[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33260-33301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16173]




[[Page 33259]]


_______________________________________________________________________

Part VII





Environmental Protection Agency





_______________________________________________________________________



40 CFR Parts 152 and 156



Pesticides and Ground Water State Management Plan Regulation; Proposed 
Rule

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

[[Page 33260]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 152 and 156

[OPP-36190; FRL-4981-9]
RIN 2070-AC46


Pesticides and Ground Water State Management Plan Regulation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed rulemaking.

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

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

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

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

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

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

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

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

I. Basis for Regulatory Action

A. Background

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

[[Page 33261]]

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

B. Goal

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

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

[[Page 33262]]

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

C. SMP Start-up

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

D. Statutory Authority

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

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

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

[[Page 33263]]

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

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

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

II. Process for Selecting Pesticides for Restriction under SMPs

A. Determining Potential to Contaminate Ground Water

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

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

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

B. Determining Potential Risk

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

[[Page 33264]]

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

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

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

C. Determining Appropriate Regulatory Action

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

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

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

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

D. Selection of Pesticides for Today's Rule

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

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

[[Page 33265]]

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



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

III. State Management Plan Specifications, Development and Approval 
Procedure

A. Introduction

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

[[Page 33266]]

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

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

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

B. Overview of Application Approval Process

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

[[Page 33267]]

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

C. Plan Requirements

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

[[Page 33268]]

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

[[Page 33269]]

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

[[Page 33270]]

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

[[Page 33271]]

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

[[Page 33272]]

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

D. Evaluation of State Management Plan Implementation

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

E. Amendment of State Management Plans

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

F. Withdrawal of Approval of a State Management Plan

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

[[Page 33273]]

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

G. Label Changes

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

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

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

H. Request for Comments

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

[[Page 33274]]

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

[[Page 33275]]

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

IV. Risk and Benefit Determination

A. Chemical Background and Characteristics

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

B. Risk Assessment

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

[[Page 33276]]

atrazine, simazine, and cyanazine are frequently referred to together 
as triazines, when the three compounds exhibit similar characteristics 
and effects.
    EPA's Integrated Risk Information System (IRIS) summarizes the 
available information on the toxicological endpoints of concern for the 
five pesticides in today's proposed rule. IRIS data are available to 
the public in both printed and on-line form, and can be accessed by 
telephoning IRIS User Support at EPA's Center for Environmental 
Research Information in Cincinnati, Ohio; (513) 569-7254. The 
discussion below does not include a detailed review of studies showing 
relatively minor adverse effects, such as changes in average body 
weight or the rate of weight gain in developing animals. More extensive 
discussion of the evidence of adverse health effects for each of these 
pesticides has been presented in other documents, e.g., for 
metolachlor, in the recent Reregistration Eligibility Decision document 
and for the triazines, in the Federal Register notice announcing the 
initiation of the triazines Special Review. A more complete description 
of the toxicological evidence to support this rulemaking, drawn from 
these existing sources, is provided in the docket for this regulation.
    All five compounds exhibit adverse effects in animals after long-
term exposure, raising concern about chronic toxicity. For example, 
long-term (usually 2-years) feeding studies with the triazines 
typically show reduced rates of weight gain, and in some cases, 
hematological effects, such as reduced red-cell count. Treatment of 
pregnant animals with all of these compounds shows some developmental 
effects, such as reduced weight gain, or reduced litter size. In 
addition, a 1-year dog study with atrazine showed cardiac effects such 
as increased heart rate and irregular heartbeat. Although these are all 
adverse effects, they do not present the same level of concern as the 
evidence of cancer risk.
    EPA had classified atrazine, simazine, cyanazine and metolachlor as 
Group C (possible human) carcinogens. EPA's Office of Pesticide 
Programs has assigned a numerical cancer potency coefficient, known as 
a Q1*, to each of these chemicals as well (see Table 2 below).
    The triazine compounds have an extremely close structural 
similarity and produce similar tumor profiles in animal bioassays, 
primarily malignant mammary tumors in female rats. In addition to 
animal study data, EPA has reviewed a number of epidemiology studies 
which suggest possible associations between triazine exposure and 
various human health effects, including ovarian cancer, non-Hodgkins 
lymphoma, and birth defects. All of the studies, however, had 
significant limitations, and the Agency does not consider any of the 
suggested health-effect associations to be established by currently 
available information.
    Alachlor was classified as a B2 (probable human) carcinogen by 
virtue of positive results in studies of both rats and mice. At this 
time, however, alachlor is considered to be not classified under the 
current agency system pending further review of scientific issues 
raised by the registrant. Metolachlor has limited evidence of liver 
carcinogenicity in animals.
    The cancer classifications cited here are likely to change in the 
future for several reasons. First, EPA has recently proposed to revise 
its guidelines for the assessment of cancer risks. The new proposed 
guidelines were made available on April 16, 1996, for a 120-day public 
comment period. The issues raised during the comment period will then 
be presented to the Agency's Science Advisory Board. New guidelines are 
likely to become final in 1997. Among other things, the new guidelines 
may change the way the Agency weighs the various kinds of laboratory 
evidence used to identify carcinogenic potential.
    In addition to changing guidelines, the registrants of the triazine 
and acetanilide herbicides have recently submitted new data which they 
believe should reduce concerns about human cancer risks for these 
compounds. It is not clear at this time how this new evidence will 
affect the Agency's risk assessment for these compounds, or how the 
evidence will be evaluated under the new guidelines. In any case, human 
cancer risk is not the only basis for the Agency's concern about these 
chemicals.
    b. Ground Water Reference Points. Table 2 of this Unit displays the 
relevant summary toxicological data for these five compounds. The 
derivation of the Ground Water Reference Points shown in Table 2 is 
discussed below.
    The Ground Water Reference Point for a compound is a representation 
of the compound's toxicity, expressed in units corresponding to 
environmental exposure. The Reference Point provides a means to assess 
the significance of known or anticipated concentrations that occur in 
ground water. As described in Unit II. of this preamble, the Agency 
normally will use MCLs established under the Safe Drinking Water Act 
(SDWA) as reference points. MCLs are derived from Maximum Contaminant 
Level Goals (MCLGs), which is that concentration, ``... at which no 
known or anticipated adverse effects on the health of persons occur and 
which allows an adequate margin of safety'' (SDWA section 1412(b)(4)). 
In most cases an MCLG is based on the Reference Dose (RfD) for the 
compound, to which standard conversion and uncertainty factors have 
been applied to account for anticipated drinking water exposure. For 
compounds classified as Group C carcinogens, EPA also applies a 10-fold 
uncertainty factor to provide for an additional margin of safety. The 
enforceable MCL, set simultaneously with the MCLG, is set ``as close to 
the [MCLG] as is feasible'' (Ibid). In the case of B2 carcinogens, 
Agency policy has been to set the MCLG at zero. The corresponding MCL 
is then set at a finite level by evaluating the performance of feasible 
water treatment and analytic technology. More information on EPA's 
methodology for setting MCLs and MCLGs is available in the final rule 
which established MCLs for atrazine and alachlor (56 FR 3526, January 
30, 1991).
    The following Table 2 is a summary of the human health risk posed 
by these five chemicals:

                                                         Table 2.--Summary of Human Health Risk                                                         
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                   Ground Water                                                                                                         
                                     Reference                           Reference Dose                                                                 
                                       Point      Source (MCL, HAL,    (RfD) (g/   Study/Endpoint\1\     Cancer Category      Q1* (1/mg/kg/d)  
                                   (g/       or other)              kg/d)                                                                      
                                        l)                                                                                                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
Atrazine.........................             3  Final MCL            35\2\                Chronic Animal       C                    0.22               
                                                                                            Study decreased                                             
                                                                                            body wt. gain;                                              
                                                                                            cardio-                                                     
                                                                                            developmental                                               
                                                                                            toxicity                                                    
Simazine.........................             4  Final MCL            5                    Chronic Rodent       C                    0.12               
                                                                                            Study (decreased                                            
                                                                                            body wt. gain                                               
                                                                                            hematological                                               
                                                                                            changes)                                                    

[[Page 33277]]

                                                                                                                                                        
Cyanazine........................             1  HA                   2                    Chronic Animal       C                    1.00               
                                                                                            Study (decreased                                            
                                                                                            body wt. gain)                                              
Alachlor.........................             2  Final MCL            10                   Sub-Chronic Dog      *                    0.08               
                                                                                            Study (hematology)                                          
Metolachlor......................            70  HA                   100                  Chronic Rodent       C                    0.009              
                                                                                            Study                                                       
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ This column refers to the study or toxicological endpoint which serves as the basis for the RFD listed in the column immediately to the left.       
\2\ The RfD for atrazine was revised in December 1992; the previous RfD (of 5 micrograms per kilogram per day) served as the basis for the current MCL  
  displayed at left.                                                                                                                                    


    In the absence of MCLs, EPA will use a Health Advisory (HA) to 
establish Ground Water Reference Points. HA levels are established 
using the same methodology used for non-zero MCLGs. MCLs have been 
established for atrazine, simazine, and alachlor, and these are Ground 
Water Reference Points for these compounds. The Reference Points for 
cyanazine and metolachlor are based on HA levels.
    In summary, the Agency feels that there is sufficient evidence to 
concluded that each of the five compounds addressed in today's rule may 
cause serious, irreversible adverse effects to the health of persons, 
if any of the compounds were present in drinking water at or above 
particular concentrations or at other concentrations for a prolonged 
period of time. In fact EPA has set drinking water standards for three 
of the compounds in this proposed rule, in order to prevent the onset 
of such effects as a result of drinking water in Public Water Systems 
(PWSs). The Agency has set Health Advisories for the other two 
compounds, in order to allow PWSs to evaluate and avert potential 
adverse effects to human health should these compounds be encountered. 
MCLs for these two compounds may also be developed at a later date.
    2. Environmental effects. In addition to their potential for 
adverse human health effects, EPA is also concerned about the potential 
adverse effects of these compounds: (1) On specific non-target plants 
and animals, including the potential economic impact associated with 
adverse effects on both commercial crops and animals; and (2) on 
ecosystems as a whole.
    EPA has far less specific data on the potential adverse ecological 
effects of these five compounds than for adverse health effects. 
However, both the chloro-triazines and the acetanilides inhibit 
photosynthesis in plants and may have phytotoxic effects to terrestrial 
and aquatic plants.
    Of these chemicals, atrazine has been the most fully studied and 
characterized for environmental effects. In comparative laboratory 
acute toxicity testing, atrazine exhibits moderate toxicity to birds, 
mammals, fish, or aquatic invertebrates. Studies representing simulated 
field conditions have also been conducted. For aquatic plants, 
available information indicates that short-term exposure to relatively 
low levels of atrazine (for example, concentrations of approximately 20 
g/l) can produce phytotoxic effects from which plant 
populations will not recover. Information on simazine and cyanzine 
indicate that longer-term exposure at even lower levels, in the range 
of about 5 g/l, can also inhibit plant reproduction.
    Substantial risks can be anticipated from continuing off-target 
movement of these five compounds and consequent exposure of aquatic 
organisms and ecosystems. Contamination of ground water can be a 
mechanism of transport for these compounds to surface water, since 
ground water provides a significant source of recharge for many bodies 
of surface water. While it is difficult to segregate potential risks 
from the presence of these compounds in ground water from those that 
might result from other means of environmental transport such as 
runoff, the risks are real enough to be of concern.
    In addition, there is a considerable body of monitoring data 
available on these five pesticides, primarily in the mid-western 
``corn-belt'' States where they are most heavily used. These data 
demonstrate that residues of these five pesticides can be detected in 
both ground and surface waters in areas of heavy use, at levels which 
frequently approach, and sometimes exceed, the MCLs or HAs. (Data for 
ground-water occurrence are discussed in more detail below).
    Thus, the Agency feels that there is sufficient evidence to infer 
that present environmental levels of these herbicides from various 
environmental transport mechanisms, including leaching to ground water, 
pose substantial risks to aquatic plant life, both in the form of 
outright phytotoxicity and in the longer-term and more subtle effect of 
inhibiting plant reproduction. If such effects occur in an aquatic 
environment, the effects on the ecosystem could be profound. Complete 
loss of habitats may occur. Even partial loss of food supply or 
protective cover can result in significant impacts on other aquatic 
organisms. Herbicides in the aquatic environment could destroy the food 
source for higher organisms, which may then starve. Herbicides may also 
reduce the amount of vegetation available for protective cover and the 
laying of eggs by aquatic species. Submerged aquatic vegetation is the 
nursery for commercial and recreational species. As such, drastic loss 
of submerged aquatic vegetation in rivers or estuaries is a serious 
environmental concern. Some experts believe that herbicide related 
ecosystem damage may already be occurring in locations such as the 
Chesapeake Bay and parts of the Mississippi delta.
    EPA has drafted a Water Quality Criteria document for atrazine that 
proposes to establish a fish-protection level of 22.7 g/l 
(measured as a 4-day average concentration over a 3-year period), below 
which ``freshwater aquatic animals and their uses should not be 
affected unacceptably ...,'' adding a peak 1-hour concentration limit 
of 571.9 g/l (not to be exceeded more than an average of once 
in a 3-year period). For the protection of freshwater aquatic plants, 
atrazine concentrations should not exceed 2.0 g/l for any 4-
day period within a 3-year period.
    The total risks of these five pesticides to aquatic ecosystems are 
beyond the scope of the regulatory action being proposed today. These 
ecological risks involve, in addition to contamination of ground water, 
contamination of surface water through many alternative routes, such as 
runoff through the unsaturated zone to a nearby water body.
    Ground water SMPs cannot be expected to address all of these 
potential routes to surface water contamination that may occur as a 
result of the legal use of these five pesticides. However, certain use 
management measures implemented by States as part

[[Page 33278]]

of their ground-water Plans may provide some ancillary protection 
against such surface-water contamination. At a minimum, no SMP will be 
approved that contains a preventive measure that will clearly increase 
the likelihood that surface water will be adversely affected as a 
consequence (see Unit III.C.7. of this preamble, and Guidance, pp 3-15-
6, Ref. 18).
    3. Ground water contamination potential-- a. Persistence and 
mobility. EPA requires that all pesticide registrants submit data on 
the physical and chemical characteristics of a pesticide in order to 
characterize its environmental fate. These data are generated through a 
battery of basic laboratory tests and limited field studies as 
specified in 40 CFR 158.290, otherwise known as the ``Subpart N'' 
Guidelines. Two important factors, known as persistence and mobility, 
are particularly relevant in predicting whether a substance has the 
potential to reach ground water.
    Persistence refers to a substance's relative resistance to 
environmental processes which tend to break that substance down, and 
thus to the length of time that substance can exist in the environment. 
Persistence is generally measured as a half-life (t1/2 or 
t50), or the length of time in which 50 percent of an 
environmental concentration disappears as a result of transport or 
degradation. Mobility refers to the potential for an ingredient to move 
away from the point of application, and is typically represented by a 
substance's resistance to binding to soil or soil constituents. 
Measures such as the soil-water partition coefficient (kd) or the 
carbon-referenced sorption coefficient (Koc) are used to indicate a 
substance's binding potential.
    A pesticide that is relatively persistent and mobile would tend to 
remain in the subsurface environment, be present at substantial 
fractions of the original environmental residue, and reach underlying 
aquifers relatively quickly. Together, persistence and mobility are 
referred to as a pesticide's leaching potential.
    (i) Parent compounds. Table 3 of this Unit contains a summary of 
the persistence and mobility characteristics for the five pesticides 
subject to today's proposed rule. The Table shows chemical-specific 
values for the seven parameters that EPA uses to evaluate a pesticide's 
propensity to reach ground water. These values, generated from the 
combination of laboratory and field studies EPA requires for 
registration, are compared against the values (displayed in the Table) 
that EPA regards as indicative of leaching potential.
    EPA proposed these values in a previous proposed rulemaking (see 56 
FR 22076, May 13, 1991) as criteria indicating a reasonable potential 
for reaching ground water on a widespread basis, for purposes of 
considering a pesticide for restricted use classification. While EPA is 
not proposing to apply these criteria to determine whether a pesticide 
needs to be subject to an SMP, the Agency provides the information as 
evidence of the pesticides' leaching potential. As indicated in Table 
3, all five pesticides display persistence and mobility characteristics 
exceeding the values EPA considers evidence of a propensity to leach. 
In the event EPA were to classify the pesticides for conventional 
restricted use independently of the regulatory action referred to 
above, the Agency believes that this evidence, combined with the 
detections of the parent compounds in ground water to date, would not 
only meet the EPA's final criteria for restricted use for ground-water 
concerns, it would establish that these pesticides could pose a serious 
hazard to the environment in the absence of the mitigation provided by 
restricted use classifications. Such evidence would be sufficient for 
EPA to propose restricted use classification for simazine and 
metolachlor, the two pesticides subject to today's proposed rule not 
now classified as such, under the existing regulations for restricted 
use classification (c.f., 40 CFR 152.170(d)).
    As shown in Table 3 below, all five pesticides are resistant to 
chemical hydrolysis, indicating their likely environmental persistence. 
The term ``stable'' as used in Table 3 means the compound was observed 
to degrade more slowly than the rate of degradation specified as the 
critical value in the criteria column, i.e., a decrease of 10 percent 
or more in the tested concentration of a substance over 30 days 
duration of a hydrolysis test.

