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OFFICE OF INSPECTOR GENERAL
Catalyst for Improving the Environment
Evaluation Report
Changes Needed to Improve
Public Confidence in
EPA's Implementation of the
Food Quality Protection Act
Report No. 2006-P-00003
October 19, 2005
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Report Contributors:
Laurie Adams
Jerri Dorsey
Gabrielle Fekete
Abbreviations
APA Administrative Procedure Act
DEEM Dietary Exposure Estimation Model
EPA Environmental Protection Agency
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FQPA Food Quality Protection Act
GAO Government Accountability Office
NRDC Natural Resources Defense Council
OIG Office of Inspector General
OPP Office of Pesticide Programs
ORD Office of Research and Development
Cover photo: The Food Quality Protection Act emphasized the need to protect children
from pesticides (EPA OIG photo).
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U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
2006-P-00003
October 19, 2005
Catalyst for Improving the Environment
Why We Did This Review
We initiated this review to
evaluate the Environmental
Protection Agency's (EPA's)
activities to implement the
Food Quality Protection Act
(FQPA) of 1996. We sought
to determine whether EPA
allows for sufficient public
participation in the pesticide
decision-making process.
Background
FQPA changed the way EPA
regulates pesticides. FQPA
emphasized the potential for
infants and children to be
especially sensitive to
pesticides and the need to
provide them adequate
protection. FQPA imposed
many new requirements on
EPA, including the need to
review and reregister older
pesticides to ensure they meet
newer standards.
Changes Needed to Improve Public Confidence in
EPA's Implementation of the Food Quality Protection Act
What We Found
This is the first in a series of planned reports on the Agency's FQPA
implementation efforts. To ensure adequate protection of children, FQPA
required EPA to make significant changes to the pesticide reregistration process.
Despite numerous changes to the process, internal and external stakeholders
expressed continued reservations over aspects of the process.
EPA allowed public comment periods when developing the Agency's major
FQPA science policy papers, and developed and implemented a public comment
policy for all pesticide reregistrations in 2002. Prior to this policy, however, the
Office of Pesticide Programs did not always solicit public comments prior to
issuance of final pesticide reregistration decisions. We believe EPA must ensure
that at least one public comment period is held prior to final pesticide
reregistration decisions. Providing opportunities for public participation is
important for increasing transparency, improving decision making, and increasing
overall public confidence.
Though EPA has an on-going research agenda related to the protection of
subgroups, OPP lacks a methodology to identify and assess major subgroups of
consumers, such as farm children, in the pesticide reregistration decision making
process. EPA should respond promptly and directly to requests and petitions from
external stakeholders. Such a methodology and responsiveness are needed to
improve public confidence.
For further information,
contact our Office of
Congressional and Public
Liaison at (202) 566-2391.
To view the full report,
click on the following link:
www.epa.aov/oia/reports/2006/
20051019-2006-P-00003.pdf
To view attachments to EPA's
response, click on:
www.epa.aov/oia/reports/2006/
20051019-2006-P-00003A.pdf
What We Recommend
We recommend that EPA's Office of Pesticide Programs allow at least one formal
public comment period prior to the issuance of final and interim reregistration
decisions. We recommend that the Office develop a defined methodology for
considering subgroups, and work with the Office of Research and Development to
continue to address these issues. We also recommend that EPA respond promptly
to requests and petitions from external stakeholders. EPA generally agreed with
the recommendations, although the Agency expressed concern that our report did
not sufficiently discuss their efforts. We made revisions when appropriate.
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^tDsx
I WASHINGTON, D.C. 20460
< JAflL \ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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OFFICE OF
INSPECTOR GENERAL
October 19, 2005
MEMORANDUM
SUBJECT:
Changes Needed to Improve Public Confidence in EPA's Implementation
of the Food Quality Protection Act
Report No. 2006-P-00003
FROM:
Jeffrey K. Harris /s/
Director for Program Evaluation, Cross Media Issues
TO:
Jim Jones
Director, Office of Pesticide Programs
This is a final report on the subject review conducted by the Office of Inspector General (OIG)
of the U.S. Environmental Protection Agency (EPA). This report contains findings that describe
the problems the OIG identified and corrective actions the OIG recommends. This report
represents the opinion of the OIG and the findings contained in this report do not necessarily
represent the final EPA position. Final determinations on matters in the report will be made by
EPA managers in accordance with established resolution procedures.
Action Required
In accordance with EPA Manual 2750, you are required to provide a written response to this
report within 90 days of the date of this report. You should include a corrective actions plan for
agreed upon actions, including milestone dates. We have no objections to the further release of
this report to the public. For your convenience, this report will be available at
http ://www. epa. gov/oi g/.
If you or your staff have any questions, please contact me at (202) 566-0831 or Jerri Dorsey,
Project Manager, at (919) 541-3601.
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Table of Contents
At a Glance
Chapters
1 Introduction 1
Purpose 1
Scope and Methodology 1
Results of Review 2
2 EPA and the Food Quality Protection Act 4
Pesticides in the United States 4
Food Quality Protection Act 5
OPP Made Substantial Changes as a Result of FQPA 6
Stakeholder Concerns 7
3 EPA Needs to Ensure Opportunities for Public Participation 10
Importance of Public Participation in Implementing FQPA 10
EPA Solicited Stakeholder Involvement in Developing Papers 11
Pilot Program Led to New Policy, but Further Guidance Needed 11
New Policy Increased Opportunities for Formal Public Comment 13
Recommendations 14
Agency Response and OIG Evaluation 14
4 Additional Opportunities Exist to Enhance Public Confidence 16
Additional Information Necessary to Identify and Assess Major Subgroups.. 16
OPP Should Respond Promptly and Directly to Stakeholder Petitions 19
Recommendations 21
Agency Response and OIG Evaluation 22
Appendices
A Agency's Response 23
B OIG Comments on Agency's Response 39
C FQPA Major Science Papers Receiving Public Comment Periods 45
D Results on Public Participation for Sampled
Final Reregistration Eligibility Decisions 46
E Distribution 47
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Chapter 1
Introduction
Purpose
We initiated this review to evaluate the Environmental Protection Agency's
(EPA's) activities to implement the Food Quality Protection Act (FQPA) of 1996.
Our overall objective was to determine the impact of FQPA on Agency practices,
data requirements, and children's health. This report is the first in a series of
planned reports to inform EPA leadership and interested stakeholders on the
Agency's FQPA implementation efforts.
EPA's Office of Pesticide Programs (OPP) seeks stakeholder consultation and
public involvement as a critical step in making the Federal pesticide program
work. According to OPP, one of the five key FQPA implementation principles is
openness. Specifically, Agency documents state that public access to information
and consultation with stakeholders will be an integral part of the policy and
program development in implementing the requirements of FQPA. To address
perception issues regarding OPP's lack of transparency in implementing FQPA,
we specifically sought to determine:
• How consistently OPP allows for public comment and participation in the
pesticide decision-making process?
• What guidance OPP has in place to address major identifiable subgroups of
consumers and to respond to petitions and requests received from external
stakeholders?
Scope and Methodology
We performed our evaluation in accordance with Government Auditing
Standards, issued by the Comptroller General of the United States. We
performed our field work from July 2004 to May 2005.
