Pesticide Tolerance Reassessment and Reregistration; Proposed
Public Participation Process
[Federal Register: March 15, 2000 (Volume 65, Number 51)]
[Notices]
[Page 14199-14205]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr00-156]
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Part IX
Environmental Protection Agency
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Pesticide Tolerance Reassessment and Reregistration; Proposed Public
Participation Process; Notice
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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: angulo.karen@epa.gov.
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: ``opp-
docket@epa.gov,'' 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
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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
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