[Federal Register Volume 69, Number 94 (Friday, May 14, 2004)]
[Notices]
[Pages 26819-26823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10985]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0411; FRL-7357-9]


Pesticide Tolerance Reassessment and Reregistration; Public 
Participation Process

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's public participation process for 
its pesticide tolerance reassessment and reregistration programs. EPA 
and the U.S. Department of Agriculture (USDA) jointly developed the 
public participation process to increase transparency and stakeholder 
involvement in the development of pesticide risk assessments and risk 
management decisions. Since August 1998, EPA and USDA have been 
actively employing a pilot public participation process for the 
tolerance reassessment and reregistration of organophosphate 
pesticides, which was developed in consultation with the Tolerance 
Reassessment Advisory Committee (TRAC). EPA and USDA recognized that 
consideration needed to be given as to whether the pilot public 
participation process or some modification of it should be adopted as 
the public participation process that would be used for tolerance 
reassessment and reregistration of all pesticides. A public 
participation process was proposed in the Federal Register on March 15, 
2000, for public comment.

FOR FURTHER INFORMATION CONTACT: Carol P. Stangel, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8007; fax 
number: (703) 308-8005; e-mail address:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of 
particular interest to stakeholders including environmental, human 
health, public health, and agricultural advocates; the chemical 
industry; pesticide users; and members of the public interested in the 
use of pesticides on food. Other Federal, state, and Tribal government 
agencies also may be interested. Since other entities also may be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0411. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to view public comments, 
access the index listing of the contents of the official public docket, 
and to access those documents in the public docket that are available 
electronically. Although not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B.1. 
Once in the system, select ``search,'' then key in the appropriate 
docket ID number.

II. What Action is EPA Taking?

A. Background

    EPA is making available to the public the full and modified 
versions of the public participation process that will be used for 
pesticide tolerance reassessment and reregistration. This public 
participation process was developed in partnership with USDA. EPA has 
considered the comments received from the public on the proposed public 
participation process that was published in the Federal Register on 
March 15, 2000 (65 FR 14199) (FRL-6496-2). EPA's response to public 
comments is available in the docket under docket ID number OPP-2003-
0411.
    This public participation process is based on EPA and USDA's 
experiences with the pilot public participation process used for the 
organophosphate pesticides, comments received from the Tolerance 
Reassessment Advisory Committee and the public during the public 
comment period, and our experience with the interim process

[[Page 26820]]