During our review, we spoke with officials from EPA's OPP, Office of Children's
Health Protection, and Office of Research and Development. We also consulted
the U.S. Department of Agriculture, Office of Management and Budget, and
Department of Health and Human Services. Further, we contacted the following
external stakeholder groups, which included industry, environmental
organizations, and children's health advocates:
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• Children's Environmental Health Network
• CropLife America
• Farmworker Justice Fund
• Natural Resources Defense Council
• Environmental health scientists, toxicologists, and epidemiologists
• Pediatricians/physicians
• Environmental law professors from universities
• Children's Environmental Health Research Centers
• Pest Management Regulatory Agency (Canada)
During our evaluation, we conducted a literature review and reviewed documents
pertinent to EPA's implementation of FQPA. We reviewed the legislative history
in order to evaluate the intent of FQPA. We also reviewed case decisions and the
requirements on the Agency's response to formal petitions from external
stakeholders. There were no pertinent reports on which to follow up during this
review.
To determine to what extent OPP allowed public comment and participation in the
pesticide decision-making process since the passage of FQPA, we reviewed a
sample of final and interim reregi strati on eligibility decisions from FQPA's
passage in 1996 through the present (October 1, 1996 through February 28, 2005).
The universe of 84 included both final and interim reregi strati on eligibility
decisions. We performed a qualitative analysis of a random sample of 29
decisions. This sample represented 35 percent of all post FQPA reregi strati on
decisions. The sample was selected assuming a 95-percent confidence level and a
15-percent margin of error for the entire universe of decisions over this period of
time.
Results of Review
FQPA required EPA to make significant changes to the reregi strati on process,
including the introduction of aggregate exposure assessment, cumulative risk
assessment, and an expedited tolerance reassessment process. Despite numerous
changes to the pesticide registration process, both internal and external
stakeholders expressed continued reservations over aspects of the process.
We found that EPA allowed public comment periods when developing the
Agency's major FQPA science policy papers, and developed a public comment
policy for all pesticide registrations in 2002. However, prior to this policy and
during the reregi strati on of a number of highly toxic pesticides, OPP did not
always solicit public comments prior to issuance of final pesticide reregi strati on
decisions. We believe EPA must ensure that at least one public comment period
is held prior to final pesticide reregi strati on decisions. Providing opportunities for
public participation is important for increasing transparency, improving decision
making, and increasing overall public confidence.
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Additionally, we determined that EPA lacks guidance on involving the public in
selected FQPA-related processes. To address certain shortcomings, EPA needs to
provide guidance on identifying and assessing major subgroups of consumers,
such as farm children, and should respond promptly to requests and petitions from
external stakeholders. Such guidance and responsiveness are needed to improve
public confidence.
The Agency concurred with many of the recommendations. However, the
Agency expressed concerns in the way OPP's performance was characterized in
the report. We summarized the comments and provided our evaluations at the end
of each chapter with recommendations. The full text of EPA's memorandum and
comments is in Appendix A, while additional attachments to that memorandum
are available at http://www.epa. gov/oig/reports/2006/20051019-2006-P-
00003A.pdf. Additionally, the full text of our comments on EPA's response is
available in Appendix B.
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Chapter 2
EPA and the Food Quality Protection Act
Pesticides in the United States
EPA defines a pesticide as any substance intended to destroy, prevent, or repel
pests, such as insects, weeds, fungi, and rodents. Pesticides are an integral part of
agriculture. Many household products are pesticides, including: cockroach
sprays and baits; insect repellents for personal use; flea and tick sprays, powders,
and pet collars; kitchen, laundry, and bath disinfectants and sanitizers; products
that kill mold and mildew; and even some swimming pool chemicals. Once
released into the environment, pesticides have the potential to pollute rivers,
groundwater, air, soil, wildlife, and food. Human exposure to pesticides can
occur through multiple pathways, including from breathing, drinking, and eating,
and through skin absorption (see Figure 2.1). Reported health effects from
chronic pesticide exposures include cancer, cognitive dysfunctions, altered
immune responses, endocrine disruptions, and deterioration of the nervous system
and body organs.
Figure 2.1: Pathways of Exposure
Source: EPA Office of Inspector General.
Children are uniquely susceptible to the health threats posed by pesticides, in both
household chemicals and in food. Children generally consume more fresh
produce and drink more water per pound of body weight than adults.
Pesticides
Food, soil, air, water, home products, etc...
Skin (dermal)
Airways
Absorption
Oral (intentional or accidental ingestion)
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Additionally, a child's exposure to pesticides can occur as early as the prenatal
phase, or during infancy through breast-feeding. Children have higher rates of
metabolism, less mature immune systems, unique diets, and distinct patterns of
activity and behavior when compared with adults. This includes hand-to-mouth
behavior and time spent close to the floor.
Food Quality Protection Act
Congress unanimously passed the FQPA in 1996, due in large part to a 1993
National Academy of Sciences report, Pesticides in the Diets of Infants and
Children. According to this report, the then-current scientific and regulatory
approaches did not adequately protect infants and children from pesticides. The
National Academy of Sciences recommended an explicit determination that
pesticide tolerances were safe for children.
According to EPA, FQPA provided a more consistent pesticide regulatory scheme
by amending the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
and the Federal Food, Drug, and Cosmetic Act (FFDCA). Under FIFRA, EPA
registers pesticides for use in the United States and prescribes labeling and other
regulatory requirements. Under FFDCA, EPA establishes tolerances for pesticide
residues in food, both domestically produced and imported. A tolerance is the
maximum level of pesticides residue allowed in or on human food and animal
feed. The following outlines many of the FQPA requirements and amendments to
FIFRA and FFDCA as interpreted by EPA:
FQPA Impact on EPA's Regulatory Process
> Requires EPA to incorporate a 10-fold safety factor to further protect infants and children unless reliable
information in the database indicates that it can be reduced or removed.
> Requires EPA to consider cumulative effects from aggregate exposure to compounds with common
mechanism of toxicity.
> Establishes a single safety standard under FFDCA by which EPA is to set tolerances-not a risk/benefit
standard (with some exceptions).
> Requires assessment to include aggregate exposures, including all dietary exposures, drinking water, and
non-occupational (e.g., residential) exposures.
> Requires consideration of cumulative effects and common mode of toxicity among related pesticides, and the
potential for endocrine disruption effects.
> Requires a special finding for the protection of infants and children.
> Establishes a tolerance reassessment program and laid out a schedule whereby EPA must reevaluate all
tolerances that were in place as of August 1996 within 10 years.
> Requires the consideration of infants, children, and other major identifiable subgroups of consumers.
FQPA Amended FIFRA
> Requires EPA to periodically review
pesticide registrations to ensure that
all pesticides meet updated safety
standards.
> Reauthorizes registration and
deregistration (licensing) of pesticides.
FQPA Amended FFDCA
> Repeals the Delaney "zero tolerance" clause for
pesticides; replaced with reasonable certainty that no
harm to humans come from aggregate exposure.
> Requires EPA to re-evaluate existing tolerances.
> Requires special provisions for infants and children.
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FQPA changed the way EPA regulates pesticides. FQPA emphasized the
potential for infants and children to be especially sensitive to pesticides and the
need to afford them adequate protection. Also, FQPA imposed many new
requirements on EPA's registration process for pesticides.
