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when first created, it is now outdated.
USDA-EPA TOLERANCE REASSESSMENT ADVISORY COMMITTEE
Work Group II Meeting
Ramada Plaza Hotel
"Old Town" Alexandria, VA
April 8 - 9, 1999
THURSDAY, April 8, 1999
John Ehrmann, Meridian Institute, welcomed participants to the Work Group
II meeting of the U.S. Department of Agriculture (USDA) - U.S. Environmental
Protection Agency (EPA) Tolerance Reassessment Advisory Committee (TRAC.)
Dr. Ehrmann then initiated a round of introductions. A list of the TRAC Work
Group II members and/or their attending alternates is presented in Docket
# OPP00537. Following the introductions, Dr. Ehrmann turned to Jim Aidala,
Associate Assistant Administrator, Office of Prevention, Pesticides, and
Toxic Substances (OPPTS)/EPA, and Keith Pitts, Special Assistant to the Deputy
Secretary, USDA, for opening remarks.
Mr. Aidala thanked Work Group II members and others for attending the meeting
and stated that their extra effort was appreciated. He observed that the
group had a lot to cover in the next two days, including various updates,
risk assessment issues, and discussion of transition strategies. Mr. Aidala
apologized that the meeting materials were not distributed earlier and explained
that EPA and USDA were working hard to make sure the materials were ready
for the meeting. He commented that the group would observe progress on
probabilistic risk assessment in addition to seeing current work
Mr. Aidala stated that the desire of EPA and USDA was not to postpone this
meeting but to hold it as scheduled and keep the process going.
Keith Pitts added that USDA had made a lot of progress on their working
relationship with EPA through the TRAC process. He stated that the presentations
for the day would show some of the progress in risk refinement and identify
some of the areas where additional work is necessary. Mr. Pitts recognized
the progress that had been made on risk assessments for the first nine
organophosphates, including azinphos-methyl (AZM.) He also noted that USDA
made some decisions that may help the group focus on transition issues. Mr.
Pitts stated that he looked forward to hearing comments from the group.
After the introductory remarks, Dr. Ehrmann reviewed the agenda for the day
as follows: Organophosphate pilot process;
Updated dietary risk assessment for AZM;
"Dry-run" technical briefing for bensulide; Gerber Agricultural Program
Dr. Ehrmann then introduced Lois Rossi Director, Special Review and Registration
Division, Office of Pesticide Programs (OPP)/EPA, to begin the presentation
on the organophosphate pilot process.
Organophosphate Pilot Process
Lois Rossi provided the group with an update on the pilot process proposed
by the TRAC for the development of risk assessments and stakeholder involvement.
Her presentation included a status of: the organophosphates in the process;
the EPA and USDA intergovernmental review process to develop revised risk
assessments; and public meetings (to be called technical briefings) that
are being planned. For the presentation, Ms. Rossi reviewed the handouts
titled, Organophosphate Pilot Process Discussion, Phases 4 and 5 of the
OP Pilot Public Participation Process, and The Status of OPs in the
Pilot Public Participation Process. Among the highlights of her discussion,
she noted that EPA has developed a methodology to use composite Pesticide
Data Program (PDP) data to estimate single servings in probabilistic risk
assessments. In addition, she stated that EPA is using the best available
data to get the most realistic exposure estimates and they are determining
the risk contributors (or "drivers") of the assessments and looking at the
underlying assumptions. Ms. Rossi also explained that EPA is developing a
standard format for an overview and a brief cover sheet for each risk assessment
to provide the public with a clear description of the data and assumptions
used in the risk assessment. She noted that EPA is also working on the process
and timing for intergovernmental reviews involving the USDA and the Department
of Health and Human Services (DHHS.) They intend to work with USDA to determine
the amount of time necessary for the review of each risk assessment based
on the complexity of the review. EPA also plans to sit down with USDA at
the start of the USDA review process to provide them with a summary of what
EPA knows about the pesticide. Ms. Rossi explained that the technical briefing
is intended to provide the public with an explanation of the assumptions
behind the risk assessment. She explained that Phase 5 of the overall process,
the Public Participation Period, will begin soon after the technical briefing.
Ms. Rossi closed her presentation by commenting that she looked forward to
the discussion on this information. For other details about her presentation,
please refer to the reference documents are available in Docket # OPP00537.
Allen Jennings, Office of Pest Management, USDA, began with the observation
that this is a new and evolving process in which everyone is learning as
they go. He commented that, in the process of reviewing the first four of
nine organophosphates, USDA identified some opportunities for improvement
in the review process. Mr. Jennings stated that, while their initial reviews
were slower than expected because of the learning curve, USDA agreed that
the timeline for review might need to be extended due to the complexity of
some of the pesticides. He explained that the timeline is dependent on the
elements of review outlined in the document titled, Reassessment Pilot:
USDA Role and Timeline (see Docket # OPP00537 for details.) He agreed
that the USDA review process would be better focused if initiated by EPA's
initial technical briefing on the chemical. In addition, based on USDA's
experience with the first four organophosphates, Mr. Jennings commented that
they intended to provide EPA with comments as they become available instead
of at the end of their review. Mr. Jennings also observed that, when considering
the element of review provided by the Land Grant Team, it was important to
remember that the role of the Team extends beyond the review process to their
involvement with risk mitigation.
Following the opening remarks, Dr. Ehrmann asked Work Group II members for
their reactions to the presentation, particularly on whether they felt the
pilot process was working and whether they had any comments regarding the
evolution from risk assessment to risk mitigation process.
One member requested that EPA clarify how the timeframe for review would
change based on the complexity of the chemical. Ms. Rossi commented that
the timeframe for the preliminary risk assessment would remain the same and
may even improve as EPA gets used to conducting and presenting the preliminary
risk assessments. She explained that the 90-day timeframe for risk refinement
might or might not be sufficient depending upon the number of Monte-Carlo
modeling runs required to identify the risk drivers.
Another individual asked when the results on residential and drinking water
risk would be available. Ms. Rossi responded that the revised risk assessments
include that information. Stephen Johnson, Acting Deputy Assistant Administrator,
OPPTS, EPA, clarified that, early on, for some of the preliminary risk
assessments, ecological and worker risk were not included. However now, he
noted, these risk assessment issues have been integrated where previously
A member commented that, based on the description of the elements of Phase
5, it seemed as though there were three rounds of public comments. Ms. Rossi
responded that they hoped that the focus in Phase 5 would be on risk mitigation.
She added that when the technical briefing takes place there will be a document
called, Response to Comments, so there will be an opportunity to view
the Agency's responses and how they impact the risk assessment. Dr. Ehrmann
added that the group would discuss risk management tomorrow under transitional
issues, at which point there would be an opportunity for Work Group II members
to comment in more detail on what happens between Phases 4 and 5 and the
linkage between risk assessment and management.
An individual requested clarification on how EPA determines the level to
which the risk assessment is refined. Ms. Rossi explained that the risk
assessment process starts with a Tier I assessment. If risk is acceptable
at that point, she stated that no additional levels of assessment would be
required. Ms. Rossi added that there would be various levels of risk assessment
required, as exemplified by the Tier 4 risk assessment of AZM. On a related
issue, the individual expressed concern about the potential impact of future
cumulative risk assessments on the level of risk posed by one chemical. Ms.
Rossi commented that EPA is clear about reserving the right to reevaluate
risk based upon the results of the cumulative risk assessment.
One member requested clarification on when the draft Reregistration Eligibility
Decision (RED) was issued in the sequence of Phases. Ms. Rossi stated that
the draft RED was issued at the end of Phase 5.