                                                           Table 3.-- Persistence and Mobility                                                          
                                                     (A value exceeding a criterion shown in Italic)                                                    
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                   Parameter         Criteria          Atrazine          Simazine         Cyanazine         Alachlor       Metolachlor  
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                        
Persistence..................  Field              > 21 days (3     60-120 days       44-231 days       6-181 days       11 days          7-292 days     
                                                                                                                                                        
  ...........................  Lab-derived       > 21 days (3      146 days          110 days          17 days          2-3 weeks        67 days        
                                aerobic soil      wks), or                                                                                              
                                metabolism half-                                                                                                        
                                life                                                                                                                    
                                                                                                                                                        
  ...........................  Hydrolysis half-  < 10% in 30       stable (pH        stable (pH        148 days (pH     stable (pH       stable (pH     
                                life              days, or          5,7,9)            5,7,9)            5), stable (pH   3,6,9)           5,7,9)        
                                                                                                        7,9)                                            
                                                                                                                                                        
  ...........................  Photolysis half-  < 10% in 30 days  > 30 days         > 30 days         6 days           NA               8 days         
                                life (soil)                                                                                                             
                                                                                                                                                        
Mobility.....................  Soil adsorption:   5 ml/ 0.20 (sand)       4.31 (clay)       0.28-2.3                          1.87 (clay)    
                                Kd                g, or                                                                                                 
                                                                                                                                                        
    .........................                                      0.73 (loam)       0.65 (sand)                                         2.16 (sandy    
                                                                                                                                          loam)         
                                                                                                                                                        
    .........................                                      0.79 (sandy       1.27 (sandy                        0.62-8.13        0.108 (sand)   
                                                                    loam)             loam)                                                             
                                                                                                                                                        
    .........................                                      2.45 (clay)       0.48 (loam)                                         0.77 (loam)    
                                                                                                                                                        
  ...........................  Soil adsorption     500  38 - 152          103 - 152         40 - 84          190 (est)\1\     22 - 110       
                                 Koc   ml/g, or                                                                                              
                                                                                                                                                        

[[Page 33279]]

                                                                                                                                                        
  ...........................  Depth of          75 cm             NA\2\             NA\2\             45 cm            122 cm            122
                                leaching in                                                                                               cm            
                                field                                                                                                                   
                                dissipation                                                                                                             
                                study                                                                                                                   
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ est = estimate.                                                                                                                                     
\2\ NA = Not Available (either not reported by the registrant or not required - waived - by EPA).                                                       


    (ii) Degradates. In the case of all five of these pesticides, the 
leaching potential of metabolites and/or degradates are an additional 
concern. For example, since the 1980s investigators have reported 
detections of triazine degradates as well as the parent compounds in 
both ground and surface water. Alachlor and metolachlor also have 
various degradation products which may be mobile and persistent enough 
to leach.
    b. Occurrence of ground water contamination. Registrants, States, 
the United States Geological Survey (USGS), and EPA's National 
Pesticide Survey are all sources of ground-water monitoring data (Refs. 
10 and 14). In reviewing monitoring data, EPA's Office of Pesticide 
Programs (OPP) records occurrence in ground water as the number of 
discrete locations where a pesticide ingredient was detected at least 
once. Multiple detections at the same well over an interval of time 
from repeat sampling are not counted as separate detections in the main 
data collections cited below. EPA recognizes that this procedure could 
function to put wells with only a single detection from repeated 
sampling on an equal footing with wells in which occurrence is 
regularly found. Specified detection limits are a measure of the 
sensitivity of the analyses. Such sites are typically water-supply 
wells or, to a lesser extent, ground-water monitoring wells. OPP uses 
the term ``wells'' to refer to occurrence sites.
    EPA's sources of ground-water data include: (1) The Pesticides in 
Ground Water Data Base (PGWDB), a data base containing the information 
described above, and periodically up-dated by OPP (Ref. 15); (2) EPA's 
National Pesticide Survey (NPS; Refs. 10 and 14), a statistically 
designed one-time survey of existing wells, including both community 
wells and rural domestic wells nationwide, (data not included in the 
PGWDB); (3) Monsanto's National Alachlor Well Water Survey (NAWWS) 
(Ref. 3)-this survey was limited to alachlor use areas, and sampling 
was limited to private rural domestic wells; (4) Ciba-Geigy (now Ciba 
Plant Protection) performed a Large-Scale Retrospective Ground-Water 
Study for Metolachlor in Four Areas of the U.S. (Ref. 2) with high 
metolachlor use and/or high vulnerability to contamination of ground 
water by pesticides; and (5) a number of State-initiated ground water 
monitoring programs. All of these information sources are described in 
greater detail in the ``Water Resources Impact Analysis for the 
Triazine Herbicides'' (Ref. 20). Tables 4 through 8 of this Unit 
summarize information developed from those sources.
    (i) Atrazine and triazine metabolites-- (a) Atrazine parent. The 
evidence of atrazine occurrence is summarized in Table 4 of this 
preamble. Atrazine was the third most often detected of all currently 
registered pesticides in OPP's Pesticides in Ground Water Data Base, 
after aldicarb (and its metabolites) and carbofuran (and also after two 
banned pesticides, EDB and DBCP).
    Atrazine was found in the National Pesticide Survey, as shown in 
Table 4, and in the Monsanto NAWWS Survey. In particular, in the 
latter, atrazine was the most frequently found pesticide, estimated to 
be present in 12 percent of wells in the alachlor use area. The study 
estimated that concentrations will exceed the MCL of 3 g/l in 
0.1 percent of the wells in the alachlor use area.
    (b) Chloro-triazine degradates and other triazine occurrence. There 
are fewer data on degradates in ground water than for the parent 
triazines; cyanazine and simazine degradates in particular are rarely 
looked for. The Pesticides in Ground Water Data Base contains 
detections of two chloro degradates of atrazine at concentrations of 
0.05 to 2.86 g/l. The NPS analyzed for only one degradation 
product of atrazine (desethyl atrazine) and the detection limit for 
that product was relatively high (2.2 g/l); the NAWWS did not 
analyze samples for degradation products of atrazine or the other 
triazines at all. Two of the three major chloro-triazine degradates of 
atrazine were analytes in Iowa's SWRL study, the results of which are 
shown in Table 4. The Wisconsin Rural Well Study provided significant 
information on the occurrence of atrazine degradates. Almost 92 percent 
of wells that were resampled in phase 2 of the study contained a 
combination of parent and degradate residues. Overall, degradates found 
in the Wisconsin Rural Well Survey accounted for 67 percent of total 
triazine residues.
    Results of a recent USGS study of herbicides and nitrates in near-
surface aquifers in the mid-continent United States (Kolpin, et. al., 
1994) reported that desethyl atrazine was the most frequently reported 
compound (18.1 percent of wells), followed by atrazine (17.4 percent), 
and desisopropyl atrazine (5.7 percent). The detection of total 
residues was 25 percent more than the detection of atrazine alone. This 
study differs from the NPS and NAWWS studies in that it sampled ambient 
ground water, not just ground water used as a source of drinking water.
    Finally, the advent of new analytic techniques such as the rapid, 
highly sensitive and relatively cheap detection methods based on 
enzyme-linked immunosorbant assay (ELISA), has allowed monitoring 
studies of ``total triazine'' levels. While typically employed as a 
``screen,'' with detections subsequently analyzed by conventional 
methods to identify and quantitate specific compounds, the PGWDB 
contains reports of one State's findings of undifferentiated ``total 
triazine'' occurrence. In 1990, Ohio reported monitoring at 863 sites, 
with 48 detections at concentrations ranging from 0.1 to 5 g/l 
(Baker, et. al., ``Nitrate and Pesticides in Private Wells of Ohio: A 
State Atlas,'' Heidelberg College, (Ongoing)).
    (ii) Simazine. The evidence of simazine occurrence in ground water 
is summarized in Table 5 of this preamble. Simazine was the eighth most 
often detected pesticide in OPP's Pesticides in Ground Water Data Base 
and the sixth most frequently detected of the currently registered 
analytes. In Kolpin, et. al. (1994) simazine residues were detected in 
1.0 percent of the wells sampled in the mid-continental U.S.
    (iii) Cyanazine. Less monitoring data exist for cyanazine in ground 
water than for atrazine and simazine. Table 6

[[Page 33280]]

summarizes data on monitoring results for cyanazine. Cyanazine was the 
15th most often detected pesticide in OPP's Pesticides in Ground Water 
Data Base, with detections in 15 out of 27 States in which samples were 
collected. Additionally, cyanazine has been reported to be found at 
concentrations greater than 0.1 g/l (or 10 percent of its reference 
point of 1 g/l) in more than 80 additional wells in 12 States.
    No detections were reported in the NPS; however, the minimum 
detection limit in that study was 2.4 g/l whereas the likely 
MCL for cyanazine is 1 g/l. NAWWS estimates that detectable 
levels of cyanazine are expected to occur in 0.3 percent of rural 
domestic wells in counties where alachlor is used. As is the case for 
simazine, this may not be a good national estimate of cyanazine 
occurrence because the use areas of cyanazine and alachlor may not 
closely coincide. The detection limit for cyanazine in this study was 
0.1 g/l; whereas the detection limit for the other 4 analytes 
was 0.03 g/l. This higher detection limit undoubtedly reduced 
the number of observed positives. No estimate was given for cyanazine 
concentrations that exceed 1 g/l. NAWWS did not analyze water 
samples for degradation products of cyanazine. Cyanazine was not an 
analyte in the Ciba-Geigy Large-Scale Retrospective Ground-Water Study. 
As regards State surveys, cyanazine was the 5th most frequently 
detected pesticide in Iowa's SWRL study (of the 27 pesticide analytes). 
Cyanazine was not an analyte in the Wisconsin study and no confirmed 
detections of cyanazine are reported in the California database. 
Cyanazine was detected in 0.7 percent of the wells sampled in the USGS 
study by Kolpin et. al. (1994).
    (iv) Alachlor (and metabolites). Table 7 of this preamble 
summarizes the information available to the Agency regarding alachlor 
occurrence in ground water. Alachlor is the seventh most often found 
pesticide in the Pesticides in Ground Water Database, with only 
aldicarb (and its metabolites), carbofuran, atrazine and oxamyl among 
the currently registered pesticides detected more often. In addition, 
alachlor has been reported to be found at concentrations greater than 
0.2 g/l (or 10 percent of its reference point) in more than 
350 wells in 21 States.
    The NPS estimated that 3,140 (or <0.1 percent) rural domestic wells 
contained alachlor at levels above the Reference Point of 2 g/
l. There were no detections of alachlor in community water system 
wells. The NAWWS estimated that alachlor occurs in approximately 1 
percent of rural wells throughout its use area. Less than half of these 
detections are at levels exceeding 0.2 g/l (or 10 percent of 
the MCL). Alachlor is estimated to occur at levels exceeding its 2 
g/l MCL in 0.02 percent (or approximately 1200 wells) of the 6 
million rural wells in the alachlor use area. There were no degradation 
products analyzed in either the NPS or the NAWWS. Alachlor residues 
were detected in 1.7 percent of the wells sampled by USGS (c.f., 
Kolpin, 1994). The State survey results are summarized in Table 7. In 
addition, several investigators (including USGS) have reported finding 
a major metabolite of alachlor, t-sulfonic acid in ground-water samples 
(c.f., Ref. 3).
    (v) Metolachlor. Metolachlor was the 12th most often found 
pesticide in the OPP Pesticides in Ground Water Database (see Table 8). 
Metolachlor was also reportedly found at concentrations exceeding 7 
g/l (or 10 percent of its reference point) in 19 wells across 
6 States. NAWWS estimates that metolachlor has a detection frequency 
near 1 percent in the surveyed ``alachlor use area.'' Less than half of 
the metolachlor detections are at levels exceeding 0.2 g/L. 
The average detection limit was 0.03 g/L.
    Results from the Ciba large-scale retrospective study of 
metolachlor indicate that metolachlor was detected in 89 of 920 samples 
(or 10 percent), and 39 of 240 wells (or 16 percent). The screening 
level was 0.1 g/l. Detections ranged from 0.1 to 88 
g/l with half of these detections at concentrations of 0.1 to 
0.5 g/l. None of the detections in this study exceeded the 
Health Advisory (HA) of 70 g/l. USGS (Kolpin, 1994) reported 
that 2.7 percent of the wells sampled in the mid-continental United 
States contained metolachlor residues. The following five tables 
(Tables 4 through 8) summarize the data on occurrence for each of the 
five pesticides.

                                                      Table 4.--Atrazine Occurrence in Ground Water                                                     
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Data Source                                                     
                                 -----------------------------------------------------------------------------------------------------------------------
Atrazine (Rf. Pt. = 3 g/                                                                                    State Surveys                      
               l)                        PGWDB                NPS                NAWWS       -----------------------------------------------------------
                                                                                                   IA: SWRL             WI: RWS             CA: WID     
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                        
 # of Wells Sampled.............  26,909 (in 40       1,349 (566 PWS,     1,430 (in 89        686                 2,200/236           6286 (in 53       
                                                                                                                                                        
Frequency & Distribution of       1,512 (in 32        NA                  166                 NA                  603/200 (143-       111 (in 21        
 Detections (# of wells).          states)\2\                                                                      208)\1\,\2\         counties)        
                                                                                                                                                        
Frequency & Distribution of       172 (in 22 states)  NA                  2                   NA                  NA/15 (56)\1\,\2\   0                 
 Wells > Rf. Pt..                                                                                                                                       
                                                                                                                                                        
Range of Detected Concentrations  trace-1500          trace - 7.0         0.1 -    0.13 - 6.61         0.10 - 16.0         0.1 - 0.19        
 (in g/l).                                                        6.72                                                                         
                                                                                                                                                        
Estimated Occurrence Rate         NA                  Among CSWs: 1.7%    12%                 4.4%(2.8-5.9)       NA                  NA                
 (Statistical Surveys only;                            (0.5-2.9%);                            3.5% \3\..........                                        
 Confidence interval ranges in                         Private wells:                         3.5%\4\...........                                        
 parens).                                              0.7% (0.1-2.0%)                                                                                  
                                                                                                                                                        
Estimated Number of Wells with    NA                  Among CSWs: 1570    720,000             NA                  NA                  NA                
 measurable residues                                   (420-2710);                                                                                      
 (Statistical Surveys only;                            Private wells:                                                                                   
 Confidence interval ranges in                         70,800 (13,300-                                                                                  
 parens).                                              214,000)                                                                                         
                                                                                                                                                        

[[Page 33281]]

                                                                                                                                                        
Estimated Occurrence Rates & #    NA                  < 0.1% Private      0.1%; 8,400         NA                  NA                  0                 
 of wells with concentrations >                        wells < 9,450       private wells                                                                
 Rf. Pt. (Statistical Surveys                          Private wells                                                                                    
 only).                                                                                                                                                 
                                                                                                                                                        
Detection Limit (g/l)..  Various             0.12                0.025               0.13                0.1                 Various           
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Results of both Phase I and II Studies shown; Phase I (immunoassay) results shown first, separatefrom Phase II with a slash (/).                    
\2\ There are additional chloro-metabolite detections reported in PGWDB, but the majority of samples and detections occur within the IA:SWRL study. Des-
  ethyl atrazine reported in 27 sites in Indiana and Iowa; des-isopropyl atrazine reported in 24 sites in Indiana and Iowa.                             
\3\ Desethyl atrazine (a chloro-metabolite).                                                                                                            
\4\ Desisopropyl atrazine (a chlorinated metabolite).                                                                                                   



                                  Table 5.--Simazine Occurrence in Ground Water                                 
----------------------------------------------------------------------------------------------------------------
                                                                    DATA SOURCE                                 
                                 -------------------------------------------------------------------------------
Simazine(Rf. Pt. = 4 g/                                                                 State Surveys  
               l)                        PGWDB                NPS                NAWWS       -------------------
                                                                                                    CA: WID     
----------------------------------------------------------------------------------------------------------------
                                                                                                                
# of Wells Sampled..............  22,374 (30 states)  *                   *                   6,752 (55         
                                                                                                                
Frequency & Distribution of       486 in 19 states    NA                  23                  308 (9 counties)  
 Detections ( of wells).                                                                               
                                                                                                                
Frequency & Distribution of       36 in 12 states     NA                  1                   0                 
 wells > Rf. Pt..                                                                                               
                                                                                                                
Range of Detected Concentrations  trace - 67          trace - 1            < 0.15 - 8.36      0.1-2.4           
 (g/l).                                                                                                
                                                                                                                
Estimated Occurrence Rate         NA                  For CSWs: 1.1%      Private wells:                        
 (Statistical Surveys only).                           (0.4-2.7%)          1.6%                                 
                                                       private wells:                                           
                                                       0.2% (< 0.1 -                                            
                                                       1.3%)                                                    
                                                                                                                
Estimated Number of Wells with    NA                  For PWSs: 1,080     96,000 private                        
 measurable residues                                   (350 - 2540)        wells                                
 (Statistical Surveys only).                           private wells:                                           
                                                       25,100 (590 -                                            
                                                       141,000)                                                 
                                                                                                                
Estimated Occurrence Rates & #    NA                  < 0.1 %             NA                                    
 of Wells with concentrations                         < 9,450 private                                           
  Rf. Pt.                                   wells.                                                   
 (Statistical Surveys only).                                                                                    
                                                                                                                
Detection Limit (g/l)..  Various             0.38                0.025               Various           
----------------------------------------------------------------------------------------------------------------


[[Page 33282]]



                                                     Table 6.--Cyanazine Occurrence in Ground Water                                                     
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         DATA SOURCE                                                    
                                    --------------------------------------------------------------------------------------------------------------------
 Cyanazine (Rf. Pt. = 1 g/                                                                                         State Surveys               
                 l)                           PGWDB                    NPS                   NAWWS         ---------------------------------------------
                                                                                                                   IA: SWRL               CA: WID       
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                        
# of Wells Sampled.................  7,468 (in 27 states)    *                       *                      686                    871 (in 24 counties) 
                                                                                                                                                        
#Frequency & Distribution of         155 in 15 states        NA                       NA                    NA                     0                    
 Detections ( of Wells).                                                                                                                       
                                                                                                                                                        
Frequency & Distribution of Wells    22 in 9 states          NA                      0                      0                      0                    
  Rf. Pt..                                                                                                                                   
                                                                                                                                                        
Range of Detected Concentrations     trace -29.0             0                       < 0.45                 0.14 - 0.84            0                    
 (g/l).                                                                                                                                        
                                                                                                                                                        
Estimated Occurrence Rate            NA                      < 0.1%                  0.3% (private wells)   1.2% (private wells)   NA                   
 (Statistical Surveys only).                                                                                                                            
                                                                                                                                                        
Estimated Number of Wells with       NA                      < 9,450 private wells   18,000 private wells   NA                     NA                   
 measurable residues (Statistical                                                                                                                       
 Surveys only).                                                                                                                                         
                                                                                                                                                        
Estimated Occurrence Rates & # of    NA                      < 0.1%                  0                      NA                     NA                   
 Wells with concentrations > Rf.                                                                                                                        
 Pt. (Statistical Surveys only).                                                                                                                        
                                                                                                                                                        
