[Federal Register Volume 65, Number 51 (Wednesday, March 15, 2000)]
[Notices]
[Pages 14200-14205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6398]



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Part IX





Environmental Protection Agency





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Pesticide Tolerance Reassessment and Reregistration; Proposed Public 
Participation Process; Notice

  Federal Register / Vol. 65, No. 51 / Wednesday, March 15, 2000 / 
Notices  

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00645; FRL-6496-2]


Pesticide Tolerance Reassessment and Reregistration; Proposed 
Public Participation Process

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notices announces EPA's proposal for a public 
participation process for pesticide tolerance reassessment and 
reregistration. This proposal is in response to a joint initiative 
between EPA and the Department of Agriculture (USDA) to increase 
transparency and stakeholder involvement in the development of 
pesticide risk assessments and risk management documents and decisions. 
EPA and USDA have been actively employing a pilot public participation 
process for tolerance reassessment and reregistration of 
organophosphate pesticides for over 1 year (since August 1998), which 
was developed in consultation with the Tolerance Reassessment Advisory 
Committee (TRAC). Consideration must now be given as to whether this 
public participation process or some modification of it should be 
adopted as the final process, and whether it should be used for 
tolerance reassessment and reregistration of all pesticides.

DATES: Comments, identified by docket control number OPP-00645, must be 
received by EPA on or before April 14, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit III. of the ``SUPPLEMENTARY INFORMATION.'' To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-00645 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: Karen Angulo, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvannia 
Ave., NW., Washington, DC 20460; telephone number: (703) 308-8004; e-
mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    This action is directed to the public in general; however, a wide 
range of stakeholders will be interested in submitting comments on the 
public participation process that EPA is proposing for tolerance 
reassessment and reregistration, including environmental, human health, 
and agricultural advocates; the chemical industry; pesticide users; and 
members of the public interested in the use of pesticides on food. As 
such, the Agency has not attempted to specifically describe all the 
entities potentially 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.''

II. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

    A. Electronically. You may obtain electronic copies of this 
document and other related documents from the EPA Internet Home Page at 
http://www.epa.gov/. To access this document, on the Home Page select 
``Laws and Regulations'' and then look up the entry for this document 
under the ``Federal Register--Environmental Documents.'' You can also 
go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    To access information about the pilot public participation process 
that is now being used for the organophosphate pesticides, you can also 
go directly to the Office of Pesticide Programs' (OPP) organophosphate 
pesticide web page at http://www.epa.gov/pesticides/op/.
    B. In Person. The Agency has established an official record for 
this action under docket control number OPP-00645. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as CBI. This official record includes the documents that are physically 
located in the docket, as well as the documents that are referenced in 
those documents. The public version of the official record does not 
include any information claimed as CBI. The public version of the 
official record, which includes printed, paper versions of any 
electronic comments submitted during an applicable comment period, is 
available for inspection in Rm. 119, Crystal Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The PIRIB telephone number is (703) 
305-5805.

III. How Can I Respond to this Action?

A. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00645 in the subject line on the 
first page of your response.
    1. By mail. Submit comments to: Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Ariel 
Rios Bldg., 1200 Pennsylvannia Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver comments to: Public Information 
and Records Integrity Branch, Information Resources and Services 
Division, Office of Pesticide Programs, Environmental Protection 
Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, 
VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
    3. Electronically. Submit electronic comments by e-mail to: ``[email protected],'' or you can submit a computer disk as described in 
this unit. Do not submit any information electronically that you 
consider to be CBI. 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 standard 
computer disks in WordPerfect 6.1/8.0 or ASCII file format. All 
comments in electronic form must be identified by the docket control 
number OPP-00645. Electronic comments may also be filed online at many 
Federal Depository Libraries.

B. How Should I Handle CBI Information that I Want to Submit to the 
Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential

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will be included in the public version of the official record without 
prior notice. If you have any questions about CBI or the procedures for 
claiming CBI, please consult the person listed under ``FOR FURTHER 
INFORMATION CONTACT.''

C. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1.Explain your views as clearly as possible.
    2.Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve this notice.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

IV. What Action is EPA Taking in this Notice?

    EPA is making available for public comment a proposal for a public 
participation process for pesticide tolerance reassessment and 
reregistration. This proposed public participation process was 
developed with USDA.
    Public comment received as a result of this notice will be 
considered by EPA and USDA and a final public participation process 
will be developed and released to the public in a notice published in 
the Federal Register. Implementation of the final public participation 
process will begin according to a schedule established and published in 
the final notice.
    This notice discusses 3 public participation processes: Pilot, 
modified, and final. The pilot public participation process refers to 
the process that EPA and USDA are now using for organophosphate 
pesticide tolerance reassessment and reregistration. The modified 
public participation process refers to the process that EPA and USDA 
proposed to the Tolerance Reassessment Advisory Committee (TRAC) during 
their October 20-21, 1999, meeting. The final public participation 
process refers to the process that is being proposed in this notice. In 
addition, for the purposes of this notice the words ``public'' and 
``stakeholders'' are used interchangeably.

V. Background

A. Food Quality Protection Act--Process Improvements for Tolerance 
Reassessment and Reregistration

    The Food Quality Protection Act (FQPA) of 1996 amended the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal 
Food, Drug, and Cosmetic Act (FFDCA). These amendments fundamentally 
changed the way EPA regulates pesticides. The many new FQPA 
requirements included a new safety standard (i.e., reasonable certainty 
of no harm) that must be applied to all pesticides used on foods. EPA 
recognized that FQPA implementation would require changes to the 
Agency's existing risk assessment processes and its approach to 
communication with the public (stakeholders). The process improvements 
would be responsive to Vice President Gore's directive to increase 
transparency and opportunities for stakeholder consultation.

B. Inception of TRAC

    TRAC was established in April 1998, as a subcommittee under the 
auspices of EPA's National Advisory Council for Environmental Policy 
and Technology (NACEPT). TRAC provided a forum for a diverse group of 
individuals representing a broad range of interests and backgrounds 
from across the country to consult with and make recommendations to the 
Administrator of EPA and the Secretary of USDA on an approach for 
pesticide tolerance reassessment and reregistration, including those 
for organophosphate pesticides, as required by FQPA. The Committee held 
seven public meetings: May 28-29; June 22-23; July 13-14; July 28-29; 
September 15-16, 1998; and April 27-28 and October 20-21, 1999. TRAC 
membership included approximately 45 members approved by the Deputy 
Administrator of EPA and the Deputy Secretary of USDA. Members were 
selected based on their relevant experience and diversity of 
perspectives on organophosphate pesticide and food safety issues, 
including those from the following sectors: Environmental and public 
interest groups; pesticide industry and trade associations; user, 
grower and commodity organizations; pediatric and public health 
organizations; Federal agencies; Tribal, State, and local governments; 
academia; and consumer groups. The Deputy Administrator of EPA and the 
Deputy Secretary of USDA served as TRAC Co-Chairs.

C. Development of the Pilot Public Participation Process

    In the summer of 1998, EPA, USDA, and TRAC set out to design a 
process that would increase transparency of regulatory processes and 
consultation with affected stakeholders; expand public access to risk 
assessment and risk management processes; and find more effective ways 
for the public to participate at critical times in the Agency's 
development of organophosphate pesticide risk assessments and risk 
management decisions. At the July 14, 1998, meeting of the TRAC, EPA, 
and USDA announced that one of the public participation process options 
considered by TRAC would be implemented as a pilot. By piloting a 
public participation process, EPA, USDA, and TRAC could test whether 
the process achieved the goals of increasing transparency and 
stakeholder consultation. A pilot effort would provide an opportunity 
to identify issues associated with public release of risk assessments 
and management documents, and to evaluate how best to obtain public 
input into the risk assessment and risk management development 
processes.

D. Need for a Final Public Participation Process

    EPA and USDA have been actively employing the pilot public 
participation process for tolerance reassessment and reregistration of 
organophosphate pesticides for over 1 year (since August 1998). 
Consideration must now be given as to whether this process or some 
modification of it should be adopted as the final process, and whether 
it should be used beyond the tolerance reassessment and reregistration 
for organophosphate pesticides and be applied to all pesticides.
    In addition, EPA and USDA will soon begin to consider the 
stakeholder involvement that will be needed for the cumulative 
assessment stage. FQPA requires the assessment of cumulative effects of 
pesticides that share a common mechanism of toxicity. Once the 
individual pesticide risk assessments are complete and the Agency has a 
cumulative assessment methodology, EPA and USDA will encourage the 
public to participate in the cumulative assessment process.