Several Work Group II members wanted to know who at EPA and USDA was involved
in different parts of the review process. One individual was interested in
how the contact person at USDA was identified and how they used information
from the crop profiles. Mr. Jennings explained that a representative of USDA,
himself, Therese Murtag, or others, uses the crop profile to determine which
states are important for the chemical in question. From that information,
the state liaison is identified and they direct USDA to the expert within
the state. He stated that USDA then coordinates with the expert on the timing
of the review. The individual was also interested in the number of reviewers
from the Agricultural Research Service (ARS.) Mr. Jennings stated that there
were five or six reviewers, depending upon the number of crops. He explained
that they focus on the top three risk drivers. Another individual asked whom
at DHHS took part in the review process. Marcia Mulkey, Director, OPP/EPA,
responded that there were some changes in DHHS and it was difficult to provide
that information at this time. The individual then asked who at USDA was
involved with public health issues. Mr. Jennings stated that Teung Chin was
the USDA representative.
One member requested that EPA comment on their plans to formalize the pilot
process. Ms. Rossi responded that, while not codified in the Federal Register,
the practices outlined in the pilot process had become a way of doing business
for EPA and USDA. She observed that much of the pilot process could be applied
to other pesticides. Mr. Aidala asked the member for his recommendation on
the pilot project. He added that the issue is open and suggested that this
could be a useful subject for future TRAC meetings. The member proposed that
EPA consider an official Federal Register notice process to institutionalize
the pilot process with the aim of increasing the predictability of the review
process. Another member agreed and added that it was necessary to formalize
the process because it has budgetary implications.
A member added that risk "drivers" were still the key issue. Ms. Rossi suggested
that the term "risk contributor" reflected more accurately the concept of
a pesticide contributing significantly to the risk cup as determined by
consumption or use. The example used by the member to clarify their concern
was a pesticide whose use on a consumable product represented a significant
risk, while its other uses did not contribute measurably to the risk cup.
The members wanted to know how EPA and USDA would preserve the less risky
uses in this case. Ms. Rossi explained that this type of circumstance could
be addressed within the 60-day comment period where EPA would focus first
on the risk "driver" but not to the exclusion of the other uses. She also
noted that identifying the risk contributors is the first step to determining
risk mitigation measures and that, while looking at the overall risk and
potential risk mitigation, EPA would begin by isolating which uses were causing
the problem. Mr. Jennings clarified that USDA would begin by reviewing the
data with EPA to make sure that they were using the best available data,
such as crop profiles, for their evaluation. Using the Land Grant Universities,
USDA would then focus their efforts on the risk "drivers" and might not address
all uses on every commodity. Keith Pitts clarified that, while USDA looks
at all contributors to the risk cup, it will prioritize significant risk
contributors when identified. He added that the use of data from crop profiles
would assure that commodities are addressed appropriately.
Another individual was interested in what EPA and USDA had learned from the
intergovernmental review process on organophosphates regarding staff skills
and the division of labor. Ms. Rossi responded that they had learned that
it would be helpful to involve the Land Grant Universities earlier on in
the process when the reregistration review is initiated. Mr. Jennings observed
that there was a need to become more familiar with the worker and ecological
risk elements of the risk assessment process and suggested that was an
appropriate focus for an EPA workshop this summer.
One member wanted to know more about the adequacy of the 60-day comment period.
Ms. Rossi indicated that initially the 60-day comment period was a challenge,
and while they have thought about the need for more time, the timeframe might
become more reasonable as the process of conducting preliminary risk assessments
Other members were interested in public access to how USDA addresses comments
received during the 60-day period. They observed that major and minor uses
were handled differently and indicated that it would be valuable to be able
to access comments and responses via the Internet on a website. Mr. Jennings
responded that this idea could be considered, but commented that the information
would likely be posted after decisions were made.
Several individuals were concerned about when cumulative risk assessment
would be addressed by the TRAC. One member felt it would be beneficial to
have a preview of preliminary thoughts on the methodology proposed for cumulative
risk assessment to anticipate the potential impact of the Food Quality Protection
Act (FQPA) and help focus research agendas on appropriate alternatives. Ms.
Mulkey commented that there is a need for both thorough scientific review
of the methodology and for public input. She explained that the methodology
is currently undergoing internal peer review and that the Scientific Advisory
Panel (SAP) will review the proposed methodology in July 1999. Ms. Mulkey
noted that, following the SAP review, EPA expects to initiate the public
comment process. Mr. Jennings added that Work Group II members would address
more on transition strategies in tomorrow's session and that USDA needs to
be more prepared with alternatives before fully addressing cumulative risk.
One individual inquired if, after refining the risk assessment and identifying
risk "drivers," EPA anticipated proposing risk mitigation measures if risk
"drivers" remain a concern? Ms. Rossi explained that, in the revised risk
assessment and the overview document, EPA would discuss the risk contributors
and how to potentially address the risk. She reiterated that public participation
is designed to start the discussion on risk management and mitigation. The
individual asked for some indication of what EPA might propose to address
risk exceedances. Ms. Rossi stated that measures might include limiting the
reentry period and personal safety equipment.
A member requested clarification from USDA on whether, in addition to information
on the use and percent of crop treated, the potential for health effects
was considered. Mr. Jennings responded that there is a parallel effort to
address exposure and those issues are addressed by the Land Grant Universities.
Following the discussion on the organophosphate pilot process, Dr. Ehrmann
turned to Ms. Rossi to begin the presentation on the updated risk assessment
Updated Dietary Risk Assessment for Azinphos-Methyl
Ms. Rossi began the presentation by explaining that she and other EPA staff
intended to describe and explain the AZM acute dietary risk assessment and
discuss possible additional data and refinements that could modify the results
of the risk assessment. She stressed that the dietary risk assessment was
a "work in progress," and that USDA is still conducting its review of the
assessment, the methodology is still being refined, and the data used in
the assessment is being examined. Ms Rossi explained that they chose to use
AZM for the example because it represents a complex dietary assessment of
a pesticide that is used on many crops, some of which are commodities commonly
eaten by children. In addition, she noted that in this example EPA was able
to show advances in a methodology using PDP data and the revisions based
on the best available data. Ms. Rossi also commented that the purpose of
the presentation was to provide an understanding of the risk assessment process
and to highlight some of the issues they are dealing with. She stated that
the AZM risk assessment has not been shared with anyone outside the federal
Ms. Rossi then introduced key members of the health risk assessment team
for AZM and described their roles in the process as follows: Barry O'Keefe,
Chemical Review Manager; Richard Dumas, Team Leader; Michael Metzger, Chemist,
Health Effects Division (HED); Felicia Fort, Residue Chemist; Cathy Eiden,
Chemist; Jess Rowland, Toxicologist; Tom Keily, Economist; and Neil Anderson,
After the introductions, Ms. Rossi made a few additional comments about the
presentation. She referenced the copies of the slides on the Acute Dietary
Risk Assessment Methodology and the paper explaining the use of data
in the Monte Carlo analysis titled, Explanation of Data Used in the Monte
Carlo Analysis (both documents are presented in Docket # OPP00537.) Ms.
Rossi requested input from Work Group II members on the content of the paper
and whether the presentation improved the transparency of the process. She
provided the group with some background on the preliminary risk assessment
which indicated that there were acute dietary risks of concern based on a
non-probabilistic model, Dietary Risk Evaluation System (DRES), tolerance
level residues, 100% crop treated, and 1977-78 USDA consumption data. Ms.
Rossi explained that the Agency initiated the 60-day public comment period
on the preliminary assessment and received approximately 15 comments addressing
AZM. She noted that the registrants felt the Agency should incorporate data
in development, and public interest groups were concerned about how the 10X
factor was applied and prompted the Agency to take action based in the results
of the preliminary assessment. Growers raised a series of concerns about
the potential negative impact of the risk assessment on apples, cherries
Based on these comments, Ms. Rossi explained that the Agency revised the
human health risk assessment in February and sent it to USDA for comments.
She noted that the revised assessment included the Monte Carlo probabilistic
model, monitoring data from PDP and the Food and Drug Administration (FDA),
percent crop treated data, and updated USDA consumption data from 1989-91.