OPP Made Substantial Changes as a Result of FQPA
A pesticide cannot be legally used if it has not been registered with EPA's OPP.
Through the pesticide registration process, EPA examines the ingredients of a
pesticide; the site or crop on which it is to be used; the amount, frequency, and
timing of its use; and storage and disposal practices. EPA evaluates the
pesticide's potential impact on humans, animals not being targeted by the
pesticide, and the environment.
According to Agency FQPA implementation documents, the new safety standard
is driving changes in risk assessment methods and science policies that support
regulatory decisions. FQPA required EPA to address a number of new scientific
areas related to pesticide regulation. Key to implementing FQPA's science
provision was the effort OPP made in developing science policy papers. OPP
developed science policy papers in several areas, including:
• 10-Fold Safety Factor;
• Dietary Exposure and Risk Assessment;
• Drinking Water Exposure;
• Residential Exposure;
• Aggregate Exposure and Risk Assessment; and
• Cumulative Risk Assessment for Pesticides with a Common Mechanism of
Toxicity.
EPA is reviewing older pesticides (those initially registered prior to November
1984) to ensure they meet current scientific and regulatory standards. This
process, called reregi strati on, considers the human health and ecological effects of
pesticides. Upon completion of the review and risk management decision for the
pesticide, EPA issues the final reregi strati on eligibility decision. The final
decision summarizes the risk assessment conclusions and outlines any risk
reduction measures needed.
FQPA required EPA to reassess all food use tolerances (pesticide residue limits in
food) in effect as of August 1996 when the law was passed. EPA must ensure
that the tolerances are at safe levels - that there is a reasonable certainty no harm
will result from exposure. Over 9,700 tolerance reassessments must be completed
within 10 years of FQPA enactment. OPP has integrated reregi strati on and
tolerance reassessment to most effectively accomplish the goals of both programs.
A Government Accountability Office (GAO) review noted EPA has made
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progress in reassessing tolerances for pesticide residues.1 GAO reported that as of
April 2000, EPA had conducted 3,471 tolerance reassessments (36 percent).
According to EPA, the Agency is on schedule to complete tolerance risk
assessments by August 2006.
In determining allowable levels of pesticide residues in food, EPA must conduct a
comprehensive assessment of each pesticide's risks, considering:
• Aggregate exposure of the public to pesticide residues from all sources,
including food, drinking water, and residential uses;
• Cumulative effects of pesticides and other substances with common
mechanisms of toxicity; and
• Special sensitivity of infants and children to pesticides.
To accomplish this, the Agency had to develop new aggregate and cumulative
exposure and risk assessment methods. OPP developed a framework for
conducting cumulative risk assessments on pesticides. However, to date, OPP has
not completed any pesticide cumulative risk assessments as required by FQPA.
OPP issues an interim decision when a pesticide has undergone the reregi strati on
process but still requires a cumulative risk assessment. According to OPP, final
reregi strati on eligibility decisions will be issued after the Agency completes the
cumulative risk assessment.
Details on the reregi strati on process are in Figure 2.2.
Stakeholder Concerns
Despite the Agency's efforts to implement the requirements of the FQPA,
stakeholders still have concerns with certain internal processes. Those concerns
most commonly voiced include: lack of transparency, insufficient data for
decision-making, inconsistent application of FQPA requirements, concerns over
the lack of protection afforded to subgroups, and lack of outcome measures on
FQPA effectiveness.
A number of stakeholders commented on the perception that OPP makes
decisions "behind closed doors," thus reducing the transparency of OPP's
decisions. Stakeholders raised concerns that OPP frequently consults with
industry without providing equal opportunities for consultation with the public
and other concerned parties. Some stakeholders expressed concerns over the lack
of publicly available information on pesticides and OPP's moving of information
off their Web site that once served as a tracking tool for the public.
1 GAO Report; GAO/HEHS-OO-175: "Children and Pesticides: New Approach to Considering Risk is Partly in
Place," September 2000.
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Figure 2.2: Decision and Comment Process for Reregistration
Significant Risk
Negligible Risk
Mtigate Risk
EPA Considers
Public
Comments
Consider
Common Modes
ofToxicity
(cumulative risk)
MsetsFQPA
Standard
Human and
Ecological Risk
Assessments
sent to
registrants
FQPA Standard:
Assess all
dietary and non-
occupational risk
for each
subpopulation
Public Comments
Reviewed and Risk
Management Decision
Developed
Final or Interim Reregistration
Eligibility decision is
Released.
Registrant 30 day Error Review
EPA Considers Registrants Comments;
Risk Assessments Revised
and Develops
Preliminary Risk Reduction Options
Public Comments on Risk Assessments and
Risk Characterization
Revised Risk Assessment and Risk
Reduction published in Federal register
Formally invites formal public comment.
Both environmental and health advocacy organizations stressed their concern over
the lack of consideration of subgroups under the FQPA. Subgroups can be
examined in terms of variations in dietary exposure, such as for a number of
minority communities, or variations in non-dietary exposures, such as for children
living in rural agricultural communities and children exposed to pesticides in
public housing. Stakeholders feel that EPA has not made a consistent effort to
identify and protect potentially susceptible subgroups under the requirements of
FQPA.
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A number of stakeholders noted that they do not believe the application of or
EPA's policies on FQPA have been consistent with its legislative intent. For
example, some stakeholders raised concerns regarding EPA's application of the
10X Children's Safety Factor,2 citing problems with the clarity and transparency
of when and how 10X is retained, when it is reduced, and how these
determinations are made. In 2000, GAO conducted a review to examine the
approach EPA developed for making decisions in applying the FQPA Children's
Safety Factor and the actual application of that factor.3 Therefore, this issue will
not be addressed by the OIG; application of the FQPA Children's Safety Factor
falls under OPP's discretion to interpret the FQPA requirements.
Other stakeholders stated concerns over EPA's implementation of the cumulative
exposure requirements and the use of interim reregi strati on eligibility decisions.
Additionally, certain stakeholders expressed concerns over whether EPA has the
data it needs to make decisions under the FQPA. This includes when to impose or
reduce safety factors, data on developmental neurotoxicty, and information on
cumulative and aggregate effects. Concerns related to data adequacy will be
addressed in a subsequent OIG report. Other stakeholders noted that without
sufficient data, it is difficult for EPA to measure its success in implementing
FQPA and in ascertaining whether FQPA is making a substantive difference in
children's health. Performance measurement will also be addressed in a
forthcoming OIG report on the impact of FQPA.
2 Specifically FQPA requires EPA to: " use an extra 10-fold safety factor to take into account potential pre- and
post-natal development toxicity and completeness of the data with respect to exposure and toxicity to infants and
children. A different safety factor may be used only if, on the basis of reliable data, such a factor will be safe for
infants and children."
3 GAO Report; GAO/HEHS-OO-175: "Children and Pesticides: New Approach to Considering Risk is Partly in
Place," September 2000.