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VI. The Pilot Public Participation Process

A. Description of the Pilot Public Participation Process

    The following provides a brief overview of the pilot public 
participation process:
    Phase 1--Registrant ``Error Only'' Review (30 days). EPA sends its 
preliminary human health and ecological risk assessments to 
registrant(s) of the pesticide for a 30-day error correction review, 
and to USDA. They are asked to identify any computational or other 
errors that EPA has made in developing its preliminary assessment of 
the pesticide's risks.
    Phase 2--EPA Considers Registrants' Error Comments (up to 30 days). 
EPA summarizes and considers comments from registrants and USDA. EPA 
incorporates comments or makes changes in the preliminary risk 
assessments to correct any errors identified. By the end of this phase, 
EPA opens a public docket for the pesticide.
    Phase 3--Public Comment on Preliminary Risk Assessments (60 days). 
EPA publishes a Federal Register (FR) Notice of Availability announcing 
its preliminary risk assessments, and opening a 60-day public review 
and comment period. Registrants, grower groups, other stakeholders, and 
the public are encouraged to submit data and other information to 
refine EPA's preliminary risk assessments. They also may begin 
submitting risk management proposals to address any risk concerns 
identified in the document. EPA may meet with registrants and other 
stakeholders to discuss risk related data, use information, and risk 
assessment/risk management alternatives.
    Phase 4--EPA Revises Risk Assessments (up to 90 days). EPA 
summarizes and considers comments, data, and risk mitigation proposals 
received during the Phase 3 public comment period. EPA develops the 
revised risk assessments and sends them to USDA for review. EPA and 
USDA may host public meetings to share the revised risk assessments 
with interested stakeholders and discuss risk management ideas.
    Phase 5--EPA Solicits Risk Management Ideas (60 days). EPA releases 
the revised risk assessments to the public for viewing in the public 
docket. EPA publishes an FR Notice of Availability opening a 60-day 
public consultation period during which risk management proposals are 
solicited. Registrants, grower groups, other stakeholders, and the 
public are encouraged to participate and submit their risk management 
proposals. EPA and USDA may meet with registrants and other 
stakeholders to discuss risk management alternatives and strategies. 
Meeting minutes will be included in the public docket.
    Phase 6--EPA Develops Risk Management Strategies (up to 60 days). 
EPA considers all risk management proposals received. With input from 
USDA, EPA develops risk management strategies that ultimately will 
contribute to the Agency's risk management decisions for this and other 
organophosphate pesticides.

B. Success of the Pilot Public Participation Process

    To date, the pilot public participation process has provided EPA 
and USDA with a great deal of information for use in refining the risk 
assessments and in developing risk management options. Stakeholder 
participation has risen substantially. In the fall of 1999, EPA and 
USDA took a qualitative look at the strengths and challenges of the 
pilot public participation process. The following provides a 
qualitative look at the comments EPA received from registrants and 
other stakeholders during the phases of the pilot public participation 
process, and how these comments affected the risk assessments and 
process schedules.
    Registrants were given an opportunity in Phase 1 to identify 
computational errors as well as grammatical and spelling errors in the 
preliminary risk assessments. In this way, if the Agency agreed with 
the registrant's error identification, EPA could correct the errors in 
Phase 2 prior to the release of the preliminary risk assessments to the 
public docket (Phase 3). EPA would inform the public of the 
registrant's error comments and the corrective actions taken by the 
Agency. However, the large majority of comments received from 
registrants during their error-identification period were considered to 
be non-error comments. In the cases where errors were identified, only 
a few resulted in a substantial change to the preliminary risk 
assessments and a delay in the release of the assessments to the 
public. The majority of non-error comments received were general 
comments about the preliminary risk assessments and promises to submit 
new studies. New studies were submitted in a few instances.
    Comments received during the public comment period on the 
preliminary risk assessments (Phase 3) substantially affected 
approximately one-third of the organophosphate preliminary risk 
assessments, typically because of the submission of information on the 
pesticide's use and usage, studies, or other technical information. In 
several cases, registrants submitted new studies and studies to confirm 
or upgrade existing, submitted studies.
    The Agency and USDA used Phase 4 to revise the preliminary risk 
assessments based on public comment. EPA released the revised risk 
assessments and related documents to the public in Phase 5 and 
initiated a public participation period for risk management. Risk 
management comments and ideas were usually received by EPA during 
meetings and conference calls rather than through written submissions. 
Minutes of meetings and conference calls were recorded and placed in 
the public docket.