Ms. Rossi summarized by stating that the revised risk assessment represents
a substantial amount of progress towards meaningful, scientifically-sound
risk assessments on which to base regulation. She then introduced Rich Dumas
for an overview of the use of AZM, followed by a presentation from Dr. Michael
Metzger on the dietary risk assessment.
Mr. Dumas stated that AZM was first registered for food use in 1959 and it
is currently registered for use on about 50 foods. He explained that the
Agency gets its use information from the USDA/National Agricultural Statistics
Service (NASS) and others, including registrants and growers. In the case
of AZM, Mr. Dumas indicated that most of the data were from the USDA. For
additional information, he referred Work Group II members to a paper recently
completed by the Agency on pesticide use policy. This policy includes sources
of use data, how estimates are developed, and how the Agency uses these estimates
in risk assessments. Mr. Dumas then summarized some of the statistics on
AZM, including the fact that an average amount of two million pounds of AZM
are applied annually in different amounts on fruit trees, nut crops, and
cotton. He added that some of the food crops for which a high percent (50
percent or more) of the crop is treated include apples, pears and cherries.
Fruit crops for which less than 25 percent of the crop is treated include
blueberries, almonds, pistachios, and cranberries. Mr. Dumas summarized some
of the public comments and introduced Dr. Metzger for a detailed description
of the acute dietary risk assessment.
Dr. Metzger presented the AZM Case Study using a set of slides titled, Acute
Dietary Risk Assessment Methodology, a copy of which is presented in
Docket # OPP00537. In his presentation he reiterated much of what Ms. Rossi
and Mr. Dumas included in their opening statements on the background and
use of AZM, the preliminary risk assessment, public input, and the status
of the review of the refined dietary risk assessment. He then reviewed the
basic risk equation and explained the values used for the variables in the
risk equation, including hazard (toxicity), uncertainty factors, and exposure
based on consumption and residues. Dr. Metzger explained that, for the
uncertainty factor, based on a complete toxicity database, the analysis of
special sensitivity of infants and children supported the removal of the
FQPA 10X safety factor. However, he noted that, because of the lack of a
no observed adverse effect level (NOAEL), the Agency decided to apply a safety
factor of 3X. The resulting uncertainty factor totaled 300X.
Dr. Metzger then explained that the Agency considered two types of dietary
risk assessments, non-probabilistic and probabilistic, and decided to apply
the probabilistic dietary Exposure Evaluation Model (DEEMTM) Monte
Carlo method for the acute dietary risk assessment of AZM. He described how
the model works and explained how a new analytical method was used to adjust
composite PDP data to reflect single servings. He noted that the method is
being modified to minimize over-estimations, and it is undergoing additional
internal review by EPA and USDA, as well as by external peers. In addition,
the method will be considered by the Science Advisory Board (SAB) in May
1999. Dr. Metzger also explained what was used for residue data (PDP and
FDA surveillance monitoring data) from nine commodity groups. He then presented
a comparison of risk estimates (percent of the reference dose (RfD)) for
food from the preliminary risk assessment and the later revised assessments,
and stated that the major risk drivers were determined to be apples, peaches,
pears, and cherries. Dr. Metzger also highlighted the improvements in the
refined risk assessment since the preliminary assessment. He summarized his
remarks by reiterating that the case study of AZM was a "work in progress."
Ms. Rossi commented on some other data refinements and related issues. She
stated that there were additional data in the pipeline, some of which were
submitted and included in the study, and some of which are due. She also
commented that there are some new percent of crop treated and single-serving
data included in the study and that additional data from an apple processing
and cherry study are expected soon. Ms. Rossi stated that EPA would incorporate
new, improved data, as they become available.
Dr. Metzger concluded with some comments on outstanding issues. He noted
that there are a series of questions on the data inputs to the model, including
calculation of use of estimated maximum percent of crop treated and decomposited
distribution, and documenting methods and standard operating procedures.
He also noted that there are questions about the output of the model such
as whether the 99.9th percentile results are driven by outliers,
conducting additional sensitivity analysis, and providing transparency and
clarity in risk characterization.
Following the presentation, Dr. Ehrmann invited clarifying questions from
the group. The questions and responses are summarized below:
What is the status of additional consumption data for infants less than one
year in age? The data for infants from 0 to 6 months are forthcoming.
In slide # 30 - Residue Data Used, what is the difference between a "range
in field trial data" and "average field trial data?" There is greater mixing
for nuts than there is for onions and cabbage.
Is the consumption data disaggregated, especially for children (e.g., raw
or processed)? The data are disaggregated to a large extent in the
DEEMTM system, as canned, cooked, or otherwise processed.
In slide # 31- AZM Analysis to Date, clarify the meaning of current assessment
of 105 percent for infants less than 1 year old with an uncertainty factor
of 300X, relative to a rat's response of lower than 1.0 milligrams per kilogram
per day (mg/kgBW/day.) It was explained that it would take 300 times the
dose to see an effect in an animal.
How does EPA intend to integrate the results of the Agency's recently completed
paper on pesticide use? EPA will address the paper in the same way they address
other policy papers by taking comment and evaluating the impact of the comments
on the paper.
In slide # 27 - Residue Data, it is not clear whether composited data are
used based on a percentage of detectable residues or whether there are more
or less than 30 detectable residues. It was explained that 30 detectable
residues represent a small percent.
How many subjects took part in the human oral study submitted on 3/22/99?
There were over 60 people in the study.
Why do the results of the EPA risk assessment differ from those of the
Environmental Working Group (EWG)? It was noted that the EWG report would
have to be reviewed to address this question.
Is an uncertainty factor of 300X used because the relative sensitivity of
animals and humans to pesticides is unknown? The response was affirmative.
In slide # 22 - Using Monitoring Data in the Acute Dietary Risk Assessment,
is Congress going to continue to support the PDP program? It was explained
that PDP data are a priority to both EPA and USDA, and that funding for PDP
single serving, drinking water residues, meat, poultry, and eggs was requested
as part of the 2000 budget for USDA.
Is there a guideline for requiring a NOAEL? A NOAEL is not a requirement
but, because there was not NOAEL, EPA decided to apply a 3X uncertainty factor
in this case.
Were there any data outliers in the composite data? Yes there were. Some
were higher and lower than the composite value. Some might have been over
the tolerance level.
Has the work that the state of California has done on worker risk been factored
into the risk assessment of AZM? Yes, while the results of the worker risk
element of the risk analysis were not presented, EPA has been working closely
with the state of California on this and worker risk has been factored into
the risk evaluation.
Following the questions of clarification, Work Group II members continued
with discussion on the presentation. Several members commented that the AZM
study was a good example of risk assessment refinement and that the presentation
was clear and helpful.
One member felt there was a need for additional clarification of slide #
31 and the current assessment result of 105 percent for infants under 1 year
in age in the 99.9 percentile. She interpreted this result to mean that AZM
is 5 percent over the risk cup and wanted to know what the actual impact
of this result would be on numbers of children at risk. Ms. Mulkey explained
that EPA has struggled with the public health significance of a threshold
like the 99.9 percentile of estimated daily exposure (a proportion of the
population for which exposure to a specific level of pesticide residue must
be safe,) and noted that they tried to address this issue more clearly in
the EPA paper titled, Choosing a Percentile of Acute Dietary Exposure
as a Threshold of Regulatory Concern (presented in Docket # OPP00537.)
Mr. Johnson confirmed that 105 percent represents an unacceptable risk. However,
he noted that this result also prompts EPA to look carefully at the exceedance
and evaluate whether there are forthcoming data and other outstanding issues
that could alter this result and bring the value within the risk cup.
The member then asked for clarification on why 105 percent represents
unacceptable risk when 100 percent is acceptable. Mr. Johnson responded that
it is difficult to answer a statistical question like this in plain English.