Detection Limit (g/l).....  Various                 2.4                     0.1                    0.12                   Various              
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                      Table 7.--Alachlor Occurrence in Ground Water                                                     
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         DATA SOURCE                                                    
                                    --------------------------------------------------------------------------------------------------------------------
Alachlor (Rf. Pt. = 2 g/l)                                                                                         State Surveys               
                                              PGWDB                    NPS                   NAWWS         ---------------------------------------------
                                                                                                                   IA: SWRL               CA: WID       
--------------------------------------------------------------------------------------------------------------------------------------------------------
# of Wells Sampled.................  26,856 (in 35 states)   *                       *                      686                    2,009 (34 counties)  
Frequency & Distribution of          543 (in 25 states)      *                       28                     NA                     1                    
 Detections ( of Wells).                                                                                                                       
Frequency & Distribution of Wells >  101 (in 16 states)      *                       NA                                            1                    
 Rf. Pt..                                                                                                                                               
Range of Detection Concentrations    trace - 3,000           4.2                     < 0.15 - 6.19          0.02 - 4.76            9.0                  
 (g/l).                                                                                                                                        
Estimated Occurrence Rate            NA                      < 0.1% (< 0.1 - 1.0%) - 0.8% - private wells   1.2% (0.4 - 2.0%)      NA                   
 (Statistical Surveys only).                                   private wells                                                                            
Estimated Number of Wells with       NA                      3,140 (1 - 101,000)     48,000 private wells                          NA                   
 measurable residues (Statistical                             private wells                                                                             
 Surveys only).                                                                                                                                         
Estimated Occurrence Rates & # of    NA                      < 0.1% (<0.1 - 1.0%);   0.02%; 1200 private                           Various              
 Wells with concentrations  Rf. Pt. (Statistical Surveys                             private wells                                                                             
 only).                                                                                                                                                 
Detection Limit (g/l).....  Various                 0.50                    0.025                  0.02                                        
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 33283]]



                                                    Table 8.--Metolachlor Occurrence in Ground Water                                                    
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         DATA SOURCE                                                    
                                    --------------------------------------------------------------------------------------------------------------------
 Metolachlor (Rf. Pt. = 70 g/l)                         PGWDB                    NPS                   NAWWS         ---------------------------------------------
                                                                                                                   IA: SWRL               CA: WID       
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                        
# of Wells Sampled.................  22,255 (in 29 states)   *                       240 (in 4 states)      686                    107 (10 counties)    
                                                                                                                                                        
Frequency & Distribution of          213 (in 20 states)      *                       39 (in 4 states)       NA                     0                    
 Detections (# of Wells).                                                                                                                               
                                                                                                                                                        
Frequency & Distribution of Wells >  3 (in 3 states)         0                       0                      NA                     0                    
 Rf. Pt..                                                                                                                                               
                                                                                                                                                        
Range of Detection Concentrations    0 - 157                 0.20 - 3.81             0.1 - 88.0             0.04 -9.00             0                    
 (g/l).                                                                                                                                        
                                                                                                                                                        
Estimated Occurrence Rate            NA                      1.0% (private wells)    16% (private wells)    1.5% (0.6- 2.4%)-      NA                   
 (Statistical Surveys only).                                                                                 private wells                              
                                                                                                                                                        
Estimated Number of Wells with       NA                      60,000 private wells    NA                     NA                     NA                   
 measurable residues (Statistical                                                                                                                       
 Surveys only).                                                                                                                                         
                                                                                                                                                        
Detection Limit (g/l).....  Various                 0.025                   0.1                    0.04                   Various              
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Legend (for Tables 4-8) Data in Tables include data on 
identifiable metabolites, shown in italics. Specific degradate 
compounds identified by footnote. Numbers in parentheses in rows 
displaying estimates for statistical surveys are 95% confidence 
intervals for a given estimate. Studies, surveys, and reports 
containing the information summarized in Table, denoted by 
abbreviations as explained below:
    PGWDB = Pesticides in Ground Water Data Base (as summarized in 
Ref. 15), which also includes the data reported in the ``state 
surveys'' in this Table - thus, ``detections'' as reported in each 
column are not additive (although the PGWDB does not include the 
detections from the NPS, NAWWS or Ciba statistical studies).
    NPS = National Pesticide Survey, Phase I Report (Ref. 10); also 
Phase II Report (Ref. 14). Data may be displayed reporting separate 
results for community-supply wells (CSWs), serving public community 
water systems and rural, private wells. The two categories were 
selected for sampling according to different stratification schemes.
    NAWWS = National Alachlor Well Water Survey (as summarized in 
Refs. 3 and 4); note that estimates of occurrence rates listed in 
the Table under the ``NAWWS'' column apply only to rural private 
water wells in the ``alachlor use area'' as defined in the NAWWS 
design; ascribing Study's occurrence rates nationally would 
overstate prospective occurrence. However, the projected number of 
wells and/or population exposed take that limitation into account.
    Ciba = Large-scale Retrospective G.W. Monitoring Study (for 
metolachlor only; Ref. 2).
    IA: SWRL= Iowa State-Wide Rural Water Survey (1990); note that 
specified occurrence rates in the Table apply to estimated 
occurrence in the State of Iowa only.
    WI: RWS = Wisconsin Rural Well Survey (1990).
    CA: WID = California Well Inventory Database (annual reports; 
data contained in Ref. 15).
    NA = Not applicable or unavailable.
    Trace = Detection below a specified detection limit.
    * = See Table 4.


    c. Conclusions--Ground water contamination potential. The five 
pesticides selected in today's proposed rule exhibit persistence and 
mobility characteristics that suggest the capacity to reach ground 
water on a widespread basis. This potential is confirmed by the record 
of occurrence produced from ground-water monitoring efforts. Each of 
the five has been detected hundreds of times in many States, indicating 
the breadth and magnitude of ground-water contamination potential. 
Moreover, each has been detected at concentrations exceeding its 
respective reference point in multiple locations, in different States, 
and across a variety of hydrologic and geologic conditions. This, and 
the fact that many more detected concentrations of each are within one 
order of magnitude (i.e., 10 percent or more) of each reference point, 
confirms that each pesticide exhibits the capacity to reach ground 
water at concentrations exceeding health-based standards. To EPA's 
knowledge, point sources do not explain the range and number of these 
occurrences. All five can be reasonably expected to contaminate ground 
water at or above their respective reference points. EPA has reached 
the tentative conclusion from this data that continued use of these 
pesticides without further controls and protective measures constitutes 
a clear risk of continued ground-water contamination.
    4. Risk conclusions. In summary, EPA concludes that exposure from 
these pesticides may present the potential for adverse human health and 
environmental effects associated with exposure from these five 
pesticides.
    These five, while they may differ among themselves in the frequency 
and severity of prior detections in ground water, entail a significant 
number of detections in multiple States. Among currently registered 
pesticides, only these five and aldicarb, which is being addressed by 
other regulatory means, have been detected above their respective 
reference points in three States or more. Second, these five share a 
substantial overlap in use sites and crops, such that each pesticide 
could represent a significant alternative to the use of one or more of 
the others. This latter circumstance plays a significant role in EPA's 
decision to subject all five to SMPs. Leaving one or more of these free 
from State management measures might constitute an incentive for users 
to substitute that pesticide for one of those subject to SMPs. EPA's 
analysis of the contamination potential of these pesticides suggests 
that such a course might only increase the occurrence of the excluded 
pesticide(s) to a frequency and severity that would rival that observed 
for atrazine and alachlor. The practical effect of such an exclusion 
might be to worsen the overall quality of the ground-water resource.
    EPA has also considered the potential impact associated with the 
increased use of substitute pesticides that may result from reduced use 
of the five under consideration here. This issue includes two separate 
considerations. The first is the possibility that increased ground-
water contamination will result from increased use of substitute

[[Page 33284]]

pesticides not subject to SMPs. EPA acknowledges that there is a 
likelihood that other pesticides will be used in substitution for these 
five in cases where State measures constrain triazine and acetanilide 
use. EPA has analyzed the likelihood for such substitutions in its 
Regulatory Impact Analysis (see Unit VIII. of this preamble); in this 
analysis the Agency has identified the likely substitute pesticides for 
a substantial variety of crops and other uses. Only a few of the 
prospective substitutes exhibit similar persistence and mobility 
characteristics; upon closer examination, moreover, it is unlikely that 
any of the prospective substitutes exhibit as severe a potential for 
ground-water contamination as these five candidates. None of the 
prospective substitutes have been detected in ground water to the 
extent and frequency as these five. Given the substantial evidence 
summarized in here that these five are the largest ground-water 
contamination risks of any pesticides in current use, EPA concludes 
that it is has no reason to anticipate that increased use of 
substitutes will result in a greater risk to ground water for the 
foreseeable future.
    The other consideration is that the increased use of substitutes 
might indirectly increase net risks, because of greater risks through 
other routes of exposure, such as dietary and worker exposures. This is 
a considerably more complex question. EPA believes that these risks 
will not measurably rise because of the use of anticipated substitutes. 
EPA reaches this conclusion, considering: (1) There will be 
comparatively little substitution of use of these pesticides with 
potentially more dangerous alternatives (at least compared to an 
outright cancellation), since EPA's analysis of impacts concludes that 
State measures will permit substantial continuing use of the five 
pesticides in question; and (2) none of the anticipated substitutes 
pose particularly elevated risks for these other exposure routes at 
reasonably expected increased levels of use. EPA has confidence that 
none of the substitutes are particularly more toxic, overall and in 
relation to particular endpoints, than the five pesticides in question. 
For example, none of the prospective substitutes are in Special Review, 
for health concerns as the triazines are.
    a. Metabolites. At this time EPA does not intend to require that 
State Plans provide for monitoring degradates of these five pesticides. 
However, EPA would like comments on: (1) Whether it should require 
State submissions to address selected metabolites of toxicological 
concern; (2) what specific metabolites should be addressed by SMPs; and 
(3) what specific SMP provisions should apply to the metabolites.
    The Agency notes that relatively inexpensive screening methods are 
available for all five of the parent compounds, and for many of their 
metabolites. Thus, a State may choose to include degradates in their 
monitoring plan, as some already do. Moreover, if additional 
information about some or all of these degradates raises concerns in 
the future, EPA may revisit this issue. The availability of practical 
analytical methods would be an important consideration in asking States 
to include degradates in their monitoring plan.

C. Costs and Benefits

    The following section completes EPA's proposed determination that 
the five pesticides may present an unreasonable risk to the environment 
without additional management measures to reduce the chances of their 
contamination of ground-water resources, by evaluating the risks 
represented by that contamination potential in light of the social and 
economic costs that SMPs represent. Costs and benefits under 
consideration are conceived on the broadest, most inclusive fashion 
(i.e., beyond the direct costs of the SMPs envisioned by this proposed 
rule and the benefits of averting human health risks represented by 
ground-water contamination). The remainder of this section summarizes 
the data, analysis and conclusions contained in the Agency's draft 
Regulatory Impact Analysis (RIA) prepared for this rule pursuant to 
Executive Order 12866 (see Unit VIII. of this preamble). Those 
interested in a more detailed analysis of costs and benefits should 
refer to that document.
    The assessment of risks and benefits associated with the decision 
to make these five pesticides subject to SMPs as a regulatory 
requirement takes into account the Agency's policy objective of 
prevention, i.e., to act in order to avert reasonably expected adverse 
effects to human health or the environment before they may occur. EPA 
must exercise its judgement on the basis of an analysis of the 
respective costs and benefits of regulatory action in a manner that 
takes into account the considerable uncertainty surrounding both. This 
entails acting on the basis of less tangible evidence of risk and 
considerable degree of uncertainty about both existing and future 
ground water contamination and its consequences, and taking 
considerable allowance of these uncertainties. It also entails weighing 
a detailed and quantified analysis of costs against an array of 
prospective benefits, many of which are difficult to describe in 
quantitative terms. Such a comparison, between what appear to be 
tangible costs and more intangible benefits, presents well-recognized 
analytic difficulties. Care must be taken not to let the quantified 
factors override consideration of important qualitative factors. In 
other words, SMPs will be justified based on a reasoned determination 
that the benefits (generally conceived and including elements difficult 
to quantify) justify the cost impacts associated with SMPs.
    In developing the Strategy (Ref. 12) EPA evaluated a range of 
available regulatory options in addition to the State Management Plan 
approach. Specifically, EPA compared three general approaches in a 
companion document to the Strategy, the ``Pesticides and Ground-Water 
Strategy: A Survey of Potential Benefits'' (February 1991; Ref. 13). 
This analysis is discussed in Unit IV.D., of this preamble.
    In the interests of presenting as full and honest a 
characterization of risk and benefit as possible, the Agency will also 
point out: (1) The relative magnitude of uncertainty regarding the true 
value of a quantity or attribute that EPA is estimating in its 
analysis; and (2) the reasons for believing that any specific estimate 
or characterization may overstate or understate the true value of such 
a quantity or attribute.
    1. Costs. EPA identifies four general areas where some level of 
adverse economic impact (i.e., both direct and indirect costs) could 
result from regulatory action in response to ground water concerns. 
Federal program costs are the attributable costs of developing and 
justifying regulatory action regarding ground-water protection, 
including the assembly and evaluation of ground-water risk data, as 
well as expenditures relating to implementation of protection measures. 
Current expenditures include the cost of ongoing regulatory and risk 
assessment activities pertaining to ground-water protection in the 
pesticides program and grants to State pesticide programs to help 
sustain the cost of ground-water protection activities and, in 
particular, the development of ``generic'' SMPs.
    EPA program costs are subdivided into headquarters (HQ) program 
costs and regional costs. As should be evident from the description in 
Unit II. of this preamble, the larger portion of EPA's effort will 
reside with the Regions. EPA estimated its regional-program costs by 
estimating a per-SMP average level of

[[Page 33285]]

effort and multiplying by the expected number of State Plans that are 
currently anticipated for these five pesticides. EPA's analysis is 
calculated on the expectation that 236 Plans will be submitted. This 
translates into an annualized cost of $1.1 million for regional 
activities. EPA estimates its annual HQ program costs will range 
approximately from $413,300 to $437,000 (in current dollars) for the 
first 3 years after promulgating this rule, with costs decreasing to an 
average of $160,600 annually thereafter.
    The margin of uncertainty for EPA's estimate is relatively small 
(mostly reflecting the relatively small dollar estimate) and relatively 
insignificant with regard to its potential impact on EPA's decision. It 
is difficult to determine whether EPA's estimate tends to understate or 
overstate the likely actual value of Federal costs, in part since a 
substantial proportion of the costs are part of ongoing regulatory 
activities. However, any error in EPA's estimate (because of these 
uncertainties) is probably more likely to understate the estimate 
slightly.
    State program costs are the estimated State expenditures for 
implementing Federal ground-water protection actions. These include the 
costs of developing five pesticide-specific SMPs and of implementing 
and enforcing elements of approved Plans and represent a substantial 
level of expenditure.
    Because the scale of State Management Plans is contingent upon 
pesticide usage and aquifer sensitivity-- which will vary not only 
between States but also within a given State--the costs of developing, 
implementing, and enforcing SMPs are particularly difficult to 
generalize. In calculating the costs of SMPs, it is reasonable to 
assume that costs will vary directly with the scale of a State's plan. 
Finally, several additional factors will influence the eventual costs 
of a State's plan. These include: the risk mitigation options available 
to State planners; the role of coordination between State agencies and 
other governmental bodies; the shifting of costs to registrants; and 
technological innovations that may lead to decreasing costs over time. 
States have reported (in the process of developing ``generic'' SMPs) a 
broad range of anticipated costs (from as little as $17,000, to write a 
generic plan to over $1 million, counting in full the conduct of 
vulnerability assessments, ground-water monitoring and data base 
management), corroborating the assumption of variable State costs.
    EPA made some critical simplifying assumptions in developing its 
cost estimates: (1) That ``States'' (including territories and some 
Indian tribal authorities) would develop and submit State Plans for all 
or most of the five pesticides in question before the effective date of 
the rule; (2) that the Plans would represent an adequate level of 
protection, i.e., would be approved by EPA; (3) that some States would 
be obliged to develop SMPs that entailed extensive protection programs 
for one or more of the five pesticides, that others would have to 
develop Plans with some additional protection and that still others 
would have to do little more than minor amendments to their ``generic'' 
SMPs to provide for future use of any of the five chemicals (based on 
an analysis of the current use patterns of the five pesticides); (4) 
that virtually all States would submit Plans that would consolidate the 
activities related to any and all pesticides as much as possible, so 
that substantial costs in ground-water vulnerability assessment and 
monitoring, for example, would be shared and not duplicated among 
individual-pesticide proposals - a reasonable assumption in this case, 
considering in particular the common use areas among these five 
candidates and their concentration in areas of high-intensity field-
crop agriculture that would otherwise be of high State concern in any 
case; and (5) that the mix of ``extensive'' and less-extensive State 
Plans would entail a level of effort that could be estimated on the 
basis of a ``model'' SMP activity, that could in turn be extrapolated 
from analysis of existing State programs, ``generic'' SMP submissions 
and the requirements of pesticide-specific SMPs embodied here in 
today's proposed rule and in the Agency's Guidance. The Agency regards 
this last assumption as particularly conservative, since the Agency 
expects that a significant number of actual Plans will turn out to be 
of the less-extensive variety. Pricing every Plan on the basis of a 
``model'' Plan will significantly overstate the true costs, since the 
Agency constructed the ``model'' to represent a relatively extensive 
level of effort.
    EPA developed its aggregate State-cost estimate by means of using 
an existing State plan (Wisconsin's) as a model or surrogate for 
individual State plans. Wisconsin's program was chosen as 
representative for several reasons; its ability and readiness to share 
its data on program development and costs; and its exemplary nature (in 
terms of level and extent of commitment and exercise of risk-management 
measures). Furthermore, Wisconsin falls into the range of moderate 
vulnerability as measured by several macro-level ground-water 
vulnerability indices. However, this latter circumstance is in itself 
not the consummate proof of Wisconsin's representativeness (or even 
adequate characterization of Wisconsin's relative ground-water 
sensitivity), since State situations in terms of vulnerability are so 
diverse as to preclude the classification of any State as ``average.'' 
Finally, EPA did not view the Wisconsin program as the maximum effort a 
State might have to exert: not only has the program dealt primarily 
with a few, particular pesticides, but it terms of general ground-water 
contamination risk, Wisconsin may not represent the greatest degree of 
vulnerability.
    EPA, in its analysis, took into account both the one-time costs of 
a Wisconsin-type program (annualized over either a 5- or 10-year 
period) and estimated annual incremental costs to arrive at a range of 
estimated annual State expenditures. One reason for using Wisconsin's 
experience as a model is the fact that it has performed some of the 
initial activities necessary to implement an SMP, enabling the Agency 
to model such activities as the establishment of pesticide usage 
surveys, vulnerability assessment, soil susceptibility mapping, other 
data base creation, monitoring (establishing and sampling sites), 
maintenance of records, personnel, public awareness and education, and 
other miscellaneous costs of plan development.
    EPA estimates State programs on the average may annually cost in 
the range of $250,000 to $750,000 during the first several years of 
implementation, with $500,000 as the average annual cost. Successive 
SMPs required by the Agency will undoubtedly require less new effort by 
the States, so that incremental costs would be expected to decline over 
the long run. EPA took this expectation into account in its estimate of 
State program costs, projecting that each State, in developing multiple 
SMPs for these five pesticides, would incur some economies by 
developing Plans with common elements. Therefore, national costs were 
calculated by positing one per-SMP cost estimate ($500,000) for a 
single Plan, and fractional estimates for accompanying Plans. 
Calculated on this basis, if States and territories were to implement a 
total of 236 SMPs (EPA's current estimate of States' intentions), their 
total annual cost of implementing this regulation would be $ 59.9 
million.
    The Agency wishes to emphasize that the use of a ``model'' level of 
effort, based largely on one State's experience, is for purposes of 
estimating the costs