C. A Proposal for a Final Public Participation Process was Made at the 
October 20-21, 1999, TRAC Meeting

    EPA and USDA proposed a modified public participation process to 
TRAC during their October 20-21, 1999, meeting. EPA and USDA approached 
TRAC with a proposal because the pilot public participation process had 
been tested for over 1 year and it was time to consider a final public 
participation process. The proposed modified public participation 
process was based on USDA's and EPA's experiences using the pilot 
public participation process. The proposed modified public 
participation process included several stakeholder participation 
enhancements. A special emphasis was placed on the public involvement 
activities that take place prior to Phase 1--before the start of the 
public participation process--to ensure that the most complete and 
accurate set of information was being used in the risk assessments. In 
addition, stakeholders would be much more informed of the schedule of 
pesticides that EPA and USDA would be working on in the next year, and 
would know when EPA and USDA needed information. Conference calls and 
public meetings (technical briefings that describe the revised risk 
assessments in general, and stakeholder meetings where the description 
of the risk assessments is focused on a particular pesticide user 
group's area of concern) would be used to initiate the public comment 
period on the risk assessments, engage the public in a discussion of 
the risk assessments, and begin the discussion of risk management.
    The proposed modified public participation process would have 
eliminated a public comment period on the preliminary risk assessments. 
This modification was a result of the recognition that the risk 
assessments

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now under development contain many more refinements than previous 
preliminary risk assessments. In the past, the preliminary risk 
assessments that were released to the public did not usually have 
refinements, such as probabilistic dietary risk assessment tools or the 
data needed for the use of these tools. The Agency saw the benefit of 
releasing these unrefined, preliminary risk assessments to the public 
as a means of encouraging the submission of data that could be used for 
refinement purposes. The risk assessments being developed now typically 
contain these refinements, therefore, the Agency proposed that 2 
comment periods on the refined risk assessments were not necessary. 
Even though the proposed modified public participation process would 
have eliminated a public comment period on the preliminary risk 
assessments, EPA and USDA would continue to encourage and organize 
stakeholder communications throughout the modified public participation 
process through a series of meetings and conference calls.
    In addition, EPA and USDA asked TRAC members if the modified public 
participation process should be applied to pesticides other than the 
organophosphates, which currently are the only class of pesticides in 
the pilot public participation process.

D. Summary of TRAC's Feedback

    During the October 20-21, 1999, TRAC meeting, TRAC members verbally 
responded to the proposed modified public participation process that 
EPA and USDA presented. Many TRAC members voiced strong support for 
increased and enhanced EPA and USDA activities in the months prior to 
formal start of the public participation process (i.e., Pre-Phase 1), 
including stakeholder meetings and conference calls, the release to the 
public at the beginning of the process of a general pesticide use and 
usage description and the schedule of pesticides entering the process, 
and discussions with pesticide registrants and stakeholders about the 
submission of data and the data submission schedule.
    Several TRAC members voiced concern over their perceived reduction 
in public participation opportunities resulting from the elimination of 
one risk assessment comment period, and also objected to the proposed 
plan for having public comment on the risk assessments and risk 
management options occur during the same phase. Certain TRAC members 
voiced concern that the risk management options issued for public 
comment would be perceived as the Agency's final risk management 
decision, giving stakeholders no real opportunity to weigh-in before 
the final decisions were made. Concern was also raised about issuing 
risk management decisions on any uses of a pesticide before the 
conclusion of the public participation process; however, the Agency has 
always reserved this authority if certain uses of a pesticide warranted 
action because of the risk levels identified in the risk assessments.
    TRAC members expressed support for EPA issuing only highly refined 
risk assessments for public comment, and for longer public comment 
periods. Support was also expressed for technical briefings and 
stakeholder meetings at the time the risk assessments are released for 
public comment, and for an enhanced public role for USDA at that time, 
including the organization of stakeholder conference calls and 
meetings. In addition, TRAC members supported the application of the 
final public participation process to all other pesticides scheduled 
for tolerance reassessment and reregistration.