He noted that the statisticians have indicated that they cannot really say
"in plain English" what the difference is. Mr. Jennings added that USDA wrestled
with the question of what the results of the Monte Carlo analysis mean in
the real world, or how the results would be reflected in the actual population,
on a daily basis. And, while he feels they are not yet sure what is actually
happening within the population at the 99.9 or other percentiles, they are
evaluating the Monte Carlo modeling output closely. He noted that modeling
was a good tool, but cautioned members not to try and over-interpret the
One individual commented on the importance of finding acute hazard data as
a benchmark to the assessment of safety factors. In this context they questioned
the need for an acute "gavage" study when divided doses given over time yield
lower peak levels than a "gavage" dose. Ms. Rossi noted that this was a good
question that needs some additional thought.
Another member expressed concern that all of the refinements to the risk
assessment of AZM resulted in lowering the level of risk. The member was
also not comfortable with the removal of the FQPA 10X safety factor for infants
and children without a developmental neurotoxicity (DNT) study. She felt
that the argument for not requiring the DNT study was out of date, and commented
that EPA would not find sensitivities in children and infants if they do
not look for them. The member was also confused about the emphasis on how,
with PDP data, the Agency feels they can assure safe food when at the same
time they have no confidence in the data outliers. In addition, she was concerned
that EPA indicated that they would not address all of the organophosphates
by the August 1999 deadline. Mr. Aidala acknowledged these concerns and commented
that the efforts to refine the risk assessments were designed to clarify
the "real" exposure, and that through risk refinement the level of risk may
decrease or increase. He observed that, commonly, if the original risk evaluation
was conservative, the results of refined assessments would tend to decrease.
An individual requested clarification on the guidelines on specific percentiles
used in these risk assessments, like the 99.9 percentile discussed in previous
TRAC meetings. Mr. Jennings commented that they have less confidence in
consumption data outside the 95th percentile because there are
fewer data points. The member felt it would be helpful for comparison to
see the results of different modeling runs at the different percentiles.
Ms. Mulkey clarified that EPA evaluates all of the available consumption
data and referred to the EPA paper on choosing the percentile of acute dietary
exposure for more details. Ms. Rossi added that the data set included exposure
data and that EPA looked at 100 percent of the exposure data and looked for
data outliers, which they have not found.
A member was not comfortable with what she saw as a lack of concern on the
part of EPA and USDA about the potential for acute risk that could vary and
increase based on factors like unusually high pest infestation that might
require increased pesticide application. It was explained that EPA tried
to address possibilities like this by assuming the maximum percent of crop
treated. The member observed that, even with this assumption for acute dietary
risk, it was still unclear how the risk would change with the addition of
cumulative risk, risk imposed by the use of additional organophosphates,
ecological and worker risks. Mr. Aidala agreed that there is more work to
do and that he hoped they would address some of these concerns in the
presentation on bensulide. Another member added that the understanding of
"real" risk could also change based on other factors like additional data
and the results of USDA's review of the refined assessment.
One individual observed that the Agency, in its review of end point selection
since the passage of FQPA, decided to base its selection on biological
significance in the absence of statistically significant data. Ms. Rossi
clarified that the Agency began reevaluating all of the organophosphates
last July as part of their reassessment for consistency, doses, etc., and
that they base their evaluation of effects on statistical and biological
Another individual expressed concern about 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. Ms. Rossi noted that, as information on risk assessment is published,
the Agency intends to address the potential impact of additional data, including
the possibility of major refinements to the risk assessment. Mr. Aidala supported
Ms. Rossi's response and added that it will be clear what the Agency does
when additional data is received and when they have determined that there
is enough data on which to base a decision. He acknowledged that there is
always a tension between waiting for more information and the need to make
decisions. Mr. Aidala suggested that it would be valuable to the Agency to
hear from Work Group II members on what they feel is "enough data."
After the discussion on the AZM presentation, Dr. Ehrmann introduced Ms.
Rossi for an overview of the presentation on the "Dry Run" of the technical
briefing on bensulide.
"Dry Run" Technical Briefing for Bensulide
Ms. Rossi explained that the Agency and the Department are proposing to hold
what are called "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.
She noted that the technical briefings would be open to the public and announced
in the Federal Register approximately two weeks prior to the briefing. Ms.
Rossi noted that, in preparing the example briefing documents on bensulide,
the Agency made an effort to present the information in a clear and concise
manner to enable a wide audience to understand the risk assessment to allow
for the fullest participation in the risk management decisions. She requested
guidance from Work Group members on aspects of the presentation including
the title of the technical briefings, the overview and summary documents
prepared for the technical briefing, and the general content and approach
of the briefings. Ms. Rossi suggested that, in its evaluation, the Work Group
consider the following questions:
Do the overview and summary documents provide a clearer understanding of
the risk assessment?
Should the technical briefing be a walk-through of these documents? If so,
in what level of detail and should the focus be only on the areas where the
level of risk concern is exceeded?
What is the most effective way to announce the briefing and assure that
interested stakeholders are notified?
Ms. Rossi then introduced the team members who worked on the bensulide review:
Dr. Kitt Farwell, Toxicologist; Jeff Dawson, Chemist, evaluating worker exposure
and risk; Loan Phan, Chemical Review Manager; and Jack Housenger, Associate
Director, Special Review and Reregistration Division, and presenter. She
noted that the presentation would review the human health assessment including
dietary, residential, worker, and ecological risk.
Mr. Housenger provided the group with an overview of the technical briefing.
Details about his presentation, including a copy of the slides for the
presentation, and the Bensulide Summary and Overview of Bensulide
Risk Assessment documents, are presented in Docket # OPP00537.
Mr. Housenger began with some background on bensulide. He noted that it was
one of the first nine organophosphate risk assessments released to the public
in August 1998. In addition, he stated that it is the only organophosphate
herbicide, and, like other organophosphates, it causes cholinesterase inhibition.
The public commented on the risk assessment, the assessment was modified,
and USDA provided their comments to the Agency. The USDA comments were
incorporated in the documents presented at this meeting for comment. He explained
that the public comments on bensulide focused on the dermal absorption value
and the duration of exposure for handlers and assumptions used in the
occupational and residential risk assessment. Additional comments addressed
various aspects of the 9 science policy issues.
Mr. Housenger explained that the Agency assessed both the acute and chronic
dietary risk to bensulide using the DRES model and worst case assumptions.
He described how the endpoints for each assessment were selected and stated
that an uncertainty factor of 100 was applied for each. He noted that the
FQPA safety factor was removed because there was no increase in sensitivities
to infants and children. He commented that the assessments will be refined
prior to the cumulative risk assessment with information on the percent of
crop treated, anticipated residue values from monitoring or field trial data,
and using the DEEMMT model. He explained that, because there are
no monitoring data for bensulide in drinking water, concentrations were estimated
using a model called PRZM EXAMS. The modeling results show that acute and
chronic exposures from contaminated drinking water are not expected; however,
contaminated drinking water from a surface water source may pose a chronic
risk concern, particularly from the application of bensulide to turf.
Mr. Housenger then detailed how occupational and residential risk assessments
were conducted for bensulide. He explained that occupational and residential
risk assessments consider all non-dietary exposures which are characterized
as handler and post application exposures. These types of exposures include
mixing/loading or applying pesticides, entering treated fields to harvest
crops, or working in the yard after treating the lawn with pesticides. From
these practices, Mr. Housenger noted that individuals might be exposed dermally,
by inhaling vapors or dust, and children might ingest the pesticide orally
after playing on a treated lawn. He stated that, for bensulide, there were
four scenarios for handler and post application exposure. Mr. Housenger explained
that these categories were further divided into 39 short-term exposure scenarios
and 35 intermediate-term scenarios.
For the presentation, he discussed only short-term exposures, and how the
target margin of exposure (MOE) was reached using what levels of protection.
