USDA-EPA TOLERANCE REASSESSMENT ADVISORY
COMMITTEE -- Final Summary
 |
Note: This information is provided for reference purposes only.
Although the information provided here was accurate and current
when first created, it is now outdated. |
August 2000
I. Background and Overview of the TRAC Process
The Food Quality Protection Action (FQPA) of 1996 amended the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) to improve the registration of pesticides.
FQPA mandates a single health-based standard for pesticides in all food;
provides special protection for infants and children; expedites approval
of safer pesticides; provides minor crop protection; and requires periodic
reevaluation of pesticide registrations and tolerances.
In April 1998, the Vice President directed EPA and USDA to work together
to ensure that implementation of FQPA followed four guiding principles:
apply sound science; provide reasonable transition for agriculture; develop
transparent regulatory process; and consult with diverse stakeholders.
The Tolerance Reassessment Advisory Committee (TRAC) was established under
the Federal Advisory Committee Act to carry out the Vice President's directive.
Co-Chaired by EPA's Deputy Administrator and USDA's Deputy Secretary,
a large group (52 members) was formed consisting of senior-level representatives
of a wide variety of stakeholders: environmental/public interest groups,
farm worker representatives, pesticide industry and trade associations,
farmer and grower organizations, food processors and distributors, State
and Federal agencies, pediatricians and public health groups. Moreover,
international observers from Canada and Mexico serve on the Committee,
and a high number of congressional staff are included as meeting participants.
The EPA Administrator considers this Committee to be an essential part
of EPA's implementation of FQPA.
Between May and September 1998, the group met five times. An additional
ten work group meetings were held during this time period. While originally
envisioned that the Committee would complete its mission by September
1998, EPA's Deputy Administrator and USDA's Deputy Secretary agreed to
continue the Committee for two more full meetings. Moreover, two "update"
meetings - one for East Coast and the other for West Coast TRAC members
- were held in February and March of 1999 to provide members with a current
understanding of the many science policy and OP risk assessment issues.
A sixth TRAC meeting was held in April 1999, at which several concerns
were raised by both TRAC members and public attendees about the desire
to continue the stakeholder process as the Agency begins to make important
risk management decisions affecting the OP pesticides. Also, with several
key science policy issues, e.g., the cumulative risk policy, the FQPA
child safety factor (or "10-X" policy), etc., being drafted
and ready for public consultation, many of the TRAC members were interested
in additional stakeholder meetings to have an effective forum to raise
concerns to both EPA and USDA as these important decisions are unfolding.
A seventh and final TRAC meeting took place on October 20 - 21, 1999,
in Arlington, Virginia.
In April 1999, the environmental/public interest group and farm worker
members resigned from the Committee based on their concerns about the
pace of Agency decision-making regarding tolerance reassessment and their
view that children and other sensitive populations are not being adequately
protected. Extensive media coverage included the Washington Post, New
York Times, several trade press and many other newspapers around the country
through the Associated Press. While this group resigned from the formal
Committee, they committed to continue working with the Agency in addressing
regulatory actions with the OPs. Despite continued efforts to regain the
participation of the environmental/public interest groups and farm worker
representatives, the groups decided not to rejoin the TRAC for the remaining
two meetings.
Following is an overview of the TRAC meetings and the supporting work
group efforts. TRAC meetings were open to the public and members of the
public were provided opportunities to comment at each meeting.
II. May 28 - 29, 1998 TRAC Meeting
The agenda for the May 28 - 29, 1998 meeting was as follows:
- Review of Federal Advisory Committee Act Procedures and Ground Rules
for the Meeting
- Group Discussion of Key Issues for TRAC Agendas
- FQPA Framework - Evolution of FQPA Implementation
- FQPA Safety Factor (10-X)
- Dietary Exposure Assessment
- Work Group Concept
- Transparency
- Next Steps
Highlights from the meeting are as follows:
A. The agenda for the meeting was designed to address the key
issues outlined in the Vice President's memorandum of April 8, 1998
including sound science, transparency, reasonable transition for agriculture,
and consultation with stakeholders.
B. EPA and USDA proposed an outline for the TRAC process which initially
involved a series of four meetings, the second of which would address
EPA progress and elements of evaluation on OPs, the third would focus
on details of the approaches for OP reassessment, and the fourth would
address transition approaches for agriculture.
C. The group heard about the FQPA framework and the
evolution of FQPA implementation. They learned that the core of FQPA
is evaluating risk in aggregate fashion, cumulative risk amongst chemicals
that act in a common way, and providing protection where special sensitivities
exist, particularly for infants and children. They also learned about
a series of consultation opportunities provided by the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP),
International Life Sciences Institute (ILSI), and other groups. Each
of the core aspects of FQPA was compared with current policy using an
interim decision logic. EPA agreed to provide the group with additional
information on the SAP and ILSI. EPA assured the TRAC that there would
be additional discussion on the transparency between the TRAC, other
scientific committees, and the development of policy. They agreed to
provide the group with copies of the decision-making logic that was
developed following the passage of FQPA.
D. TRAC members heard a presentation on the 10-X Safety factor. They
were asked to consider questions on the definition of "completeness"
affected by emerging science and new data requirements, the potential
need for additional testing, and potential regulatory action if the
estimated risks exceed this newly revised "risk cup." Some
of their concerns included: the ability to integrate risk mitigation
in the decision-making process; how and when the safety factor will
be applied; and the use of data call-ins.
E. The group received an overview of dietary exposure and Monte-Carlo
techniques for undetected residues. They were asked to comment on the
percentile to regulate to with the Monte-Carlo analysis, the possibility
of regulating to different percentiles for different toxicological effects,
whether Monte-Carlo runs should routinely be done for different types
of crops. Members expressed concern that the Monte-Carlo method has
not been used long enough to have confidence in its use to evaluate
risk to children. It was recognized that the method would yield better
results if based on a better database. There was concern that the Monte-Carlo
technique was so complex it was perceived as a "black box"
approach so it would be hard for many to judge the adequacy of the method.
The potential for unnecessary loss of products was noted as a concern
as well as the potential for FQPA implementation to disrupt the food
supply.
F. To respond to the group's interest to know more about how EPA views
the overall flow of the policy framework, two Work Groups were formed
and comprised of smaller groups of TRAC members to think through how
the larger policy framework on risk assessment will work, and to discuss
what happens once the framework is established. The Work Groups were
identified as Work Group #1 (WG1) - Risk Assessment Framework, and Work
Group #2 (WG2) - Risk Management - What Happens Once the Framework is
in Place/Transparency.
G. The group also heard about how the Agency planned to make the regulatory
process and decision-making more open, accessible, and transparent.
It was proposed that there be more opportunities for involvement in
the registration process, Section 18s, and the reregistration process,
with tolerance reassessment a critical part of registration and reregistration.
