesticide contamination of ground

water. The option relied to a

considerable degree upon remediation

of projected contamination sites to

address the problem; as such, it was

tantamount to addressing the problem of

pesticides in ground water through

other environmental statutes, especially

the Safe Drinking Water and Superfund

(CERCLA) Acts. Consequently, the costs

of remediation, and, by extension, the

costs associated with degradation of

ground water as a natural resource, were

construed to be a larger component of

this option’s cost impacts than any

other. While these impacts were not

directly monetized in EPA’s 1991

analysis (for the same considerations

discussed in Unit IV.C. of this

preamble), by indirect analysis EPA

concluded that the ‘‘status quo’’ option

would bear considerably higher societalcost impacts than the SMP approach.

Moreover, such an approach would be

unacceptable on policy grounds,

representing insufficient commitment to

a preventive approach. This policy

preference, of course, in part reflects

EPA’s discomfort about the ability to

correct (much less correctly estimate the

price of) ground-water contamination

once it occurs. EPA’s view is that such

ground-water contamination may be in

many circumstances practically

irreversible, based in part on the

economics of remedial action (where

millions of dollars can be spent for

uncertain results at a single site).

Likewise, outright cancellation of one

or more pesticides that might represent

a substantial risk via ground water

stands to entail far higher societal costs

than other regulatory alternatives, such

as SMPs. As the Taylor analysis (Ref. 5)

indicates, the magnitude of user and

consumer impacts associated with

cancellation of these five pesticides

dwarf those that might be associated

with SMPs. Taking into account the

additional administrative and technical

program costs associated with the SMP

approach (that would not be necessary

if the pesticides were canceled instead),

the SMP approach still appears to

represent the most cost-effective

approach. While absolute cancellation

may provide a degree of greater surety

that ground-water contamination will be

averted (and in that way affords greater

benefits), it is unlikely that the

incremental gain in surety justifies the

enormous difference in economic

impact between the two options.
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33293

F. Request for Comments

EPA is interested in receiving

comments on its determination of the

risks and benefits associated with its

proposal to classify these five pesticides

as subject to SMPs. EPA in particular

invites all interested persons to submit

further information concerning the risks

and benefits (with respect to groundwater contamination, its prevention and

any ancillary issues) associated with the

use of atrazine, simazine, cyanazine,

alachlor, and metolachlor, as discussed

in this proposed rule. EPA would like

comments on its estimate of the

economic impacts of the proposed rule.

For instance, has the Agency

sufficiently addressed the indirect costs,

such as those associated with minor use

sites (e.g., fruits, nuts, and turf)? Of

particular interest would be suggestions

for how to improve both: (1) The

estimate of present/future risks posed by

these five pesticides in ground water

absent further risk-reduction measures

like SMPs; and (2) the estimate of

environmental results likely to be

achieved by SMPs.

V. Public Docket

A record has been established for this

rulemaking under docket number OPP–

36190 (including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8 a.m. to

4:30 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Room 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer all comments received

electronically into printed, paper form

as they are received and will place the

paper copies in the official rulemaking

record which will also include all

comments submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

VI. Notification to Secretary of

Agriculture and the Scientific Advisory

Panel

As provided in 40 CFR 153.31(b), EPA

has transmitted copies of this Notice

and the Regulatory Impact Analysis, to

the Secretary of Agriculture and the

Scientific Advisory Panel for comment,

prior to today’s publication. In the

process of reviewing the proposed

regulation USDA has raised a number of

concerns that the Agency has addressed

in the text of the proposal. Among those

concerns are the effects on minor uses,

the potential for de facto cancellations

with the States’ failure to have an

approved Plan, possible costs incurred

by USDA programs, the need for an

appropriate balancing of risks and

benefits in the development and

approval of SMPs, and the most

appropriate statutory authority for

taking regulatory action. USDA looks

forward to a full public consideration of

these and other critical issues in the

promulgation of the final regulation. In

particular, USDA urges the Agency to

adopt a streamlined process which

examines a broad range of possible

alternatives for efficiently mitigating the

environmental impacts while preserving

sound agricultural production. The

Panel had no written comments.

VII. References

1. Baker, David B., et.al., ‘‘Immunoassay

Screens for Alachlor in Rural Wells: False

Positives and an Alachlor Soil Metabolite,’’

Environmental Science Technology., 1993,

27, 562–4.

2. Roux, Paul R., Large-Scale Retrospective

Ground-Water Study for Metolachlor in Four

Areas of the U.S., [Ciba-Geigy, Corp.], 1989.

3. Holden, L.R., and Graham, J.A., ‘‘Project

Summary of the National Alachlor Well

Water Survey,’’ (Project Summary and 6

Volumes), Monsanto Agricultural Co., St.

Louis, MO, February 1990.

4. ‘‘Review of the Monsanto Company

National Alachlor Well Water Survey,’’ Phase

II Report prepared for EPA by ICF, Inc.,

March 29, 1991.

5. Taylor, C. Robert, et. al., ‘‘Economic

Impacts of Chemical Use Reduction in the

South,’’ Southern Journal of Agricultural

Economics, July 1991.

6. USEPA-OPTS, 1987a: ‘‘Agricultural

Chemicals in Ground Water: Summary

Minutes from the 1987 Pesticide Strategy

Workshop,’’ October 1987.

7. USEPA-OPTS, 1987b: ‘‘Agricultural

Chemicals in Ground Water: Proposed

Pesticide Strategy,’’ December 1987.

8. USEPA-OPTS, 1988a: ‘‘Summary of

State Commissioners Meeting on EPA

Proposed Strategy on Agricultural Chemicals

in Ground Water,’’ August 1988.

9. USEPA-OPTS, 1988b: ‘‘Pesticides in

Ground Water Data-Base 1988 Interim

Report,’’ December 1988.

10. USEPA, 1990: National Survey of

Pesticides in Drinking Water Wells: Phase I

Report, EPA 570/9–90–015, November 1990.

11. USEPA 1991a, Protecting the Nation’s

Ground Water: EPA’s Strategy for the 1990s

(The Final Report of the EPA Ground-Water

Task Force), 21Z-1020, July 1991.

12. USEPA 1991b, Pesticides and GroundWater Strategy, 21T-1022, October 1991.

13. USEPA, 1991c; USEPA, Office of

Pesticide Programs, Biological and Economic

Analysis Division (Economic Analysis

Branch), ‘‘Pesticides and Ground-Water

Strategy: A Survey of Potential Benefits,’’

February 1991.