Mr. Housenger then presented an example of how an actual dose calculation
was made for the short-term dermal risk assessment for bensulide. Following
this example, he summarized some of the issues for the handler risk assessment,
including: whether an intermediate-term risk assessment should be performed;
whether there should be a label restriction restricting the use of bensulide
on golf tees and greens; and restricting the application of bensulide by
air, in greenhouses, and on sod farms. He then briefly addressed post application
scenarios and some of the considerations made in assessing that risk. The
results of the risk assessments indicate that there is little concern for
exposure in agricultural scenarios, but for turf there is a concern for both
workers entering treated areas and for adults and children exposed to treated
lawns. Mr. Housenger also noted that EPA conducted an ecological risk assessment
which also points to concerns largely from the use of bensulide on turf.
He provided the group with an idea of how EPA might address the concerns
raised in the risk assessment prior to the next TRAC meeting. Mr. Housenger
closed the presentation with the statement that the next phase in the process
is the public discussion on risk management options, which should focus on
the use of bensulide on turf.
After the presentation on the technical briefing, Dr. Ehrmann asked Work
Group II members to comment on the content, approach and format of the briefing.
Before the discussion began, Mr. Aidala explained that, historically, elements
of the preceding presentation were addressed in the development of the RED.
However, he indicated that the Agency and the Department want to expand the
public participation rate by condensing the results of the risk assessment
in the overview and the summary, and including an oral presentation of the
information. He asked the group to consider if whether the technical briefing
was worth doing in every instance, or on a selected basis? Ms. Rossi added
that the key reason for the technical briefings was to establish a basis
of common understanding of what the risk assessment says. Ms. Mulkey also
noted that the technical briefings were also designed to make the risk
assessments more accessible in response to comments from grower groups and
others that the to 60-day comment period was not sufficient to cover the
density of information included in the risk assessments.
Many members felt the presentation was informative and effective. It was
noted that a clear oral presentation of a complicated risk assessment was
very helpful. Several individuals commented that the content of the technical
briefing was appropriate. Some additional suggestions are summarized below:
Consider presenting some of the material in tabular form to allow for comparison.
Make the information available on the Internet and foster two-way communication.
Improving access to the information and input will be beneficial to state
agencies and growers.
Include information on incident data and highlight where worker exposure
is a problem.
The impact of pesticide drift should be addressed and is key in the risk
There is a need to perform a Tier 4 risk assessment on all chemicals without
using assumptions because the degree of risk refinement necessary to maintain
safe food is still unknown.
It would be helpful to have the overview and summary documents available
as soon as possible and sometime within the 60-day comment period on the
revised risk assessment, for side-by-side comparison with the risk assessment
Another individual commented that some of the assumptions on handling bensulide
were not correct. Specifically, she noted that bensulide is applied before
growth and water is used to move the pesticide into the soil. She stressed
the importance of communicating with the registrant and the users to obtain
accurate information on application and the potential for exposure.
A member observed that the evaluation of occupational risks was based on
the assumption that all handlers comply 100 percent with personal protective
measures. He asked for clarification on how the Agency addressed actual exposure
to handlers and non-handlers during application, including enforcement measures
to insure compliance. Ms. Mulkey responded that the Agency addresses
non-compliance by focusing on compliance. She indicated that, while states
take the lead role in enforcement, EPA plays a role also and they plan to
focus increased attention on worker protection this year. Ms. Mulkey commented
that this is an opportunity to increase compliance with labels. Mr. Dawson
added that EPA is also trying to integrate into the compliance picture more
information from residential exposure by reevaluating the residential standard
operating procedures document and through monitoring studies. Ms. Rossi also
stated that those kinds of considerations are evaluated when considering
risk mitigation measures. In addition, it was noted that if a consistent
pattern of misuse is observed, the risk is evaluated.
At the suggestion of gathering additional data to refine risk, one participant
asked EPA to clarify its approach to addressing additional data needs and
defining when there are enough data for decision-making on chemicals. Ms.
Rossi commented that there is a substantial database because chemicals have
been undergoing reregistration for a long time. She stated that, while there
will always be a need for additional data, based on the substantial database,
EPA is able to closely approximate "real" risk. The member acknowledged her
explanation, but noted that the risk assessment process is dynamic and, as
exemplified in the bensulide study, specific core data needs are being identified
on a regular basis. He felt that people should have the opportunity to provide
additional data within a reasonable timeframe when data needs are identified.
Mr. Aidala explained the importance of understanding the context in which
the data need is identified. For instance, he suggested that data should
be collected when core data are missing, as opposed to collecting additional
data that would be useful and could make a difference in 3 years. He suggested
that, as a general rule, people should be able to collect additional data
in the proper context and when it makes sense to do so. Mr. Johnson added
that this issue has been an issue since the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) was passed and TRAC was not provided a clear
path on how to deal with it. He noted that data call-ins are used frequently,
but call-ins could be a waste of time if required for all situations. He
urged Work Group members to think about where to draw the line on data
requirements and provide EPA with their suggestions as to EPA's approach,
including ideas on setting timeframes for the receipt of additional data.
Several participants were concerned about the discussion on potentially expanding
the timeframe for individual chemicals to accommodate additional data collection,
and stressed that EPA should stick to their established timetables. Another
member was supportive of the technical briefing as a means for EPA and USDA
to get input on the risk assessment prior to the next step of decision-making.
It was helpful to him to have some clarity on what EPA does and does not
know, however he felt the presentation was lacking because it did not define
the extent to which EPA operates with uncertainty. In particular, he suggested
that EPA should clarify its assumption of 100 percent compliance in the handling
of bensulide and provide information on the impact to the public if 100 percent
compliance is not achieved. He noted several other issues of uncertainty
such as drift and labor enforcement, and asked about other areas of uncertainty
about which the public should know. As another example, he referenced EPA's
apparent assumption that pesticides are necessary to achieve pest management
goals, when at other TRAC meetings it was implied that a reliance on pesticides
is not necessary to achieve these goals. He suggested that he would have
more confidence if the uncertainties were identified and explored in combination
with the evaluation of pesticide alternatives.
Gerber Agriculture Program Presentation
Jan Relford, Senior Vice President, Research, Development and Quality Assurance,
Gerber Products Company, presented an overview of the Gerber Agricultural
Program. A copy of the slides for his presentation are in Docket # OPP00537.
Mr. Relford began his presentation by stating that the goal of Gerber pest
management systems is to eliminate residues from the finished product. He
explained that management structures were developed throughout the company
to support this goal and the company adopted a pesticide philosophy to maximize
"no pesticide use" and shift as much production as possible to low risk
biological materials as rapidly as possible. Further, risk and safety criteria
are clearly defined and the risk posed by pesticides is quantitatively
characterized. In addition, Gerber has initiated programs to modify practices
that measurably reduce the risk of pesticide residue exposure. Mr. Relford
also explained that through the Agricultural Research Group, Gerber plans
and coordinates field trials for new technologies. Similarly, through the
crop management associations, they scout crops and provide detailed supervision
and implementation of Gerber practices in the field.
With this as a background on the company, Mr. Relford described how Gerber
evaluates risk. He outlined a hazard analysis of control points including
the soil, seeds, plants, growth, harvest and produce processing, and commented
that different equipment is needed at different control points to insure
that there is no chemical detection. Mr. Relford then summarized Gerber's
integrated pest management successes for 1998. Some of the highlights of
their program included: 100 percent of Michigan crops without organophosphates;
carrots with no organophosphates; and peas with no insecticides or fungicides
and most without herbicides. Mr. Relford also provided an overview of some
of their work with alternatives to organophosphates and carbamates used in
green bean production. He summarized his presentation by stating that Gerber
is making progress and that the progress is consumer-driven.
After the presentation, Work Group members were invited to ask questions
of clarification. One member asked if consumers know about the Gerber program?