used in developing decisions for a number of non-organophosphate 
pesticides during the past few years. EPA remains strongly committed to 
public participation, and as a result of the experience gained from the 
pilot, has learned how to effectively tailor our public participation 
process to meet the needs of our stakeholders in the most efficient and 
timely manner possible. The public participation process encompasses 
full and modified versions that enable EPA to tailor the level of 
review to the level of risk, use, complexity, and public concern 
associated with each pesticide. Highlights of the public participation 
process include increased communication with stakeholders prior to 
initiating the process, meetings and conference calls with stakeholders 
and our regulatory partners throughout the process, public meetings as 
appropriate on the risk assessments and risk reduction proposals, and 
scheduled public comment periods on risk assessments and risk reduction 
proposals. In addition, the public participation process emphasizes 
increased communication among those Federal government agencies 
concerned with pesticides and pest management - EPA and primarily USDA, 
the Food and Drug Administration (FDA), the Centers for Disease Control 
and Prevention (CDC) of the Department of Health and Human Services, 
which has the lead in working with EPA to address public health 
pesticide issues, and the Department of the Interior, Department of 
Commerce, and Department of Defense, as appropriate.
    EPA is applying the full public participation process or one of the 
modified versions described below to all pesticides beginning tolerance 
reassessment and reregistration eligibility decision making. The 
decision to extend an updated version of the organophosphate pilot 
process to all pesticides still to be reviewed for reregistration and 
tolerance reassessment was supported by public comment. Implementation 
of the public participation process is proceeding according to 
schedules established annually and published in the Agency's Federal 
Register notices on Pesticide Reregistration Performance Measures and 
Goals, posted on EPA's Web site at http://www.epa.gov/pesticides/reregistration/status.htm. Schedules for upcoming reregistration 
eligibility and tolerance reassessment decisions also are posted on the 
Agency's Web site at http://www.epa.gov/pesticides/reregistration/candidates.htm.
    EPA seeks to achieve environmental justice, the fair treatment and 
meaningful involvement of all people, regardless of race, color, 
national origin, or income, in the development, implementation, and 
enforcement of environmental laws, regulations, and policies. In 
working to achieve this goal, the Agency recognizes the need to 
identify and address, as appropriate, disproportionately high pesticide 
exposure and potential adverse human health and environmental effects 
on minority or low-income populations. This public participation 
process provides an opportunity to obtain additional information that 
will enable the Agency to consider environmental justice in its 
pesticide reregistration and tolerance reassessment decision-making.
    EPA will continue to issue risk management decisions for certain 
uses of pesticides at any time before or during the public 
participation process if such action is warranted by high risk concerns 
identified in the risk assessments. While EPA may exercise this 
authority at any time during this process, the Agency will work to 
ensure that USDA and as appropriate other Federal agencies, EPA's state 
and Tribal regulatory partners, and stakeholders, including proponents 
of public health pesticide uses, will be involved in the process.
    1. Modifications to the public participation process. EPA is 
applying the principles of public participation to all pesticides 
undergoing tolerance reassessment and reregistration. In conducting 
these programs, the Agency reserves the right to tailor its public 
participation process to be commensurate with the level of risk, extent 
of use, overall complexity of the issues, and amount of public concern 
associated with each individual pesticide.
    EPA's experience during the past several years has been that the 
full, 6-phase public participation process is not necessary for many 
pesticides under review. In most cases, the Agency can use a 4-phase 
process, or shorter, to obtain public input as needed while making 
timely decisions and meeting our statutory deadlines and program goals. 
Today, many initial pesticide risk assessments are highly refined, or 
pesticide risk screening studies are available in the public literature 
to adequately characterize risks. The Agency often can reach 
conclusions about risk and the need for risk mitigation early in the 
process. In such cases, EPA accelerates the process to avoid 
unnecessary delays in completing decisions. Tailoring the public 
participation process in this manner is good public policy -- it 
enables EPA and others to target resources most effectively, and avoids 
process for its own sake, while still providing transparency and 
opportunities for consultation and public participation. Such a 
flexible, tailored process is essential to meeting the Agency's 
tolerance reassessment and reregistration deadlines and goals.
    During the past several years, alterations to the public 
participation process have typically included a tailoring of the 
stakeholder communication opportunities. For example, the public 
participation process has often been modified for pesticides with a 
small number of users by substituting a stakeholder meeting(s) for a 
technical briefing upon release of the risk assessments for public 
comment in Phase 3. (Stakeholder meetings are opportunities for 
stakeholder groups to meet with EPA, USDA, and other appropriate 
Federal government agencies to discuss specific uses of the pesticide 
that are of significant concern to them, whereas technical briefings 
provide a general overview of the pesticide's risk assessments.) In 
another example, pesticides with highly refined risk assessments, 
limited use, low risk concerns, few complex issues, and/or low public 
interest may need only one public comment period, at most, as long as 
appropriate consultation opportunities are utilized.
    EPA will inform the public of any modifications to the public 
participation process that will be used for a specific pesticide.
    a. 4-Phase process. A modified, 4-phase public participation 
process often is appropriate for pesticides with highly refined risk 
assessments and other factors. A pesticide with highly refined risk 
assessments that requires some risk mitigation - and that has limited 
use, a small number of users, few complex issues, few interested 
stakeholders, and/or other factors - may need only one public comment 
period, as long as ample opportunity for public consultation is 
afforded. The 4-phase process provides a framework for public input and 
consultation among government agencies and stakeholders during EPA's 
review of such pesticides.
    b. Low risk process. EPA has found that we can expeditiously reach 
decisions for certain pesticides, that pose few or no risk concerns and 
require little or no risk mitigation. These pesticides often show low 
levels of (non-target) toxicity and/or pass through screening models 
and show very low levels of risk. Agency toxicology reviews for these 
pesticides may be supplemented with studies available in the public 
literature. These pesticides may have low use, and they do not raise