III. June 22, 1998 WG2 Risk Management/Transparency Meeting
WG2 met on June 22, 1998 to define the role and subject matter for WG2,
describe the key issues and tasks, and develop an approach for discussing
these issues.
A. The group addressed the issue of whether to conduct cumulative risk
assessment analysis first, or analyze individual chemical's risks and
then conduct the cumulative analysis for all OPs.
B. The group also briefly discussed mitigation measures and potential
decision-making criteria to be used in making risk management decisions.
C. The group agreed to meet again and agreed to address the issues
discussed in additional detail.
D. EPA agreed to consider, as a starting point to the discussions,
the Staff Framework of Reassessment and Transition, the decision process
flow chart and the listing of potential decision-making criteria.
IV. June 22 - 23, 1998 TRAC Meeting
The agenda for the June 22 - 23, 1998 TRAC meeting was as follows:
- Discussion of Staff Paper on Description of the Risk Assessment Process
(Staff Paper # 7)
- Discussion of Framework Refining FQPA Science Policies (Staff
Papers # 8.1, 8.2)
- Discussion of Graphical Information on Preliminary Assessment of OP
Pesticides (Staff Paper # 9)
- Designing an Approach for Refining Dietary Risk Assessments of OP
Tolerance Reassessment (Staff Papers # 10.1, 10.2)
- Designing a Decision Making Process for OP Tolerance Reassessment
(Staff Paper # 11)
Highlights of the meeting follow:
A. Based on the concerns raised by TRAC members at
the May meeting about making the risk assessment process understandable
to the non-risk assessor, EPA drafted the paper on the risk assessment
process in language tailored to a broader audience. TRAC members provided
suggestions to improve the document including: clarifying the difference
between the public process and the public's Right-to-Know; information
on what data is used, how it is used, and what assumptions are made
in the risk assessment process; tools to make reasonable decisions on
risk that are based on facts and common sense; posting a schedule of
what information it needs by when in order to make timely decisions;
developing a more general explanation of the risk assessment process
that would be clearer for farmers to use, transparency on the process
and data and assumptions used in determining children's and adult exposures;
an example of how the risk assessment was applied to a real product;
and including the public throughout the risk assessment process.
B. The group heard a presentation on a Framework for Refining FQPA
Science Policies and for Risk Assessment Policy Making which were developed
by EPA to address concerns raised by TRAC members at the May meeting
on the broad science policy issues of FQPA and how they fit together.
The presentation addressed the eight science polices identified by the
Work Group, information on the current approach in risk assessment,
timing, suggestions for improving transparency, and the timeline for
publication and comment on each issue. TRAC members provided suggestions
to improve the document including: adding reliable data as the ninth
issue; adding background information on policy options and information
from other related guidance groups; clarifying the comment periods and
what happens with the papers after TRAC comments are provided; involving
more qualified scientists for the discussion on reliable data; using
a range of percentiles for Monte-Carol analyses; providing more information
on the percent of crops treated, frequency of crop treatment; and risk
reduction, using actual data more frequently and base product cancellation
from the market on real data.
C. EPA presented information on the preliminary assessment of the OP
pesticides with active registrations including information on acute
vs. chronic risk and no observed effects level (NOEL), the Dietary Risk
Evaluation System (DRES), chronic dietary assessment refinements to
date, and the most refined dietary estimates to date. TRAC members provided
comments on the presentation. Comments included: the need to clarify
the distinction between what was meant by the most sensitive and most
highly exposed populations; providing a "sensitivity uncertainty
analysis" on each assessment, defining the target audience for
the graphs; providing attachments to the graphs explaining the assumptions;
correlating the organophosphates with particular crop uses to help the
reader evaluate which uses are most vulnerable; the need to provide
additional information about the assumptions driving the risk for each
chemical; the need to provide additional information on chemical use
and the names of the chemicals for adequate interpretation of the information;
the preliminary risk numbers are not accurate enough to use for regulation;
the need to clarify how non-detections are established and how non-detections
in the risk assessment process; and clarification on the assumptions
on what drives the risk process.
D. EPA presented an overview of refining dietary risk assessments for
OP tolerance reassessment. Representatives of American Crop Protection
Association (ACPA) offered to work with EPA and the Environmental Working
Group (EWG) to prepare a presentation of a full risk assessment walk-through
on one or more OPs. The group heard presentations on the framework for
tolerance reassessment and transitions, and refining chemical risk assessments.
TRAC member's comments on the presentation included: the need for the
Rule for notification of the Registrant to allow the opportunity for
the Registrant to provide clarification of their information; the lack
of trust and the need to build trust into the process; the need to develop
public confidence in the process and the importance of taking the time
to ensure accurate information before public disclosure.
E. USDA provided a presentation on designing a decision making process
for OP tolerance reassessment. TRAC members commented on: the importance
of USDA involvement for successful transition; the impact of foods consumed
by children; strategic use of this process by EPA to address the risks
of selected organophosphates; the involvement of growers in a process
to develop a good cumulative risk assessment; additional criteria for
decision making including Registrant support of the chemical use; opportunities
for risk reduction and mitigation; prescription use; unintended consequences;
and methods to rescue affected pesticide users; considering examples
of how different states currently approach the same issue; learning
from FDA practices; and the importance of available alternatives.
F. Next steps for WG1 were as follows: discuss and refine framework
for addressing the broad science policies; present 2 or 3 examples of
OP assessment results with a variety of drivers; further discuss/update
refining chemical-specific risk assessment; update Staff Paper on risk
assessment process based on comments received; and present a preliminary
OP assessment. The next steps for WG2 were: identify means to make mitigation
negotiations transparent; and address a way to allow for growers and
other stakeholders to be involved in mitigation decisions.
V. June 30, 1998 WG1 Risk Assessment Meeting
On June 30, 1998, WG1 met to discuss the following topics:
A. The group reviewed the Science Policies on 10-X and Monte Carlo
in detail and agreed to discuss the last six Science Policies at the
next Work Group meeting. Science Policies would be updated according
to comments received, and notice and public comment periods would be
provided for each of the Science Policies and associated documents.
EPA would conduct workshops for further discussion on the most important
topics in fall of 1998.
B. The group discussed two ideas for the example OP risk assessment
presentation: 1) Discuss specific OP's as offered by Jay Vroom of ACPA;
and 2) Discuss the full Risk Assessment process, highlighting key Science
Policy decisions using examples from different OP assessments in preparation
for the next TRAC meeting.