Mr. Relford responded that consumers do not know about what Gerber does and
the company believes that people simply assume that the food is residual-free.
The member also inquired how farmers working with Gerber respond to a new
pest control program? Mr. Relford commented that Gerber generally approaches
farmers with alternative programs as a partnership. In response, farmers
are sometimes supportive and other times it is necessary to start with a
small example of the alternative to prove that it works and then move on
to requiring it for larger scale use. The member was encouraged by Gerber's
use of partnerships and stressed that partnerships help foster consumer trust
in the produce. Another individual commented that people learn from their
peers and recommended that USDA look for growers who are farming without
pesticides and urge them to teach others what they are doing.
Another individual asked whether growers for Gerber commit all of their crops
to Gerber. Mr. Relford explained that Gerber commits to a specified volume
of produce and certifies selected crops. It is then up to the grower to sell
A third member observed that custom growing for business is not always "the
rule of thumb." In addition, he noted that the public ultimately dictates
what the grower does and that, at this point, all customers do not demand
There were no comments from the public.
FRIDAY, April 9, 1999
Dr. Ehrmann opened the second day of the Work Group II meeting with a review
of the agenda for the day. The agenda topics included elements of transition,
a 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, and time for public comment. Dr. Ehrmann then turned
to Allen Jennings for the presentation on the elements of transition.
Elements of Transition
Mr. Jennings provided the group with an overview of the core elements of
a transition strategy. A copy of the slides used for his presentation are
in Docket # OPP00537. Mr. Jennings began his presentation by recognizing
some of the key staff involved with transition strategies including Therese
Murtagh, Wilfred Burr, and Susan Deatheridge. He stated that the purpose
of the presentation was to share USDA's current thinking on transition strategies
and to hear input from the Work Group on where the USDA should go next in
the process. Mr. Jennings noted that this was a new, open process for USDA,
one in which they hoped to see broad stakeholder involvement.
To orient the group, Mr. Jennings reviewed a list of considerations USDA
worked through to begin developing the strategy. One consideration was which
crops to address first and what criteria should be used to select the crops
(e.g., is the crop consumed in high quantities by infants and children?)
The next consideration was whether chemicals should be addressed individually
or by class, or in some other way? Another factor was how to state the goals
and measure progress on the transition strategy. Suggestions included measuring
the frequency and magnitude of residue detection, using the PDP or some other
program to routinely monitor some foods, and grower extension programs and
training. Current chemical uses were also a consideration, addressing issues
like what pests drive the use of selected chemicals. Alternative pest controls
represented an additional consideration, particularly how they fit into IPM
and resistance management and whether they were registered alternatives or
non-chemical approaches. Another consideration was future options such products
in the "pipeline" and other promising alternatives. A final consideration
was research and education needs including basic applied research needs,
the need for grower education, and incentive programs.
Mr. Jennings then described how some of the different stakeholders affected
by transition are and could be involved with transitional issues. He categorized
their involvement as action items, commitments and schedules. Some of USDA's
commitments included crop profile and pipeline databases, education and training
through the extension services, and transition strategies. EPA's responsibilities
included accelerated registration of alternatives through Sections 3, 24C,
and 18, and flexible regulatory strategy. Grower Organizations, Land Grant
Universities and Public Interest Groups could contribute technical expertise
to the process. Mr. Jennings then referenced a draft commodity list to ground
some of the ideas for transition strategies.
Keith Pitts added that, in addition to the budget from the TRAC process,
the USDA is planning a meeting to review the year 2000 budget to help evaluate
how it would best be applied to enhance USDA transition strategies.
After the opening remarks, Work Group II members asked clarifying questions
and provided comments on the presentation.
Some members commented on the approach to chemicals considered in the transition
strategy. They were concerned about the prospect of basing the approach on
one chemical, and suggested that, in the absence of the results of a cumulative
risk assessment, transitional strategies should address chemicals by class.
They felt that the approach should hinge on the results of cumulative risk
assessment and that proceeding otherwise would be like working in the dark.
One individual commented that, in the absence of the results of the cumulative
risk assessment, he was reluctant to stop using a pesticide until it was
proven to be problematic. Another member observed that there have been questions
about pesticides for years, and they hoped that there would be some interim
way to address the current uncertainty about the impact of pesticides that
would meet the needs of all. Mr. Jennings clarified that it is necessary
to start the transition process now, and it is the intention of the Department
to use a "chemical class" approach.
One member commented on alternative pest management tools, noting that farmers
are already applying many of the alternatives referenced by Mr. Jennings,
including moderating the pesticide spraying based on need, and other IPM
programs, because the alternatives are more economical. He suggested adding
"economical" as a criterion for alternative tools. Mr. Aidala commented that
the economics and practicality of the alternative are automatically considered.
Another member added that, in addition to economical, the criteria should
include "environmental" to help prevent further strain on biodiversity. Mr.
Aidala also stated that the Department and the Agency are trying to "look
at big picture" and are evaluating all factors including resistance. In this
regard, Mr. Aidala explained that EPA is meeting with grower groups and working
with the Department to identify what alternatives are available.
Another member expressed concern about USDA's request for help from stakeholders
outside the Department, such at the grower community, to make decisions on
risk management strategies. While he was supportive of soliciting information
on pesticide use from this and other communities, he cautioned against involving
them in the decision-making process because it could foster competition between
grower groups. Mr. Jennings explained that the Department is currently looking
at a commodity approach which they do not see contributing to grower competition.
He reiterated the need to get input on establishing a process now to assist
in the transition from reliance on one pesticide to another that may run
into problems later. Mr. Pitts added that USDA and EPA are trying to be proactive
and initiate a process to address transitions that will be required once
the cumulative assessments are completed.
An individual asked for clarification on whether, in the intergovernmental
review, all elements of risk assessment were reviewed. Mr. Jennings responded
affirmatively and explained that the review included the dietary, non-dietary
and ecological assessments.
It was unclear to some how public health considerations fit into the risk
assessment process. Mr. Jennings noted that the Department relies on the
DHHS to address public health issues. Another individual suggested that the
benefits of pesticide use to public health be addressed in the risk assessment
process and the Agency and the Department consider making allowances for
the benefits in the final determination of the risk cup. He noted that one
way of doing this would be to use exemptions where benefits exceed the risks.
The individual added that transition of pesticides in the urban environment
is driven by the market place and stressed the need for USDA to involve pesticide
professionals in this area when addressing transition and public health.
Mr. Jennings commented that this was a good point.
One member observed that there were different elements of transition, one
of which is regulatory transition. He noted that the elements of transition
also included economics, the environment, farmers and agriculture. The member
commented that it was necessary to view transition from the perspective of
the farmer regarding how they can stay in business while at the same time
making the necessary changes for transition. He suggested that USDA approach
transition from the perspective of the farmer and make sure they are poised
to support them in transition with economic, research and educational needs.
Another individual stated that there were barriers to adopting integrated
pest management (IPM) approaches which could play an effective part in
transition. He saw a need to provide better information about IPM to help
people overcome the inertia that operates against implementing them. He urged
USDA to consider how to make better use of limited funds to help overcome
Also in this regard, another member commented on the need for USDA to consider
pest management systems in addition to individual chemical replacements.
As an example, when looking at a benefits assessment of a nematode problem,
he saw the need to question farmers in the same region who do and do not
have a nematode problem, on their management systems, including what is being
done and why. With an understanding of the whole management system, a farmer
would then be better equipped to evaluate alternatives such as the need for
a softer chemical, different tilling methods or patterns, or other alternatives
to chemical response. Mr. Pitts commented that USDA considers this approach
and it is consistent with the definition of IPM.