[[Page 26821]]

complex issues or public concerns. Once EPA assesses uses and risks for 
such pesticides and finds that little or no risk mitigation is needed, 
the Agency may go straight to a decision and prepare a document 
summarizing its findings. This decision document and the risk 
assessments and other related documents will be issued simultaneously 
for public review and comment.
    c. Pesticides needing only tolerance reassessment decisions. EPA 
anticipates that a modified version of the public participation 
process, that is, a 4-phase or low risk single phase process as 
described above, generally will be appropriate for pesticides that 
require tolerance reassessment but do not also require reregistration 
eligibility decisions at this time.
    Many pesticides are subject to both tolerance reassessment and 
reregistration; however, some pesticides require only tolerance 
reassessment decisions at present. Tolerances were established for 
these pesticides before the Food Quality Protection Act (FQPA) was 
enacted on August 3, 1996; now the Agency must apply the new, stricter 
standards brought about by that law to the existing tolerances. While 
their tolerances must be reassessed to ensure compliance with current 
standards, these pesticides do not need to undergo reregistration 
because:
    a. EPA completed Reregistration Eligibility Decisions for the 
pesticides earlier, before FQPA was enacted.
    b. The pesticides were initially registered after November 1, 1984, 
and are not subject to reregistration.
    c. The pesticides are not registered for use in the United States 
but tolerances are established that allow crops treated with them to be 
imported from other countries.
    Tolerance reassessment decisions, involving only the assessment and 
management of a pesticide's aggregate risks through food, drinking 
water, residential, and any other non-occupational exposures, generally 
are narrower in scope and have fewer issues than decisions including 
both tolerance reassessment and reregistration eligibility. In cases 
where EPA's assessment indicates that low or no aggregate risks are 
posed and little or no risk mitigation is needed, a modified process 
provides transparency and opportunities for consultation and public 
input, while enabling EPA to complete a tolerance reassessment decision 
expeditiously. A modified process also facilitates the Agency's 
continuing completion of tolerance reassessment within statutory 
deadlines.
    2. Pesticide registration - process for tolerance reassessment 
through registration and revocation. Through the Agency's routine 
pesticide registration process, EPA also may complete tolerance 
reassessment decisions and provide opportunities for public 
participation through notice and comment rulemaking. No additional 
public participation is needed or envisioned for these decisions.
    a. Registration. EPA completes certain tolerance reassessment 
decisions during the pesticide registration process, in evaluating 
proposed new food uses for registered pesticides. To determine whether 
a proposed new food use meets the current safety standard, EPA first 
must reassess all the existing tolerances established for the 
pesticide. These tolerance reassessment decisions are made through the 
notice and comment rulemaking process used to establish the new food 
use tolerance.
    b. Revocation. EPA completes other tolerance reassessment decisions 
by revoking tolerances for pesticide uses that have been voluntarily 
canceled by their registrants. In handling these tolerance revocation 
requests, the Agency also uses a notice and comment rulemaking process 
to inform and involve the public.