14. USEPA, 1992a, National Survey of

Pesticides in Drinking Water Wells: Phase II

Report, EPA 570/9–91–021, Winter 1992.

15. USEPA, 1992b, Pesticides in Ground

Water Database: A Compilation of

Monitoring Studies: 1971 - 1991 (11 volumes:

a National Summary and 10 Regional

Summaries), EPA 734–123–92–001,

September 1992.

16. USEPA, 1992c, ‘‘EPA Definition of

‘Pollution Prevention’,’’ Memorandum to all

EPA personnel from F. Henry Habicht,

Deputy Administrator, May 28, 1992.

17. USEPA, 1992d, Final Comprehensive

State Ground Water Protection Program

Guidance, EPA 100–R–93–001, December

1992.

18. USEPA, 1993; USEPA-OPPTS,

Guidance for Pesticides and Ground Water

State Management Plans: Implementation

Document for the Pesticides and Ground

Water Strategy, EPA 735–B–93–005a,

December, 1993; and two Appendices (EPA

735–B–93–005b, and EPA 735–B–93–005c).

19. USEPA, 1995, ‘‘A Framework for

Measuring the Economic Benefits of Ground

Water,’’ EPA 230–B–95–003, October 1995.

20 USEPA, 1996, ‘‘Water Resources Impact

Analysis for the Triazine Herbicides,’’

[unpublished]

21. Nowak, Peter, Wolfe, Steven, et. al.,

‘‘Assessment of 1992 Wisconsin Atrazine

Rule (Ag 30),’’ Final Report - University of

Wisconsin College of Agricultural and Life

Sciences, May 1993).

22. WDATCP, 1996: Wisconsin Department

of Agriculture, Trade and Consumer

Protectiion (Postle, Jeff), ‘‘Resampling Wells

that Previously Exceeded a Pesticide

Enforcement Standard,’’ Final Report -

February 1996.

VIII. Regulatory Assessment

Requirements

A. Executive Order 12866

Pursuant to Executive Order 12866

(58 FR 51735, October 4, 1993), it has

been determined that this is a

‘‘significant regulatory action’’ because

it may result in an annual effect of $100

million or more. This action was

therefore submitted to the Office of

Management and Budget (OMB) for

review, and any comments or changes

made during that review have been

documented in the public record.
33294 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

In addition, the Agency has

conducted an economic analysis of the

potential impacts associated with this

proposed action, which is included in a

Regulatory Impact Analysis’ document

prepared for this regulation. A copy of

this analysis, which is discussed in Unit

IV. of this preamble, is also included in

the public record.

B. Regulatory Flexibility Act

Pursuant to the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.), EPA has

determined that this regulatory action

does not impose any adverse economic

impacts on small entities.

An analysis of the prospective

impacts of this proposed rule on small

States, pesticide distributors, and

agricultural producers was prepared as

part of the Agency’s economic analysis

for this proposed action, which is

summarized in Unit IV. of this

preamble. This analysis is included in a

Regulatory Impact Analysis’ document,

a copy of which is included in the

public record for this action. This

information is also being forwarded to

the Chief Counsel for Advocacy of the

Small Business Administration. Any

comments regarding the economic

impacts that this proposed regulatory

action may impose on small entities

should be submitted to the Agency at

the address listed above.

C. Paperwork Reduction Act

The information collection

requirements in this proposed rule have

been submitted for approval to the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act (PRA), 44 U.S.C. 3501 et seq. An

Information Collection Request (ICR)

document has been prepared by EPA

(EPA ICR No. 1771.01) and a copy may

be obtained from Sandy Farmer, OPPE

Regulatory Information Division; U.S.

Environmental Protection Agency

(2136); 401 M St., SW.; Washington, DC

20460, by calling (202) 260–2740, or by

sending an e-mail request to:

farmer.sandy@epamail.epa.gov.

For PRA purposes, ‘‘burden’’ means

the total time, effort, or financial

resources expended by persons to

generate, maintain, retain, or disclose or

provide information to or for a Federal

agency. This includes the time needed

to review instructions; develop, acquire,

install, and utilize technology and

systems for the purposes of collecting,

validating, and verifying information,

processing and maintaining

information, and disclosing and

providing information; adjust the

existing ways to comply with any

previously applicable instructions and

requirements; train personnel to be able

to respond to a collection of

information; search data sources;

complete and review the collection of

information; and transmit or otherwise

disclose the information.

Development and implementation of

pesticide SMPs entails the collection of

various sorts of information. In

particular, States will need to create

and/or gather information to conduct

ground water vulnerability assessments,

including data on agronomic practices

(e.g., pesticide use, cropping patterns)

and aquifer sensitivity; the States will

either gather the data themselves or

require third parties (users and/or

pesticide registrants) to report the data.

States will then use this data to assess

the vulnerability of ground water to the

pesticides requiring Pesticide SMPs. In

addition, States may need to develop

and/or maintain ground-water

monitoring efforts, or expand their

existing efforts to gather chemical,

physical, geological, biological, and

other environmental data. This data will

be necessary to support Pesticide SMP

activities such as determining ground

water levels, analyzing the existence

and extent of contamination, and

evaluating the effectiveness of

management measures. Furthermore,

once Pesticide SMPs are approved by

EPA, States will need to submit an SMP

Biennial Report every 2 years beginning

2 years from the EPA approval date and

continuing every 2 years thereafter. The

SMP Biennial Report will provide a

basis for measuring States’ progress

toward protection of ground water

resources from pesticide contamination.

The commitment to develop and report

such information is a mandatory

component of SMPs.

The total annual burden for the

information collection related activities

associated with this proposed action is

estimated to average 412,560 hours per

year for all respondents, including State

(and territorial) government, and private

parties. The per respondent burden (i.e.,

burden for each State, territory, or

private party divided by the number of

States, territories and tribal authorities

expected to submit SMPs) is expected to

average 7,367 hours per year. First year

burden is estimated to be a total of

673,083 hours, with 12,1019 hours per

respondent. The total annual costs for

the information collection related

activities associated with this proposed

action is estimated to average

$18,043,080 per year for all

respondents, with an annual estimated

cost of $322,198 per year for each

respondent. First year start-up costs are

expected to be $22,395,865, with an

estimated $399,926 cost per respondent.