C. The group reviewed three options for refining chemical-specific
risk assessments and discussed a refined approach. The refined approach,
which was NOT agreed upon by the group, included a strict 30-day comment
period by registrants upon completion of a draft preliminary risk assessment
indicating errors and mistakes made by EPA. Within another 30 days,
EPA would revise the risk assessments, documenting the comments on errors
received, as well as details on any alterations made to the risk assessments,
and publish (or otherwise make fully available) the preliminary risk
assessments along with the documented comments and alterations. At that
point, a full 90-day public review and comment period would proceed,
in accordance with the timeline of Option 1.
D. The revised 'Plain English' Guide to Risk Assessment document was
reviewed by all TRAC members.
E. The Work Group agreed that it would be helpful for the TRAC to discuss
Mark Whalon's work at Michigan State University briefly at the next
TRAC meeting.
VI. July 1, 1998 WG2 Risk Management/Transparency Meeting
On July 1, 1998, WG2 met to discuss the following issues:
A. The Work Group reviewed a draft listing of decision-making criteria
used by EPA and discussed in previous meetings. They revised the criteria
and grouped them according to six major principles. The next
draft of Criteria would be presented for discussion at the next TRAC
meeting.
B. The Work Group reviewed a number of flow charts outlining potential
elements to the risk management decision process. Some of the flow charts
attempted to represent the relationships between risk assessment and
management activities as well as approaches for conducting the cumulative
risk assessments. Work Group members indicated that these charts may
be directionally correct in making a transparent and effective decision-making
process, but members indicated that they required additional refinements
and consolidation. The charts would be refined for discussion at the
next TRAC meeting.
C. The Work Group received presentations on current USDA and EPA data
gathering and research efforts. Presentations for the next TRAC meeting
concerning use and usage information as well as on the USDA Crop Profiles
and Transition Strategy would be developed.
VII. July 13 - 14, 1998 TRAC Meeting
The agenda for the July 13- 14, 1998 TRAC meeting was as follows:
- WG1 Risk Assessment Topics
- Plans for a Case Study Presentation on OPs
- WG2 Risk Management Topics
- Update on USDA Crop Information
- Presentation on Research Priorities.
Highlights of the meeting follow:
A. The group heard an overview of progress on the science policy framework
for refining the science policies including a summary matrix for quick
reference, and the preliminary schedule for release of guidance on science
policy issues to put the plans for the science policies in the broader
context of the statutory requirements under FQPA. TRAC members were
concerned about a variety of issues, including: the way in which residential
exposure was addressed and the need to include updated information in
the process; interim nature of decisions and the process of revising
interim decisions, particularly those that are based on less developed
components of the risk assessment process like cumulative risk, risk
from drinking water, and residential risk; and the possibility of additional
science policy issues including one to clarify the concept of reliable
data and another to address end point selection.
B. EPA provided an overview of the four options for refining chemical
risk assessments, including: OPTION # 1 - The preliminary risk assessment
is completed and sent to the Registrant; OPTION # 2 - The Agency posts
a notice of availability of the preliminary risk assessment and provides
the opportunity for both the public and the Registrant to comment on
the assessment concurrently; OPTION # 3 - The current refinement process
used by the Agency; and OPTION # 4 - The Preliminary Risk Assessment
is completed and sent to the Registrant. Some of the members concerns
are summarized as follows: it was unclear how each option would influence
the timing of when the preliminary risk assessment would become available
to the public; different options allowed for more transparency than
others; timelines were short and unrealistic; OPTION # 4 appeared to
provide a middle ground addressing concerns about timing and transparency;
and it was unclear when refined data would be integrated in the process.
C. The group heard a presentation on planning for the OP case study.
A member of American Crop Protection Association (ACPA) expressed interest
in presenting a case study of an OP at the July 28, 1998 TRAC meeting.
The presentation would be shared by EPA and the Registrant or a representative
of ACPA. The presentation would include input from an individual representing
the public interest community and include information on the sources
of data, major drivers, scenarios of zero detection and half of the
detection limit, and a discussion on mitigation or changes to the label.
D. TRAC members were provided with an overview of the upcoming SAP
meeting to be held on July 29 - 30, 1998 which would include updates
on methods of estimating risk from drinking water, cancer risk decisions,
sources of uncertainty, and other related issues.
E. EPA provided the group with an overview of the decision criteria
and straw risk management decision process developed by WG2 designed
to help make choices between uses where "a reasonable certainty
of no harm" finding cannot be made based on the presently registered
uses. TRAC members commented on the list of decision-making criteria,
criteria grouping, criteria measurement, and the measurement and weighting
of individual chemicals based on the criteria; integration of the criteria
to address stakeholder concerns, and the process for stakeholder involvement.
TRAC member's commented on the following: apply the decision-making
criteria at the end of the risk assessment process; apply criteria to
individual pesticides and groups of pesticides in a way that combines
the principles of toxicity and exposure to establish risk reduction
objectives; simplify the criteria; focus on risk reduction; clarify
some of the language including what is meant by "non-dietary"
concerns; add drinking water and a discussion on non-detections and
whether the chemical is regulated under the Safe Drinking Water Act;
add a criterion for analytical methodology; add a criterion to address
consumer impact and impact on the food supply; add a criterion for impact
on trade; make criteria on risk to children explicit; and avoid the
loss of important minor uses of organophosphates for public health in
the decision-making process.
F. The group heard a presentation on tolerance reassessment principles,
approach and transition. Two approaches were summarized: the Phased
Cumulative Reassessment Approach, which considered aggregate and cumulative
non-occupational risk from all routes of exposure posed by an individual
chemical; and the Cumulative Reassessment Approach, which addressed
the cumulative risk posed by chemicals thought to have a common mechanism
of toxicity. The group discussed the pros and cons of each approach.
Some of their comments are as follows: some of what is required under
FIFRA (e.g., worker and other types of acute risk) should be incorporated
in both approaches; focus on designing the best, most timely tolerance
assessment approach, not refining the criteria; clarify the potential
ramifications of determining the allocation or uses of specific commodities;
the timing required for each approach might be an issue, particularly
with regard to the unknowns about the cumulative risk assessment process;
and the role of "default assumptions" where there is insufficient
information was of concern.
G. TRAC members heard a presentation on organophosphate use in Michigan,
including residue mitigation as an untapped solution to many minor crop
FQPA challenges, production systems, organophosphate reduction patterns,
and how many minor and some major crops are trapped by legal quality
standards and pesticide regulation.
H. EPA and USDA presented a pilot approach for identifying and correcting
errors in the preliminary risk assessments, including a timetable for
the release of the information. The approach addressed the three Freedom
of Information Act (FOIA) requests related to the TRAC; the nine organophosphates
for which the preliminary risk assessments are complete and have been
shared and discussed with the Registrant; the seven organophosphates
for which preliminary risk assessments are complete but have not yet
been shared with the Registrant; and the 24 remaining organophosphates.