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Chapter 3
EPA Needs to Ensure Opportunities for
Public Participation
Agency policy notes public consultation improves the quality and transparency of
the Agency's decisions, and that it is essential that the public plays a major role in
environmental decision making. However, OPP's use of public comment periods
has varied by activity and over time. OPP allowed public comment periods when
developing the Agency's major FQPA science policy papers, but there were
limited formal public comment periods between 1996 and 2002, prior to the
release of final pesticide reregi strati on eligibility decisions. EPA rectified this
situation prior to the release of the final decision by a change in OPP policy
effective in 2002. In 2004, OPP finalized the policy on public comment for
pesticide registrations and reregistrations to allow at least one formal comment
period, with the exception of pesticides classified as reduced risk. Also, the
Agency listed in its 2004 policy the factors it considers in determining whether to
use a four- or six-phase public participation process, but we believe the criteria for
selecting the number of public comment periods should be more clearly defined.
Importance of Public Participation in Implementing FQPA
Providing opportunities for public participation is an important vehicle for
increasing transparency, improving decision making, and increasing overall
public confidence. By including stakeholders and other members of the public in
the process, EPA hopes to arrive at the fairest, most realistic, and most informed
decisions possible. In an August 1993 memo to all employees, the EPA
Administrator stated:
In all its programs, EPA must provide for the most extensive public
participation possible in decision-making. This requires that we remain
open to all points of view and take affirmative steps to solicit input fi'om
those who will be affected by decisions.
A consent decree dated March 30, 2000, states the Agency's interest in providing
opportunities for public participation in pesticide reregi strati on.4 EPA reiterated
that transparency of the Agency's regulatory decisions is an area of emphasis and
importance in the Agency's Fiscal Year 2005 Annual Plan, and in EPA's May 14,
2005, Federal Register notice on the public participation process.5 EPA states that
4 Amended Partial Consent Decree Case No. C-99-3701 CAL.
5 "Pesticide Tolerance Reassessment and Reregistration; Public Participation Process," Federal Register: May 14,
2004 (Volume 69, Number 94), Pages 26819-26823.
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it is strongly committed to involving stakeholders and the public in its
development of pesticide reregi strati on and tolerance reassessment decisions.
EPA Solicited Stakeholder Involvement in Developing Papers
EPA recognized that building the scientific framework for implementing FQPA
would require consultation with external scientists, and therefore utilized advisory
committees. Since 1996, the Agency has developed multiple major science policy
papers (see Appendix B) in collaboration with other Agency program offices and
external representation from industry, environmental groups, and other interested
entities. Public comment periods were held for all of the FQPA major science
policy papers.
Pilot Program Led to New Policy, but Further Guidance Needed
Although OPP finalized a policy for soliciting public comment under the pesticide
reregi strati on process in 2004, the policy lacks criteria for clearly determining the
level of review required for a particular pesticide. While the Agency does
describe factors affecting the decision to offer one or two comment periods in the
May 14, 2004, Federal Register Notice, it does not provide clear guidance as to
which process to use for each instance. This leaves the process open to criticism
from stakeholders.
As part of the Agency's ongoing FQPA implementation, EPA began conducting
individual assessments of the organophosphate pesticides.6 In 1998, the Agency
developed a six-phase pilot reregi strati on process (see Table 3.1) for reviewing
organophosphates which, according to Agency documents, would provide the
public greater access to information about these pesticides. This would include
EPA's preliminary risk assessments and risk management proposals.
Organophosphate pesticides are currently registered under interim reregi strati on
eligibility decisions, which cannot be finalized until publication of a final
cumulative risk assessment for those pesticides. In our sample review, all eight
interim decisions (including the seven organophosphates indicated in footnote 6)
had the two required formal public comment periods.
Within 2 years after the initiation of the organophosphate pilot, EPA extended a
similar public participation process to non-organophosphate pesticides
undergoing tolerance reassessment and pesticide reregi strati on. On March 15,
2000, EPA published its proposed six-phase process for all pesticides scheduled
for tolerance reassessment and reregistration; however, this policy was not
finalized until the spring of 2004. According to OPP, the policy was largely in
6 Organophosphates are a high priority group of chemicals with a common mechanism of toxicity that affects the
nervous system, and requires a cumulative risk assessment. They can pose known risks of acute and chronic toxicity
to humans and wildlife. They are widely used on many food crops, and in residential and commercial settings. The
seven organophosphates within our sample which were also included in the pilot are: Disulfoton, Methyl Parathion,
Oxydemeton-methyl, Pirimiphos-methyl, Profenofos, Propetamphos, and Terbufos.
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place and being closely followed by 2002. This new policy increases
opportunities for public participation in the development of pesticide risk
assessments and risk management decisions. The steps listed in Table 3.1 are to
be taken after OPP has assessed the potential hazards to human health and the
environment.
Table 3.1: Six-phase Public Participation Process for Tolerance Reassessment and Reregistration
Phase
Time Frame
Description
1
30 days
Registrant "Error Only" Review
Human health and ecological risk assessments are sent to registrants for error correction
review.
2
Up to 30 days
EPA Considers Registrants' Comments
Errors Identified by registrants are reviewed by EPA and corrected as appropriate.
3
60 days
Public Comments on Risk Assessments and Risk Characterization
EPA publishes a Federal Register notice announcing availability of risk assessments and
related documents from public docket and EPA's Web site.
4
Up to 90 days
EPA Revises Risk Assessments, Develops Preliminary Risk Reduction Options, and
Considers Public Comments
5
60 days
Public Comments on Risk Reduction
EPA publishes a Federal Register notice announcing availability of revised risk assessments
and response to the initial public comments received. EPA also releases and invites formal
public comments.
6
Up to 60 days
EPA Develops Final Risk Management
EPA considers public comments from previous phase and develops risk management
decision. The final or interim reregistration eligibility decision is released.
The new policy on public participation offers a four-phase alternative process that
could be used in some situations that would allow for one opportunity for public
comment prior to issuance of a decision (see Table 3.2).
Table 3.2
: Four-phase Phase Public Participation Process for Tolerance Reassessment and Reregistration
Phase
Time Frame
Description
1
30 days
Registrant "Error Only" Review
Human health and ecological risk assessments are sent to registrants for error correction
review.
2
30-60 days
EPA Considers Registrants' Comments
Errors identified by registrants are reviewed by EPA and corrected as appropriate.
3
60-90 days
Public Comments on Risk Assessments and Preliminary Risk Reduction Options
EPA publishes a Federal Register notice announcing availability of risk assessments and
preliminary risk reduction options for formal public comment.
4
Up to 90 days
EPA Develops Final Risk Management
EPA considers public comments received, risk management ideas, and proposals received
during previous phase to develop risk management decision. The final or interim reregistration
eligibility decision is released.
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The various options for public comment give OPP the flexibility to consult with
stakeholders and obtain public input as needed while still making timely decisions
and meeting statutory goals and deadlines. Although the reregi strati on process
has clearly defined opportunities for public comment, the Federal Register notice
announcing the final reregi strati on processes does not articulate what method
(six-phase or four-phase) the Agency should use for any particular pesticide or
pesticide class.7 OPP officials indicated the selection method is determined on a
case-by-case basis, generally based on past experience. The six-phase process
provides more opportunities for public comment than the four-phase process, and
the lack of clear selection guidance potentially leaves the process determination
open to criticism from outside stakeholders.