B. The Public Participation Process

    The number of days indicated for each phase of the process 
represents EPA's goal for each phase; however, the circumstances of a 
particular evaluation may require the Agency to adjust the length of 
these phases.
    EPA will inform the public well in advance about pesticides that 
are scheduled for the public participation process. Registrants will be 
asked to identify any ongoing studies and analyses that are relevant to 
the risk assessments, and EPA will establish for each pesticide the due 
dates for the submission of data, information, and analyses. In this 
way, the public will be able to prepare for the initiation of the 
public participation process for pesticides that they may be interested 
in. Registrants and the public may prepare data and information for 
consideration by the Agency.
    1. The full public participation process. The full public 
participation process is described below.
    a. Pre-phase 1--Stakeholder and government Agency engagement, and 
develop updated pesticide use and usage information. A significant 
focus of the process is to engage stakeholders as early as possible to 
ensure the accuracy of key information on pesticide use and use 
practices that affect risk assessment. The information on current 
labeled uses, actual pesticide use and usage, and other information on 
pesticide use practices serves as important building blocks for the 
dietary, residential, worker, and ecological exposure and risk 
assessments. Pre-Phase 1 ideally begins approximately 1 year prior to 
the formal initiation of the public participation process (i.e., 
release of the risk assessments to the registrants for error 
correction). Initially, EPA shares information describing EPA's 
understanding of currently labeled pesticide uses and summary usage 
information with USDA and other appropriate Federal, state, and Tribal 
government agencies and with key stakeholders, including as appropriate 
the public health use community, and posts this information on the 
Internet for public viewing. EPA also reviews any already completed 
Agency assessments for the pesticide (for example, from pesticide 
program registration-related records and files) and identifies crops 
and other use sites for which updated use and usage information could 
be particularly valuable in developing the risk assessments for public 
review and comment. To help address potential environmental justice 
issues, EPA seeks information on any groups or segments of the 
population who, as a result of their location, cultural practices, or 
other factors, may have atypical, unusually high exposure to the 
pesticide, compared to the general population.
    To initiate Pre-Phase 1 for a pesticide, EPA, USDA, and other 
Federal government agencies may work cooperatively to organize a 
meeting or meetings with interested stakeholders who possess unique and 
specific information on a pesticide's use and usage, and encourage them 
to share their information with the agencies. One of the objectives of 
these meetings is to allow for the early refinement of key use-related 
inputs to the dietary, residential, worker, and ecological risk 
assessments. Ideally, this early input and sharing of key use-related 
information will result in more accurate and representative risk 
assessment documents earlier in the process. Within 60 days after the 
use/usage meeting(s), and following its verification and analysis, EPA 
provides an updated summary of its understanding of current use, usage, 
and use practices for crops and other use sites to be included in the 
pesticide's risk assessments. Stakeholders' submissions are compiled 
and made publically available (preferably on the Internet) to encourage 
further discussion. This updating may

[[Page 26822]]