TRAC members commented on the proposed pilot. Some of their comments
are summarized as follows: some members were supportive of the pilot
proposal; some members were concerned about implementing the pilot and
adopting option # 4 before the group reached resolution on the science
policy issues; and several members were concerned about the potential
for misinterpretation of preliminary information.
I. EPA and USDA proposed a clarification on what was meant by the term
"error" to be used only as an operating procedure for this
set of organophosphates.
J. USDA and EPA presented a summary of crop information, including
EPA Crop Matrices, USDA Crop Profiles and List of Crop Profiles, and
USDA Transition Strategies. TRAC members asked questions of clarification
and provided some suggestions on the presentations.
K. USDA presented an overview on USDA research priorities, including
risk drivers, short-term programming, and long-term programming on implementation.
Some of the TRAC member comments included: a suggestion to develop a
Memorandum of Understanding (MOU) to define the financial resources
for work related to the FQPA and to protect committed resources for
other USDA responsibilities; and a caution to avoid narrowing the options
available to growers by prescriptive agriculture.
VIII. July 28, 1998 TRAC Meeting
The agenda for the July 28, 1998 TRAC meeting was as follows:
- Example Preliminary OP Risk Assessment Presentation
- WG1 Comments on Example Presentation and Discussion
- Presentation on Collaboration for Pesticide Risk Reduction
- Presentation on Pest Management in Organic Farming
- WG1 Meeting Review, Questions, and Discussion
- WG2 Meeting Review, Questions, and Discussion
- Status Report on Release of Preliminary Risk Assessments
Highlights of the meeting are as follows:
A. EPA presented an overview of the case study on the Methidathion
Risk Assessment. The assessment focused on dietary risk. There were
no residential, public health or non-occupational uses, and the risk
assessment on drinking water was in progress. The objectives of the
case study were to illustrate the dietary risk assessment process and
its complexity, the tiered risk assessment process, and the drivers
of the risk assessment (opportunities for refinement and mitigation).
Some of the concerns raised by TRAC members included: the 10-X safety
factor combined with the "reasonable certainty of no harm"
issue and the lack of a developmental neurotoxicant study; EPA's decision
to use the percent of crop treated in the determination of acute risk;
the impact of unintended consequences; the handling of the 10-X safety
factor; making better use of more sophisticated risk assessment techniques.
B. The WWF presented an overview of a collaborative effort between
the WWF and Wisconsin Potato and Vegetable Growers Association (WPVGA)
to look at problems and solutions to toxic loadings that were threatening
the health of people and ecosystems in the Great Lakes Basin.
C. An organic farmer from the Pavich Family Farms presented an overview
of insect and disease management in organic grape production.
D. EPA presented an overview of WG1 discussions including: follow-up
items with FDA; framework for addressing the nine science policy issues,
Staff Paper # 20; science policy issues # 3 - 9; other issues; status
of the release of the organophosphates; and Plain English version of
the Risk Assessment Process. Some of the TRAC members comments were
as follows: add a distinction between what is meant by "error"
versus "refinement"; address how EPA will address comments
such as the Implementation Working Group's (IWG) "Road Map"
Report on a science-based framework for implementing FQPA; and explain
how the issue of testing pesticides on humans will be addressed within
the TRAC process.
E. EPA presented an overview of WG2 discussions including: clarification
of the process modeled in the flow-chart designed to portray the need
to perform individual risk assessments to establish the basic science
on the individual chemicals, while at the same time conveying the reality
that it will take time to work out some of the essential science policies,
such as how to perform cumulative risk assessments; and issues and decision
points for the organophosphate tolerance reassessment process, such
as mitigation of individual organophosphate risk endpoints and the fundamental
question of whether to complete individual assessments before performing
the cumulative risk assessments, or whether to proceed by doing things
in parallel. WG2 also discussed the principles for transition, transition
timetables, and the research and information to support transition.
Some of the comments and concerns raised by TRAC members included: the
need to define what is meant by the "detection level"; the
importance of providing alternatives that are economical; the potential
for the phased cumulative approach to change the goal post in the risk
process; and the possibility for some tolerances to be determined at
an early stage.
IX. August 14, 1998 WG1 Meeting
Following is a summary of key elements of the discussion, major agreements,
and next steps of the WG1 meeting:
A. WG1 will participate in an agenda planning conference call for the
fifth TRAC meeting on August 31, 1998. Potential agenda items proposed
by Work Group members include: the Plain English Risk Assessment Paper
and the Federal Register Notice for the nine Science Policy Issues;
and Documentation on EPA's current practices on the science policy issues.
B. Work Group members discussed FDA's approach to food additive regulation,
as it may be applicable to FQPA implementation. Work Group members discussed
FDA's approach to food additive regulation, as it may be applicable
to FQPA implementation. Work Group members were interested in the potential
applicability of FDA's experience with the use of guidance documents.
C. The group discussed aspects of USDA's Food Consumption Survey, including
the use of limited data (e.g., those sample sizes that do not meet reporting
guidelines), the validity of basing risk decisions on limited data,
how to address data variability and the impact of removing extreme values
from the data base.
D. Work Group members discussed the use of data from the Pesticide
Data Program (PDP) in FQPA implementation, including the protocol for
the uses of PDP and other data in risk assessments; use of PDP data
in acute dietary risk assessments (single serving versus blended); protocol
for, and integration of, proprietary data; and the use of the limit
of detection versus zero detection.
E. The group discussed the use of percent of crop treated in acute
dietary risk assessments. They commented on the limitations of using
a national average for percent crop treated, EPA's Biological and Economic
Analysis Division (BEAD) practice of including information for regions
or states with unusually high pesticide usages in the Risk Assessment,
and bridging studies.
F. Work Group members discussed additional modifications
to the revised Plain English Risk Assessment Paper, including making
reference the applicable science policy issues, and the process for
finalizing the document.
G. The group commented on the Draft Federal Register Notice and agreed
to OPTION 1, Immediate issue of Federal Register notice on
the nine Science Policy Issues and later publication of the remaining
components of the tolerance reassessment process, including a summary
of the materials published previously on science policy and risk assessment
refinement.
X. August 13 - 14, 1998 WG2 Meeting
Following is a summary of key elements of the discussion,
major agreements, and next steps of the WG2 meeting:
A. WG2 will participate in an agenda planning conference
call for the fifth TRAC meeting on August 31, 1998. Potential agenda
items proposed by Work Group members include: Early Assessment; Regulatory
Tools; USDA "consensus" statement; criteria for reasonable
alternatives; and Public Participation in the Risk Management process.
B. WG2 discussed criteria for determining a "reasonable"
alternative to a pesticide. It was suggested that these criteria be
included with the decision criteria. Some of the major factors for consideration
of a "reasonable" alternative are the time, help, equipment
and cost of using the alternative.