New Policy Increased Opportunities for Formal Public Comment
A consistent lack of formal public comment opportunities prior to the release of
final reregistrations issued between 1996 and 2002 was rectified by the change in
OPP policy in 2002.8 We reviewed 35 percent (21 decisions) of the universe of
60 post-FQPA completed final reregi strati on eligibility decisions. We found that
only 19 percent (4 decisions) of the decisions reviewed had some formal public
comment period prior to the issuance of the reregi strati on—all decided after the
implementation of the new policy (see Table 3.3 and Appendix C). Similarly, we
reviewed one third (8 total) of the universe of 24 post-FQPA interim reregi strati on
eligibility decisions and found that all of these decisions had formal comment
periods prior to the issuance of the interim decision in accordance with the new
policy.
Table 3.3 illustrates that prior to OPP's policy change, all final decisions reviewed
had no formal public comment opportunities prior to publication. However, of
the decisions reviewed that were finalized after the 2002 policy change, we found
that all had one or more public comment opportunities in 2002 and subsequent
years.
7 "Pesticide Tolerance Reassessment and Reregistration; Public Participation Process," Federal Register:
May 14, 2004 (Volume 69, Number 94), Pages 26819-26823.
8 OPP provided a table demonstrating the impacts of the 2002 public involvement policy. As a result of the policy
change, all 26 reregistration eligibility decisions and 11 interim reregistration eligibility decisions, except those for
low-risk pesticides, received either one or two public comment periods prior to the publication of the final
reregistration eligibility decisions or interim reregistration eligibility decisions.
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Table 3.3: Public Comment Opportunities for Reregistrations
Sample of
Number of Opportunities
Final Reregistration
for Formal Public Comment
Eligibility Decisions
Two One None
1996
0
0
1
1997
0
0
7
1998
0
0
4
1999
0
0
3
2000
0
0
2
2001
0
0
0
2002
0
1
0
2003
0
1
0
2004
0
2
0
Total Final Reregistration Eligibility Decisions
0
4
17
We recognize that OPP published a final policy on public involvement in May
2004, as previously discussed; FQPA implementation, however, began in 1996.
According to OPP officials, even though the policy was not finalized until May of
2004, they began implementing the proposed public participation requirements in
2002. However, Agency documents show that many reregi strati on decisions were
completed prior to implementation of the new policy. According to Agency
reports, for example OPP had reassessed 3,290 tolerances by July 30, 1999. Of
the reassessments completed, 66 percent (2,178) were in the first, or the highest
risk, priority group. Although this represents significant progress for OPP in the
pesticide reregi strati on process, it indicates that a majority of the pesticide
decisions up to that point were made prior to finalizing and implementing the new
public involvement policy.
Recommendations
We recommend that the Director of the Office of Pesticide Programs:
3-1 Continue to allow for at least one public comment period prior to the
issuance of a final reregi strati on eligibility decision. We recommend that
OPP provide written justification for deviating from the six-phase process.
3-2 Develop further guidance to demonstrate to the public which version of
the public participation process OPP selects, and make this information
readily accessible on their website.
Agency Response and OIG Evaluation
The Agency agreed in general to the recommendations provided in Chapter 3 and
the overall message that it needs to ensure ample opportunities for public
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participation. However, the Agency believed that the report does not take into
account the expansion of the amount of public participation provided and is thus
misleading in its description of OPP's public participation procedures.
The Agency commented that "if the analysis focused on approved reregi strati on
eligibility decisions since OPP began to routinely use its voluntary public
participation process, the results would be different." However, Agency
documents show that many reregi strati on decisions were completed prior to the
new policy ensuring public participation, and these decisions remain in effect.
Moreover, FQPA requires EPA to give highest priority to pesticides that appear to
pose the greatest risk. Our conclusions on OPP's post-FQPA public participation
efforts in reregi strati on decisions were based on review results from a statistically
valid sample of completed reregi strati on decisions from FQPA's passage
(October 1996) until the present day (February 28, 2005). The sampling universe
and sampling methodology are fully explained within Chapter 1.
In its comments to the draft report, the Agency did not agree with our use of
formal comment periods as exclusive indications of public participation. While
we recognize that there are other modes of public participation, including the
examples provided in the Agency's response, we believe the use of formal public
participation comment periods is a key method for the Agency to ensure that all
interested stakeholders have a chance to review and comment on the proposed
reregi strati on decision.
Although the Agency agreed with Recommendation 3-2 concerning guidance
with the pesticide reregi strati on process (the six-phase or four-phase process),
OPP believed that the draft report overstates the importance of setting additional
criteria and fails to give credence to the Agency's current policy. We recognized
in the report that OPP has such as policy in place; however, it is our position that
guidance is needed to ensure that decisions about the frequency of public
participation cannot be perceived to be arbitrary.
Appendix A provides the full text of the Agency's response, while additional
attachments to that memorandum are available at
http://www.epa.gov/oig/reports/2006/20051019-2006-P-000Q3A.pdf.
Appendix B provides more detailed OIG comments on the Agency's response.
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Chapter 4
Additional Opportunities Exist to Enhance
Public Confidence
We identified the following areas where guidance is still needed to address
shortcomings and improve public confidence:
• Gathering data to identify and assess additional major subgroups of consumers
for the pesticide decision making process; and
• Responding promptly and directly to petitions and requests from external
stakeholders.
Generic resolution of science and policy questions through the development of
guidance documents puts the public on notice of the way the Agency plans to
resolve future questions of the same general substance. Guidance also helps
broaden opportunities for public participation in policymaking and helps prevent
the appearance of arbitrary decisions. OPP needs to respond promptly to external
petitions and requests to increase public confidence. Responding promptly and
directly to petitions and requests from external stakeholders will improve public
confidence in OPP's work.
Additional Information Necessary to Identify and Assess Major
Subgroups
Stakeholders expressed concerns that OPP's current dietary and nondietary risk
assessment processes do not sufficiently protect major identifiable subgroups of
consumers. For example, some stakeholders noted that OPP lacks information
regarding the consideration of certain non-dietary exposure pathways for
subgroups, including take-home and spray drift exposures from pesticides. Other
stakeholders indicated that OPP also lacks dietary exposure information for a
number of racial minority subgroups.
GAO recommended in 1989 that EPA establish a policy concerning whether,
and/or in what circumstances, tolerance decisions are to be based on the most
highly exposed subgroup(s).9 Furthermore, concerns over the protection of
subgroups culminated in a 2003 lawsuit against the Agency by a coalition of
environmental and public health groups with regard to the designation of farm
children as a major identifiable subgroup. This lawsuit was subsequently
dismissed for a lack of jurisdiction.
9 GAO Testimony to the Subcommittee on Health and the Environment Committee on Energy and Commerce,
House of Representatives; GAO/T-RCED-89-35: "Guidelines Needed for EPA's Tolerance Assessments of
Pesticide Residues in Food," May 1989.
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Among the changes to the Agency's processes required by FQPA was the
consideration of available information on the aggregate exposures, variability of
sensitivities, and dietary consumption patterns of major identifiable subgroups of
consumers. Specifically, Section 405 states:
SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
"(D) FACTORS.—In establishing, modifying, leaving in effect, or revoking a tolerance or
exemption for a pesticide chemical residue, the Administrator shall consider, among other
relevant factors—
"(iv) available information concerning the dietary consumption patterns of consumers (and
major identifiable subgroups of consumers);
"(vi) available information concerning the aggregate exposure levels of consumers (and
major identifiable subgroups of consumers) to the pesticide chemical residue and to other
related substances, including dietary exposure under the tolerance and all other tolerances
in effect for the pesticide chemical residue, and exposure from other non- occupational
sources;
"(vii) available information concerning the variability of the sensitivities of major identifiable
subgroups of consumers...."