An Agency may not conduct or

sponsor, and a person is not required to

respond to a collection of information

unless it displays a currently valid OMB

control number. The OMB control

numbers for EPA’s regulations are listed

in 40 CFR part 9 and 48 CFR chapter 15.

Comments are requested on the

Agency’s need for this information, the

accuracy of the provided burden

estimates, and any suggested methods

for minimizing respondent burden,

including through the use of automated

collection techniques. Send comments

on the ICR to the Director, OPPE

Regulatory Information Division, U.S.

Environmental Protection Agency

(2136), 401 M St., SW., Washington, DC

20460, and to the Office of Information

and Regulatory Affairs, Office of

Management and Budget, 725 17th St.,

NW., Washington, DC 20503, marked

‘‘Attention: Desk Officer for EPA.’’

Include the ICR number in any

correspondence. Comments related to

these estimates may be submitted to the

address listed in the ADDRESSES unit

anytime during the comment period for

the proposed action. However, since

OMB is required to make a decision

concerning the proposed collection

between 30 and 60 days after June 26,

1996, a comment to OMB is best assured

of having its full effect if OMB receives

it by July 26, 1996. The final rule will

respond to any OMB or public

comments on the information collection

requirements contained in this proposal.

D. Unfunded Mandates Reform Act and

Executive Order 12875

Pursuant to Title II of the Unfunded

Mandates Reform Act (UMRA) of 1995

(Pub. L. 104–4), EPA has determined

that this regulatory action contains a

Federal mandate that may result in

expenditures of $100 million or more

for State, local and tribal governments,

in the aggregate, or to the private sector

in any 1–year. Accordingly, EPA has

prepared the following description of

the intergovernmental consultation

under UMRA, and Executive Order

12875 (58 FR 58093, October 28, 1993),

entitled ‘‘Enhancing the

Intergovernmental Partnership.’’ The

basis for EPA’s determination is

contained in the economic analysis

accompanying this rule, which is

included in the public record for this

action and summarized in Unit IV. of

this preamble.

UMRA requires that such a rule be

accompanied by a statement that, among

other things, documents that the rule is

the least costly, most cost-effective or

least burdensome alternative that

achieves the regulatory objective. In the

absence of such documentation, UMRA
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33295

provides that the head of the

promulgating Agency may otherwise

provide in the statement an explanation

of why the least burdensome approach

was not adopted or is inconsistent with

law. The discussion in part E of Unit IV

of this preamble describes the Agency’s

analysis of regulatory options. As this

discussion, and the earlier analysis cited

therein (c.f., Ref. 13) indicates, the

Agency believes that this proposed

action is the most cost-effective and

least burdensome alternative to the

alternatives considered in the

development of the Pesticides and

Ground-Water Strategy (Ref. 12),

developed as the groundwork for

today’s proposed rule. A particularly

advantageous feature of the chosen

option is that it allows States to

determine the most appropriate

approach for preventing unreasonable

adverse effects within their individual

States. The practical alternatives are a

choice between different kinds of

Federally mandated restrictions, either

national standards and/or risk-reduction

measures (principally in the form of

label changes) or outright cancellations

of use. The principal disadvantage of

both is that they can not take State

specific issues into consideration, and

so can be anticipated to increase the loss

of economic benefits associated with the

pesticides’ use, relative to the impacts of

SMPs. National-level measures are

potentially less certain of meeting the

regulatory objective, that is, of achieving

the goal of preventing unreasonable

levels of ground-water contamination.

This greater uncertainty is caused by the

relative inability to tailor riskmanagement measures, proceeding

instead on a ‘‘lowest common

denominator’’ approach. Still another

conceivable (but unanalyzed) option is

doing nothing at the Federal level,

leaving the potential for ground-water

contamination to be addressed, if at all,

by voluntary action and/or independent

State action. This alternative was not

analyzed because it clearly failed to

meet the regulatory objective. Such an

option that freely permits contamination

would entail no direct regulatory costs,

but the far larger reduction in the value

of the resource must be compared to the

more conventional economic impacts.

The statement required by UMRA also

requires a summary description of State/

local/Tribal governmental input in the

rule’s development. Prior consultation

with State and Tribal authorities has

been extensive. The Pesticides and

Ground Water Strategy development

process began with a major public

workshop held in 1986 in Coolfont,

West Virginia. State Agriculture,

Environment and Health agencies were

among the participants. A second public

workshop was held at Coolfont during

the summer of 1987, also with similar

participation. Beyond the Strategy, State

regulatory officials were involved in the

development of the subsequent

Guidance beginning in 1989, when EPA

sponsored working sessions to

determine how best to guide the process

of managing pesticide use to protect the

ground water resource. Two week long

sessions were held in Fredericksburg,

Virginia during October and November

of 1989. These sessions were actual

working sessions to develop the

document that today is the SMP

guidance document. Between five and

seven States participated in each

session. Drafts of the guidance

document were shared with all 50 State

Lead Agencies for Pesticides, EPA

Regional Offices, and other Federal

agencies.

During development of the proposed

rule, many issues were discussed with

the Water Quality Working Committee

Group of the State FIFRA Issues

Research and Evaluation Group

(SFIREG) on which eight State Lead

Agencies sit. This group meets three

times per year with OPP to discuss

water quality issues and this forum was

used extensively in the early stages of

development of the proposed rule.

The proposed regulation itself has

been provided as an initial draft twice

to EPA’s 10 regional offices and all 50

states for review and comment, in

addition to the SFIREG Water Quality

Committee and to SFIREG’s parent

body, the American Association of

Pesticide Control Officials (AAPCO).

The first round of review in fall 1994

elicited 38 written comments from State

and Tribal agencies; the second round

in spring 1995 elicited 18 further

comments. As a result of each round of

review, the draft proposed rule was

modified. These written comments are

in the public record and were

considered in the development of the

proposed rule. Virtually all of the

principal State comments and concerns

are reflected in the discussion in Unit III

of this preamble, and in the request for

comments accompanying that Unit.

All other UMRA requirements for the

accompanying statement to a

‘‘significant regulatory action,’’ e.g.,

descriptions of statutory authority,

anticipated costs and benefits,

compliance costs, are contained

throughout this preamble, in the

appropriate headings.

E. Executive Order 12898

Pursuant to Executive Order 12898

(59 FR 7629, February 16, 1994), the

Agency has considered environmental

justice related issues with regard to the

potential impacts of this action on the

environmental and health conditions in

low-income and minority communities.