C. The group commented on EPA's draft description of
the possible criteria for identifying OP uses with very low risk contribution
and/or high public value that potentially could be subject to an early
assessment.
D. WG2 members developed a "consensus statement"
regarding how EPA should use and interpret the RA'/RM Cumulative flow
chart presented as the OP Tolerance Reassessment Process.
E. The group commented on EPA's draft description of
the regulatory mechanisms available for achieving pesticide risk mitigation.
F. WG2 members discussed USDA's plans for FQPA Implementation
and developed a consensus statement regarding USDA's role in Transition.
G. The group discussed the level of public participation
appropriate for the risk management process and agreed that in the risk
assessment process, the TRAC had identified a fairly clear and definitive
role for public participation that would be both transparent and rational.
For Risk Management, the opportunities for public input outlined in
the flow chart on Straw Risk Management Decision Process might be burdensome
and duplicative for all.
XI. August 31, 1998 WG1 & 2 Conference Call
Work Group members discussed the following topics on the conference call:
A. The Status of TRAC Work Products including providing
sufficient time for TRAC members to review the documents prior to the
September 15 - 16, 1998 TRAC meeting and the amount of time allocated
to discuss the materials at the meeting.
B. Follow-up on TRAC issues, including insuring
a mechanism for continued involvement in finalizing the science policies,
particularly, the 10-X safety factor and cumulative risk.
C. Ways to help focus TRAC discussions at the final
meeting, such as providing TRAC members with a brief written summary
of the Co-Chairs comments on the TRAC.
D. Post-TRAC Activities including the need for some
forum to continue the discussion and development of TRAC issues (e.g.,
the progress of TRAC decisions and issues overall, discussion on the
risk management process, involvement at critical decision-making points,
include all or a representative subset of TRAC members in the post-TRAC
activities, ensure USDA continues a primary involvement, and effective
reporting on the progress of TRAC issues.)
E. Alternatives to the TRAC (e.g., utilizing existing groups and resources
including one or some combination of the Pesticide Program Dialogue
Committee (PPDC), SAP, and Science Advisory Board (SAB), reconfiguring
the PPDC to involve USDA as an integral part of the membership and a
representative subset of TRAC members, using the model of USDA Pesticide
Issues Discussion Group, and ensuring an effective report-back mechanism
to TRAC members on the progress of TRAC issues)
F. The draft Agenda for the next TRAC meeting including: sufficient
time to discuss Work Group topics; feedback from EPA and USDA on what
they learned from the TRAC; progress made; intensions to address the
issues identified in the TRAC; unintended consequences of the TRAC process;
the integration paper; closing comments from TRAC members; and suggestions
for time allocation for agenda topics.
XII. September 9, 1998 WG1 Conference Call
In preparation for the TRAC meeting on September 15 -
16, 1998, WG1 members participated in a conference call to discuss comments
on the WG1 materials for the next TRAC meeting, the draft Federal Register
Notice, the final agenda for the next TRAC meeting, and the 'integration'
paper on integrating the risk assessment and risk management processes.
The results of their discussions were reflected in the agenda and meeting
materials for the September TRAC meeting.
XIII. September 9, 1998 WG2 Conference Call
Also in preparation for the September 15 - 16, 1998 TRAC meeting, WG2
continued its discussion of public participation in the risk management
process, comments on the other WG2 documents, USDA's role in the transition
process, and the 'integration' paper on integrating the risk assessment
and risk management processes. The results of their discussions were reflected
in the agenda and meeting materials for the September TRAC meeting.
XIV. September 15 - 16, 1998 TRAC Meeting
The agenda for the September 15 - 16, 1998 TRAC meeting was as follows:
-
Update from WG1
-
Update from WG2
-
Integration Paper on the Decision Making Process
-
Update on the Human Testing Issue
-
USDA's Priorities and Activities
Highlights of the meeting are as follows:
A. EPA provided the group with an overview of WG1's discussions on
risk assessment including the risk assessment process and the framework
for addressing the key science policy issues, and the pilot for public
participation in refining risk assessments on OPs.
B. Some of the comments on the risk assessment process were: describe
more explicitly the role of USDA in risk assessment and cross-reference
the Staff Papers on USDA's Role in Risk Assessment, Risk Management,
and Transition Strategies; clarify that "safe" means "reasonable
certainty of no harm," as defined by FQPA; because children's levels
of exposure differ from those of adults, explicitly reference exposure
to children; clarify where the tolerance will be set; clarify the intended
audience for the document; and explain the use of different percentiles
with different modeling approaches.
C. Some of the comments on the framework for addressing key science
policy issues included: clarify what regulating to a certain percentile
using the Monte Carlo analysis means; clarify how comments such as those
presented in the IWG "road map" referenced on page 20 will
be addressed in the process; explain how USDA's other efforts will be
integrated regarding refining consumption data statistical methods for
composite to single servings and addressing issues of accuracy of reported
high-end consumption; the indication that organophosphates and carbamates
have a common mechanism of toxicity that is based on cholinesterase
inhibition is a misrepresentation; specify that the language in FQPA
allows for an increase in the 10-X safety factor in addition to reduction,
removal or retaining the safety factor; discuss issues of a lack of
reliable data to evaluate residential exposure; clarify when and why
it is necessary to apply single-serving-size exposure data.
D. Comments on public participation in risk assessment included: questioning
how the process will be evaluated and with what criteria; clarifying
USDA involvement in the process; concern with EPA posting errors when
they may have had the time to make corrections before posting the preliminary
risk assessments and the potential for causing problems among agricultural
users and consumers as a result of releasing preliminary risk assessments;
and the clarification on the time period for the pilot.
E. EPA and USDA provided an overview of WG2's risk management discussion,
including decision-making criteria, early assessment for OP uses with
very low risk contribution and/or high public value, risk assessment
and risk management process, regulatory mechanisms for achieving pesticide
risk mitigation, and public participation in the risk management process.
F. Comments on the decision-making criteria included: clarification
on some of the timeframes; the need to clarify what is meant by limits
of detection; clarify that benefits are not used to decide how much
risk to tolerate; emphasize the intent of the statute to make food safe
for children; encourage the use of less toxic pesticides; develop criteria
to channel resources to address high exposure scenarios; clarify how
these criteria would be used to make a regulatory decision; clarify
that the process will be for organophosphates and other pesticides;
and clarify that the criteria address cumulative risk.
G. TRAC members provided the following comments on early assessments:
there is a need for criteria on how EPA would weigh public health use
in the decision making process; clarify that EPA plans to address the
chemicals that present the greatest risk first; and substitute the concept
of giving some uses a "bye" rather than guaranteeing a spot
for them in the risk cup.