[[Page 33286]]

and benefits of this proposed rule. The analysis is not meant to 
represent pre-conceptions about the contents of State submissions. 
State Plans could depart substantially from the details presented in 
the ``model.'' Such differences could be caused by the State's 
particular situation (varying in size, ground-water vulnerability, and 
pesticide use patterns from the model) or by an innovative approach 
that EPA has not anticipated. These Plans would be found adequate to 
the extent States could demonstrate to the satisfaction of the 
reviewing Region that they assure adequate protection. At the same 
time, the Agency believes that it has projected the particulars of the 
``model'' Plan in a manner that depicts the kind of effort necessary to 
meet the objectives of this proposed rule. To that extent, EPA offers 
the State-cost analysis as a reasonable basis for evaluating the cost 
and benefit of this rule.
    Moreover, the Agency wishes to emphasize that the estimate of $59.9 
million is the annual average of aggregate State costs over a 10-year 
period. As such, it represents: (1) The amortization of high one-time 
costs, such as drilling monitoring wells or performing baseline 
vulnerability assessments; and (2) several years of operation of fully-
developed, mature State programs. Under no circumstances should the 
figure be construed to be the immediate, first- (or even second-) year 
costs the States will incur. As stated in Unit III. of this proposed 
rule, EPA anticipates that States can be expected to have to phase in 
``capital'' elements of an SMP (e.g., the development of monitoring and 
vulnerability assessment activities).
    EPA's assumption of broad State participation (that all States will 
develop Plans for most of the five pesticides, and that many will 
develop Plans for all five) may appear to be particularly tenuous, 
since there is no compulsion on the States to develop such Plans, 
beyond the loss of the legal use of a pesticide within the State. The 
consequences of error in this assumption are two-fold with respect to 
estimating costs: (1) EPA's estimate of State costs may overestimate 
actual State costs, because the Agency has over-estimated State 
participation; but (2) in that event, EPA's estimate of user impacts 
might be low. Since the absence of an acceptable SMP would result in 
prohibition of a pesticide's use in a State, more user impacts may 
result than EPA has estimated. The fact that the effects of error in 
this assumption are at least potentially offsetting reduces the 
Agency's concern.
    EPA has confidence in the validity of assuming maximum State 
participation, however. First, the Agency believes the States have 
strong incentive to avoid these increased impacts to its own users by 
developing Plans. This belief is bolstered by the strong evidence of 
the States' interest in assuming the responsibility for managing 
pesticide use to protect ground water (for example, the near-universal 
acceptance of grants and development of ``generic'' SMPs). At the same 
time, EPA has little alternative to such an assumption. EPA does not 
have any basis for estimating which or how many States might fail to 
implement plans, beyond current informal communications between EPA 
regions and the States. Finally, it seems reasonable to assume the 
States least likely to participate are those with the least incentive 
to do so (i.e., those with little or no current or projected use of the 
pesticides), so that their non-participation would have comparatively 
little effect on current use (and consequently little user impact).
    Among the other sources of EPA's uncertainty of its estimate are 
the inherent variation in the size and level of agricultural activity 
across States, and the anticipated variation in State approaches, 
ground-water protection objectives and the like. EPA does not believe 
the margin of uncertainty in its estimate exceeds the magnitude of the 
estimates. Among the reasons for believing EPA's estimate 
underestimates the true impact of regulatory action are unanticipated 
difficulties or obstacles in State implementation of its requirements 
(such as unanticipated non-compliance, necessitating substantially more 
enforcement activities), as well as those considerations described 
above. In addition, EPA has not taken into account potential increased 
costs of Federal-State enforcement of sale/use prohibitions for those 
States that fail to develop Plans. For the reasons explained above in 
describing the assumptions, EPA does not anticipate many States will 
not develop approveable Plans for all five pesticides. For those few 
cases that may arise it is EPA's expectation that enforcement and 
compliance costs will be minimal, since part of the reason for State 
disinterest in developing SMPs for these pesticides will be their 
insignificant use in the State. Among the reasons for anticipating that 
EPA's estimate overstates the true level of State expenditures would be 
the deliberate conservatism in pricing aggregate State costs on the 
basis of a ``model'' Plan that represents substantial effort, limiting 
the estimate of economies-of-scale achieved by developing multiple SMPs 
and the possibilities for innovations in ground-water assessment and 
monitoring techniques (particularly the latter).
    Registrant (or pesticide-industry) impacts are those that would be 
the direct result of regulatory action, apart from any anticipated loss 
of income from reduced use of the products attributable to regulatory 
restriction. Attributable costs would include: (1) The lost revenue 
associated with decreased use of the products, caused by State risk-
management measures; (2) the costs of increased technical assistance 
(such as ground-water monitoring) and outreach to users that the 
registrants might provide, to help them ascertain and follow the new, 
applicable State management measures or other safeguards on the 
chemicals' continued use; and (3) the direct costs of relabeling and 
compliance with the administrative provisions of this proposed rule. 
The first category, lost revenue, was calculated as a function of 
likely State actions, which in turn are represented as three scenarios 
of differing regulatory stringency. Projected annual lost revenues for 
a ``medium impact'' scenario was calculated to be $33.6 million. Using 
current sales figures from the major registrants of these five 
pesticides, this figure represents an estimated 0.06 percent decrease 
in total sales, and a 0.48 percent decrease in pesticide-product sales 
for these registrants. The estimated costs in the second category are 
those that are incremental to ongoing ground-water monitoring, 
technical assistance or outreach efforts the registrants now perform 
with regards to ground-water protection. They are estimated to be in 
the range of $3.1 to 12.7 million annually, conceived as substantial 
new ground-water monitoring activities performed in addition to State 
efforts. These costs can also be attributed to the possible new ground-
water monitoring requirements that EPA may prescribe on registrants 
concurrently with State development of SMPs (see Unit III. of this 
preamble). While EPA has not committed to the development of such 
requirements at this time, the Agency nevertheless includes a cost 
estimate for the activity in the interests of not underestimating 
costs. Uncertainties include EPA's actual specification of those 
requirements, the level of effort represented by that specification, 
the identification of further technical-assistance activities and their 
delineation from ongoing regulatory efforts.
    By far the most substantial impact (in terms of relative magnitude) 
is anticipated to be impacts on agricultural

[[Page 33287]]

and non-agricultural users, and associated indirect impacts of reduced 
consumer benefits. These impacts pertain to the changes caused by 
regulatory restrictions in use of pesticides and the consequent changes 
in agricultural (and other economic) productivity and expenditures. In 
addition to being the largest component of cost, its magnitude is the 
most uncertain and difficult to estimate. Estimating these impacts 
entails an econometric analysis with consideration of a multitude of 
cascading secondary effects across geographic regions and economic 
sectors and with estimated impacts expressed through a variety of 
economic measures. These difficulties are compounded by the necessary 
consideration of the combined behavior changes of perhaps a million 
affected farmers and other users, the normal uncertainties in the 
agricultural sector (the effect of weather, etc.) and the like.
    EPA attempted to anticipate as many of these interactions and 
uncertainties as possible by using a widely used multi-sector, multi-
regional econometric computer simulation model called AGSIM. The 
analysis was performed to take into account not only regional 
variations in commodity supply and production (i.e., varying responses 
to changes in per-acre yields, variable costs, and prices) but also the 
present and projected influences of farm policy elements (e.g., Federal 
price-support and conservation programs, Federal monetary policy, etc). 
These measures aggregate into separate (and additive) dollar estimates 
of the combined impact to the agricultural-production sectors 
(expressed as the change in net agricultural production and income) and 
the consequent decrease in domestic-consumer benefits (sometimes 
referred to as ``surplus value,'' or the amount of additional consumer 
expenditures to maintain the same standard of living as reflected in 
the ``baseline'' conditions, prior to a regulatory action).
    In order to estimate impacts it is necessary to estimate certain 
effects of the SMPs and use these as inputs to the econometric model. 
Specifically, a critical task was to estimate how State risk-management 
measures would influence: (1) The acreage where these five pesticides 
are used; (2) yield impacts; and (3) input (i.e., pesticide-chemical) 
cost impacts. Thus, SMP impacts on users are estimated by a matrix of 
combinations of these three factors (taking the availability of non-SMP 
pesticide substitutes into account) and the consequent change in crop 
yield and price. The critical measure of impact is the reduced treated 
acreage associated with State risk-management measures. These values 
must be regarded as a proxy for the variety of potential effects that 
SMPs may have on agricultural practices. They are not intended to 
represent a forecast of actual State practices, but rather a surrogate 
measure of their potential effect on agricultural practices.
    These estimates were made by consultation with a variety of 
sources. Affected acreage was identified by the use of a Ground-water 
Vulnerability Index for Pesticides designed by Robert Kellogg of USDA's 
Soil Conservation Service. A percentage of these affected acres was 
assumed to be subject to either restricted or prohibited use under 
State Management Plans; this percentage varied according to impact 
scenario and was based upon the 1992 Wisconsin Atrazine Rule. EPA tried 
to account for the considerable uncertainty about the impact of State 
management measures by positing a variety of reduced-use scenarios 
across the principal use areas of these five pesticides. EPA believes 
the most-likely estimate of user impacts rests with its medium-impact 
scenario, but has provided companion low- and high-impact scenarios for 
comparison. The Regulatory Impact Analysis accompanying this proposal 
provides a fuller explanation of EPA's estimates and the methodology 
used to derive them. The SMP-use restrictions have the anticipated 
effect of lowering expected yields and pesticide input costs. 
Restrictions on application rates lower pesticide input costs since 
total usage declines; use prohibitions also lower costs since the cost 
of alternative pesticides are less than that of the SMP pesticides. 
Crop producers are actually expected to be better off in terms of net 
crop revenues as a result of such restrictions, due to the combination 
of increased prices obtained for affected commodities and reduced input 
costs. Increased commodity prices are predicted due to reduced acreage 
planted, which in turn, decreases the total supply of a particular 
commodity. However, increased prices resulting from reduced supply are 
a net negative impact to the economy overall, in the form of reduced 
consumer surplus value.
    At the same time, increased feed crop (corn, soybean, sorghum) 
prices raise input costs for livestock producers. Coupled with stagnant 
or declining demand for livestock products, increased input costs 
negatively impact livestock returns in this analysis by reducing 
livestock revenues. Because the reduction in livestock returns is 
estimated to be greater than the increase in crop returns, net impacts 
to the U.S. agricultural sector are negative, but relatively minor (-$1 
million to -$11 million, across the three scenarios).
    Correspondingly, indirect impacts, in the form of reduced consumer 
benefits, are estimated to be in the range of $242 to $254 million.
    While the absolute magnitude of such impacts appear to be 
substantial, in relative terms such impacts are moderate. Relative to 
the economic value of U.S. field corn production ($16 to $23 billion), 
such impacts are small. For example, the SMP-use restrictions are 
anticipated to lower U.S. field corn production by about 1 percent, 
leading to a potential 1.1 percent increase in market prices. Such 
impacts would have a de minimis effect on the Gross Domestic Product. 
Average annual consumer expenditures and food prices would change less 
than $1.00 per person (from $0.94 to $0.98) as a result of these 
impacts. Individual farmer income in the aggregate would also change 
little, but regional effects of greater magnitudes (both positive and 
negative) could occur.
    This range of projected impacts compares to impacts of $ 3.6 
billion or more in combined user costs and reduced consumer benefits, 
associated with either outright cancellation of the five pesticides 
(plus aldicarb, which had minimal costs associated with its management) 
or more stringent, nationwide use restrictions, as estimated by Taylor, 
et al. in 1991, using a similar econometric approach.
    EPA's method for estimating user impacts, like its projection of 
State-program costs, relies on some key simplifying assumptions: (1) A 
degree of regulatory restriction will translate into a discrete (and 
predictable) level of decreased (or alternative) pesticide use, 
resulting in predictable adverse effects to agricultural production and 
the other relevant economic effects summarized above; and (2) the 
scenarios vary (predictably) in the degree of regulatory restriction 
they represent, and this difference can be expressed in terms of the 
cropped acreage subject to reduced, substituted or eliminated pesticide 
use. Among the reasons for anticipating that EPA's estimate understates 
the true potential impact of ground-water protection measures are: (1) 
That the analysis pertains only to uses on field crops (which, however, 
represent over 90 percent of the combined current use of these five), 
overlooking the potential impact on fruit and vegetable crops; and (2) 
that EPA assumes all States will participate, so that no greater 
restrictions on use will ensue from the fact that State inaction causes 
a

[[Page 33288]]

complete curb on use. However, EPA has equal or greater reason to 
believe its estimate overstates the actual potential impact; chief 
among these is faith in the States' ability to develop a variety of 
innovative management measures that will minimize the disruption in 
crop production caused by ground-water safeguards. State 
resourcefulness in developing new approaches will undoubtedly outrun 
the Agency's present expectations. It is already clear, for instance, 
that States will emphasize measures that will enhance the 
sustainability of agricultural production simultaneously with ground-
water protection, preserving much of the necessary use of the 
pesticides in question. Also, inevitable improvements in ground-water 
monitoring and vulnerability-assessment techniques will enable states 
to ``fine-tune'' necessary restrictions to a degree EPA cannot yet 
anticipate in its estimate. In addition, in developing its estimates of 
crop yield losses, EPA did not take into account the considerable 
promise that is subsequently emerging in the areas of integrated pest 
management and other reduced-use strategies.
    In summary, it needs to be stated that in distinguishing the 
various costs that may be attributable to Federal regulatory action for 
purposes of weighing the costs and benefits of any action, EPA did not 
attempt to assess the reasonable likelihood that a particular category 
of parties would actually incur the costs. For example, the boundaries 
between ``State'' and ``registrant'' costs may be considerably more 
blurred than our analysis would suggest. A variety of activities 
attributed to the States in managing the use of a pesticide subject to 
an SMP rule (including those involving substantial levels of effort, 
such as ground-water monitoring or user education and outreach), for 
example, could in practice be either performed (in part or in whole) or 
paid for (either directly or through State imposition of fees) by the 
registrants. Likewise, some of the activities identified by EPA as 
``registrant costs,'' e.g., the provision of increased user training 
and technical assistance, could be expected to be performed often at 
the behest of State agencies pursuant to their Plans. Accrual of 
expenditures accurately to the various parties was of less importance 
to EPA in making this analysis than was concern for the projection of 
overall level of effort and expenditure attributable to this rule.
    2. Benefits. Chapter 7 of the RIA contains the Agency's appraisal 
of the potential benefits associated with establishing SMPs for these 
five pesticides. This appraisal begins by cataloging the different 
kinds of values associated with protecting ground water as a natural 
resource. These values are categorized in terms of their various 
services as a resource. This categorization follows a recent Agency 
conceptual framework for assessing the economic value of ground-water 
protection in evaluating regulatory impacts (Ref. 19). Each of these 
service values, (associated with two general functions of ground water: 
both as a source of water stock and as a discharge to surface water 
supplies) may be subject to a variety of economic valuation techniques. 
Since these categories generally involve the value of the resource in 
terms of its economic use, other categories of value recognized by 
natural-resources economists must also be acknowledged: the so-called 
altruistic, bequest, and existence values (sometimes referred 
collectively as ``non-use value'') associated with protecting a natural 
resource per se.
    In general, however, the benefits of SMPs will accrue from the 
reduced levels of ground-water contamination, by substances associated 
with adverse human and/or environmental effects, that result from the 
regulatory safeguards required by the individual Plans. It is the 
presence of this contamination that jeopardizes any and all of the use 
and non-use values under consideration.
    In order to perform a reasonable quantitative analysis of benefits, 
accurate and reliable estimation of exposure levels (both existing and 
projected, and in the case of the latter, projected for a number of 
different regulatory options) are critical. Unfortunately, reliable 
estimation of ground-water contamination occurrence is among the most 
difficult and uncertain issues with regards to ground-water concerns. 
Past and current efforts at ground-water monitoring have not been of a 
sufficient level and frequency to give adequate assurance that the 
Agency knows the levels of occurrence of pesticide contamination of 
ground water, either of the specific pesticides addressed in this 
proposed rule or of pesticides in general.
    The United States Department of Interior, in comments submitted to 
EPA regarding the proposed Ground Water Restricted Use Rule (in 56 FR 
22076, referred to in Unit I. of this preamble), characterized the 
state of knowledge associated with the nation's ground-water monitoring 
efforts as follows: ``Given shortcomings in national ground-water 
monitoring efforts, it is highly unlikely that all locations of all 
contaminants in ground water have been determined.'' [July 5, 1991 
letter from Jonathan P. Deason, Director, Office of Environmental 
Affairs; exhibit 7 in OPP comment file no. 36172]. While not 
necessarily reflecting the views of EPA, these comments are testimony 
to the limitations associated with the evidence of contamination from 
current ground-water monitoring results, particularly the substantial 
likelihood of under-estimating the present and future level of 
exposure. Other methods of estimating prospective occurrence, such as 
projections from data on the leaching potential, volume and location of 
use of a pesticide or projections using environmental-fate-and-
transport models, have even greater limitations (see, for example, 
National Resource Council, ``Ground Water Vulnerability Assessment,'' 
NAS Press, 1993, for a fuller description of the strengths and 
weaknesses of various ground-water analytic techniques).
    The consequences of this potential under-measurement of present 
ground-water contamination has another dimension. Since known ground-
water contamination is particularly localized, it is characterized by 
the incidence of limited ``hot spots'' of high concentrations. 
Occurrence of ground-water contamination is unevenly distributed, due 
to the variety of hydrologic and topographic factors. Locations of high 
concentrations of pesticides (and a corresponding high risk of 
potential adverse effects) in ground water are dispersed unevenly 
across the country. The overall profile of the risks associated with 
pesticides in ground water, then is one of large numbers of people at 
relatively low risk, punctuated with ``hot spots'' of higher risk. The 
risk concentrated in these ``hot spots'' are likely to exceed national 
average risks, but are difficult to characterize using aggregate 
occurrence estimates. This unevenness in the distribution of risk 
levels raises concerns regarding ``environmental equity,'' to the 
extent that effects are disproportionately high and adverse, which the 
Agency is committed to take into account as a matter of policy.
    Finally, it should be noted that taking the next step of 
quantifying human health risk by combining population exposure figures 
with some benchmark of toxicity associated with a unit quantity of 
exposure, is hampered by limited methodologies for quantifying hazard. 
At present, the Agency customarily confines hazard quantification to 
carcinogenicity (e.g., projecting ``number of cancer cases avoided''), 
while the possible consequences of other toxicological endpoints cannot 
usually be presented with the same appearance of precision.