OPP has traditionally used a dietary exposure model known as the Dietary
Exposure Estimation Model (DEEM) to assess pesticide exposures. According to
OPP officials, the DEEM system examines 27 different subgroups based on age,
region, and race. In evaluating residential exposures, OPP officials said that four
additional subgroups are examined, including toddlers, youth, young adults, and
applicators. According to OPP, almost all of the subgroups included in the
DEEM and other exposure models were considered by OPP prior to the passage
of FQPA. Nevertheless, there is still controversy as to whether additional
subgroups should be examined.
Actions Taken to Protect Subgroups
In addition to considering the aforementioned subgroups for its dietary risk and
residential assessments, OPP indicated that it considered additional subgroups on
a case-by-case basis if it believed the additional subgroup might potentially
receive greater exposure than one of the standard subgroups. OPP provided nine
examples of decisions where specified subgroups were taken into consideration in
the decision-making process. While OPP considered subgroups in the decision-
making process for the examples provided, we found that OPP determined that no
further action was deemed necessary to protect subgroups in five of the nine
examples provided.
Three of the nine examples involved subgroups in addition to the standard
subgroups. OPP concluded that these additional subgroups did not face a risk of
concern that required additional risk mitigation or for which additional data were
necessary and did not exist. Consequently, OPP's consideration of the additional
subgroup in these three examples did not lead to a change in tolerance levels or
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provide other steps to protect these subgroups in the final reregi strati on eligibility
decisions.
Of the nine examples provided by OPP, three were instances where consideration
of risks to children's subgroups did result in OPP attempting to take action to
protect children or address a regional subpopulation. For example, OPP took
significant action to protect infants and children from the risks posed by
organophosphate pesticides, including diazinon and chlorpyrifos, through the
cancellation of certain product uses.
Additional information on OPP's measures of success in terms of the pesticide
registration and reregi strati on programs is planned for a subsequent OIG report.
The ninth example, the cumulative risk assessment of the organophosphate
pesticides, is not yet finalized. Details on the nine examples are in Table 4.1.
Table 4.1: Actions Taken to Protect Subgroups in Examples Provided by OPP
Pesticide
Subpopulation
Exposure
Pathway
Actions to Protect
Subgroups
Lindane
Alaskan Native
Subpopulation
Dietary
None; increased exposure to
subgroups found not to cause
risk of concern.
Cumulative risk
assessment for
organophosphates
Regional variations
Drinking Water
None; not yet final.
Triclopyr
Pregnant females,
Native Americans
in California
Dietary
None; increased exposure to
subpopulation found not to
cause risk of concern.
Zinc Phosphide
Children who eat
rat poison
Oral
(accidental
ingestion)
Although found risk of concern
to subpopulation, formulation
changes did not occur as
recommended.
Fenamiphos
Regional variations
Drinking Water
Registrant cancelled all uses.
Propargite
San Joaquin-
Tulare study unit
Drinking Water
None; increased exposure to
subpopulation found not to
cause risk of concern.
Risk Assessment
Process Changes
Age groups of
children
Dietary
None (policy change).
Diazinon
Age groups of
children
Dietary and
residential
Residential uses cancelled,
some crop uses restricted.
Chlorpyrifos
Age groups of
children
Dietary and
residential
Residential uses cancelled,
some crop uses restricted.
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Additional Data Needed
We found additional data are needed for the identification of subgroups
potentially more highly exposed to pesticides, particularly those via non-dietary
pathways. OPP officials noted that the identification of subgroups is complicated
and requires additional information and research. OPP examined the different
consumption patterns among children based on age-related subgroupings. In
aggregating exposure, OPP sums both dietary exposures and non-dietary
exposures for an age group when that is appropriate given a pesticide's use.
EPA's Office of Research and Development (ORD) conducts research on
susceptible and highly exposed life stages and subgroups. As part of this
research, subgroups may be based on regional, life stage, gender, background,
health status, and dietary variations. According to ORD's Strategy for
Environmental Risks to Children, the examination of subgroups hypothesized to
be highly exposed, including special groups such as children living on farms, is a
high priority area.
Working with ORD to develop a research agenda related to the protection of
subgroups would be an opportunity for OPP to gather necessary data to protect
subgroups under FQPA. However, before gathering this information, OPP needs
a prescribed methodology for considering additional subgroups. OPP also needs a
strategy for collecting and disseminating information about subgroups. OPP
should work with ORD to prioritize and develop a research agenda on subgroups
for use in pesticide registrations and reregistrations under FQPA.
OPP Should Respond Promptly and Directly to Stakeholder Petitions
Stakeholders expressed concern that OPP did not respond promptly to petitions
and requests. We are aware of three petitions where the Agency's response could
be perceived as not being timely, direct, or transparent. In one case, for a petition
filed by the Natural Resources Defense Council (NRDC), we found that it took
EPA 6 years to respond. The response to this petition was incorporated into
another policy decision and not addressed directly to the petitioners involved. We
also found EPA failed to respond in a clear and transparent manner to petitions
filed by external stakeholders concerning the 10X children's safety factor10 and
on the wood preservative copper chromatic arsenic.11 We believe that OPP
should respond to petitions and requests from external stakeholders within a
reasonable amount of time and in a direct manner.
10 NRDC, et. al. Petition to the Administrator, U.S. Environmental Protection Agency. Petition for a directive that
the agency fulfill its duty to retain the child-protective tenfold safety factor mandated by the Food Quality Protection
Act. Filed April 23, 1998.
11 Beyond Pesticides, et. al. Petition For Suspension and Cancellation of Creosote. Petition for the Administrator of
the Environmental Protection Agency (EPA) to issue a Notice of Intent to Cancel the registration of the wood
preservative creosote pursuant to Section 6 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Filed February 26, 2002.
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OPP Should Respond Promptly to Stakeholder Petitions
One concern arose over the lack of response to petitions filed with the Agency
under the Administrative Procedure Act (APA).12 In 1998, the NRDC petitioned
EPA under the APA to consider, among other issues, farm children as a major
identifiable subgroup as defined by the FQPA. According to OPP, it issued a
response to NRDC's 1998 Farm Children Petition as part of a ruling in the
Federal Register on objections filed concerning Imidacloprid tolerances.13
However this was not issued until May 2004, 6 years after NRDC's petition.
NRDC received direct notice on August 23, 2005, from OPP that the Imidacloprid
ruling served as a response to the Farm Children petition, 1 year after the
publication of the decision in the Federal Register.
While there are no formal Agency regulations or procedures that prescribe the
manner and timing of the Agency's response to an APA petition like NRDC's, we
found that the U.S. Court of Appeals, District of Columbia Circuit, held in a June
2004 decision that, under the APA, a Federal agency is obligated to conclude a
matter presented to it within a reasonable time.14 According to the Circuit Court
opinion, "While there is no per se rule as to how long is too long to wait for
agency action, a reasonable time for agency action is typically counted in weeks
or months, not years." The court ruled that under the circumstances in that case,
the 6-year-plus delay in the case considered was "nothing less than egregious."