As related throughout this document,

the approach the Agency is proposing to

address the problem of pesticides in

ground water is based on a full

appreciation of the localized nature of

the problem, and this approach strives

to be the most effective strategy for

localized protection of the ground-water

resource. As the Strategy highlights,

alternatives to effective local-level risk

reduction measures (e.g., national-level

regulation or no regulatory protection)

are considered likely to either overregulate pesticide use (causing undue

economic hardship to affected parties)

or under-protect (increasing the risk of

various adverse health and

environmental effects to specific

parties).

List of Subjects

40 CFR Part 152

Environmental protection,

Administrative practice and procedure,

Pesticides and pest, Reporting and

recordkeeping requirements.

40 CFR Part 156

Environmental protection, Labeling,

Occupational safety and health,

Pesticides and pest, Reporting and

recordkeeping requirements.

Dated: June 19, 1996.

Carol M. Browner,

Administrator.

Therefore, 40 CFR chapter I, is

proposed to be amended as follows:

1. In Part 152:

PART 152 —[AMENDED]

a. The authority citation for part 152

would continue to read as follows:

Authority: 7 U.S.C. 136-136y; Subpart U is

also issued under 31 U.S.C. 9701.

b. By adding a new subpart J to part

152, to read as follows:

Subpart J—Ground-Water State

Management Plans

Sec.

152.180 Applicability.

152.183 Definitions.

152.185 Restriction.

152.187 Submission and approval of

ground-water State Management Plans.

152.190 Specifications and requirements

of a ground-water State Management Plan.

152.191 Evaluation of State Management

Plan Implementation.

152.193 Amendment of State

Management Plans.
33296 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

152.195 Withdrawal of approval of a

State Management Plan.

152.198 Pesticides classified for restricted

use subject to a ground water State

Management Plan.

Subpart J—Ground-Water State

Management Plans

§ 152.180 Applicability.

This subpart applies to any pesticide

or pesticide product designated to be

subject to the requirements and

provisions of ground-water State

Management Plans by means of a

Restricted Use Classification.

§ 152.183 Definitions.

In addition to the definitions in

§ 152.3, the following terms also apply

to this subpart:

Ground Water Reference Point means

an environmental concentration of a

pesticide ingredient based on any of the

following:

(1) Maximum Contaminant Levels

(MCLs) established under the Safe

Drinking Water Act; or

(2) Health Advisories (where MCLs

are not available for a substance); or

(3) Water Quality Standards (where

the ingredient poses adverse effects to

ecosystems affected by closely

hydrologically linked surface waters)

under the Clean Water Act.

Plan means a State Management Plan

developed for the purpose of managing

the use of a pesticide in order to prevent

unreasonable risks of ground water

contamination.

State means each of the 50 States,

Puerto Rico, the U.S. Virgin Islands, the

District of Columbia, Guam, American

Samoa and other Pacific Island

Territories of the United States, as well

as Indian Lands under Tribal

jurisdiction.

§ 152.185 Restriction.

(a) Restriction. A pesticide or

pesticide product classified for

restricted use subject to a State

Management Plan may be used only in

accordance with the provisions and

requirements of an Agency-approved

State Management Plan, after a date 33

months from the date the pesticide or

product is so classified. Such a pesticide

or pesticide product may not be sold or

used after that date within the

boundaries of a State without an

Agency-approved State Management

Plan.

(b) Labeling. (1) Upon classification of

a pesticide for restricted use, subject to

ground-water State Management Plans,

each registrant of a product subject to

that classification shall, within 12

months after the date of that

classification by final Agency rule,

submit for such product:

(i) A copy of the labeling amended to

include the statement specified in

§ 156.137(a)(2)(ii) of this chapter.

(ii) A statement that the registrant will

comply with the labeling requirements

prescribed by the Agency by the

effective date of this rule. The Agency

will regard such statement to be a report

under the Act. The Agency may deny

registration or initiate cancellation

proceedings if a registrant fails to

comply with the timetables established

in this section.

(2) A product whose labeling bears

directions for end use and that has been

classified as subject to ground-water

State Management Plans must be

labeled in accordance with the

requirements of § 156.10 of this chapter

after the effective date of the restriction.

(c) Distribution and sale of classified

products. No product with a use

classified for restricted use, subject to

ground-water State Management Plans,

may be distributed or sold by a retailer

or other person after the effective date

of the restriction, unless the product

bears a label or labeling which contains

the terms of the classification and

otherwise complies with paragraph

(b)(2) of this section.

§ 152.187 Submission and approval of

ground-water State Management Plans.

If any State, at any time after the

classification of a pesticide or pesticide

product to be subject to State

Management Plans by final rule, wishes

to establish a ground-water State

Management Plan for such a pesticide or

pesticide product, that State shall

submit a proposed Plan for that purpose

to the Administrator. The Administrator

will approve the Plan submitted by any

State if, in the Administrator’s

judgement, the Plan meets the

requirements of § 152.190.

(a) Schedule. A State that wishes to

implement a Plan on the effective date

of the State Management Plan restriction

shall submit a proposed Plan, along

with the administrative record

accompanying development of the

proposed Plan to the appropriate EPA

region under 40 CFR 1.7, before a date

24 months from the date a pesticide or

product is classified. The submission

shall include an electronic file in

Wordperfect 5.1 or higher or ASCII for

all material. The Administrator will

review such submittals and approve or

disapprove Plans within 9 months of

receipt of a complete submittal.

(b) Review. Upon receipt of a

proposed State Plan submitted for EPA

approval, the Administrator or a

designee will first review the proposed

Plan to determine that all requirements

as provided in § 152.190 have been

addressed. Upon completion of this

review, the Administrator will notify

the State in writing of the initial

determination of the completeness of

the submission. In the event that the

Administrator determines that the

submission fails to address all

requirements, the Administrator will

request the State revise its submission to

provide the missing components. Once

the Administrator is satisfied that the

submission is complete, full evaluation

of the submission will proceed.

(c) Approval. Upon completion of the

review of the submission, if the

Administrator finds that the Plan meets

the requirements of § 152.190, then the

Administrator will publish a Notice of

Approval in the Federal Register and a

letter of notification to the State official

designated as State Liaison, pursuant to

§ 152.190(b), informing of the approval.