An individual commented on the importance of viewing chemicals in terms of
how they fit into a broader resistance management strategy. He noted that
resistance differs from the way it was viewed in the past because of the
number of changes in industry and the environment. In particular, he felt
that changes in regulatory programs are driving towards a potential resistance
crisis in the next decade. He observed that resistance was last studied by
National Research Council (NRC) in 1986, at which time it was recommended
that USDA assemble experts to identify resistance drivers to prevent a regulatory
process that would accelerate the resistance problem. Mr. Pitts acknowledged
these concerns and stated that the Department is evaluating where they are
headed in this area. He commented that the Department is making an effort
to combine information from regional census projects, technical expertise
and how they regulate to help address this concern and they are asking NRC
for input. Another individual observed that industry could take the same
Several members stated that outline presented by Mr. Jennings was good. One
individual observed that transition meant moving away from certain chemicals
and reducing the use of others. In this regard, he stressed the need for
alternatives as well as a means to measure the progress and success of shifting
to the alternatives. Another member found it disturbing to hear the suggestion
that all organophosphates or other classes of chemicals might be cancelled.
She commented that, basing decisions on sound science might result in the
cancellation of some chemicals, while others would remain in use. In other
words, they felt that uncertainty goes both ways. In addition, she felt it
was important to look at reduction in frequency and use of chemicals as compared
to the potential impact of pesticide cancellations.
One individual acknowledged that limited resources challenged transition.
He felt that all TRAC members were committed to helping with transition by
supporting appropriations and operations necessary for transitional efforts.
In the interest of transparency, he also stressed the importance of stating
the goals of transition and how progress towards achieving the goals will
be measured. In addition, he requested clarification on who is taking the
lead in transition. Mr. Pitts added that EPA is looking to USDA for
recommendations and that EPA is in the lead. Mr. Aidala clarified that the
Agency and the Department are dividing the responsibilities of transition
based on who does what best. He commented that who is in the lead is for
others to decide. The member noted that clarity and definition of the process
would be helpful for all involved.
Presentation by Sarah Lynch, World Wildlife Fund
Following the discussion on the elements of transition, Sarah Lynch, WWF,
provided the group with an overview of a collaborative effort between the
WWF and the Wisconsin Potato and Vegetable Growers Association (WPVGA) to
address toxic loadings to the Great Lakes Basin. A copy of her slides is
presented in Docket # OPP00537. She explained that as these groups began
to focus on the problem of toxic loading they acknowledged that there was
an agro-environmental gridlock on the issue and that something needed to
be done to break the gridlock. In addition, Ms. Lynch noted that the group
agreed that shifting to biological IPM could be beneficial to both farmers
and the environment. To achieve the shift, they agreed that active farmer
participation was essential and it was necessary to establish some goals
and timetable in order to accelerate change. Ms. Lynch reviewed what WWF
and WPVGA considered to be critical elements of success, including setting
measurable targets and timetables, establishing a process for monitoring
progress towards meeting goals using a transparent, a credible measuring
system, and rewarding progress for meeting the goals. She then explained
that the groups established 1, 3, and 5-year goals for eliminating 11 high-risk
pesticides, and a 10-year goal for accelerating the adoption of biologically
based, lower risk IPM. Ms. Lynch also described how the growers and the
environmentalists decided to measure progress towards these goals.
With this information as background, Ms. Lynch then summarized the results
of the collaborative effort. She commented that after tracking the change
in pesticide usage between 1995 and 1997 it was apparent that there was a
25 percent reduction in toxicity units for 11 high-risk pesticides and a
20 percent reduction in toxicity units for all pesticides. Ms. Lynch commented
on the types of preventive practices used to achieve these reductions and
explained how to provide the incentive to use a diverse set of tools for
pest management WWF and the WPVGA established a point system which assigned
points to different categories of preventive practices. Using a series of
bar graphs, Ms. Lynch showed how much farmers are using different preventative
practices. She also summarized the 1998 external budget for the collaborative
effort, $278,000, and stated that it would take between $500,000 and $600,000
to "do the job right." Ms. Lynch closed her presentation with the comments
that it takes choices, confidence, consumers, and courage to succeed with
an effort like this. Work Group members were then invited to comment on her
The group asked some clarifying questions and commented on the estimated
budget for external funds. A summary of their comments is presented below:
Field research appears to represent a key component of the budget. How could
this need be addressed more broadly? There is a need to rechannel USDA research
activities to focus on the collaborative needs.
Does this mean a need for new funds or a shift in the focus of research?
It was noted that this is a tough question to answer.
Assuming additional funds were made available, are the proportional allocations
correct. The answer to this question was yes.
Is it possible to provide information on the financial return of this program
to the grower? It was explained that, given time and resources, this information
could be developed.
The time for University research is not included in the budget. The cost
of this component of the budget would likely increase to something like $200,000.
An estimate for the up front investment to initiate an effort like this is
not included in the budget. It was acknowledged that building the relationships
and confidence necessary for this effort was time consuming.
How much did it cost the growers to make the shift to IPM? It was noted that
the effort relied on people voting with their feet and the impetus was that
the shift was economically viable. Economic viability was viewed as an essential
and priority ingredient to success.
Were products labeled differently? It was explained that products were not
yet labeled differently.
Additional funding is necessary in other arenas, such as University Extension
EPA should focus less on the risk assessments and more on implementing the
use of less toxic pesticides. This kind of shift necessitates that industry
is more open-minded in their use of pesticides.
It is unclear whether this kind of collaborative approach, if it worked in
all circumstances, would be economically viable for all parties. It was suggested
by some that unless the system changed to selling an integrated product,
it would not be economically viable.
To some degree this is a philosophical discussion on the power of having
a shared a vision for agriculture in the U.S. While this is an important
discussion to have, it is also important to separate the discussion on philosophy
from the scientific policy issues.
Remember that consumer demand is a key driver in the selection of alternative
pest management. Consumers do not yet feel that they are provided enough
information on pesticide use to make informed choices. Agreeing on a way
to get adequate information to the consumer would harness economic forces.
Peter Robertson's Remarks
After the WWF presentation, Dr. Ehrmann introduced Peter Robertson, Acting
Deputy Administrator, EPA, for some general remarks. Mr. Robertson began
by explaining that both EPA and USDA agree that committing to the additional
time and meetings for the TRAC process is valuable. He explained that while
he has been coming up to speed on the process he has come to recognize that
TRAC has progressed because the members have been willing to stay at the
table and help EPA and USDA work through some very difficult issues. He thanked
USDA enormously for their help in the process and stated that without their
help the chance of success would be slim. Mr. Robertson stated that he was
proud of what members of the TRAC had accomplished and observed that they
had made major strides on the risk assessment process and on the nine science
policies. However, he also recognized that there are more issues to yet address,
some of which are being discussed at this meeting. Mr. Robertson recognized
that the ongoing efforts of TRAC members is key to the successful implementation
of FQPA. He noted that the next TRAC meeting was important, and that USDA
and EPA need input from this session on the agenda for that meeting to make
it what it should be. Mr. Robertson finished his remarks by stating that,
while he could not stay for the rest of the meeting, he had learned a lot
from what he had heard at this meeting.
Following Mr. Robertson's remarks, Dr. Ehrmann invited comments from the
workgroup. One member complimented EPA and USDA staff for all of their hard
work and progress on the risk assessment process and the science policies.
Mr. Robertson responded that he appreciated hearing that. Several members
cautioned that there were some dissenting voices on this opinion and some
TRAC members continued to be concerned about the reluctance of EPA to take
some concrete action on some of the pesticides, such as AZM, based on the
results of the risk assessments. Mr. Robertson explained that, while the
TRAC process is useful, there was no reluctance on the part of EPA to take
action. He observed that there might be differences of opinion on that and
the "proof will be in the pudding." Mr. Robertson commented that he hoped
the commenter would remain at the table to make sure the actions taken are
the best possible.