OPP acknowledged that its response time to petitions has in some instances been
lengthy, but argued that the reasonableness of the timing of its response should
balance other factors, including OPP's statutory obligations under the FQPA. We
believe that OPP should respond to petitions and requests from external
stakeholders within a reasonable amount of time. The 6 years it took OPP to
respond to the Farm Children Petition is inconsistent with OPP's stated policies
on openness and transparency. Ultimately, it would be up to a court to undertake
the complex balancing of factors to determine if OPP's response was
unreasonable delayed. Nonetheless, OPP's response is contrary to one of its
published policies, the Public Involvement Policy from May 2003.
12
The Administrative Procedure Act, 5 United States Code 553, The APA, enacted in 1946, established procedures
which federal agencies must follow in the development and issuance of regulations and in the procedures to be used
for adjudications. The Attorney General guidance to implement the APA states that the basic purposes of the APA
are:
1) To require agencies to keep the public informed of their organization, procedures and rules;
2) To provide for public participation in the rulemaking process;
3) To establish uniform standards for the conduct of formal rulemaking and adjudication; and
4) To restate the law scope of judicial review.
13 "Imidacloprid; Order Denying Objections to Issuance of Tolerance," Federal Register: May 26, 2004 (Volume 69,
Number 102), pages 30041 - 30076.
14 In Re: American Rivers and Idaho Rivers United. United States Court of Appeals, District of Columbia Circuit.
No. 03-1122, argued March 16, 2004, decided June 22, 2004.
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OPP Should Respond Directly to Stakeholder Petitions
We also urge EPA to respond to petitions in a more direct manner. For example,
the title of the Federal Register ruling on Imidacloprid contains no mention of the
NRDC Farm Children Petition and NRDC was not immediately mailed a copy of
the ruling.15 Additionally, in response to the aforementioned stakeholder
concerns, OPP said that it responded to petitions concerning the children's safety
factor and aggregate exposure in the context of the science policy papers and
response to comment documents on those topics. According to OPP, they are
addressing the copper chromatic arsenic petition in the context of its ongoing
effort to make a reregi strati on determination on wood preservatives.
OPP stated that the petitions it has received have frequently raised either broad
policy issues or a combination of policy issues and detailed scientific questions.
OPP explained that because of the high resource demands posed by the
completion of the FQPA tolerance reassessment program, it has frequently dealt
with petitions by folding the response to them into more generalized actions in
support of tolerance reassessment or other required actions that are part of the
tolerance program. OPP stated that it believes this approach has the added benefit
of including its response to petitions in widely-disseminated public documents so
that all interested parties would be aware of OPP's decision. While this has
allowed OPP to allocate its resources in a manner it considers most likely to
achieve its highest FQPA priority, it has also decreased stakeholder confidence in
and the transparency of OPP's processes.
Although we understand the benefit to OPP of incorporating petition responses
into other public documents, it would require little for OPP to additionally
provide direct personal notice to petitioning parties. Such notice is appropriate
for parties who have submitted petitions. Responding to petitions and requests
from external stakeholders in a prompt and direct manner will enhance public
participation, transparency, and clarity.
Recommendations
We recommend that the Director, Office of Pesticide Programs:
4-1 Develop guidance that provides a defined methodology for identifying
additional subgroups in a systematic manner, as well as a strategy for
collecting and disseminating information about subgroups. Continue to
work with ORD to develop a research agenda focusing on exposures to
major identifiable subgroups.
4-2 Respond to petitions and requests from external stakeholders as promptly
as possible given statutory obligations. All responses to petitions should
15 See footnote 11.
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be directly communicated to petitioners. Develop a policy that stresses the
importance of Agency response to external comment in a timely manner.
Agency Response and OIG Evaluation
The Agency agreed in general to the recommendations provided in Chapter 4.
However, the Agency provided numerous comments regarding the accuracy and
presentation of the narrative within the report preceding the recommendations.
We added clarification and made corrections as deemed necessary. We stand by
the remainder of our facts.
In response to OIG Recommendation 4-1, the Agency stated that the OIG does
not explain what it means by a "defined methodology for identifying additional
subpopulations in a systematic manner." We believe it is imperative that the
Agency first have a methodology in place describing at a minimum how it will
identify additional subgroups on a case-by-case basis. We recommend that OPP
document the methodology by which it currently considers additional subgroups
that might potentially receive greater exposure than one of the standard
subgroups.
The Agency agreed with the recommendation to develop a strategy for collecting
and disseminating information about subgroups. In response to the
recommendation for OPP to continue to work with ORD to develop a research
agenda focusing on exposures to major identifiable subgroups, OPP
acknowledged the value of such collaboration. Specifically, OPP plans to
continue to work with ORD to develop a research agenda that seeks to identify
meaningful exposures to pesticide residues.
In responding to OIG Recommendation 4-2, the Agency stated that, "we agree
with the spirit of the recommendation that petitions should be responded to in a
timely manner and we would admit that we have been frustrated that it has taken
an extensive period of time to address some FQPA petitions." The Agency stated
that the conclusions drawn by the OIG were "devoid of any legal reasoning." We
conducted a policy, not a legal, analysis of these decisions. We determined that
the responses by OPP to the petitions in question are inconsistent with the intent
of Agency policy regarding transparency. We believe that OPP should take
additional steps to communicate directly to the petitioners as a means to increase
clarity and public confidence. According to the Agency's response, it "will
consider such steps to further transparency."
Appendix A provides the full text of the Agency's response, while additional
attachments to that memorandum are available at
http://www.epa.gov/oig/reports/2006/20051019-2006-P-000Q3A.pdf.
Appendix B provides more detailed OIG comments on the Agency's response.
22
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Appendix A
Agency's Response
MEMORANDUM
SUBJECT: Draft Evaluation Report:
Changes Needed to Improve Public Confidence in EPA's Implementation of the
Food Quality Protection Act
Assignment No. 2004-001191
FROM: Jim Jones
Director, Office of Pesticide Programs
TO: Jeffrey K. Harris
Director for Program Evaluation, Cross Media
Office of Inspector General
Thank you for the opportunity to comment on the draft evaluation, dated [June 23, 2005,
and amended on] September 2, 2005, by the Office of Inspector General on EPA's
Implementation of the Food Quality Protection Act (FQPA). The Office of Pesticide Programs
(OPP) appreciates the Office of Inspector General's effort to understand OPP's legal and
regulatory framework and OPP's procedures for processing pesticide registrations and
reregistrations to implement the provision of FQPA.
In general, we agree with many of the recommendations provided in the report because
they reflect how we have been consistently performing. However, as will be discussed in this
response letter, we are concerned in the way OPP's performance has been characterized in the
text of the report. We will provide specific examples illustrating inaccuracies and mis-
representations throughout our response.