[[Page 33289]]

    Despite the limitations on available evidence and methodologies 
discussed above, as a matter of illustration the Agency has presented 
in the RIA a number of different estimates of nationwide human exposure 
to these five pesticides in drinking water using ground-water sources. 
These alternatives represent different data sources and estimation 
methods. Three of these data sources have been referenced earlier in 
Unit IV. of this preamble: the Pesticides in Ground Water Data Base, 
the National Pesticide Survey and the National Alachlor Water Well 
Survey. Another estimate is based on the application of a modeling 
procedure, i.e., the application of an environmental-fate model using 
assumed values for prevailing hydrogeological conditions across all 
local areas where corn pesticides are used. This estimate is provided 
in a yet-unpublished Agency analysis of the cumulative risks and 
benefits of a host of pesticides frequently used on corn, a so-called 
``corn cluster'' analysis. A copy of this analysis is available in the 
public docket for this rule-making.
    The Agency presents these alternative estimates without making a 
judgement that one estimate is superior to another, or that any (or 
all, considered collectively) can be considered a reliable estimate of 
nationwide exposure and hence, national risk. Three of the four 
analyses provide estimates of both: (1) the number of individuals 
exposed to any measurable concentration of these five pesticides (or, 
in the case of the NPS, a surrogate estimate of ``total pesticide'' 
exposure); and (2) the number of individuals exposed to concentrations 
at or above health-based ground water reference points. The model-based 
estimate also estimates total population with any exposure, but offers 
a calculation of baseline cancer and non-cancer risk in place of the 
number of individuals exposed above reference points.
    It is notable that when viewed together, there is a wide variation 
in central-tendency estimates of population exposed among the studies, 
as well as considerable uncertainty surrounding each estimate, taken 
individually and together. For example, best estimates derived from the 
available statistically-based studies of total population exposed to 
any concentration of the five pesticides, from domestic wells alone, 
range from a few hundred thousand to as many as 5 million. Estimates 
from the non-statistically based Pesticides in Ground Water Data Base, 
which does not differentiate private and public well occurrence, range 
to more than 20 million. More importantly, the estimated numbers 
exposed to high concentrations range from nearly none to one-half 
million people or more; taking estimates of random error into account, 
the number exposed above health-based standards could theoretically 
also be as high as 20 million. Estimates from the Data Base for this 
subset run as high as 2.84 million people.
    In addition, each of the four estimations discussed has specific 
shortcomings which need to be recognized before relying on any 
estimate, considered either individually or together, as a credible 
basis for estimating the benefits of the rule. Some of the problems to 
be aware of with these studies are: (1) Most fail to account for the 
entire nationwide exposure potential, leaving out parts of the total 
exposed population (e.g., those drinking from community water systems); 
(2) not every data source addresses precisely the five pesticides in 
question; (3) most are based on limited and imperfect monitoring data 
(i.e., data from surveys with design flaws, or data that are not 
statistically based), and the modeling exercise is not based on 
monitoring results at all; (4) all of them measure or estimate the 
frequency and concentration of well contamination and not human 
exposure per se, which means that certain unverified assumptions were 
made regarding the numbers of people drinking well water to produce 
population-exposure estimates; and (5) they all produce estimates that 
are highly uncertain, for example, with the potential for random error 
(among the statistically designed studies) represented by 95 percent 
confidence intervals ranging from zero to the hundreds of thousands. 
One method (based on the PGWDB) is based on a larger amount of well 
water sampling, but such sampling is not statistically based, so no 
estimate of the degree of expected random error in the estimate is 
possible.
    Given the wide range of divergent estimates, and the significant 
limitations on their reliability, the Agency cannot reasonably identify 
a single ``best estimate'' of prevailing exposure to the SMP pesticides 
in ground water. The Agency believes that the evidence of substantial 
contamination of ground-water-based drinking water supplies, indicated 
by the data summarized in Unit IV. of this preamble, provides reason to 
believe: (1) That many individuals (running up to the thousands, or 
even hundreds of thousands) are or will be consuming ground water 
contaminated by one or more of these pesticides at levels above health-
based standards, in the absence of effective, localized risk-reduction 
measures as envisioned in SMPs; and (2) that many more individuals 
(running into the millions) are or will be consuming ground water with 
at least detectable levels of contamination. While concern tends to 
focus on the former subset, SMPs can be expected to substantially 
reduce the exposure to the larger population as well. The Agency 
further believes that the potential health risk represented by this 
magnitude of occurrence/exposure bears a reasonable relation to the 
magnitude of the economic impacts discussed in the section above.
    The uncertainty surrounding the actual levels of individual 
exposure makes it very difficult to take the next step, that is, 
combining indications of toxicological potency with the estimates of 
exposure to obtain an estimate of human health risk. Where the 
particular study cited presents no estimates of population risk 
associated with the estimated exposure, the Agency has not developed 
any subsequent estimates. However, one of the studies (the modeling-
based analysis associated with the Corn Cluster) offers both estimates 
of cancer and non-cancer population risks. The analysis suggests that 
these five pesticides together represent about 0.4 excess cancer cases 
per year, given a 3-meter depth of ground water as a drinking water 
source. The preponderance of this risk comes from one chemical alone, 
atrazine. The analysis arrives at an estimate of maximum individual 
cancer risk at this depth of 2  x  10-4. To put the magnitude of 
this risk into perspective, as a measure of risk in hotspots, is to 
note that it is roughly twice as great as the incremental lifetime risk 
that this analysis estimates for the dietary pathway, about 8  x  
10-5 for an individual of average exposure. A less conservative 
assumption that a 1 meter depth is representative of ground water 
recharge leads to an estimate of about 5 statistical cancers a year, 
with a corresponding estimate of maximum individual cancer risk of 3 
x  10-3, or nearly 40 times the average dietary estimate stated 
earlier. However, given that neither estimate can be regarded as a 
direct representation of ground-water exposure (since the model only 
simulates the loading to ground water via percolation through crop root 
zones), the Agency regards neither estimate as authoritative. In 
particular, the Agency has reason to believe the 3 meter estimate 
understates ground-water occurrence, based on the Agency's

[[Page 33290]]

experience with controlled field-scale studies, and describes this 
experience in Chapter 7 of the RIA. In addition, it is very likely that 
the cluster analysis underestimates the risk posed by pesticides other 
than atrazine. Specifically, risks presented by alachlor and simazine 
should be only slightly less than that of atrazine, based on the 
monitoring record.
    The Agency is not attempting to authoritatively quantify the risks 
of ground-water contamination by these five pesticides, nor to monetize 
the value of avoiding these risks. The Agency believes such estimates 
are difficult to support scientifically, under these circumstances. The 
Agency solicits comment on the reliability of risk estimates that may 
be developed from these exposure estimates cited above, or from other 
sources.
    Beyond the difficulties of characterizing the magnitude of 
potential human exposure to these pesticides in drinking water, absent 
the risk reduction afforded by SMPs, there remains the question of how 
effective SMPs will be in reducing that risk. The main impediment to 
the evaluation of SMPs' prospective effectiveness is the fact that 
individual SMP provisions remain to be set. However, even making some 
assumptions as to the general features of future SMPs, there remains 
the problem of estimating ground-water contamination occurrences. As 
mentioned earlier, present levels of ground-water monitoring are 
inadequate to gauge the levels of overall ground-water contamination 
with confidence. Alternatives to monitoring, e.g., environmental fate 
models, are not yet developed to provide an adequate substitute to 
monitoring results.
    However, what little evidence is available to the Agency appears to 
support the conclusion that the risk-management measures contained in 
SMPs are likely to be effective in reducing the occurrence of ground-
water contamination. The most reasonable approach to assessing the 
prospective effectiveness of SMPs is to consider the closest existing 
analogue to SMPs, i.e., the performance of existing State-imposed 
localized risk-reduction measures. Very few such analogues presently 
exist, but there is recent information that the Wisconsin atrazine use 
restrictions referred to earlier have resulted in an overall reduction 
in atrazine concentrations in contaminated wells.
    In 1995, the Wisconsin Department of Agriculture, Trade and 
Consumer Protection (DATCP) conducted an extensive analysis of atrazine 
and its metabolites in drinking water wells located within risk-
management areas imposed by the Department beginning in 1992, which had 
been previously monitored (Ref. 22). Seventy-six (84 percent) of 90 
wells sampled in 1995 declined in total atrazine concentration, and 16 
percent increased. For the 76 wells that decreased in concentration, 
levels decreased an average of 2.5 parts per billion (ppb). While the 
re-sampling of these wells generally occurred in one time period, from 
June to September 1995, the study compares these results to a baseline 
sampling frame that varies for each well. Each well was sampled with 
varying frequency across a period that spans from March 1990 to 
September 1994. Relative to the State standard, 57 percent of a 
slightly larger universe of 111 wells (encompassing the 90 cited above) 
are now below 3 ppb (with an average concentration of 1.4 ppb). The 43 
percent of wells still above the 3 ppb standard had an average 
concentration of 5.9 ppb. The overall average concentration for the 111 
wells is 3.3 ppb. While the report attributes the reductions in 
contamination to the use reductions, it was less able to explain the 
reasons for the occasional increases. However, the report mentions 
several plausible reasons, including the possibility that these wells 
are deeper (and so experienced higher levels of contamination from pre-
controlled atrazine use later than the norm), or are located in more 
recently designated areas, or were affected by continued illegal use or 
spills near the wells. These are in addition to the common-sense 
explanations, i.e., the natural variability in sample results over time 
and/or metabolite contributions from non-prohibited triazine use in the 
areas (because atrazine, simazine, and cyanazine have some common 
degradation by-products that will be detected by first-round analytic 
methods). These data provide some evidence that state risk-reduction 
measures seem to have a beneficial effect, reducing both the number of 
occurrences of pesticide contamination in affected areas and the level 
of that contamination.
    In addition to health effects, the Agency believes that the 
possibility of resource effects need to be acknowledged and considered 
in the decision whether to exact further regulatory protection for 
these pesticides. There are two major considerations. First is the 
adverse effect to ecosystems linked to ground-water sources. The 
scientific basis for estimating such things as the location, frequency, 
and duration of sensitive-ecosystem exposure to such ground-water 
contamination is less developed than even the limited information 
discussed above for human exposure. At the same time, the risk of 
ecological adverse effects is certainly a real possibility, and should 
not be discounted merely out of lack of currently available scientific 
means of ascertaining it. Second, there is an even more inestimable, 
but nonetheless relevant, concern over the intrinsic or future value of 
ground water as a resource, as free of man-made pollution as may be 
practicable. Studies that estimate ``willingness to pay'' based on 
survey methodologies have suggested proxy values of substantial 
magnitude, which if extrapolated to national scale, amount to billions 
of dollars, but the estimates from this controversial approach have 
uncertain applicability. One can hypothesize a threshold willingness to 
pay commensurate to the estimated costs of this proposed rule, which 
would compare favorably to the results of previous studies. 
Specifically, if an estimated 5 to 8 million potentially-affected 
households (an estimated 15 to 20 million potentially exposed 
individuals divided by the national-average per household population of 
2.64) were willing to spend between $47 to $63 annually, these sums 
would be commensurate with the $356 million projected cost of the SMP 
rule. EPA believes that these estimates are well within the range of 
expectations, but only a carefully conducted survey, expressly 
clarifying the expected risk-reductions specifically associated with 
SMPs, could confirm these expectations. Likewise, prevention is a value 
that EPA subscribes to because the costs of prevention can be expected 
to be much lower than the costs of remediating contaminated ground 
water when and if it occurs.
    The fact that the dimensions of risk and the effect of risk-
reduction efforts are both highly uncertain dictates a policy to 
proceed cautiously and with maximum flexibility. The Agency believes 
the prudent course in the face of the uncertainties presented by 
pesticidal ground-water contamination is to take positive action that 
avoids irrevocable national policy courses at the outset that might 
lead to programmatic dead-ends. The Agency believes this is the essence 
of the SMP approach, and that this is the most practical policy course 
from among the regulatory alternatives.
    EPA therefore recognizes the lack of information necessary to 
calculate quantifiable benefits that may be associated with the SMP 
approach. However, the States, in electing to participate, will have 
made a practical

[[Page 33291]]

evaluation of both the real and intangible benefits of ground-water 
protection measures, and their participation will represent the choice 
for prevention over remediation. These States will have evaluated the 
benefits of participating relative to their respective environmental 
policy philosophy and goals and on the State economies depending upon 
pesticide use.

D. Risk-Benefit Conclusions

    Based on the information currently available, it is EPA's reasoned 
determination that the benefits of preventing ground-water 
contamination by these five pesticides justify the expected costs of 
implementing preventive measures through the SMP approach, and further, 
that the SMP approach appears to be the most cost-effective of the 
means available for protecting ground water.
    EPA believes that the level and nature of protection to be afforded 
by SMPs is appropriate to the magnitude and character of contamination 
potential indicated by the evidence. In developing the SMP approach in 
cooperation with a broad spectrum of interested parties from the public 
and private sectors, there was much discussion of the alternative 
approach of having EPA impose national-level risk-reduction measures, 
such as labeling or use restricted to certified applicators. That 
alternative is discussed in Unit III. of this preamble and is being 
offered for comment in this proposal. The Agency wishes to point out, 
however, several factors which led EPA to propose the SMP approach 
rather than the national-level restrictions approach.
    The main issue is whether label changes alone, or in combination 
with restricted use classification, and perhaps additional requirements 
placed on the registrants would be sufficient to address the risks of 
ground-water contamination. The evidence of each of the five 
pesticides' ground-water contamination risks suggests no particular, 
specific circumstances causing such contamination. The evidence of 
present ground-water contamination is so broad and general that it is 
unlikely that a pesticide user could readily identify a specific 
condition that would, to a high degree of certainty, cause the 
pesticide to contaminate ground water. Consequently, it seems 
questionable whether clear and simple label instructions could be 
developed that would adequately identify conditions for a user to avoid 
such that ground water risks would be significantly reduced or 
eliminated. Many ground water experts, including EPA staff, believe 
that reliable neutralization of the risks requires a knowledge of 
technical, site-specific factors that most pesticide users cannot 
reasonably be expected to possess. Furthermore, as a matter of policy, 
EPA believes that the users of pesticide products should not be given 
the burden of interpreting label instructions that are either 
unreasonably complex or technical, or are uncertain to achieve their 
purpose. The training associated with classification for restricted use 
may alleviate some of this concern, but would not address the issue of 
whether label restrictions would actually work.
    If this alternative approach were to include monitoring 
requirements to demonstrate effectiveness, and use prohibitions if 
specific detection triggers were met, then this approach might well end 
up being substantially more onerous to both users and registrants than 
SMPs. The Agency is requesting detailed comments on this alternative 
from all potentially affected parties.
    In considering the issue of national-level labeling measures, EPA 
has taken into consideration the fact that new risk-reduction measures 
have recently been in effect for atrazine (since 1992) which are 
intended to reduce the pesticide's contamination potential for both 
surface and ground water. These measures include label changes 
providing for the deletion of certain non-crop uses including highway 
and railroad rights-of-way, reduction of the rates of application for 
remaining crop uses and the imposition of set-backs (non-application 
zones) for wells and bodies of water, prohibiting use and mixing/
loading within specified distances from surface waters and drinking 
water wells. These measures have not been in place long enough for EPA 
to discern any positive effect on the ground-water contamination 
potential of this pesticide. However, when EPA agreed to these risk-
reduction proposals (which were voluntary measures proposed by the 
registrant), it made clear that additional measures would have to be 
considered. Furthermore, the Agency is taking into account the 
voluntary phase-out and eventual cancellation of cyanazine, announced 
in August 1995 (see 1., below). Finally, EPA is anticipating that all 
the pesticides ultimately subject to SMPs will also be classified for 
``conventional'' restricted use, that is, restricted to use by or under 
the direct supervision of a certified applicator.
    In the Strategy EPA committed to considering existing State and 
local measures in making its regulatory decisions about pesticides with 
ground-water concerns. To EPA's knowledge, a total of 10 States have or 
are working on some kind of independent restriction for one or more 
pesticides with ground-water concerns. However, not all of these apply 
to the five pesticides discussed here. Another 12 States have some 
authority to impose such restrictions, but have heretofore not employed 
it. From a national perspective, this level of effort appears to be 
inadequate to address the extent and character of ground-water 
contamination potential associated with these five pesticides. It 
appears that, in the main, States are anticipating that this proposed 
rule requiring pesticide-specific SMPs will serve as the framework for 
their own efforts in this regard.
    Finally, it is EPA's belief and expectation that SMPs should 
sufficiently reduce the risks associated with the ground-water 
contamination potential of these five pesticides, so that full 
cancellation of use based on ground-water concerns alone is not likely 
to be necessary. While the potential risks represented by these five 
are substantial and warrant the imposition of effective preventive 
measures, the measures to be taken by the States should be adequate to 
mitigate the risks.
    A remaining issue is whether the risks associated with ground water 
may combine with other routes of exposure for any of these five 
pesticides to constitute an unreasonable risk and thus warrant 
cancellation. EPA customarily uses the Special Review procedure to 
determine whether the combination of different routes of exposures 
represents unreasonable risks. Alachlor and cyanazine have been subject 
to Special Reviews in the past, and the three triazine active 
ingredients (atrazine, simazine, and cyanazine) have just recently 
begun Special Review. Any or all of these five may be subject to this 
further consideration in the future. In such Special Reviews, EPA will 
take into account the level of risk-reduction expected to be afforded 
by SMPs in making an evaluation of the pesticides' overall risk to 
human health and the environment.
    1. Cyanazine special review. The recent agreement between the 
Agency and DuPont Agricultural Products, the principal registrant of 
cyanazine in the United States, to phase out and eventually terminate 
sale and use of cyanazine, affects this proposed rule. On August 4, 
1995, DuPont signed an agreement with EPA whereby DuPont will amend its 
registration to: (1) Reduce the maximum use rates on cyanazine labels 
in four increments,