Another individual observed that some of the earlier comments on the challenges
facing farmers as a result of FQPA implementation served as an important
reminder that there are others watching as FQPA unfolds. In that regard,
he suggested thinking about the need to harmonize the international component
of FQPA implementation and how it will mesh with other related issues such
Brief Update on Nine Science Policies
Dr. Ehrmann introduced William Jordan for a brief update on the nine science
policies. Mr. Jordan referred the group to two background documents for the
presentation which were titled, Data for Refining Anticipated Residue
Estimates Used in Dietary Risk Assessments for Organophosphate Pesticides
(the "bridging" paper,) and Choosing a Percentile of Acute Dietary
Exposure as a Threshold of Regulatory Concern. He also referenced a copy
of the slides, which was titled, and Food Quality Protection Act TRAC
Science Policy Issues. All of the documents are presented in Docket #
OPP00537. Mr. Jordan provided the group with a status of the science policies.
He explained that there were a total of 19 papers for the nine science policy
issues, 10 of which have been issued, and one of which is final. He noted
that EPA might have to reschedule the completion dates for some of the remaining
papers. Mr. Jordan commented that, based on yesterday's discussion on the
99.9 percentile there was still some misunderstanding about where EPA sets
the point for decision-making on pesticide residues. He also commented on
the "bridging paper" on refining risk as it relates to the discussion on
transition and stressed the importance of understanding the tools that are
available for risk refinement.
Mr. Jordan acknowledged that, in some cases, it has taken EPA longer than
expected to get the work done on the science policy papers. However, he noted
that they would be busy over the next two months. They hope by the end of
April to issue papers on: the statistical manipulation on composite residues
and how to calculate decomposited values; the 10X FQPA safety factor; and
early assessments. In May, he noted that EPA hopes to make available four
additional papers on: approach to food exposure estimates; revised paper
on thresholds; aggregate risk; and cholinesterase end point considerations.
In addition, Mr. Jordan stated that EPA expects to issue a paper on human
studies, contingent on the results of the SAB review, in April or May. He
closed his presentation by thanking TRAC members for the thoughtful, comments
from like-minded groups that EPA has received through the public comment
Additional Discussion on the Organophosphate Pilot Process
The group continued its discussion on additional data and defining "how much
data is enough" in the risk assessment process. One member agreed that there
has to be some limit on the submission of additional data for the risk assessment
process. She advised that EPA view additional data in a fair way and accept
data within a reasonable timeframe that affects decisions on risk, including
data that should have been submitted or new data submitted because of new
requirements. In this regard, Mr. Aidala asked all TRAC members to consider
the parameters for additional data, such as the timing of submission and
the purpose of the additional data. Another individual felt there was enough
data and stressed the urgency for EPA to begin to make decisions on some
of the pesticides, such as AZM.
A member suggested allowing the registrant to provide additional input on
the risk assessment prior to the technical briefing to help assure the most
up-to-date information is used and "real" risk is represented. Ms. Mulkey
stated that EPA has historically struggled with the issue of when to integrate
registrants in the risk assessment process and whether they should be integrated
differently from other stakeholders. She explained that the intent of the
30-day error correction period was to provide for their input. She noted
that one of the issues is that other stakeholders could also contribute valuable
information just prior to the technical briefing. Another individual reiterated
her support of public disclosure now taking place in the tolerance reassessment
One member commented on the transition strategies presented by Mr. Jennings.
He felt that the listing was comprehensive and logical but that many of the
Land Grant Universities and farmers have been applying these ideas for years.
To him, the hard part of making decisions was yet to come.
Another individual expressed concern about how information on the risk assessment
is presented to the public in advance of a regulatory decision because of
the potential for negative public reaction. In addition, he felt that precedents
are set with the earlier releases and those chemicals may receive the brunt
of public reaction. He suggested that EPA build a mechanism to address these
concerns into the release and review process. Mr. Aidala acknowledged this
concern and asked TRAC members for input on how to properly balance the need
for public disclosure and concern about potential reactions to the information.
An individual commented that the idea of a technical briefing was good. She
added that she would like to see incident data included and expressed concern
that worker and ecological risk were not included as part of the briefing.
Ms. Rossi assured the member that future technical briefings would include
all elements of risk.
In a similar vein, another member commented that it was unclear when and
how worker safety issues were addressed in the context of risk management
and the phases of the pilot process. He wanted to know if, as with dietary
risk, input on worker safety issues was sought from the registrants and growers
in Phase 5 of the pilot process and how it was integrated with other information
on risk and risk mitigation to issue the final RED in Phase 6. In addition,
he wanted to know how USDA was involved in this process as it relates to
the drivers for risk mitigation. Ms. Rossi commented that historically when
REDs were issued all elements of risk were considered in determining mitigation
measures. She expected that the pilot process would work similarly. Ms. Rossi
also clarified that if risks are determined to be unacceptable the registrant
is consulted and a course for mitigation is discussed. In addition, she explained
that in Phase 5 of the pilot process USDA comes prepared with ideas for risk
mitigation. The member observed that the current process differs from the
previous process because DHHS and other public health representatives are
involved. Mr. Johnson added that the process differs from past practices
because the Agency is receiving input from many sources, not just registrants.
He noted that the intent of Phase 5 of the pilot process is to honor the
commitment to transparency while at the same time hearing from those who
wish to provide input. Mr. Jennings commented that the hope is to identify
the risk drivers so that the technical briefing and meetings with the growers
can focus on the worst first. He also recognized the need to balance the
process of addressing the endpoints of dietary risk as required by statute,
in addition to addressing ecological risk.
A member added that based on the substantial change observed in the results
of the risk assessment for AZM it might make sense to provide an additional
opportunity for registrant input in Phase 4 of the pilot process. As an example,
another individual commented that the accuracy of the technical briefing
on bensulide would have been improved if the registrant was given the opportunity
to provide additional information. Ms. Mulkey commented that registrants
generally provide additional information other than that required for error
correction in the 30-day error correction period. Ms. Rossi agreed and stated
that any additional data would have to be clearly rationalized.
For perspective, one member commented that worker risk is based on theory
rather than actual measurement. He also stated that education on how to use
pesticides could help to reduce the potential for worker risk.
Another member asked for the current status of the public health pest list.
They were also interested in the status of the Memorandum of Understanding
(MOU) between EPA and DHHS regarding public health issues. Ms. Mulkey responded
that EPA is working on both issues. She commented that she would have to
check on the status of the MOU for more details. Ms. Mulkey noted that the
list in draft form but there is some discussion on what to include on the
list. The member suggested that EPA and USDA consider including an update
on these issues, in addition to presenting information on benefits and risk,
at the next TRAC meeting.
Agenda Planning for the TRAC Meeting on April 27 28, 1999
A draft list of agenda ideas for the April 27 - 28, 1999 meeting was drawn
from the discussion at the meeting and used as a starting point for agenda
planning. The group considered the list and made some additional suggestions.
The resulting modified list of agenda ideas for the next TRAC meeting is
Data needs - timing
Review of data collection activities (and other relevant data)
Refining the Pilot Process
Update of Risk Assessments
Transition - mechanics of moving from risk assessment to risk management
- specific suggestions on process
Public health issues (invite the DHHS; discuss benefits)
International context/import issues
Report from Work Group II
Update on water and non-dietary risk.
It was suggested that TRAC members receive a copy of the agenda for the next
TRAC meeting as soon as possible to provide sufficient time to prepare for
the meeting. It was also suggested that the agenda and other meeting materials
be posted on the web prior to the April 27 - 28, 1999 meeting.
Bruce Bernard, SRA Consulting - complimented EPA and USDA on the
wide-ranging, balanced approach they took to addressing different subjects.
He felt that the TRAC process was valuable and suggested that the Agency
and the Department consider continuing the process. Mr. Bernard was supportive
of EPA and USDA using the best available science and expressed the hope that
they would continue to do so.
Dr. Ehrmann closed the meeting by thanking members for their time and commitment
to the process.
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