continue throughout the process as additional use/usage information 
becomes available to the Agency.
    b. Phase 1--Risk assessment registrant error-only review (30 Days). 
EPA initiates the public participation process by transmitting its 
human health and ecological risk assessments to technical registrant(s) 
of the pesticide for a 30-day error correction review. The registrants 
are asked to identify and correct any computational or other errors 
that EPA has made in developing its assessment of the pesticide's 
risks. Registrants are asked again about due dates for the submission 
of data and information to EPA, and for an indication of how any 
additional studies or analyses may change the risk assessments. EPA 
will not delay its work in assessing the potential risks associated 
with the use of the pesticide when a study submission date is beyond 
the time frame for the public participation process.
    EPA, working with TRAC, determined that it was appropriate to 
provide registrants with this opportunity to review the initial risk 
assessments, prior to their public release, so that the registrants 
could provide comments on any errors in the documents, such as in data 
transcription or calculations, that might result in erroneous risk 
estimates. Comments on the analysis and interpretation of the data are 
not expected in this phase of the process, and any such comments 
received will be considered during Phase 3, along with comments 
received from other stakeholders.
    Soon after the risk assessments are sent to registrants, EPA 
transmits the risk assessments to USDA and other appropriate Federal 
government agencies to initiate their review and comment. If the 
pesticide has public health uses, then the risk assessments would be 
sent to CDC and other relevant agencies as appropriate at this time.
    c. Phase 2--Agency considers registrant error comments (Up to 30 
Days). In Phase 2, EPA summarizes and considers the errors that have 
been identified by the registrant(s) and makes changes in the risk 
assessments to correct any errors, as appropriate. EPA also considers 
risk assessment comments received from the initial review by USDA and 
other Federal government agencies, and transmits an overview that 
summarizes the pesticide's risk assessments to USDA and other 
appropriate Federal agencies. By the end of this phase, the risk 
assessments are prepared for public release. Discussions with other 
Federal government agencies on comments and issues will continue 
throughout the public participation process, as needed.
    d. Phase 3--Public Participation period: public comment on risk 
assessments and risk characterization (60 to 90 Days). Phase 3 provides 
the public and pesticide registrants with an opportunity to comment on 
the pesticide's risk assessments. The phase begins when EPA publishes 
in the Federal Register a Notice of Availability of the risk 
assessments and related documents (e.g., overview, summary, 
registrant's error comments, and EPA's response to comments, etc.) for 
a 60- to 90-day public review and comment period. The length of the 
public comment period will be set according to the complexity of the 
risk issues associated with the pesticide in order to give stakeholders 
adequate time for review and comment. The summary documents will 
clearly characterize the risks associated with each use of the 
pesticide, and identify areas that the risk assessment indicates may be 
of concern (e.g., dietary risks). To help address potential 
environmental justice issues, EPA requests information on any groups or 
segments of the population who may have atypical, unusually high 
exposure to the pesticide, compared to the general population. All of 
the documents will be made available in the public docket and in the 
EDOCKET on EPA's Internet website.
    In addition, an effort will be initiated among Federal government 
agencies to engage stakeholders in a dialogue on the risk assessments 
and risk characterization; this effort will continue through Phase 5 of 
the public participation process. EPA will keep its state and Tribal 
partners informed and will bring them into the dialogue as appropriate. 
During Phase 3, EPA (and USDA) also may begin to solicit input from 
stakeholders on the role and importance of the pesticide in pest 
management for particular crops and/or uses. For pesticides with public 
health uses, EPA will begin to solicit input on the role and importance 
of these uses from interested stakeholders and CDC. In some situations, 
EPA could begin to consult with CDC earlier.
    e. Phase 4--EPA Revises risk assessments and develops preliminary 
risk reduction options (up to 90 days). EPA considers comments and 
information received from stakeholders during Phase 3. The Agency then 
develops the revised risk assessments and preliminary risk reduction 
options.
    If as a result of comments received during Phase 3 EPA finds that 
issues can be resolved without a second comment period, the Agency may 
proceed directly to Phase 6 and develop a risk management decision, 
which the Agency will issue for public review and comment.
    When potential risk reduction measures include changes that 
significantly affect a pesticide's use, EPA may prepare and release an 
initial characterization of the benefits of the pesticide for 
particular uses, early in Phase 4. When agricultural uses (including 
turf, ornamental, and forestry uses) are affected, EPA will consult 
with USDA, and stakeholders as needed, regarding the potential benefits 
and risk reduction proposals. EPA will consult with CDC on the benefits 
of public health uses, with other agencies as appropriate, and with 
other parties who commented during Phase 3.
    A Federal interagency senior management briefing may be held to 
discuss the revised risk assessments and preliminary risk reduction 
options. EPA also will keep its state and Tribal regulatory partners 
informed, and may hold a regulatory partners conference call with 
interested states and Tribes to discuss the risk assessments and 
initial risk reduction options.
    USDA, when appropriate, will organize conference calls with 
stakeholders to review and discuss the revised risk assessments and 
preliminary risk reduction options. Minutes from all meetings and 
conference calls that EPA participates in will be included in the 
public docket. EPA and USDA will work to summarize and address the 
comments and ideas received during the stakeholder conference calls. In 
addition, an effort will be made among Federal government agencies to 
continue to engage stakeholders in a dialogue on the risk assessments 
and risk characterization, and to discuss pesticide benefits and 
transition. This effort may continue through Phase 6 of the public 
participation process.
    Where EPA deems appropriate, a comprehensive, general technical 
briefing and/or smaller, more specifically focused stakeholder 
meeting(s) (as appropriate for pesticides with limited use and usage, a 
small number of stakeholders, or other factors) may be held at the end 
of Phase 4 to share with the public the revised risk assessments and 
begin discussing the range of possible risk reduction options.
    f. Phase 5--Public participation period: public comment on risk 
reduction (60 days). EPA publishes a Federal Register Notice of 
Availability announcing the release to the public of the revised risk 
assessments and the Agency's response to public comments. This Federal 
Register notice will also announce the release of EPA's