(d) Disapproval. If, after completion of

the review of the submission, the

Administrator finds that the submission

fails to meet the requirements of

§ 152.190, the Administrator shall notify

the State Liaison by letter that EPA will

not approve the Plan as submitted, and

specifying the deficiencies in the Plan

that prevent its approval. If, after further

consultation, the Administrator still

finds that the submission fails to meet

the requirements, the Administrator will

publish a notice in the Federal Register

announcing the disapproval of the Plan

and including the reasons for finding

the Plan inadequate pursuant to

§ 152.190. In this event, sale or use in

the State of the pesticide that is the

subject of the Plan shall be prohibited

33 months after the promulgation of a

rule classifying the pesticide as subject

to a ground-water State Management

Plan.

§ 152.190 Specifications and requirements

of a ground-water State Management Plan.

The Administrator shall approve the

State Management Plan submitted by

any State, or any modification thereof,

if in the Administrator’s judgement, the

Plan fulfills the following requirements.

(a) State’s philosophy and goals

toward protecting ground water. An

acceptable Plan must, to the satisfaction

of the Administrator, contain a

description of the State’s ground-water

protection philosophy and goals

regarding pesticide management,

including an explanation how its

philosophy and goals will be no less

protective than EPA’s goal of preventing

adverse effects to human health and the

environment and protecting the

environmental integrity of the nation’s

ground water.
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33297

(b) Roles and responsibilities of State

agencies. An acceptable Plan must, to

the satisfaction of the Administrator:

(1) Identify and describe both the

general responsibility of, and the

specific technical and administrative

tasks to be performed by, each

participating agency responsible for the

development and implementation

(including enforcement) of the Plan,

including a description of how the State

agencies intend to use the programs and

expertise of Federal agencies in carrying

out the Plan.

(2) Identify a Liaison who will serve

as a single contact point for all formal

communications concerning the Plan

process between EPA and the State,

including responsibility for the

transmittal and receipt of official

correspondence and information.

(3) Describe the coordination

mechanisms between all participating

State agencies, local entities, and

appropriate Federal agencies.

(4) Describe how local governments

are included in activities under the

Plan. When local governments have

authority to address State ground-waterrelated objectives and priorities, the

State must demonstrate that program

coordination, guidance, or oversight is

provided.

(5) Contain official concurrences from

the directors of all State agencies with

responsibilities under the Plan stating

their agreement with the Plan, and their

commitment to carry out their

responsibilities under the Plan.

(6) Discuss any relevant inter-State

multi-jurisdictional coordination,

including how any multi-jurisdictional

issues will be resolved for purposes of

implementing the Plan.

(c) Legal authority. An acceptable

Plan must, to the satisfaction of the

Administrator:

(1) Contain regulatory authorities that

are sufficient to accomplish the

objectives of the Plan, established in

paragraph (a) of this section.

(2) Specify the legal authorities of the

State to implement the Plan successfully

and specify the State’s authority to

impose preventive measures, its

remedial action authority and its

compliance and enforcement

authorities, citing all relevant State laws

and regulations and including Federal

legislation, regulations and program

delegation, available to the State.

(3) Identify the specific authorities

that will be used to carry out the

specific commitments made in the Plan.

The State must specifically identify the

authority to conduct or require others to

conduct monitoring, prohibit use in

specific areas, close public wells, or

supply or require others to supply

alternative sources of water, where such

actions are elements of the Plan, must

be identified.

(d) Resources. An acceptable Plan

must, to the satisfaction of the

Administrator, demonstrate there are

adequate resources available to

implement and enforce the program.

Resources include technical expertise

and personnel, physical and operational

capabilities, and funding. The Plan must

demonstrate there is an adequate match

between revenues and proposed

expenditures and that the necessary

expertise is available.

(e) Basis for assessment and planning.

An acceptable Plan must, to the

satisfaction of the Administrator,

specify the State’s approach and

activities to assess vulnerability for the

geographic area in which the State

intends to allow pesticide use,

identifying the sources of all such data.

The State shall specifically describe the

State’s available pesticide use data (e.g.,

geographic use and application rates)

and how it will be factored into

assessing vulnerability.

(f) Monitoring. An acceptable Plan

must, to the satisfaction of the

Administrator, demonstrate that

monitoring activities (including groundwater monitoring) performed pursuant

to the Plan are appropriate for the

purposes of the Plan, with assurances

that the activities will be carried out

adequately. Specifically, an acceptable

Plan must identify and describe key

elements of the monitoring program,

including the scope and objective (in

relation to the purposes of the Plan) of

such monitoring, design and

justification (including the number of

sites to be sampled, the number of

samples to be taken and the frequency

of sampling) of such monitoring,

monitoring protocols, quality assurance/

quality control, sampling methodology,

analytical methods, and analytes. Such

description must make clear how the

placement of monitoring sites relates to

the State’s priorities for protecting

ground water, and will allow evaluation

of the effectiveness of prevention and

response measures specified in

paragraphs (g) and (h) of this section.

Monitoring performed for the purpose of

fulfilling this requirement must be

performed in accordance with an EPAapproved Quality Assurance Project

Plan (as described in Chapter 5.4.2 of

Appendix B, ‘‘Assessment, Prevention,

Monitoring and Response Components

of State Management Plans,’’ to the

Guidance for Pesticides and State

Management Plans (EPA 735-B-93-005c,

February 1994). This incorporation by

reference was approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

Copies may be obtained from the Public

Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Copies may be inspected at the above

address or at the Office of the Federal

Register, 800 North Capitol St., NW.,

suite 700, Washington, DC. Good

Laboratory Practice Standards (40 CFR

part 160) do not apply to monitoring

performed for the purpose of fulfilling

this requirement.

(g) Prevention actions. An acceptable

Plan must, to the satisfaction of the

Administrator, specify the actions a

State will take to manage the use of the

pesticide classified for use subject to the

Plan, to fulfill the State’s goals and

principles enunciated pursuant to

paragraph (a) of this section and will

otherwise prevent unreasonable adverse

effects to human health and protect the

environmental integrity of the nation’s

ground-water resources.

(h) Response to detections of

pesticides. An acceptable Plan must, in

the judgement of the Administrator,

adequately specify the measures that the

State will take (and the circumstances

under which the State will take them)

to respond to contamination so that

Ground Water Reference Points are not

reached, and specify the actions the

State will take in the event Reference

Points are met or exceeded. This

description must be presented in the

form of a general corrective response

scheme, illustrating the State’s capacity

for timely, coordinated response to

contamination.