VII. Proposal for the Final Tolerance Reassessment and 
Reregistration Process

A. EPA and USDA's Consideration of a New Public Participation Process

    EPA and USDA have considered the comments received from TRAC during 
their October 20-21, 1999, meeting, and are releasing in this notice a 
proposal for a final public participation process. EPA and USDA 
reconsidered the process approach presented to TRAC, and have developed 
a new public participation process proposal. The new proposed public 
participation process melds together the pilot public participation 
process and the modified public participation process that was proposed 
to TRAC. The new proposed public participation process retains the 6 
phases and much of the structure of the pilot public participation 
process currently used for the organophosphate pesticides, and it 
incorporates the considerable enhancements to public participation 
found in the modified public participation process that was presented 
to TRAC. These enhancements include increasing the communication with 
stakeholders prior to the initiation of the public participation 
process, the addition of conference calls with stakeholders throughout 
the process, the lengthening of a public participation phase, and the 
release of risk management proposals to the public at the beginning of 
Phase 5. In addition, the proposed public participation process 
emphasizes increased communication among those Federal government 
agencies concerned with pesticides.
    EPA is also proposing that this public participation process be 
applied to all pesticides scheduled for tolerance reassessment and 
reregistration. Interim planning for bringing non-organophosphate 
pesticides under a formal public participation process is discussed at 
the end of this notice.
    The Agency anticipates that modifications to the public 
participation process will be appropriate for pesticides with limited 
use and usage, low risk concerns, small numbers of pesticide users, or 
other factors. EPA will inform the public of modifications to the 
public participation process that are warranted for a pesticide. For 
pesticides meeting these criteria, alterations to the public 
participation process will most typically include a tailoring of the 
stakeholder communication opportunities. For example, the public 
participation process could be modified for a pesticide with a small 
number of users by the substitution of a stakeholder meeting(s) for a 
technical briefing upon release of the risk assessments for public 
comment (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, a pesticide with limited use and usage, low risk 
concerns, and highly refined risk assessments may only need one public 
comment period on the risk assessments as long as ample public 
consultation opportunities are utilized. EPA will inform the public of 
pesticides that will have modified public participation processes.
    EPA will continue to issue risk management decisions on certain 
uses of a pesticide at any time before or during the public 
participation process if such action is warranted by high risk levels 
identified in the risk assessments. While EPA may exercise this 
authority at anytime during this process, the Agency will ensure that 
stakeholders and other Federal government agencies will be informed and 
involved in the decisionmaking process through meetings and conference 
calls.

B. Proposed Public Participation Process

    The proposed final public participation process contains many of 
the same elements of the Pilot Public

[[Page 14204]]

Participation Process and enhances public participation at important 
stages. It must be noted that the proposed final public participation 
process does not use the word ``preliminary'' to describe the risk 
assessments that are released to the public in the early phases of the 
public participation process. This is because the risk assessments now 
under development contain many more refinements than previous 
preliminary risk assessments.
    Pre-Phase 1--Public Engagement. A significant focus of the process 
is to engage stakeholders as early as possible to ensure that risk 
assessments reflect actual use and usage, available data, current 
labeling, and other information on use practices that stakeholders can 
provide. In the months prior to the formal initiation of the public 
participation process (which starts with release of the risk 
assessments to the registrants for error correction), USDA, EPA, and 
other Federal government agencies (e.g., the Department of Health and 
Human Services (HHS), and the Food and Drug Agency (FDA)) will work 
cooperatively to organize meetings with interested stakeholders to 
discuss pesticide use and usage, and to encourage them to share their 
information with the agencies.
    In addition, 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 announce 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, including the preparation of data and information 
for consideration by the agencies.
    Phase 1--Risk Assessment Registrant Error-Only Review, Chemical Use 
and Usage Description, and Federal Government Agency Engagement (30 
Days). Phase 1 of the proposed public participation process is the same 
as the pilot public participation process, in that the risk assessments 
are sent to the pesticide's registrant(s) for error correction, but an 
increased effort at disseminating information to the public has been 
added as well as enhanced Federal agency communication. EPA initiates 
the public participation process by transmitting its human health and 
ecological risk assessments to registrant(s) of the pesticide for a 30-
day error correction review. They 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 will be asked again 
about due dates for the submission of data and information to EPA, and 
for an indication of how the study or analysis 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 timeframe for the public participation process.
    In addition, EPA recognizes that the public would find useful for 
their planning purposes a description of the pesticide that has started 
the public participation process. The Agency will publish a FR Notice 
of Availability announcing the release of the pesticide's use and usage 
description to the public docket and internet website for 30-day public 
comment. The pesticide's use and usage description would characterize 
the use, usage, and types of data and information used in the risk 
assessments.
    At the same time that the risk assessments are sent to registrants, 
EPA transmits the risk assessments and related documents (including the 
pesticide's overview that summarizes the risk assessments, the 
Qualitative Usage Analysis, and the pesticide's use and usage 
description) to USDA and other appropriate Federal government agencies 
for review and comment.
    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 will also 
address risk assessment comments received from other Federal government 
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.
    Phase 3--Public Participation Period: Public Comment on Risk 
Assessments and Risk Characterization (60-90 Days). Phase 3 provides 
the public with an opportunity to comment on the pesticide's risk 
assessments. The phase begins when EPA publishes a FR Notice of 
Availability of the risk assessments and related documents (e.g., 
overview, summary, table summarizing risk assessment information, 
registrant's error comments, and EPA's response to comments, etc.) for 
a 60 to 90-day public review and comment period. The summary documents 
will clearly characterize the risks associated with each use of the 
pesticide and include a use impact discussion that identifies possible 
pesticide alternatives for significant uses, thereby allowing the 
public to discern the Agency's level of concern (if any) for each use 
at this stage in the development of the risk assessments. All of the 
documents will be made available in the public docket and EPA's 
internet website. 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.
    In addition, an effort will be initiated among Federal government 
agencies to engage stakeholders in a dialogue on the risk assessments 
and risk characterization, and will continue through Phase 5 of the 
public participation process.
    Phase 4--EPA Revises Risk Assessments and Develops Risk Management 
Proposal (up to 90 days). EPA considers stakeholders comments received 
during Phase 3's public comment period, and develops the revised risk 
assessments and a risk management proposal. An inter-Federal government 
agency senior management briefing will be held to discuss the revised 
risk assessments and risk management proposal.
    USDA may organize conference calls with stakeholders to review and 
discuss the revised risk assessments and risk management proposal. 
Minutes from all meetings and conference calls 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 initiated among Federal government agencies 
to engage stakeholders in a dialogue on the risk assessments and risk 
characterization, and this effort will continue through Phase 5 of the 
public participation process.
    A technical briefing and/or stakeholder meeting(s) (as appropriate 
for pesticides with limited use and usage, low risk concerns, small 
numbers of stakeholders, or other factors) will be held at the end of 
Phase 4 in order to share with the public the revised risk assessments 
and the range of possible risk management options.
    Phase 5--EPA Solicits Comments on Risk Management Proposal (60 
days). EPA publishes a FR Notice of Availability announcing the release 
to the public of the revised risk assessments and the Agency's response 
to public comments. This FR notice will also release EPA's risk 
management proposal, a use impact discussion that identifies possible 
pesticide alternatives for significant uses, and a transition