[[Page 33292]]

from 1997 to 1999; (2) cease production and sale at the end of 1999; 
and (3) prohibit all uses of cyanazine by the end of the year 2002. 
This arrangement will resolve the Agency's concerns with respect to 
cyanazine in its Special Review of the three triazines. EPA will soon 
publish its termination of the cyanazine Special Review. However, EPA 
will proceed with proposing cyanazine to be subject to SMPs in this 
rule, for several reasons. First, until the Special Review is 
officially terminated and the registrant's voluntary actions go into 
effect, the ground-water risks enumerated in this notice will remain, 
warranting at least proposed regulatory action. Second, even when the 
agreement is implemented, the phase-out schedule provides for a brief 
interval during which cyanazine may be used in States that would need 
SMPs. Third, the Agency is concerned with the possibility that 
cyanazine could be registered at some future date as a completely new 
pesticide. In that event, it is the Agency's judgement at this time 
that the present evidence of the pesticide's severe contamination 
potential requires that any such future use needs to be subject to 
SMPs.
    It may be EPA's judgement in considering a final SMP rule that 
cyanazine's eventual cancellation will be sufficient to address the 
Agency's ground-water concerns; if so, it may choose to issue a final 
rule for only four of the pesticides proposed today. In any event, the 
Agency wishes to emphasize that the fact that cyanazine use will 
terminate soon after the effective date of the SMP restriction will be 
taken into account when EPA evaluates State submissions. EPA does not 
anticipate that State Plans for cyanazine will have to be as extensive 
or detailed as for pesticides whose uses are expected to continue 
indefinitely.
    2. Alachlor Special Review. In 1985, EPA initiated a Special Review 
of Alachlor (50 FR 1115, January 9, 1985). As noted above, alachlor was 
classified as a B2 (probable human) carcinogen, and the 
carcinogenicity potential has been quantified, although the 
classification is now under review. EPA concluded the Special Review of 
alachlor (52 FR 49480, December 31, 1987), after taking the following 
actions to reduce risk for workers: EPA classified alachlor for 
restricted use by certified applicators; prohibited aerial application 
using human flaggers; and required persons applying alachlor to 300 or 
more acres per year to use mechanical transfer systems for mixing and 
loading alachlor. In addition to these regulatory actions, however, EPA 
deferred action on whether the risks posed from alachlor in drinking 
water from contamination of ground water required regulatory action. 
EPA concluded that the further evaluation of the ground-water risks 
would offer an appropriate occasion to revisit the overall risks and 
benefits of alachlor (including dietary risks) on a crop-by-crop basis 
to determine whether the risk benefit balance had changed to a degree 
requiring regulatory action.
    Since 1987, Monsanto has submitted the National Alachlor Well Water 
Survey (NAWWS) and review has been completed. EPA's concerns with 
respect to continuing ground-water risks are evident in its proposal to 
classify alachlor for SMPs in this proposed rule. In addition, EPA has 
reviewed recent trends in usage and percent of crop treated with 
alachlor and determined it is not necessary to revisit the risk/benefit 
determination of alachlor on a crop-by-crop basis. The dietary risks 
posed by alachlor were in the 10-6 range at the time the Special 
Review was concluded and have declined further since then.
    EPA has determined that the remaining Special Review concern about 
alachlor in ground-water is adequately addressed by the actions 
proposed in today's document. Thus, EPA concludes that the concerns 
deferred by the Special Review will have been addressed with 
promulgation of this proposed rule and no further action related to the 
Special Review of alachlor will be necessary upon this proposed rule's 
promulgation. In a separate notice, EPA will announce the cessation of 
the alachlor special review.

E . Analysis of Regulatory Options

    In developing the Strategy EPA evaluated a range of available 
regulatory options in addition to the SMP approach. Specifically, EPA 
compared three general approaches in a companion document to the 
Strategy, the ``Pesticides and Ground-Water Strategy: A Survey of 
Potential Benefits'' (Ref. 13). In supporting the comparative 
advantages of the SMP approach, this document compared it to the option 
of a projected extension of current national-level risk-reduction 
measures, and another of full cancellation of a problem pesticide. Both 
options were regarded as establishing the extremes of potentially 
effective and reasonably feasible alternatives to the SMP approach.
    The first alternative to SMPs was construed to permit significant 
levels of ground-water contamination before milder forms of regulatory 
action (e.g., label changes or restricted use) would be considered. In 
other words, the option constituted a non-prevention-oriented approach 
that, although contrary to Agency policy, constituted a conceivable 
approach to the problem of pesticide contamination of ground water. The 
option relied to a considerable degree upon remediation of projected 
contamination sites to address the problem; as such, it was tantamount 
to addressing the problem of pesticides in ground water through other 
environmental statutes, especially the Safe Drinking Water and 
Superfund (CERCLA) Acts. Consequently, the costs of remediation, and, 
by extension, the costs associated with degradation of ground water as 
a natural resource, were construed to be a larger component of this 
option's cost impacts than any other. While these impacts were not 
directly monetized in EPA's 1991 analysis (for the same considerations 
discussed in Unit IV.C. of this preamble), by indirect analysis EPA 
concluded that the ``status quo'' option would bear considerably higher 
societal-cost impacts than the SMP approach. Moreover, such an approach 
would be unacceptable on policy grounds, representing insufficient 
commitment to a preventive approach. This policy preference, of course, 
in part reflects EPA's discomfort about the ability to correct (much 
less correctly estimate the price of) ground-water contamination once 
it occurs. EPA's view is that such ground-water contamination may be in 
many circumstances practically irreversible, based in part on the 
economics of remedial action (where millions of dollars can be spent 
for uncertain results at a single site).
    Likewise, outright cancellation of one or more pesticides that 
might represent a substantial risk via ground water stands to entail 
far higher societal costs than other regulatory alternatives, such as 
SMPs. As the Taylor analysis (Ref. 5) indicates, the magnitude of user 
and consumer impacts associated with cancellation of these five 
pesticides dwarf those that might be associated with SMPs. Taking into 
account the additional administrative and technical program costs 
associated with the SMP approach (that would not be necessary if the 
pesticides were canceled instead), the SMP approach still appears to 
represent the most cost-effective approach. While absolute cancellation 
may provide a degree of greater surety that ground-water contamination 
will be averted (and in that way affords greater benefits), it is 
unlikely that the incremental gain in surety justifies the enormous 
difference in economic impact between the two options.

[[Page 33293]]

F. Request for Comments

    EPA is interested in receiving comments on its determination of the 
risks and benefits associated with its proposal to classify these five 
pesticides as subject to SMPs. EPA in particular invites all interested 
persons to submit further information concerning the risks and benefits 
(with respect to ground-water contamination, its prevention and any 
ancillary issues) associated with the use of atrazine, simazine, 
cyanazine, alachlor, and metolachlor, as discussed in this proposed 
rule. EPA would like comments on its estimate of the economic impacts 
of the proposed rule. For instance, has the Agency sufficiently 
addressed the indirect costs, such as those associated with minor use 
sites (e.g., fruits, nuts, and turf)? Of particular interest would be 
suggestions for how to improve both: (1) The estimate of present/future 
risks posed by these five pesticides in ground water absent further 
risk-reduction measures like SMPs; and (2) the estimate of 
environmental results likely to be achieved by SMPs.

V. Public Docket

     A record has been established for this rulemaking under docket 
number OPP-36190 (including comments and data submitted electronically 
as described below). A public version of this record, including 
printed, paper versions of electronic comments, which does not include 
any information claimed as CBI, is available for inspection from 8 a.m. 
to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
public record is located in Room 1132 of the Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in ``ADDRESSES'' at the 
beginning of this document.

VI. Notification to Secretary of Agriculture and the Scientific 
Advisory Panel

    As provided in 40 CFR 153.31(b), EPA has transmitted copies of this 
Notice and the Regulatory Impact Analysis, to the Secretary of 
Agriculture and the Scientific Advisory Panel for comment, prior to 
today's publication. In the process of reviewing the proposed 
regulation USDA has raised a number of concerns that the Agency has 
addressed in the text of the proposal. Among those concerns are the 
effects on minor uses, the potential for de facto cancellations with 
the States' failure to have an approved Plan, possible costs incurred 
by USDA programs, the need for an appropriate balancing of risks and 
benefits in the development and approval of SMPs, and the most 
appropriate statutory authority for taking regulatory action. USDA 
looks forward to a full public consideration of these and other 
critical issues in the promulgation of the final regulation. In 
particular, USDA urges the Agency to adopt a streamlined process which 
examines a broad range of possible alternatives for efficiently 
mitigating the environmental impacts while preserving sound 
agricultural production. The Panel had no written comments.

VII. References

    1. Baker, David B., et.al., ``Immunoassay Screens for Alachlor 
in Rural Wells: False Positives and an Alachlor Soil Metabolite,'' 
Environmental Science Technology., 1993, 27, 562-4.
    2. Roux, Paul R., Large-Scale Retrospective Ground-Water Study 
for Metolachlor in Four Areas of the U.S., [Ciba-Geigy, Corp.], 
1989.
    3. Holden, L.R., and Graham, J.A., ``Project Summary of the 
National Alachlor Well Water Survey,'' (Project Summary and 6 
Volumes), Monsanto Agricultural Co., St. Louis, MO, February 1990.
    4. ``Review of the Monsanto Company National Alachlor Well Water 
Survey,'' Phase II Report prepared for EPA by ICF, Inc., March 29, 
1991.
    5. Taylor, C. Robert, et. al., ``Economic Impacts of Chemical 
Use Reduction in the South,'' Southern Journal of Agricultural 
Economics, July 1991.
    6. USEPA-OPTS, 1987a: ``Agricultural Chemicals in Ground Water: 
Summary Minutes from the 1987 Pesticide Strategy Workshop,'' October 
1987.
    7. USEPA-OPTS, 1987b: ``Agricultural Chemicals in Ground Water: 
Proposed Pesticide Strategy,'' December 1987.
    8. USEPA-OPTS, 1988a: ``Summary of State Commissioners Meeting 
on EPA Proposed Strategy on Agricultural Chemicals in Ground 
Water,'' August 1988.
    9. USEPA-OPTS, 1988b: ``Pesticides in Ground Water Data-Base 
1988 Interim Report,'' December 1988.
    10. USEPA, 1990: National Survey of Pesticides in Drinking Water 
Wells: Phase I Report, EPA 570/9-90-015, November 1990.
    11. USEPA 1991a, Protecting the Nation's Ground Water: EPA's 
Strategy for the 1990s (The Final Report of the EPA Ground-Water 
Task Force), 21Z-1020, July 1991.
    12. USEPA 1991b, Pesticides and Ground-Water Strategy, 21T-1022, 
October 1991.
    13. USEPA, 1991c; USEPA, Office of Pesticide Programs, 
Biological and Economic Analysis Division (Economic Analysis 
Branch), ``Pesticides and Ground-Water Strategy: A Survey of 
Potential Benefits,'' February 1991.
    14. USEPA, 1992a, National Survey of Pesticides in Drinking 
Water Wells: Phase II Report, EPA 570/9-91-021, Winter 1992.
    15. USEPA, 1992b, Pesticides in Ground Water Database: A 
Compilation of Monitoring Studies: 1971 - 1991 (11 volumes: a 
National Summary and 10 Regional Summaries), EPA 734-123-92-001, 
September 1992.
    16. USEPA, 1992c, ``EPA Definition of `Pollution Prevention','' 
Memorandum to all EPA personnel from F. Henry Habicht, Deputy 
Administrator, May 28, 1992.
    17. USEPA, 1992d, Final Comprehensive State Ground Water 
Protection Program Guidance, EPA 100-R-93-001, December 1992.
    18. USEPA, 1993; USEPA-OPPTS, Guidance for Pesticides and Ground 
Water State Management Plans: Implementation Document for the 
Pesticides and Ground Water Strategy, EPA 735-B-93-005a, December, 
1993; and two Appendices (EPA 735-B-93-005b, and EPA 735-B-93-005c).
    19. USEPA, 1995, ``A Framework for Measuring the Economic 
Benefits of Ground Water,'' EPA 230-B-95-003, October 1995.
    20 USEPA, 1996, ``Water Resources Impact Analysis for the 
Triazine Herbicides,'' [unpublished]
    21. Nowak, Peter, Wolfe, Steven, et. al., ``Assessment of 1992 
Wisconsin Atrazine Rule (Ag 30),'' Final Report - University of 
Wisconsin College of Agricultural and Life Sciences, May 1993).
    22. WDATCP, 1996: Wisconsin Department of Agriculture, Trade and 
Consumer Protectiion (Postle, Jeff), ``Resampling Wells that 
Previously Exceeded a Pesticide Enforcement Standard,'' Final Report 
- February 1996.

VIII. Regulatory Assessment Requirements

A. Executive Order 12866

    Pursuant to Executive Order 12866 (58 FR 51735, October 4, 1993), 
it has been determined that this is a ``significant regulatory action'' 
because it may result in an annual effect of $100 million or more. This 
action was therefore submitted to the Office of Management and Budget 
(OMB) for review, and any comments or changes made during that review 
have been documented in the public record.

[[Page 33294]]

    In addition, the Agency has conducted an economic analysis of the 
potential impacts associated with this proposed action, which is 
included in a Regulatory Impact Analysis' document prepared for this 
regulation. A copy of this analysis, which is discussed in Unit IV. of 
this preamble, is also included in the public record.

B. Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), 
EPA has determined that this regulatory action does not impose any 
adverse economic impacts on small entities.
    An analysis of the prospective impacts of this proposed rule on 
small States, pesticide distributors, and agricultural producers was 
prepared as part of the Agency's economic analysis for this proposed 
action, which is summarized in Unit IV. of this preamble. This analysis 
is included in a Regulatory Impact Analysis' document, a copy of which 
is included in the public record for this action. This information is 
also being forwarded to the Chief Counsel for Advocacy of the Small 
Business Administration. Any comments regarding the economic impacts 
that this proposed regulatory action may impose on small entities 
should be submitted to the Agency at the address listed above.

C. Paperwork Reduction Act

    The information collection requirements in this proposed rule have 
been submitted for approval to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. 
An Information Collection Request (ICR) document has been prepared by 
EPA (EPA ICR No. 1771.01) and a copy may be obtained from Sandy Farmer, 
OPPE Regulatory Information Division; U.S. Environmental Protection 
Agency (2136); 401 M St., SW.; Washington, DC 20460, by calling (202) 
260-2740, or by sending an e-mail request to: 
[email protected].
    For PRA purposes, ``burden'' means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
or disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.
    Development and implementation of pesticide SMPs entails the 
collection of various sorts of information. In particular, States will 
need to create and/or gather information to conduct ground water 
vulnerability assessments, including data on agronomic practices (e.g., 
pesticide use, cropping patterns) and aquifer sensitivity; the States 
will either gather the data themselves or require third parties (users 
and/or pesticide registrants) to report the data. States will then use 
this data to assess the vulnerability of ground water to the pesticides 
requiring Pesticide SMPs. In addition, States may need to develop and/
or maintain ground-water monitoring efforts, or expand their existing 
efforts to gather chemical, physical, geological, biological, and other 
environmental data. This data will be necessary to support Pesticide 
SMP activities such as determining ground water levels, analyzing the 
existence and extent of contamination, and evaluating the effectiveness 
of management measures. Furthermore, once Pesticide SMPs are approved 
by EPA, States will need to submit an SMP Biennial Report every 2 years 
beginning 2 years from the EPA approval date and continuing every 2 
years thereafter. The SMP Biennial Report will provide a basis for 
measuring States' progress toward protection of ground water resources 
from pesticide contamination. The commitment to develop and report such 
information is a mandatory component of SMPs.
    The total annual burden for the information collection related 
activities associated with this proposed action is estimated to average 
412,560 hours per year for all respondents, including State (and 
territorial) government, and private parties. The per respondent burden 
(i.e., burden for each State, territory, or private party divided by 
the number of States, territories and tribal authorities expected to 
submit SMPs) is expected to average 7,367 hours per year. First year 
burden is estimated to be a total of 673,083 hours, with 12,1019 hours 
per respondent. The total annual costs for the information collection 
related activities associated with this proposed action is estimated to 
average $18,043,080 per year for all respondents, with an annual 
estimated cost of $322,198 per year for each respondent. First year 
start-up costs are expected to be $22,395,865, with an estimated 
$399,926 cost per respondent.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
    Comments are requested on the Agency's need for this information, 
the accuracy of the provided burden estimates, and any suggested 
methods for minimizing respondent burden, including through the use of 
automated collection techniques. Send comments on the ICR to the 
Director, OPPE Regulatory Information Division, U.S. Environmental 
Protection Agency (2136), 401 M St., SW., Washington, DC 20460, and to 
the Office of Information and Regulatory Affairs, Office of Management 
and Budget, 725 17th St., NW., Washington, DC 20503, marked 
``Attention: Desk Officer for EPA.'' Include the ICR number in any 
correspondence. Comments related to these estimates may be submitted to 
the address listed in the ADDRESSES unit anytime during the comment 
period for the proposed action. However, since OMB is required to make 
a decision concerning the proposed collection between 30 and 60 days 
after June 26, 1996, a comment to OMB is best assured of having its 
full effect if OMB receives it by July 26, 1996. The final rule will 
respond to any OMB or public comments on the information collection 
requirements contained in this proposal.