(i) Enforcement mechanisms. An

acceptable Plan must, to the satisfaction

of the Administrator, demonstrate that

the State’s enforcement authorities and

capabilities are adequate to implement

and to monitor compliance with the

specific measures included in the Plan,

describing authorities and capabilities

that are intended to protect ground

water from contamination and response

actions where contamination has

already occurred. Enforcement authority

must be identified by the State, and the

roles and responsibilities of each State

agency must be defined, including how

coordination of enforcement capabilities

within agencies will work to prevent

and respond to contamination.

(j) Public awareness and

participation. An acceptable Plan must,

to the satisfaction of the Administrator,

demonstrate that there is notice and

opportunity for public comment within

the process of Plan development, and

will be informed of significant Plan
33298 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

implementation activities. This

demonstration must:

(1) Describe the public role regarding

development of the Plan and decisionmaking in implementing the Plan, and

identify or describe existing legal

requirements within the State that

would ensure public participation in the

process (i.e., an Administrative

Procedure Act requiring notice and

comment, etc.). If no such legal

requirements exist within the State, the

Plan must describe any other public

participation process that the State uses

in the development of the Plan.

(2) The Plan must also specify the

level of detection in ground water that

is considered by the State to be of such

significance that the State will inform

the public. Indicate how, when, and by

whom the public will be informed of

detections in ground water that are

considered significant, providing for, at

a minimum:

(i) The notification of any well owner

of any detections in ground water; and

(ii) The notification of all users of any

detections above the reference point.

(3) Include a description of the

process and means of communication

by which the public will be made aware

of important regulatory actions taken

under the Plan.

(k) Information dissemination. An

adequate Plan must, to the satisfaction

of the Administrator, describe the

means by which measures prescribed

pursuant to the Plan will be

communicated to pesticide users and all

other interested parties. A plan must:

(1) Describe how information

regarding prevention measures (e.g., use

limitations and precautions) will be

relayed to the appropriate audiences.

(2) Describe how pesticide users will

be trained or educated in how to comply

with requirements of applying a

pesticide where use is governed by the

Plan.

(3) Identify the targeted parties and

discuss how information will be

relayed.

(4) Explain why the information

dissemination approach is appropriate

for the type of contamination prevention

actions being employed, and the

education and/or awareness of the

targeted audience is required.

(5) Describe how information will be

updated as requirements change. Such

discussion should include the form

these updates will take and the

distribution methods. The Plan should

also discuss any existing mechanisms

(i.e., Memoranda of Understanding,

cooperative agreements, etc.) between

the State and other entities that will be

involved in this effort.

(l) Records and reporting. An

adequate Plan must, to the satisfaction

of the Administrator:

(1) Include a commitment by the State

to maintain essential records relating to

Plan implementation for a period of at

least 6 years. The information

maintained must include, but is not

limited to, records on any monitoring or

sampling conducted, results of analyses,

issuance of permits, types and numbers

of enforcement actions taken, records of

any site-specific regulatory actions, and

administrative actions. The State must

commit to promptly make available to

the Agency, upon request, records

related to the development or

implementation of the Plan.

(2) Commit to developing and

submitting to the appropriate Regional

Office a Plan Biennial Report, as

described in § 152.191(a), and to report

any significant findings to the

appropriate Agency Regional Office.

(3) Commit to submitting with each

report to EPA a signed certification,

worded as follows:

I certify under penalty of law that I have

personally examined and am familiar with

the information submitted herein and based

on my inquiry of those individuals

immediately responsible for obtaining the

information, I believe the submitted

information is true, accurate and complete. I

am aware that there are significant penalties

for submitting false information, including

the possibility of fine and imprisonment. See

18 U.S.C. section 1001 and 7 U.S.C. section

136).

§ 152.191 Evaluation of State Management

Plan Implementation.

Any State Management Plan approved

under § 152.190 shall be subject to

periodic evaluations of its

implementation by the Agency, in order

to assure implementation of the Plan

consistent with its goals and

commitments, to determine the

environmental effectiveness and the

level of ground-water protection

provided by the Plan, and to ensure a

minimum level of national consistency.

(a) Biennial Report. A Biennial

Report, as described in § 152.190 (l)(2),

must be developed and submitted by the

State in order to maintain Agency

approval, and will be used by the

Agency and by State officials to evaluate

a State’s effectiveness in protecting its

ground-water resources from pesticide

contamination. The State shall prepare

the Biennial Report according to the

provisions of Chapter 5 of Appendix A,

‘‘Review, Approval and Evaluation of

State Plans,’’ to the Guidance for

Pesticides and State Management Plans

(EPA 735-B-93-005b, February 1994).

(b) Evaluation reporting requirements.

The Biennial Report must be approved

by State officials directing the key State

agencies that play a role in

implementing the Plan. The Biennial

Report must be submitted in October of

alternate years, starting in October [of

the year 4 years after date of publication

of the final rule] to the appropriate

Agency Regional Office. The State may

submit a single Biennial Report in the

event it implements Plans for more than

one classified pesticide. In that event,

the report must include programmatic

and environmental evaluations

addressing each approved Plan. States

will also submit a programmatic and an

environmental evaluation that addresses

any progress made in implementing the

Plan.

§ 152.193 Amendment of State

Management Plans.

(a) The State will amend an approved

Plan as part of the Biennial Report

required under § 152.191(a) when:

(1) The evaluation performed

pursuant to § 152.191 demonstrates that

the provisions in the Plan do not

adequately protect the ground-water

resource from pesticide contamination.

(2) A change in the legal (statutory or

regulatory) and enforcement framework

for Plan development and

implementation necessitates a change in

the Plan.

(3) A State, through experience, finds

more effective ways to assess groundwater contamination, to prevent and

respond to contamination, and to

educate affected parties or disseminate

information.

(4) Changes in pesticide management

measures or approaches become

necessary as a result of significant

changes in crops or crop production

systems and technologies within the

State.

(5) Roles and responsibilities of State

agencies involved in the

implementation of the Plan change so as

to necessitate a change in the Plan.

(b) If a State is aware that an

amendment is needed, then that

amendment should be submitted as part

of the Plan Biennial Report. In addition,

if the Regional Office that is the

recipient of that Report determines

through the evaluation process that the

Plan needs to be updated, then the

Regional Administrator of that region, or

a designee, can initiate the updating

process by requesting that the State

submit a Plan Update Report. In every

case, the Update Report must include:

(1) A description of the proposed

changes in the Plan.

(2) An explanation of why the

changes are necessary.