H. Comments on the risk assessment and risk management process were
as follows: clarify that EPA will address the "worst first"
and clarify how and when in the process critical uses of organophosphates
and the pesticides with older chemistries were addressed.
I. TRAC members provided the following comments on regulatory mechanisms
for achieving pesticide risk mitigation: regional or geographic differences
should be addressed; add suspension to the list of outcomes for an acute
significant risk as determined with a refined risk assessment; limited
uses should be reflected in the summary table; uncertainty about the
effectiveness of label changes as a regulatory mechanism; the difficulty
of advising the Agency and USDA on how to go about the risk management
process until the nine science policies are in place.
J. Comments on public participation in the risk management process
were as follows: it is necessary to have a clear structure for the process
to succeed; the timeframes proposed for the public involvement process
may or may not be appropriate depending upon how much information is
available at the start of the process; and providing a schedule of release
for EPA's work plan for making decisions on organophosphates and cumulative
risk would be helpful.
K. The group discussed the need for post-TRAC activities. EPA would
be supportive of extending the TRAC if it were structured in a way that
lessens the burden on EPA staff with meetings that are focused on tightly
defined activities, spaced sensibly, and limited in number. USDA agreed
that additional TRAC activities should be less rigorous. TRAC members
shared the following comments and concerns about extending the process:
extending the TRAC process should not be done at the cost of diverting
the staff at EPA from the work necessary to proceed with FQPA implementation;
other mechanisms for public input should be explored; wait to reconvene
the TRAC process until the defined process was tested and after EPA
receives public comments on the preliminary risk assessments and resolves
its guidance on the risk assessment process; more time is necessary
to strive for closure on outstanding issues such as how the Agency applied
the decision criteria to a complex mixture question, risk management
after the science policy issues are resolved, residential and drinking
water exposure data are refined, aggregate and cumulative analyses are
refined; insure that the process does not discourage healthy competition
amongst Registrants; and evaluate the impacts on international trade.
L. USDA provided an overview of its priorities including their role
in risk assessment, risk management, and transition strategies. Some
of the comments USDA received were as follows: insure USDA data is utilized
and the agricultural community is preserved; insure short term availability
of alternatives; update the agricultural community on crop profiles;
address the lack of data to determine exposure from drinking water;
expand beyond the Land Grant University system for data and alternative
controls; look for alternatives that reduce reliance on chemicals; develop
the crop profiles for the highest risk crops first; act as an honest
broker by bringing information from growers into the process and communicating
"real" risk; recognize the consequence of increasing regulation
and the consequent increase in imported foods; there is not a level
playing field between domestic and foreign producers; there is a need
to link National Agricultural Statistical Service (NASS) and PDP data
for commodities; there is a need for accurate field data on use and
usage; the risk posed by some of the processed foods that are heavily
consumed should be viewed more closely; and biocontrol needs more funding;
clarify that USDA's role in FQPA is essential and an active role is
critical, particularly in providing data on pesticide use and consumption.
M. EPA provided the group with an update on the human testing issue.
There were many different and strong views about the issue. EPA agreed
to craft a memorandum directing Office of Prevention, Pesticides, and
Toxic Substances (OPPTS) to develop this policy to be finalized by February
1999 and hold the joint SAP/SAB meeting augmented by ethicists and other
experts. The process to address the issue of human testing would include
new research performed by others and would involve a lot of discussion
with a number of experts and would take time.
N. EPA presented an overview of the integration paper on risk assessment
and risk management. Some of the comments from the TRAC included the
following: good first step towards describing how the pieces fit together
which also highlights the amount of remaining work; need to define whether
and if early assessments would tax EPA resources; consider whether EPA
can identify the low risk pesticides without spending time and resources;
and clarify how EPA plans to make the parallel process work; distinguish
between negligible risk and zero risk.
XV. February 25, 1999 East Coast and March 2, 1999 West Coast "Update"
Meetings
To provide TRAC participants with information on the progress of USDA
and EPA since the September 15 - 16, 1998 meeting, two TRAC 'update' meetings
were held, one on the East Cost on February 25, 1999, and a second on
the West Coast on March 2, 1999. TRAC members were provided with updates
on the following:
- Science Policy Framework Development
- Other Relevant and Recent Policy Developments (e.g., early assessment,
role of use-related information in risk assessment, and human testing)
- Overall Status of Tolerance Reassessment
- Status of the OP Pilot
- Transition Strategies
- Other Upcoming Events of Interest.
XVI. April 8 - 9, 1999 WG2 Meeting
The agenda for the April 8 - 9, 1999 WG2 meeting was as follows:
-
OP Pilot Process
-
Updated Dietary Risk Assessment for AZM
-
"Dry-run" Technical Briefing for
Bensulide
-
Gerber Agricultural Program presentation
- Elements of transition
- Presentation from Sarah Lynch, WWF
- Updates on the Nine Science Policies
- Additional Comments on the Pilot Program
- Agenda Ideas for the TRAC April 27-28, 1999 Meeting
Highlights of the meeting are summarized below:
A. EPA provided the group with an update on the pilot process proposed
by the TRAC for the development of risk assessments and stakeholder
involvement including a status of: the OPs in the process; the EPA and
USDA intergovernmental review process to develop revised risk assessments;
and public meetings (to be called technical briefings). Some of the
comments and concerns of WG2 members follow: the potential for a complex
chemical to increase the timeframe; determine to what level risk must
be refined; clarify who at EPA and USDA was involved in different parts
of the review process; define when the pilot will become formal; "risk
contributors" were key issues; application of lessons learned from
EPA and USDA coordination thus far in the process; clarify USDA's involvement
in the review process; and cumulative risk remains a key issue in the
process.
B. EPA presented an updated dietary risk assessment for Azinphos-Methyl
(AZM) including possible additional data and refinements that could
modify the results of the risk assessment. Some of the comments and
concerns noted by TRAC members are as follows: there is a need to represent
what the percentiles of risk mean in plain English; there is a need
to evaluate the importance of finding acute hazard data as a benchmark
to the assessment of safety factors; concern was expressed that the
risk refinements resulted in lowering the level of risk; it was acknowledged
that this evaluation could change with the addition of cumulative risk,
the use of additional OPs, and factoring in ecological and worker risks;
and public reaction to refined risk assessments that may be modified
based on additional data, and the combined effects of updated information
on additional organophosphates and cumulative risk was of concern.
C. EPA and USDA described the concept of "technical briefings"
for the purpose of presenting the results of the risk assessments and
to obtain recommendations on risk management proposals prior to placing
the revised risk assessment into the public docket. TRAC members were
generally supportive of the concept. A summary of some of their additional
comments is as follows: present the information in tabular form; make
the information available on the Internet; highlight worker exposure
and include incident data; provide an overview and summary of the material
promptly to compare with the risk assessment; correct assumption errors;
and clarify the approach to addressing additional data needs and defining
when there are enough data for decision-making on chemicals.