[[Page 14205]]

strategy, and open a 60-day comment period during which the public is 
encouraged to comment on the risk management proposal.
    The effort among Federal government agencies to engage stakeholders 
in a dialogue on the risk management proposal will continue throughout 
Phase 5.
    Phase 6--Develop Final Risk Management (up to 60 Days). In Phase 6, 
EPA summaries, 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. With input from USDA and other Federal 
government agencies, EPA develops the risk management documents. EPA 
releases to the public the risk assessments, the response to public 
comments, and the risk management decisions for the pesticide.

VIII. Interim Public Participation Process

    EPA and USDA are now considering how to accomplish the movement 
from the public participation process that was tested as a pilot (i.e., 
the pilot public participation process now used exclusively for 
organophosphate pesticides) to the public participation process that 
will be adopted for future pesticide tolerance reassessment and 
reregistration. The majority of organophosphate pesticides have made 
significant progress through the pilot public participation's phases, 
and many are nearing completion, therefore, the pilot public 
participation process will continue to be applied to those 
organophosphates. The public participation process that will be 
finalized after the notice and comment period described in this FR 
notice will be fully applied to pesticide tolerance reassessment and 
reregistration by 2001. An interim policy must be developed for the 
non-organophosphate pesticides scheduled for tolerance reassessment and 
reregistration development work in 2000.
    The interim policy must take into account that the risk assessments 
are substantially complete for many of the non-organophosphate 
pesticides scheduled for 2000. An example of the public participation 
process that EPA is considering as an interim policy for pesticides 
that already have significant risk assessment work underway would 
involve: A registrant error correction period; a period for the Agency 
to respond to the registrant's error comments; the release of the 
refined risk assessments and risk characterizations to the public via 
the docket and internet without a formal public comment period; a 
significant effort on stakeholder consultations, such as meetings and 
conference calls; and the issuance of the risk management document to 
the public after the consideration of issues and discussions with 
stakeholders.
    EPA and USDA are in the process of identifying the development 
status of each pesticide scheduled for tolerance reassessment and 
reregistration. EPA will inform stakeholders of the interim plan for 
each pesticide once a final public participation process is selected.

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.

    Dated: March 9, 2000.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 00-6398 Filed 3-14-00; 8:45 am]
BILLING CODE 6560-50-F