(3) An analysis of the impact the

changes will have on the other
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33299

components of the Plan, the

implementation of the Plan and the

protection of the resource.

(4) If changes will affect pesticide

users, a description of how users will be

alerted to the changes in the Plan.

(5) Concurrences by all officials

directing the key State agencies.

(6) If changes are significant, a

description of how the State received

public input on changes to the Plan, and

the administrative record developed in

the course of changing the Plan.

Amendments to Plans must be

concurred or approved by the Regional

Administrator.

§ 152.195 Withdrawal of approval of a

State Management Plan.

(a) If, in the judgement of the

Administrator or a designee, either:

(1) A State fails to demonstrate that it

is satisfactorily implementing the Plan;

or

(2) A State’s Plan is not protecting

ground water from contamination at or

above ground water reference points (as

specified in § 152.198); or

(3) A State fails to address

deficiencies identified by the Plan

evaluation through updating the Plan

and/or improving implementation of the

Plan; or

(4) A State fails to submit a biennial

report;

he or she shall notify the designated

State Liaison, named pursuant to

§ 152.190(b), and relevant State

administrators of the Agency’s concerns.

In that event, the State will have 90 days

to respond to these deficiencies in its

Pesticide Plans, either through the Plan

updating process or by demonstrating to

the Region that the Plan is being

satisfactorily implemented.

(b)(1) If the Administrator determines

that the State has failed to address the

deficiencies identified by the Agency or

has failed to correct the deficiencies, the

Administrator shall notify the officials

directing the key State agencies

involved in implementing the Plan and

the designated State Liaison by letter

that withdrawal of Agency approval is

being considered. The notice will

include:

(i) A statement concerning the

potential withdrawal of Agency

approval of the Plan.

(ii) A listing of the deficiencies of the

Plan or a description of the failure of the

Plan or its implementation to protect

ground water.

(iii) A brief summary of the events

that led to the withdrawal notice.

(iv) Dates by which the State can

respond to the deficiencies to stop the

withdrawal process.

(2) The State must respond to the

notice within 30 days of receipt of the

notice in writing with a commitment to

address the deficiencies in the Plan

itself or in its implementation. If the

State disagrees with the judgement or

the findings of the Administrator in the

initial notice described in paragraph (b)

of this section, the State may request to

meet with the Administrator within 60

calendar days from the time the EPA

Administrator sends the letter of

potential withdrawal to the

Administrators of the key State

agencies.

(3) If, in the Administrator’s

judgement, continued use of the

pesticide within the State presents

unreasonable adverse effects on the

environment because of the deficiencies

cited pursuant to paragraph (b)(1) of this

section, the Administrator may prohibit

further sale and use of the pesticide in

the State until the Agency and the State

reach an agreement on how to address

the Plan’s deficiencies. Such a

prohibition shall be published in a

Federal Register notice describing the

basis for the Administrator’s findings,

and soliciting comment thereon. After

addressing any public comment, the

Administrator may take final action

temporarily prohibiting use of the

pesticide in the State.

(c) If the State does not respond to the

notice that withdrawal of approval is

being considered or fails to address the

deficiencies identified in the notice to

the satisfaction of the Administrator, the

Administrator will send a formal letter

to the officials directing the key State

agencies and the State Liaison

indicating that EPA is publishing a

Federal Register Notice proposing to

withdraw the Pesticide Plan. In the

event the State does not respond to this

notice, the Administrator will publish a

Federal Register Notice to provide an

opportunity for public comment on

withdrawal of the Plan. After addressing

any public comments, the Region will

publish a Notice of Withdrawal in the

Federal Register and prohibit the sale

and use of the pesticide in the State.

(d) Upon publication of the final

Notice of Withdrawal in the Federal

Register, sale and use of the pesticide

within the boundaries of the State will

be prohibited.

§ 152.198 Pesticides classified for

restricted use subject to a ground water

State Management Plan.

Pesticide products containing the

active ingredients listed in the table to

this section, with the corresponding

Ground Water Reference Points

specified are classified for restricted

use, to be subject to the provisions and

requirements of an EPA-approved State

Management Plan.

Active Ingredient CAS Number Ground Water Reference Point

Alachlor 15972-60-8 2 μg/l

Atrazine 1912-24-9 3 μg/l

Cyanazine 21725-46-2 1 μg/l

Metolachlor 51218-45-2 70 μg/l

Simazine 122-34-9 4 μg/l

2. In Part 156:

PART 156—[AMENDED]

a. The authority citation for part 156

continues to read as follows:

Authority: 7 U.S.C. 136-136y.

b. In § 156.10, by revising paragraphs

(a)(1)(viii) and (a)(1)(ix) and removing

paragraph (i) to read as follows:

§ 156.10 Labeling Requirements

(a) * * *

(1) * * *

(viii) The directions for use as

prescribed in subpart G of this part; and

(ix) The use classification(s) as

prescribed in subpart G of this part.

* * * * *

c. By adding a new subpart G to part

156 to read as follows:

Subpart G—Directions for Use

Sec.

156.120 General requirements.

156.121 Contents of directions for use.

156.135 Statements of use classification.

156.136 General use statements.

[Reserved]

156.137 Restricted use statements.
33300 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules

Subpart G—Directions for Use

156.120 General requirements.

(a) Adequacy and clarity of directions.

Directions for use must be stated in

terms which can be easily read and

understood by the average person likely

to use or to supervise the use of the

pesticide. When followed, directions

must be adequate to protect the public

from fraud and from personal injury and

to prevent unreasonable adverse effects

on the environment.

(b) Placement of directions for use.

Directions may appear on any portion of

the label provided that they are

conspicuous enough to be easily read by

the user of the pesticide product.

Directions for use may appear on

printed or graphic matter which

accompanies the pesticide provided

that:

(1) If required by the Agency, such

printed or graphic matter is securely

attached to each package of the

pesticide, or placed within the outside

wrapper or bag.

(2) The label bears a reference to the

directions for use in accompanying

leaflets or circulars, such as ‘‘See

directions in the enclosed circular.’’

(3) The Administrator determines that

it is not necessary for such directions to

appear on the label.

(c) Exceptions to requirement for

direction for use—(1) Detailed

directions for use may be omitted from

labeling of pesticides which are

intended for use only by manufacturers

of products other than pesticide

products in their regular manufacturing

processes, provided that:

(i) The label clearly shows that the

product is intended for use only in

manufacturing processes and specifies

the type(s) of products involved.