D. The group received a presentation on the Gerber Agricultural Program
including how Gerber evaluates risk.
E. USDA provided the group with an overview of the core elements of
a transition strategy. Some of the comments and concerns raised by TRAC
members follow: in the absence of the results of a cumulative risk assessment,
transitional strategies should address chemicals by class; add "economical"
to the criteria for alternative tools; reconsider the idea of requesting
help from the grower community on risk management strategies because
it could foster competition between grower groups; clarify how public
health considerations fit into the risk assessment process; recognize
that there are different elements of transition, including regulatory
transition, economics, the environment, farmers and agriculture; provide
more information on Integrated Pest Management (IPM) to help foster
its use; consider how chemicals fit into a broader resistance management
strategy; and recognize and address the need for resources to address
transition issues.
F. TRAC members then heard a presentation on an FQPA-Targeted Pesticide
Residue Study performed by Michigan State University (MSU) and the Michigan
Department of Agriculture for Region 5.
G. The group heard an overview of the elements of a transition strategy.
Some of their concerns follow: economical considerations in pest control
alternatives; unintended consequences; need for grower outreach; consideration
of different production regions; include input from registrants and
state lead agencies; clarify USDA's priorities; address the issues and
concerns regarding imported foods; the use of crop profiles; the importance
of new products; and the use of input from land grant universities.
USDA acknowledged the importance of their role in transition and mitigation,
including building partnerships and address import issues to protect
the consumers and the agriculture of the country.
H. The group discussed the timing for the final TRAC meeting, agenda
items, and other issues relevant to how the TRAC should operate in the
future. September 1999 was suggested as the time for the final meeting.
Many TRAC members felt ending the TRAC process in September was premature
because there were many unresolved issues. Some ideas for the agenda
included: use the list generated in the WG2 meeting as a basis; cumulative
risk; worker risk; data needs and a review of data collection activities;
risk benefit; and non-dietary residential risk process. Other comments
included the following: welcome those who left the process to rejoin
the final meeting; make sure the products addressed earlier in the review
process benefit from lessons learned from the pilot process before making
decisions on the OPs; allow for more preparation on worker safety issues
including consideration by the PPDC and case studies; access to privately
maintained databases; consider setting national performance standards
for worker safety.
I. The Agency and USDA committed to one additional TRAC meeting. They
suggested that the agenda might include: progress on a "mini-cumulative
analyses on several OPs; and additional developments on transition;
institutionalizing the pilot process for OPs; and other classes of chemicals.
XVII. April 27 - 28, 1999 TRAC Meeting
The agenda for the April 27 - 28, 1999 meeting was as follows:
- Report Back on the WG2 Meeting
- Review of OP Pilot Process
- Prototype Briefing for AZM
- Key Perspectives Regarding the OP Pilot Process and AZM Briefing from
Representative TRAC Members
- OP Worker Risk Issues
- Update on the Nine Science Policies
- Presentation by Mark Whalon on Transition Activities in Michigan
- Transition Issues with USDA
- Planning for the Final TRAC Meeting.
Highlights of the meeting are as follows:
A. The group heard a brief overview of the WG2 meeting which was held
on April 8 - 9, 1999.
B. TRAC members were provided with an update on the pilot process proposed
by the TRAC for the development of risk assessments and stakeholder
involvement. The presentation included an overview of the six stages
of the pilot process and comments on the process. USDA involvement in
the review process was also described. TRAC members requested clarification
on the following: the handling of non-error comments in the "error
only" review; adequacy of the period for USDA review of the risk
assessment; adequacy of time for EPA review in Phases 4 and 6; conclusions
to be drawn from the sensitivity analysis for risk drivers, including
possible refinements on the scope of data collection; the value of the
crop profiles in the risk assessment process; lessons learned from public
comments from the different phases; the extent to which EPA evaluates
different percentiles in the probabilistic risk assessment; OPs that
pose public health risks; plans for use of state composite data; modifications
in the preliminary risk assessments as a result of the pilot process;
and future plans for making the risk mitigation process transparent.
C. TRAC members were provided with an overview of the prototype briefing
on AZM. The presentation included the dietary portion of the risk assessment
as well as information on the other components of the overall risk assessment
to illustrate how the risk assessment has changed and evolved through
the various phases of the TRAC pilot public participation process. The
group then heard key perspectives regarding the organophosphates pilot
process and AZM prototype briefing from the grower and Registrant communities.
D. TRAC members heard a general overview of how the Agency conducts
a worker risk assessment, including the basic methodologies, a discussion
of the issues gleaned from the OP assessments conducted thus far, and
how to address them. Some of the concerns raised by the group were as
follows: how reduction on worker exposure is addressed in the equation
on risk; relying on the data in the Pesticide Handlers Exposure Database
(PHED) and the use of default values; limitations with the assumptions
used for hazard identification; assumptions used for dermal absorption;
the potential consequence of pesticide cancellation as a result of worker
protection concerns; and consideration of worker safety strategies used
in other organizations like NIOSH and OSHA.
E. The group was provided a brief update on the nine science policies.
F. TRAC members then heard a presentation on an FQPA-Targeted Pesticide
Residue Study performed by Michigan State University (MSU) and the Michigan
Department of Agriculture for Region 5.
G. The group heard an overview of the elements of a transition strategy.
Some of their concerns follow: economical considerations in pest control
alternatives; unintended consequences; need for grower outreach; consideration
of different production regions; include input from registrants and
state lead agencies; clarify USDA's priorities; address the issues and
concerns regarding imported foods; the use of crop profiles; the importance
of new products; and the use of input from land grant universities.
USDA acknowledged the importance of their role in transition and mitigation,
including building partnerships and address import issues to protect
the consumers and the agriculture of the country.
H. The group discussed the timing for the final TRAC meeting, agenda
items, and other issues relevant to how the TRAC should operate in the
future. September 1999 was suggested as the time for the final meeting.
Many TRAC members felt ending the TRAC process in September was premature
because there were many unresolved issues. Some ideas for the agenda
included: use the list generated in the WG2 meeting as a basis; cumulative
risk; worker risk; data needs and a review of data collection activities;
risk benefit; and non-dietary residential risk process. Other comments
included the following: welcome those who left the process to rejoin
the final meeting; make sure the products addressed earlier in the review
process benefit from lessons learned from the pilot process before making
decisions on the OPs; allow for more preparation on worker safety issues
including consideration by the PPDC and case studies; access to privately
maintained databases; consider setting national performance standards
for worker safety.
I. The Agency and USDA committed to one additional TRAC meeting. They
suggested that the agenda might include: progress on a "mini-cumulative
analyses on several OPs; and additional developments on transition;
institutionalizing the pilot process for OPs; and other classes of chemicals.