D. Unfunded Mandates Reform Act and Executive Order 12875

    Pursuant to Title II of the Unfunded Mandates Reform Act (UMRA) of 
1995 (Pub. L. 104-4), EPA has determined that this regulatory action 
contains a Federal mandate that may result in expenditures of $100 
million or more for State, local and tribal governments, in the 
aggregate, or to the private sector in any 1-year. Accordingly, EPA has 
prepared the following description of the intergovernmental 
consultation under UMRA, and Executive Order 12875 (58 FR 58093, 
October 28, 1993), entitled ``Enhancing the Intergovernmental 
Partnership.'' The basis for EPA's determination is contained in the 
economic analysis accompanying this rule, which is included in the 
public record for this action and summarized in Unit IV. of this 
preamble.
    UMRA requires that such a rule be accompanied by a statement that, 
among other things, documents that the rule is the least costly, most 
cost-effective or least burdensome alternative that achieves the 
regulatory objective. In the absence of such documentation, UMRA

[[Page 33295]]

provides that the head of the promulgating Agency may otherwise provide 
in the statement an explanation of why the least burdensome approach 
was not adopted or is inconsistent with law. The discussion in part E 
of Unit IV of this preamble describes the Agency's analysis of 
regulatory options. As this discussion, and the earlier analysis cited 
therein (c.f., Ref. 13) indicates, the Agency believes that this 
proposed action is the most cost-effective and least burdensome 
alternative to the alternatives considered in the development of the 
Pesticides and Ground-Water Strategy (Ref. 12), developed as the 
groundwork for today's proposed rule. A particularly advantageous 
feature of the chosen option is that it allows States to determine the 
most appropriate approach for preventing unreasonable adverse effects 
within their individual States. The practical alternatives are a choice 
between different kinds of Federally mandated restrictions, either 
national standards and/or risk-reduction measures (principally in the 
form of label changes) or outright cancellations of use. The principal 
disadvantage of both is that they can not take State specific issues 
into consideration, and so can be anticipated to increase the loss of 
economic benefits associated with the pesticides' use, relative to the 
impacts of SMPs. National-level measures are potentially less certain 
of meeting the regulatory objective, that is, of achieving the goal of 
preventing unreasonable levels of ground-water contamination. This 
greater uncertainty is caused by the relative inability to tailor risk-
management measures, proceeding instead on a ``lowest common 
denominator'' approach. Still another conceivable (but unanalyzed) 
option is doing nothing at the Federal level, leaving the potential for 
ground-water contamination to be addressed, if at all, by voluntary 
action and/or independent State action. This alternative was not 
analyzed because it clearly failed to meet the regulatory objective. 
Such an option that freely permits contamination would entail no direct 
regulatory costs, but the far larger reduction in the value of the 
resource must be compared to the more conventional economic impacts.
    The statement required by UMRA also requires a summary description 
of State/local/Tribal governmental input in the rule's development. 
Prior consultation with State and Tribal authorities has been 
extensive. The Pesticides and Ground Water Strategy development process 
began with a major public workshop held in 1986 in Coolfont, West 
Virginia. State Agriculture, Environment and Health agencies were among 
the participants. A second public workshop was held at Coolfont during 
the summer of 1987, also with similar participation. Beyond the 
Strategy, State regulatory officials were involved in the development 
of the subsequent Guidance beginning in 1989, when EPA sponsored 
working sessions to determine how best to guide the process of managing 
pesticide use to protect the ground water resource. Two week long 
sessions were held in Fredericksburg, Virginia during October and 
November of 1989. These sessions were actual working sessions to 
develop the document that today is the SMP guidance document. Between 
five and seven States participated in each session. Drafts of the 
guidance document were shared with all 50 State Lead Agencies for 
Pesticides, EPA Regional Offices, and other Federal agencies.
    During development of the proposed rule, many issues were discussed 
with the Water Quality Working Committee Group of the State FIFRA 
Issues Research and Evaluation Group (SFIREG) on which eight State Lead 
Agencies sit. This group meets three times per year with OPP to discuss 
water quality issues and this forum was used extensively in the early 
stages of development of the proposed rule.
    The proposed regulation itself has been provided as an initial 
draft twice to EPA's 10 regional offices and all 50 states for review 
and comment, in addition to the SFIREG Water Quality Committee and to 
SFIREG's parent body, the American Association of Pesticide Control 
Officials (AAPCO). The first round of review in fall 1994 elicited 38 
written comments from State and Tribal agencies; the second round in 
spring 1995 elicited 18 further comments. As a result of each round of 
review, the draft proposed rule was modified. These written comments 
are in the public record and were considered in the development of the 
proposed rule. Virtually all of the principal State comments and 
concerns are reflected in the discussion in Unit III of this preamble, 
and in the request for comments accompanying that Unit.
    All other UMRA requirements for the accompanying statement to a 
``significant regulatory action,'' e.g., descriptions of statutory 
authority, anticipated costs and benefits, compliance costs, are 
contained throughout this preamble, in the appropriate headings.

E. Executive Order 12898

    Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), 
the Agency has considered environmental justice related issues with 
regard to the potential impacts of this action on the environmental and 
health conditions in low-income and minority communities. As related 
throughout this document, the approach the Agency is proposing to 
address the problem of pesticides in ground water is based on a full 
appreciation of the localized nature of the problem, and this approach 
strives to be the most effective strategy for localized protection of 
the ground-water resource. As the Strategy highlights, alternatives to 
effective local-level risk reduction measures (e.g., national-level 
regulation or no regulatory protection) are considered likely to either 
over-regulate pesticide use (causing undue economic hardship to 
affected parties) or under-protect (increasing the risk of various 
adverse health and environmental effects to specific parties).

List of Subjects

40 CFR Part 152

    Environmental protection, Administrative practice and procedure, 
Pesticides and pest, Reporting and recordkeeping requirements.

40 CFR Part 156

    Environmental protection, Labeling, Occupational safety and health, 
Pesticides and pest, Reporting and recordkeeping requirements.

    Dated: June 19, 1996.
Carol M. Browner,
Administrator.

    Therefore, 40 CFR chapter I, is proposed to be amended as follows:
    1. In Part 152:

PART 152 --[AMENDED]

    a. The authority citation for part 152 would continue to read as 
follows:

    Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 
U.S.C. 9701.

    b. By adding a new subpart J to part 152, to read as follows:

Subpart J--Ground-Water State Management Plans

Sec.
152.180    Applicability.
152.183    Definitions.
152.185    Restriction.
152.187    Submission and approval of ground-water State Management 
Plans.
152.190    Specifications and requirements of a ground-water State 
Management Plan.
152.191    Evaluation of State Management Plan Implementation.
152.193    Amendment of State Management Plans.

[[Page 33296]]

152.195    Withdrawal of approval of a State Management Plan.
152.198    Pesticides classified for restricted use subject to a 
ground water State Management Plan.
Subpart J--Ground-Water State Management Plans


Sec. 152.180   Applicability.

    This subpart applies to any pesticide or pesticide product 
designated to be subject to the requirements and provisions of ground-
water State Management Plans by means of a Restricted Use 
Classification.


Sec. 152.183   Definitions.

    In addition to the definitions in Sec. 152.3, the following terms 
also apply to this subpart:
    Ground Water Reference Point means an environmental concentration 
of a pesticide ingredient based on any of the following:
    (1) Maximum Contaminant Levels (MCLs) established under the Safe 
Drinking Water Act; or
    (2) Health Advisories (where MCLs are not available for a 
substance); or
    (3) Water Quality Standards (where the ingredient poses adverse 
effects to ecosystems affected by closely hydrologically linked surface 
waters) under the Clean Water Act.
    Plan means a State Management Plan developed for the purpose of 
managing the use of a pesticide in order to prevent unreasonable risks 
of ground water contamination.
    State means each of the 50 States, Puerto Rico, the U.S. Virgin 
Islands, the District of Columbia, Guam, American Samoa and other 
Pacific Island Territories of the United States, as well as Indian 
Lands under Tribal jurisdiction.


Sec. 152.185   Restriction.

    (a) Restriction. A pesticide or pesticide product classified for 
restricted use subject to a State Management Plan may be used only in 
accordance with the provisions and requirements of an Agency-approved 
State Management Plan, after a date 33 months from the date the 
pesticide or product is so classified. Such a pesticide or pesticide 
product may not be sold or used after that date within the boundaries 
of a State without an Agency-approved State Management Plan.
    (b) Labeling. (1) Upon classification of a pesticide for restricted 
use, subject to ground-water State Management Plans, each registrant of 
a product subject to that classification shall, within 12 months after 
the date of that classification by final Agency rule, submit for such 
product:
    (i) A copy of the labeling amended to include the statement 
specified in Sec. 156.137(a)(2)(ii) of this chapter.
    (ii) A statement that the registrant will comply with the labeling 
requirements prescribed by the Agency by the effective date of this 
rule. The Agency will regard such statement to be a report under the 
Act. The Agency may deny registration or initiate cancellation 
proceedings if a registrant fails to comply with the timetables 
established in this section.
    (2) A product whose labeling bears directions for end use and that 
has been classified as subject to ground-water State Management Plans 
must be labeled in accordance with the requirements of Sec. 156.10 of 
this chapter after the effective date of the restriction.
    (c) Distribution and sale of classified products. No product with a 
use classified for restricted use, subject to ground-water State 
Management Plans, may be distributed or sold by a retailer or other 
person after the effective date of the restriction, unless the product 
bears a label or labeling which contains the terms of the 
classification and otherwise complies with paragraph (b)(2) of this 
section.


Sec. 152.187   Submission and approval of ground-water State Management 
Plans.

    If any State, at any time after the classification of a pesticide 
or pesticide product to be subject to State Management Plans by final 
rule, wishes to establish a ground-water State Management Plan for such 
a pesticide or pesticide product, that State shall submit a proposed 
Plan for that purpose to the Administrator. The Administrator will 
approve the Plan submitted by any State if, in the Administrator's 
judgement, the Plan meets the requirements of Sec. 152.190.
    (a) Schedule. A State that wishes to implement a Plan on the 
effective date of the State Management Plan restriction shall submit a 
proposed Plan, along with the administrative record accompanying 
development of the proposed Plan to the appropriate EPA region under 40 
CFR 1.7, before a date 24 months from the date a pesticide or product 
is classified. The submission shall include an electronic file in 
Wordperfect 5.1 or higher or ASCII for all material. The Administrator 
will review such submittals and approve or disapprove Plans within 9 
months of receipt of a complete submittal.
    (b) Review. Upon receipt of a proposed State Plan submitted for EPA 
approval, the Administrator or a designee will first review the 
proposed Plan to determine that all requirements as provided in 
Sec. 152.190 have been addressed. Upon completion of this review, the 
Administrator will notify the State in writing of the initial 
determination of the completeness of the submission. In the event that 
the Administrator determines that the submission fails to address all 
requirements, the Administrator will request the State revise its 
submission to provide the missing components. Once the Administrator is 
satisfied that the submission is complete, full evaluation of the 
submission will proceed.
    (c) Approval. Upon completion of the review of the submission, if 
the Administrator finds that the Plan meets the requirements of 
Sec. 152.190, then the Administrator will publish a Notice of Approval 
in the Federal Register and a letter of notification to the State 
official designated as State Liaison, pursuant to Sec. 152.190(b), 
informing of the approval.
    (d) Disapproval. If, after completion of the review of the 
submission, the Administrator finds that the submission fails to meet 
the requirements of Sec. 152.190, the Administrator shall notify the 
State Liaison by letter that EPA will not approve the Plan as 
submitted, and specifying the deficiencies in the Plan that prevent its 
approval. If, after further consultation, the Administrator still finds 
that the submission fails to meet the requirements, the Administrator 
will publish a notice in the Federal Register announcing the 
disapproval of the Plan and including the reasons for finding the Plan 
inadequate pursuant to Sec. 152.190. In this event, sale or use in the 
State of the pesticide that is the subject of the Plan shall be 
prohibited 33 months after the promulgation of a rule classifying the 
pesticide as subject to a ground-water State Management Plan.


Sec. 152.190   Specifications and requirements of a ground-water State 
Management Plan.

    The Administrator shall approve the State Management Plan submitted 
by any State, or any modification thereof, if in the Administrator's 
judgement, the Plan fulfills the following requirements.
    (a) State's philosophy and goals toward protecting ground water. An 
acceptable Plan must, to the satisfaction of the Administrator, contain 
a description of the State's ground-water protection philosophy and 
goals regarding pesticide management, including an explanation how its 
philosophy and goals will be no less protective than EPA's goal of 
preventing adverse effects to human health and the environment and 
protecting the environmental integrity of the nation's ground water.

[[Page 33297]]

    (b) Roles and responsibilities of State agencies. An acceptable 
Plan must, to the satisfaction of the Administrator:
    (1) Identify and describe both the general responsibility of, and 
the specific technical and administrative tasks to be performed by, 
each participating agency responsible for the development and 
implementation (including enforcement) of the Plan, including a 
description of how the State agencies intend to use the programs and 
expertise of Federal agencies in carrying out the Plan.
    (2) Identify a Liaison who will serve as a single contact point for 
all formal communications concerning the Plan process between EPA and 
the State, including responsibility for the transmittal and receipt of 
official correspondence and information.
    (3) Describe the coordination mechanisms between all participating 
State agencies, local entities, and appropriate Federal agencies.
    (4) Describe how local governments are included in activities under 
the Plan. When local governments have authority to address State 
ground-water-related objectives and priorities, the State must 
demonstrate that program coordination, guidance, or oversight is 
provided.
    (5) Contain official concurrences from the directors of all State 
agencies with responsibilities under the Plan stating their agreement 
with the Plan, and their commitment to carry out their responsibilities 
under the Plan.
    (6) Discuss any relevant inter-State multi-jurisdictional 
coordination, including how any multi-jurisdictional issues will be 
resolved for purposes of implementing the Plan.
    (c) Legal authority. An acceptable Plan must, to the satisfaction 
of the Administrator:
    (1) Contain regulatory authorities that are sufficient to 
accomplish the objectives of the Plan, established in paragraph (a) of 
this section.
    (2) Specify the legal authorities of the State to implement the 
Plan successfully and specify the State's authority to impose 
preventive measures, its remedial action authority and its compliance 
and enforcement authorities, citing all relevant State laws and 
regulations and including Federal legislation, regulations and program 
delegation, available to the State.
    (3) Identify the specific authorities that will be used to carry 
out the specific commitments made in the Plan. The State must 
specifically identify the authority to conduct or require others to 
conduct monitoring, prohibit use in specific areas, close public wells, 
or supply or require others to supply alternative sources of water, 
where such actions are elements of the Plan, must be identified.
    (d) Resources. An acceptable Plan must, to the satisfaction of the 
Administrator, demonstrate there are adequate resources available to 
implement and enforce the program. Resources include technical 
expertise and personnel, physical and operational capabilities, and 
funding. The Plan must demonstrate there is an adequate match between 
revenues and proposed expenditures and that the necessary expertise is 
available.
    (e) Basis for assessment and planning. An acceptable Plan must, to 
the satisfaction of the Administrator, specify the State's approach and 
activities to assess vulnerability for the geographic area in which the 
State intends to allow pesticide use, identifying the sources of all 
such data. The State shall specifically describe the State's available 
pesticide use data (e.g., geographic use and application rates) and how 
it will be factored into assessing vulnerability.
    (f) Monitoring. An acceptable Plan must, to the satisfaction of the 
Administrator, demonstrate that monitoring activities (including 
ground-water monitoring) performed pursuant to the Plan are appropriate 
for the purposes of the Plan, with assurances that the activities will 
be carried out adequately. Specifically, an acceptable Plan must 
identify and describe key elements of the monitoring program, including 
the scope and objective (in relation to the purposes of the Plan) of 
such monitoring, design and justification (including the number of 
sites to be sampled, the number of samples to be taken and the 
frequency of sampling) of such monitoring, monitoring protocols, 
quality assurance/quality control, sampling methodology, analytical 
methods, and analytes. Such description must make clear how the 
placement of monitoring sites relates to the State's priorities for 
protecting ground water, and will allow evaluation of the effectiveness 
of prevention and response measures specified in paragraphs (g) and (h) 
of this section. Monitoring performed for the purpose of fulfilling 
this requirement must be performed in accordance with an EPA-approved 
Quality Assurance Project Plan (as described in Chapter 5.4.2 of 
Appendix B, ``Assessment, Prevention, Monitoring and Response 
Components of State Management Plans,'' to the Guidance for Pesticides 
and State Management Plans (EPA 735-B-93-005c, February 1994). This 
incorporation by reference was approved by the Director of the Federal 
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be obtained from the Public Response and Program Resources Branch, 
Field Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Copies may be inspected at the above address or at the Office of the 
Federal Register, 800 North Capitol St., NW., suite 700, Washington, 
DC. Good Laboratory Practice Standards (40 CFR part 160) do not apply 
to monitoring performed for the purpose of fulfilling this requirement.
    (g) Prevention actions. An acceptable Plan must, to the 
satisfaction of the Administrator, specify the actions a State will 
take to manage the use of the pesticide classified for use subject to 
the Plan, to fulfill the State's goals and principles enunciated 
pursuant to paragraph (a) of this section and will otherwise prevent 
unreasonable adverse effects to human health and protect the 
environmental integrity of the nation's ground-water resources.
    (h) Response to detections of pesticides. An acceptable Plan must, 
in the judgement of the Administrator, adequately specify the measures 
that the State will take (and the circumstances under which the State 
will take them) to respond to contamination so that Ground Water 
Reference Points are not reached, and specify the actions the State 
will take in the event Reference Points are met or exceeded. This 
description must be presented in the form of a general corrective 
response scheme, illustrating the State's capacity for timely, 
coordinated response to contamination.
    (i) Enforcement mechanisms. An acceptable Plan must, to the 
satisfaction of the Administrator, demonstrate that the State's 
enforcement authorities and capabilities are adequate to implement and 
to monitor compliance with the specific measures included in the Plan, 
describing authorities and capabilities that are intended to protect 
ground water from contamination and response actions where 
contamination has already occurred. Enforcement authority must be 
identified by the State, and the roles and responsibilities of each 
State agency must be defined, including how coordination of enforcement 
capabilities within agencies will work to prevent and respond to 
contamination.
    (j) Public awareness and participation. An acceptable Plan must, to 
the satisfaction of the Administrator, demonstrate that there is notice 
and opportunity for public comment within the process of Plan 
development, and will be informed of significant Plan

[[Page 33298]]

implementation activities. This demonstration must:
    (1) Describe the public role regarding development of the Plan and 
decision-making in implementing the Plan, and identify or describe 
existing legal requirements within the State that would ensure public 
participation in the process (i.e., an Administrative Procedure Act 
requiring notice and comment, etc.). If no such legal requirements 
exist within the State, the Plan must describe any other public 
participation process that the State uses in the development of the 
Plan.
    (2) The Plan must also specify the level of detection in ground 
water that is considered by the State to be of such significance that 
the State will inform the public. Indicate how, when, and by whom the 
public will be informed of detections in ground water that are 
considered significant, providing for, at a minimum:
    (i) The notification of any well owner of any detections in ground 
water; and
    (ii) The notification of all users of any detections above the 
reference point.
    (3) Include a description of the process and means of communication 
by which the public will be made aware of important regulatory actions 
taken under the Plan.
    (k) Information dissemination. An adequate Plan must, to the 
satisfaction of the Administrator, describe the means by which measures 
prescribed pursuant to the Plan will be communicated to pesticide users 
and all other interested parties. A plan must:
    (1) Describe how information regarding prevention measures (e.g., 
use limitations and precautions) will be relayed to the appropriate 
audiences.
    (2) Describe how pesticide users will be trained or educated in how 
to comply with requirements of applying a pesticide where use is 
governed by the Plan.
    (3) Identify the targeted parties and discuss how information will 
be relayed.
    (4) Explain why the information dissemination approach is 
appropriate for the type of contamination prevention actions being 
employed, and the education and/or awareness of the targeted audience 
is required.
    (5) Describe how information will be updated as requirements 
change. Such discussion should include the form these updates will take 
and the distribution methods. The Plan should also discuss any existing 
mechanisms (i.e., Memoranda of Understanding, cooperative agreements, 
etc.) between the State and other entities that will be involved in 
this effort.
    (l) Records and reporting. An adequate Plan must, to the 
satisfaction of the Administrator:
    (1) Include a commitment by the State to maintain essential records 
relating to Plan implementation for a period of at least 6 years. The 
information maintained must include, but is not limited to, records on 
any monitoring or sampling conducted, results of analyses, issuance of 
permits, types and numbers of enforcement actions taken, records of any 
site-specific regulatory actions, and administrative actions. The State 
must commit to promptly make available to the Agency, upon request, 
records related to the development or implementation of the Plan.
    (2) Commit to developing and submitting to the appropriate Regional 
Office a Plan Biennial Report, as described in Sec. 152.191(a), and to 
report any significant findings to the appropriate Agency Regional 
Office.
    (3) Commit to submitting with each report to EPA a signed 
certification, worded as follows:

    I certify under penalty of law that I have personally examined 
and am familiar with the information submitted herein and based on 
my inquiry of those individuals immediately responsible for 
obtaining the information, I believe the submitted information is 
true, accurate and complete. I am aware that there are significant 
penalties for submitting false information, including the 
possibility of fine and imprisonment. See 18 U.S.C. section 1001 and 
7 U.S.C. section 136).