(ii) Adequate information such as

technical data sheets or bulletins, is

available to the trade specifying the type

of product involved and its proper use

in manufacturing processes.

(iii) The product will not come into

the hands of the general public except

after incorporation into finished

products.

(iv) The Administrator determines

that such directions are not necessary to

prevent unreasonable adverse effects on

man or the environment.

(2) Detailed directions for use may be

omitted from the labeling of pesticide

products for which sale is limited to

physicians, veterinarians, or druggists,

provided that:

(i) The label clearly states that the

product is for use only by physicians or

veterinarians.

(ii) The Administrator determines that

such directions are not necessary to

prevent unreasonable adverse effects on

man or the environment.

(iii) The product is also a drug and

regulated under the provisions of the

Federal Food, Drug and Cosmetic Act.

(3) Detailed directions for use may be

omitted from the labeling of pesticide

products which are intended for use

only by formulators in preparing

pesticides for sale to the public,

provided that:

(i) There is information readily

available to the formulators on the

composition, toxicity, methods of use,

applicable restrictions or limitations,

and effectiveness of the product for

pesticide purposes.

(ii) The label clearly states that the

product is intended for use only in

manufacturing, formulating, mixing, or

repacking for use as a pesticide and

specifies the type(s) of pesticide

products involved.

(iii) The product as finally

manufactured, formulated, mixed, or

repackaged is registered.

(iv) The Administrator determines

that such directions are not necessary to

prevent unreasonable adverse effects on

man or the environment.

156.121 Contents of directions of general

use.

The directions for use shall include

the following, under the headings

‘‘Directions for Use’’:

(a) The statement of use classification

as prescribed in paragraph (j) of this

section immediately under the heading

‘‘Directions for Use.’’

(b) Immediately below the statement

of use classification, the statement ‘‘It is

a violation of Federal law to use this

product in a manner inconsistent with

its labeling.’’

(c) The site(s) of application, as for

example the crops, animals, areas, or

objects to be treated.

(d) The target pest(s) associated with

each site.

(e) The dosage rate associated with

each site and pest.

(f) The method of application,

including instructions for dilution, if

required, and type(s) of application

apparatus or equipment required.

(g) The frequency and timing of

applications necessary to obtain

effective results without causing

unreasonable adverse effects on the

environment.

(h) Worker protection statements

meeting the requirements of subpart K

of this part.

(i) Specific directions concerning the

storage and disposal of the pesticide and

its container, meeting the requirements

of 40 CFR part 165. These instructions

shall be grouped and appear under the

heading ‘‘Storage and Disposal.’’ This

heading must be set in type of the same

minimum sizes as required for the child

hazard warning. (See Table in

§ 162.10(h)(1)(iv))

(j) Any limitations or restrictions on

use required to prevent unreasonable

adverse effects, such as:

(1) Required intervals between

application and harvest of food or feed

crops.

(2) Rotational crop restrictions.

(3) Warnings as required against use

on certain crops, animals, objects, or in

or adjacent to certain areas.

(4) [Reserved]

(5) For restricted use pesticides, a

statement that the pesticide may be

applied under the direct supervision of

a certified applicator who is not

physically present at the site of

application but nonetheless available to

the person applying the pesticide,

unless the Agency has determined that

the pesticide may only be applied under

the direct supervision of a certified

applicator who is physically present.

(6) Other pertinent information which

the Administrator determines to be

necessary for the protection of man and

the environment.

§ 156.135 Statements of use classification.

(a) Requirement. Each product bearing

one or more uses that has been

classified for restricted use must bear a

classification statement on the label of

the product, and also in any

supplemental labeling that accompanies

the product in sale or distribution. A

product that bears only unclassified

uses as described in § 152.160 or uses

classified for general use is not required

to bear any classification statement.

Restricted use statements are set out in

§ 156.137.

(b) Products bearing mixed classified

uses. A product for which some uses are

not classified, and other uses are

classified for general use or for

restricted use must have a separate

registration for uses that are restricted,

except that a product bearing restricted

uses may also bear unclassified or

general uses in addition to the restricted

uses. A product bearing mixed restricted

uses and other uses is considered a

restricted use product.

(c) Placement of classification

statements. (1) Statements of restricted

use classification must be located at the

top of the front panel of the label (the

‘‘Restricted Use’’ area), and in a

similarly prominent location in

supplemental labeling. No other label

statements shall appear above the

restricted use statements, and no other

statements than those prescribed by the
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Proposed Rules 33301

Agency shall appear in the restricted

use area of the label.

(2) The restricted use statements shall

be distinguished from surrounding label

text by suitable means, such as white

space or a box around the statements.

The words ‘‘Restricted Use Pesticide’’

shall appear in a type size at least that

of the signal word prescribed by

§ 156.10(h)(1)(iv).

§ 156.136 General use statements.

[Reserved]

§ 156.137 Restricted use statements.

(a) A product that is classified for

restricted use must bear, on the front

panel in accordance with § 156.135(c),

the statements in paragraphs (a)(1) and

(a)(2) of this section.

(1) The phrase, ‘‘Restricted Use

Pesticide.’’

(2) Immediately below the phrase

‘‘Restricted Use Pesticide,’’ a statement

of the reason for the restricted use

classification. This statement will

describe the characteristic of the

pesticide, its formulation, or its use

pattern, that is the basis for the

classification. These characteristics

include acute or chronic toxicity,

environmental fate (biodegradability,

leaching potential, etc.), or non-target

organism toxicity. The Agency will

prescribe the nature and wording of the

statement.

(i) A product that is restricted to use

by certified applicators (for example,

pesticides and uses listed in § 152.170)

must bear the statement, ‘‘For retail sale

to and use only by Certified Applicators

or persons under their direct

supervision and only for those uses

covered by the Certified Applicator’s

certification.’’

(ii) A product that is classified for

restricted use subject to a ground-water

State Management Plan (SMP) under

subpart J of part 152 of this chapter

must bear the statement, ‘‘For use only

in accordance with an EPA-approved

State Management Plan for groundwater protection. Sale and use are

prohibited in States that do not have an

EPA-approved State Management Plan.’’

(b) The Agency may develop and

require a label statement different from,

or in addition to, those described in

paragraphs (b)(1) and (b)(2) of this

section, for any product classified for

‘‘restricted use.’’

[FR Doc. 96–16173 Filed 6–25–96; 8:45 am]

BILLING CODE 6560–50–F