XVIII. October 20 - 21, 1999 TRAC Meeting
The agenda for the October 20 - 21, 1999 TRAC meeting was as follows:
- EPA Updates on TRAC Issues, Including Cumulative Risk, Human Studies,
Tolerance Reassessment Progress, and Worker Risk Assessments
- Status Report on OPs
- Transition Issues
- Tolerance Revocations/Channels of Trade
- Public Participation Process (including options for the final
process, experiences from the pilot process, FY 99 reregistration eligibility
decision documents (REDs), non-OP REDs and the development process)
- Post-TRAC Activities.
Highlights of the TRAC meeting are as follows:
- TRAC members heard updates on a series of TRAC issues including:
cumulative risk; human studies; tolerance reassessment progress; and
worker risk assessments. ∙ The group heard a status report on
OPs including an update on the schedule for review of the individual
OPs, technical briefings and stakeholder meetings, and highlights of
decisions regarding several OPs, and MP and AZM. A number of individuals
expressed concern that the timeframe in which the Agency made decisions
on MP and AZM was short. Other comments and concerns were as follows:
the absence of DHHS and their apparent lack of focus on these issues;
the need to establish schedules in the pilot process and stick to them;
the need to clarify the way in which different interest groups, including
growers, are consulted in the process and the timing of that involvement;
reserve evaluation of the AZM and MP decisions until EPA determines
what to do with new registrations and whether they fit in with existing
IPM systems; post information on the preliminary risk assessments on
the Docket in a timely way; focus on refined risk assessments because
preliminary risk assessments are of limited value; focus on addressing
the risk to children and infants; clarify the RED process.
- USDA provided TRAC members with an overview of the progress
on transition issues. They also heard a presentation on a foundation
for a transition strategy for lessening dependency on OPs in the Mid-Atlantic/Appalachian/Southeastern
apple production region, as an example of the technical basis for the
discussion. TRAC members commented on the following: the need for new
products and new uses to help prioritize the next steps in the pest
management plan; the need for alternatives to be viable; the value of
a systems approach; share some of the success stories with the public;
consider alternatives for all pesticides; regulation to the degree of
risk posed by the pesticide; the need to have viable alternatives to
OPs in place before considering cancellations; increased consideration
of organic farming alternatives; expansion of the role of USDA in risk
assessments and risk mitigation; consideration of resistance management
as a critical factor; and additional research endpoints.
- TRAC members were provided with an overview of the channel of
trade issue and the "safe harbor provision" in FQPA that addresses
it. They also heard how the U.S. Food and Drug Administration (FDA)
views and addresses this issue. TRAC members shared the following comments
and concerns: the limited ability of FDA to inspect imported and domestically
grown foods; the challenges of changes in tolerance levels both domestically
and internationally; dissipation of pesticide levels on produce; challenges
imposed by foods stored for extended periods of time; the challenges
inherent with harmonizing with neighbors regarding changes in pesticide
use; the application of the tolerance revocation; issues specific to
foreign trade and the channels of trade; the need for guidance on how
producers can meet the standard that will allow them to meet the safe
harbor provision within common timeframes; the potential for this issue
to result in taking OPs off the market.
- EPA provided the group with an update on data call-in for neurotoxicity
information and the PR notice on worker protection.
- EPA provided the TRAC with a presentation on the public participation
process for tolerance reassessment and the reregistration of OPs. Based
on the lessons learned in the pilot process, several modifications to
the six-phase process were proposed, including: a pre-Phase 1 Public
Engagement process where stakeholders would be involved early in the
process to ensure that the risk assessments reflect actual use and usage,
available data, current labeling, and other information on use practices
that stakeholders can provide; a similar Phase 1 with two additional
activities with regard to the chemical profile and interagency engagement;
similar Phase 2 with the additions of holding a potential conference
call with stakeholders to review and discuss the overview of the risk
assessment and working with USDA to address the suggestions from the
stakeholders and comments from DHHS, FDA, and USDA before the revised
assessment is released; modified Phase - 3 - Public Participation Period:
Technical Briefing, Public Comment on Risk Assessment, and Risk Management
Options which would include the release of risk management options for
the same 90-day period and holding a technical briefing for chemicals
with lots of uses at which point an interagency effort would also begin
to engage stakeholders in a dialogue on risk assessment and management
options through means like conference calls to solicit their ideas on
these issues; and Phase 4 - Develop Final Risk Assessments and Risk
Management - to develop final risk assessment and risk management decisions.
- Some of the comments and concerns noted by TRAC members were
as follows: the addition of pre-Phase 1 including SMART meetings is
good; discontinuing the practice of requiring a preliminary risk assessment
and focusing instead on an initial refined risk assessment is preferable;
apply the new process to all pesticides; in Phase 3 include some time
to meet with growers and registrants to discuss how the different interests
in a pesticide come together and what the success or survivability of
the product is relative to some of the uses; separate the risk assessment
review from the risk management discussion but include information on
what the Agency believes the risk drivers are; stop short of discussing
ideas on how to address those issues and these comments would be part
of the discussion on risk management; represent public health concerns
more integrally in the process; and include an evaluation loop in Phase
4.
- The group discussed their ideas regarding post-TRAC activities.
Many TRAC members felt that there should be some forum for ongoing stakeholder
activities following the TRAC. They felt the forum should include continued
transparency of Agency and Department actions and processes. Some of
the specific suggestions included the following: include DHHS in the
regulation of public health pesticides; standardize and implement a
public participation process to address risk assessment and risk management
actions; clarify the policy for carcinogenic pesticides; provide a forum
for resolving worker protection issues; avoid default assumptions; finish
developing the FQPA science policies; address other pesticides; evaluate
the economic impact of FQPA implementation on affected industries; insure
that future stakeholder activities are less resource intensive for the
Agency and the Department; have a TRAC-like group meet less frequently
and utilize work groups that would meet on a more frequent basis to
address selected issues; address issues like the remaining science policy
issues and transition; maintain the same level of senior involvement;
establish more predictable time frames; name the next group Committee
for Advising on Reregistration and Transition; invite renewed participation
from the environmental and public interest communities; remain focused
on assuring the world's safest, affordable, abundant food supply; and
include benefits in the discussion.
- EPA and USDA did not determine the details of potential post-TRAC
activities; however, some of the key impressions from the meeting were
as follows; there was good rationale for some kind of process for stakeholder
input on remaining issues; the use of work groups and workshops could
be beneficial; there was a need for a continuing dialogue and stakeholder
involvement; there was a need to expand the pilot process to address
other pesticides; transition was a key topic; and EPA was committed
to following the TRAC design process of notice and comment to bring
to closure the nine science policies and future science policies.
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