Sec. 152.191   Evaluation of State Management Plan Implementation.

    Any State Management Plan approved under Sec. 152.190 shall be 
subject to periodic evaluations of its implementation by the Agency, in 
order to assure implementation of the Plan consistent with its goals 
and commitments, to determine the environmental effectiveness and the 
level of ground-water protection provided by the Plan, and to ensure a 
minimum level of national consistency.
    (a) Biennial Report. A Biennial Report, as described in 
Sec. 152.190 (l)(2), must be developed and submitted by the State in 
order to maintain Agency approval, and will be used by the Agency and 
by State officials to evaluate a State's effectiveness in protecting 
its ground-water resources from pesticide contamination. The State 
shall prepare the Biennial Report according to the provisions of 
Chapter 5 of Appendix A, ``Review, Approval and Evaluation of State 
Plans,'' to the Guidance for Pesticides and State Management Plans (EPA 
735-B-93-005b, February 1994).
    (b) Evaluation reporting requirements. The Biennial Report must be 
approved by State officials directing the key State agencies that play 
a role in implementing the Plan. The Biennial Report must be submitted 
in October of alternate years, starting in October [of the year 4 years 
after date of publication of the final rule] to the appropriate Agency 
Regional Office. The State may submit a single Biennial Report in the 
event it implements Plans for more than one classified pesticide. In 
that event, the report must include programmatic and environmental 
evaluations addressing each approved Plan. States will also submit a 
programmatic and an environmental evaluation that addresses any 
progress made in implementing the Plan.


Sec. 152.193   Amendment of State Management Plans.

    (a) The State will amend an approved Plan as part of the Biennial 
Report required under Sec. 152.191(a) when:
    (1) The evaluation performed pursuant to Sec. 152.191 demonstrates 
that the provisions in the Plan do not adequately protect the ground-
water resource from pesticide contamination.
    (2) A change in the legal (statutory or regulatory) and enforcement 
framework for Plan development and implementation necessitates a change 
in the Plan.
    (3) A State, through experience, finds more effective ways to 
assess ground-water contamination, to prevent and respond to 
contamination, and to educate affected parties or disseminate 
information.
    (4) Changes in pesticide management measures or approaches become 
necessary as a result of significant changes in crops or crop 
production systems and technologies within the State.
    (5) Roles and responsibilities of State agencies involved in the 
implementation of the Plan change so as to necessitate a change in the 
Plan.
    (b) If a State is aware that an amendment is needed, then that 
amendment should be submitted as part of the Plan Biennial Report. In 
addition, if the Regional Office that is the recipient of that Report 
determines through the evaluation process that the Plan needs to be 
updated, then the Regional Administrator of that region, or a designee, 
can initiate the updating process by requesting that the State submit a 
Plan Update Report. In every case, the Update Report must include:
    (1) A description of the proposed changes in the Plan.
    (2) An explanation of why the changes are necessary.
    (3) An analysis of the impact the changes will have on the other

[[Page 33299]]

components of the Plan, the implementation of the Plan and the 
protection of the resource.
    (4) If changes will affect pesticide users, a description of how 
users will be alerted to the changes in the Plan.
    (5) Concurrences by all officials directing the key State agencies.
    (6) If changes are significant, a description of how the State 
received public input on changes to the Plan, and the administrative 
record developed in the course of changing the Plan. Amendments to 
Plans must be concurred or approved by the Regional Administrator.


Sec. 152.195   Withdrawal of approval of a State Management Plan.

    (a) If, in the judgement of the Administrator or a designee, 
either:
    (1) A State fails to demonstrate that it is satisfactorily 
implementing the Plan; or
    (2) A State's Plan is not protecting ground water from 
contamination at or above ground water reference points (as specified 
in Sec. 152.198); or
    (3) A State fails to address deficiencies identified by the Plan 
evaluation through updating the Plan and/or improving implementation of 
the Plan; or
    (4) A State fails to submit a biennial report;
he or she shall notify the designated State Liaison, named pursuant to 
Sec. 152.190(b), and relevant State administrators of the Agency's 
concerns. In that event, the State will have 90 days to respond to 
these deficiencies in its Pesticide Plans, either through the Plan 
updating process or by demonstrating to the Region that the Plan is 
being satisfactorily implemented.
    (b)(1) If the Administrator determines that the State has failed to 
address the deficiencies identified by the Agency or has failed to 
correct the deficiencies, the Administrator shall notify the officials 
directing the key State agencies involved in implementing the Plan and 
the designated State Liaison by letter that withdrawal of Agency 
approval is being considered. The notice will include:
    (i) A statement concerning the potential withdrawal of Agency 
approval of the Plan.
    (ii) A listing of the deficiencies of the Plan or a description of 
the failure of the Plan or its implementation to protect ground water.
    (iii) A brief summary of the events that led to the withdrawal 
notice.
    (iv) Dates by which the State can respond to the deficiencies to 
stop the withdrawal process.
    (2) The State must respond to the notice within 30 days of receipt 
of the notice in writing with a commitment to address the deficiencies 
in the Plan itself or in its implementation. If the State disagrees 
with the judgement or the findings of the Administrator in the initial 
notice described in paragraph (b) of this section, the State may 
request to meet with the Administrator within 60 calendar days from the 
time the EPA Administrator sends the letter of potential withdrawal to 
the Administrators of the key State agencies.
    (3) If, in the Administrator's judgement, continued use of the 
pesticide within the State presents unreasonable adverse effects on the 
environment because of the deficiencies cited pursuant to paragraph 
(b)(1) of this section, the Administrator may prohibit further sale and 
use of the pesticide in the State until the Agency and the State reach 
an agreement on how to address the Plan's deficiencies. Such a 
prohibition shall be published in a Federal Register notice describing 
the basis for the Administrator's findings, and soliciting comment 
thereon. After addressing any public comment, the Administrator may 
take final action temporarily prohibiting use of the pesticide in the 
State.
    (c) If the State does not respond to the notice that withdrawal of 
approval is being considered or fails to address the deficiencies 
identified in the notice to the satisfaction of the Administrator, the 
Administrator will send a formal letter to the officials directing the 
key State agencies and the State Liaison indicating that EPA is 
publishing a Federal Register Notice proposing to withdraw the 
Pesticide Plan. In the event the State does not respond to this notice, 
the Administrator will publish a Federal Register Notice to provide an 
opportunity for public comment on withdrawal of the Plan. After 
addressing any public comments, the Region will publish a Notice of 
Withdrawal in the Federal Register and prohibit the sale and use of the 
pesticide in the State.
    (d) Upon publication of the final Notice of Withdrawal in the 
Federal Register, sale and use of the pesticide within the boundaries 
of the State will be prohibited.


Sec. 152.198   Pesticides classified for restricted use subject to a 
ground water State Management Plan.

    Pesticide products containing the active ingredients listed in the 
table to this section, with the corresponding Ground Water Reference 
Points specified are classified for restricted use, to be subject to 
the provisions and requirements of an EPA-approved State Management 
Plan.

                                                                        
------------------------------------------------------------------------
                                                         Ground Water   
        Active Ingredient             CAS Number        Reference Point 
------------------------------------------------------------------------
Alachlor                          15972-60-8          2 g/l    
Atrazine                          1912-24-9           3 g/l    
Cyanazine                         21725-46-2          1 g/l    
Metolachlor                       51218-45-2          70 g/l   
Simazine                          122-34-9            4 g/l    
------------------------------------------------------------------------

    2. In Part 156:

PART 156--[AMENDED]

    a. The authority citation for part 156 continues to read as 
follows:

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

    b. In Sec. 156.10, by revising paragraphs (a)(1)(viii) and 
(a)(1)(ix) and removing paragraph (i) to read as follows:


Sec. 156.10   Labeling Requirements

    (a) *  *  *
    (1) *  *  *
    (viii) The directions for use as prescribed in subpart G of this 
part; and
    (ix) The use classification(s) as prescribed in subpart G of this 
part.
      *    *    *    *    *
    c. By adding a new subpart G to part 156 to read as follows:

Subpart G--Directions for Use

Sec.
156.120    General requirements.
156.121    Contents of directions for use.
156.135    Statements of use classification.
156.136    General use statements. [Reserved]
156.137    Restricted use statements.

[[Page 33300]]

Subpart G--Directions for Use


156.120   General requirements.

    (a) Adequacy and clarity of directions. Directions for use must be 
stated in terms which can be easily read and understood by the average 
person likely to use or to supervise the use of the pesticide. When 
followed, directions must be adequate to protect the public from fraud 
and from personal injury and to prevent unreasonable adverse effects on 
the environment.
    (b) Placement of directions for use. Directions may appear on any 
portion of the label provided that they are conspicuous enough to be 
easily read by the user of the pesticide product. Directions for use 
may appear on printed or graphic matter which accompanies the pesticide 
provided that:
    (1) If required by the Agency, such printed or graphic matter is 
securely attached to each package of the pesticide, or placed within 
the outside wrapper or bag.
    (2) The label bears a reference to the directions for use in 
accompanying leaflets or circulars, such as ``See directions in the 
enclosed circular.''
    (3) The Administrator determines that it is not necessary for such 
directions to appear on the label.
    (c) Exceptions to requirement for direction for use--(1) Detailed 
directions for use may be omitted from labeling of pesticides which are 
intended for use only by manufacturers of products other than pesticide 
products in their regular manufacturing processes, provided that:
    (i) The label clearly shows that the product is intended for use 
only in manufacturing processes and specifies the type(s) of products 
involved.
    (ii) Adequate information such as technical data sheets or 
bulletins, is available to the trade specifying the type of product 
involved and its proper use in manufacturing processes.
    (iii) The product will not come into the hands of the general 
public except after incorporation into finished products.
    (iv) The Administrator determines that such directions are not 
necessary to prevent unreasonable adverse effects on man or the 
environment.
    (2) Detailed directions for use may be omitted from the labeling of 
pesticide products for which sale is limited to physicians, 
veterinarians, or druggists, provided that:
    (i) The label clearly states that the product is for use only by 
physicians or veterinarians.
    (ii) The Administrator determines that such directions are not 
necessary to prevent unreasonable adverse effects on man or the 
environment.
    (iii) The product is also a drug and regulated under the provisions 
of the Federal Food, Drug and Cosmetic Act.
    (3) Detailed directions for use may be omitted from the labeling of 
pesticide products which are intended for use only by formulators in 
preparing pesticides for sale to the public, provided that:
    (i) There is information readily available to the formulators on 
the composition, toxicity, methods of use, applicable restrictions or 
limitations, and effectiveness of the product for pesticide purposes.
    (ii) The label clearly states that the product is intended for use 
only in manufacturing, formulating, mixing, or repacking for use as a 
pesticide and specifies the type(s) of pesticide products involved.
    (iii) The product as finally manufactured, formulated, mixed, or 
repackaged is registered.
    (iv) The Administrator determines that such directions are not 
necessary to prevent unreasonable adverse effects on man or the 
environment.


156.121   Contents of directions of general use.

    The directions for use shall include the following, under the 
headings ``Directions for Use'':
    (a) The statement of use classification as prescribed in paragraph 
(j) of this section immediately under the heading ``Directions for 
Use.''
    (b) Immediately below the statement of use classification, the 
statement ``It is a violation of Federal law to use this product in a 
manner inconsistent with its labeling.''
    (c) The site(s) of application, as for example the crops, animals, 
areas, or objects to be treated.
    (d) The target pest(s) associated with each site.
    (e) The dosage rate associated with each site and pest.
    (f) The method of application, including instructions for dilution, 
if required, and type(s) of application apparatus or equipment 
required.
    (g) The frequency and timing of applications necessary to obtain 
effective results without causing unreasonable adverse effects on the 
environment.
    (h) Worker protection statements meeting the requirements of 
subpart K of this part.
    (i) Specific directions concerning the storage and disposal of the 
pesticide and its container, meeting the requirements of 40 CFR part 
165. These instructions shall be grouped and appear under the heading 
``Storage and Disposal.'' This heading must be set in type of the same 
minimum sizes as required for the child hazard warning. (See Table in 
Sec. 162.10(h)(1)(iv))
    (j) Any limitations or restrictions on use required to prevent 
unreasonable adverse effects, such as:
    (1) Required intervals between application and harvest of food or 
feed crops.
    (2) Rotational crop restrictions.
    (3) Warnings as required against use on certain crops, animals, 
objects, or in or adjacent to certain areas.
    (4) [Reserved]
    (5) For restricted use pesticides, a statement that the pesticide 
may be applied under the direct supervision of a certified applicator 
who is not physically present at the site of application but 
nonetheless available to the person applying the pesticide, unless the 
Agency has determined that the pesticide may only be applied under the 
direct supervision of a certified applicator who is physically present.
    (6) Other pertinent information which the Administrator determines 
to be necessary for the protection of man and the environment.


Sec. 156.135   Statements of use classification.

    (a) Requirement. Each product bearing one or more uses that has 
been classified for restricted use must bear a classification statement 
on the label of the product, and also in any supplemental labeling that 
accompanies the product in sale or distribution. A product that bears 
only unclassified uses as described in Sec. 152.160 or uses classified 
for general use is not required to bear any classification statement. 
Restricted use statements are set out in Sec. 156.137.
    (b) Products bearing mixed classified uses. A product for which 
some uses are not classified, and other uses are classified for general 
use or for restricted use must have a separate registration for uses 
that are restricted, except that a product bearing restricted uses may 
also bear unclassified or general uses in addition to the restricted 
uses. A product bearing mixed restricted uses and other uses is 
considered a restricted use product.
    (c) Placement of classification statements. (1) Statements of 
restricted use classification must be located at the top of the front 
panel of the label (the ``Restricted Use'' area), and in a similarly 
prominent location in supplemental labeling. No other label statements 
shall appear above the restricted use statements, and no other 
statements than those prescribed by the

[[Page 33301]]

Agency shall appear in the restricted use area of the label.
    (2) The restricted use statements shall be distinguished from 
surrounding label text by suitable means, such as white space or a box 
around the statements. The words ``Restricted Use Pesticide'' shall 
appear in a type size at least that of the signal word prescribed by 
Sec. 156.10(h)(1)(iv).


Sec. 156.136   General use statements. [Reserved]


Sec. 156.137   Restricted use statements.

    (a) A product that is classified for restricted use must bear, on 
the front panel in accordance with Sec. 156.135(c), the statements in 
paragraphs (a)(1) and (a)(2) of this section.
    (1) The phrase, ``Restricted Use Pesticide.''
    (2) Immediately below the phrase ``Restricted Use Pesticide,'' a 
statement of the reason for the restricted use classification. This 
statement will describe the characteristic of the pesticide, its 
formulation, or its use pattern, that is the basis for the 
classification. These characteristics include acute or chronic 
toxicity, environmental fate (biodegradability, leaching potential, 
etc.), or non-target organism toxicity. The Agency will prescribe the 
nature and wording of the statement.
    (i) A product that is restricted to use by certified applicators 
(for example, pesticides and uses listed in Sec. 152.170) must bear the 
statement, ``For retail sale to and use only by Certified Applicators 
or persons under their direct supervision and only for those uses 
covered by the Certified Applicator's certification.''
    (ii) A product that is classified for restricted use subject to a 
ground-water State Management Plan (SMP) under subpart J of part 152 of 
this chapter must bear the statement, ``For use only in accordance with 
an EPA-approved State Management Plan for ground-water protection. Sale 
and use are prohibited in States that do not have an EPA-approved State 
Management Plan.''
    (b) The Agency may develop and require a label statement different 
from, or in addition to, those described in paragraphs (b)(1) and 
(b)(2) of this section, for any product classified for ``restricted 
use.''

[FR Doc. 96-16173 Filed 6-25-96; 8:45 am]
BILLING CODE 6560-50-F