[[Page 26823]]

preliminary risk reduction options, EPA's initial assessment of the 
impacts of risk reduction options, and/or EPA's preliminary assessment 
of benefits in cases where the Agency has identified risks of concern, 
and a discussion of any potential transition issues identified by USDA, 
CDC, and other agencies as appropriate. The Federal Register notice 
will open a 60-day (or longer, if needed) comment period during which 
the public is encouraged to comment on the preliminary risk reduction 
options, the initial impacts and/or preliminary benefits assessment(s) 
described above, and any transition issues. The public also is 
encouraged to suggest risk management proposals.
    The effort among Federal government agencies during Phase 5 to 
engage stakeholders in a dialogue on risk reduction and management, 
including EPA's regulatory partners as appropriate, may continue 
through Phase 6. For pesticides that pose risks of concern from a 
public health use, EPA will work closely with CDC and interested 
stakeholders to identify and propose mitigation measures to reduce 
those risks while maintaining the benefits of the pesticide's public 
health use to the greatest extent possible.
    g. Phase 6--Develop final risk management (up to 60 Days). In Phase 
6, EPA summarizes, reviews, and considers the comments, data, and risk 
management ideas and proposals received during the Phase 5 public 
comment period, and during stakeholder dialogue and the meetings that 
have occurred during Phases 3 - 5. EPA continues to elicit input from 
USDA and other Federal government agencies, as well as EPA's regulatory 
partners and stakeholders. EPA develops the risk management documents, 
and a revised impacts assessment and/or benefits assessment, if needed. 
EPA releases to the public the risk management decisions for the 
pesticide, including the revised impacts and/or benefits assessment. 
USDA may prepare a transition strategy, if needed. The transition 
strategy is likely to include time frames in which EPA expects to make 
decisions regarding registration of new pesticides/uses.
    2. The modified public participation process--a. The 4-Phase 
Process--Pre-Phase 1 - Stakeholder and government agency engagement, 
and develop updated pesticide use and usage information. Same as the 
full public participation process.
    Phase 1 - Risk assessment registrant error-only review (30 Days). 
Same as the full public participation process.
    Phase 2 - EPA considers registrant error comments on risk 
assessments, and develops preliminary risk reduction options (30 to 60 
Days). Phase 2 is the same as in the full public participation process. 
However, in addition to preparing the risk assessments for public 
release, EPA also develops preliminary risk reduction options, making a 
significant effort to consult with stakeholders and other Federal and 
state government agencies. Meetings, conference calls, and other 
discussions with stakeholders and other agencies on issues and risk 
reduction options will continue through Phases 3 and 4, as needed.
    Phase 3 - Public participation period: public comment on risk 
assessments and preliminary risk reduction options (60 to 90 Days). 
Phase 3 provides the public and pesticide registrants an opportunity to 
comment on EPA's pesticide risk assessments, risk characterization, and 
preliminary risk reduction options, and to suggest risk management 
ideas and proposals. This phase begins when EPA publishes a Federal 
Register Notice of Availability announcing the release of the risk 
assessments and preliminary risk reduction options for 60 to 90 days of 
public comment. EPA releases the risk assessments and related documents 
through the public docket and EDOCKET on the Agency's website. During 
the comment period, to help address potential environmental justice 
issues, EPA requests information on any groups or segments of the 
population who may have atypical, unusually high exposure to the 
pesticide, compared to the general population. EPA continues 
significant efforts to consult with other government agencies and 
stakeholders on the pesticide's uses and possible risk management 
options.
    Phase 4 - EPA Develops Final Risk Assessments And Risk Management 
(Up to 90 Days). EPA reviews and considers the comments and risk 
management ideas and proposals received during Phase 3, continues the 
ongoing dialogue with other government agencies and stakeholders as 
needed, and develops a risk management decision, which the Agency 
issues for public review and comment. If EPA finds that additional 
issues warranting further discussion were raised during Phase 3, the 
Agency may decide to lengthen the process and include a second comment 
period, as needed.
    b. The low risk process. If EPA's initial screening of a pesticide 
indicates that it has low use/usage, affects few if any stakeholders or 
members of the public, and/or poses low risk and requires little or no 
risk mitigation, the Agency may determine that neither the full 6-phase 
process nor the modified 4-phase process is needed. In such cases, the 
Agency would go straight to a regulatory determination and prepare a 
decision document for the pesticide, concluding the review process. 
This decision document, the risk assessments, and other related 
documents will be issued for public review and comment.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated:May 6, 2004.
James Jones,
Director, Office of Pesticide Programs.
[FR Doc. 04-10985 Filed 5-13-04; 8:45 am]
BILLING CODE 6560-50-S