I. Introduction to OPP's Response to OIG's Report
Historically, OPP regulates pesticides under two major federal statutes. Under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), OPP registers pesticides for use in
the United States and prescribes labeling and other regulatory requirements to prevent
unreasonable adverse effects on health or the environment. Under the Federal Food, Drug, and
Cosmetic Act (FFDCA), OPP establishes tolerances (maximum legally permissible levels) for
pesticide residues in food. Tolerances are enforced by the Department of Health and Human
Services/Food and Drug Administration (HHS/FDA) for most foods, U.S. Department of
Agriculture/Food Safety and Inspection Service (USDA/FSIS) for meat, poultry, and some egg
products.
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FQPA amended both major pesticide laws to establish a more consistent, protective
regulatory scheme, grounded in sound science. It mandated a single, health-based standard for
all pesticides in all foods. It also provided special protections for infants and children; expedited
the approval of safer pesticides; created incentives for the development and maintenance of
effective crop protection tools for American farmers; and required periodic re-evaluation of
pesticide registrations and tolerances to ensure that the scientific data supporting pesticide
registrations will remain up to date in the future.
The EPA was directed by then Vice President Gore to ensure that implementation of the
law was based on four key principles: the use of sound science in protecting public health; the
use of an open, transparent process for decision-making; the allowance of a reasonable transition
for agriculture; and the establishment of an effective means of consultation with the public and
other agencies.
The EPA's OIG draft report "Changes Needed to Improve Public Confidence in EPA's
Implementation of the Food Quality Protection Act" focuses upon the following issues: whether
OPP allows for public comment and participation in the pesticide decision-making process; and
what methodology OPP has in place to address: (a) major identifiable subgroups of consumers;
and (b) OPP's responsiveness to petitions received from external stakeholders.
OIG's recommendations and OPP's comments on the draft report and the
recommendations are below.
II. Chapters 1 and 2 - Introduction to the Report, Pesticide Regulation, and FQPA
The first two chapters of the report provide background on the scope and methodology of
the report and on FIFRA and FQPA generally. We appreciate OIG's effort in meeting with a
variety of stakeholders to gain their perspectives upon FQPA implementation.
In addition, OIG's draft report recognizes OPP's work to set the implementation of
FQPA's requirements in motion, finding that "OPP Made Substantial Changes as a Result of
FQPA." FQPA's new safety standard required changes in pesticide risk assessment methods and
science policies. As OIG's report notes, "Key to implementing FQPA's science provision was
the effort OPP made in developing science policy papers."
III. "Chapter 3 - EPA Needs to Ensure Opportunities for Public Participation"
OPP agrees that we need to ensure ample opportunities for public participation and that
we do so in accordance with the Agency's Public Involvement Policy (2003) and our own public
participation policy (2004). OIG concluded that OPP actively solicited stakeholder involvement
in developing the science policy papers, utilizing advisory committees, and collaborating with
other EPA offices, and representatives from industry, environmental groups, and other interested
external stakeholders. OPP held a large number of public meetings, including the meetings of
24
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the Tolerance Reassessment Advisory Committee (TRAC) and the Committee to Advise on
Reassessment and Transition (CARAT) to ensure active stakeholder involvement in the
development of the science policies. However, OIG mis-characterizes
OPP's public participation efforts in reregi strati on decisions since FQPA's
passage and inaccurately concludes that OPP has not consistently solicited
public participation. OPP disagrees with this conclusion and will discuss
how public participation has been a vital component of the Agency's
pesticide regulatory program.
III.A. OIG Recommendation 3-1:
"Continue to allow for at least one comment period prior to the issuance of a final
registration or reregistration eligibility decision. OPP should provide written justification
for exceptions to the public comment policy, including for low-risk pesticides omitted from
the public participation process."
OPP Response:
OPP agrees that we need to allow for at least one comment period prior to the issuance of
a final reregistration eligibility decision (RED). The reregistration public participation process
that OPP has been using for all reregistration actions for the last few years and intends to use
through the completion of reregistration is, with one justifiable exception, fully consistent with
this recommendation and the Agency's Public Involvement Policy. In brief, OPP's policy since
early 2000 is to hold at least one public comment period for chemicals being reviewed under the
reregistration process. As a result, by 2002 at least one comment period was provided prior to
the signature of all REDs, with the sole exception of REDs on pesticides judged to be of low-
risk.
OPP has always allowed for some public participation in the reregistration/tolerance
reassessment program. The amount and timing of public participation has evolved over the years
as OPP has gained experience with the program. Importantly, several years ago OPP
implemented its current public participation process which includes pre-signature public
comment periods for REDs for all pesticides except those posing low risk. Because the draft
OIG Report does not take into account that the amount of public participation has expanded and
the timing of such participation has been moved earlier in the process, the Report presents a
highly misleading description of OPP's public participation procedures. Below, we trace the
evolution of our public participation procedures and point out how the
analysis in the draft OIG Report errs in describing the percentage of
REDs that currently receive pre-signature public comment periods.
See OIG Comment
in Appendix B,
Note 1
See OIG Comment
in Appendix B,
Note 2
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Background on Reregistration Public Participation
With the enactment of FQPA, the need for extensive broad public involvement was clear
because the first group of pesticides reviewed under FQPA had risk concerns and generally were
efficacious and economical. The need for enhanced involvement, in combination with the Vice
President's memo directing public involvement in food quality protection, lead to the formation
of a formal Federal Advisory Committee Act (FACA) committee, the TRAC, in early 1998.
Based on the input received from this committee, OPP began the Pilot Public
Participation Process for the organophosphate (OP) pesticides. This pilot process included
numerous pre-signature opportunities for public comment. Given the success of the OP pilot
process, OPP chose to expand the process to all reregistration decisions and issued notice of the
proposed public participation process in the Federal Register in 2000 (March 15, 2000; 65 FR
14199). Although the proposed process recognized that the amount of public process should
vary based on the pesticide involved, at a minimum, the proposed process included at least one
pre-signature public comment period for all pesticides save those presenting the lowest risks.
This process was largely in place and being closely followed by 2002, although it was not
formally finalized until 2004. The finalized procedures provided for a full and a modified public
participation process to enable OPP to tailor the level of review to the level of risk, use,
complexity and public concern associated with each pesticide.
On May 14, 2004, OPP published in the Federal Register: "Notice - Pesticide Tolerance
Reassessment and Reregistration; Public Participation Process." An overview of the different
public participation processes is described at Attachment 1.
New Public Participation Process Affords Flexibility Appropriate to Individual Pesticide
Decisions
By May 2004, when the Agency finalized its public participation process with several
more years of reregistration experience, it had became clear that differences in the complexity of
individual pesticide decisions required a more flexible public participation process. Although
initially conceived as a six-phase process, for some decisions a shorter process afforded ample
opportunity for public participation while shortening the decision time. The final process is
designed to provide the Agency the flexibility to make judgments regarding the number and
timing of public comment periods and to modify the process on a case-by-case basis. Even
though the one-phase process used for low risk chemicals is conducted following signature of the
RED, this process still provides an opportunity for public comment that can affect the final
action. If the Agency receives a comment that may affect the RED decision, the comment is
evaluated and the RED is amended, as appropriate.
Currently, all conventional chemicals undergo either the original six-phase process for
the most complex decisions, the four-phase process for less complex decisions, or a single phase
process for pesticides posing little or no risk concerns.
26
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Biochemical/microbial pesticides are by definition low-risk, and are almost exclusively
accorded the single phase process. Antimicrobial pesticide chemicals may fall within the six-
phase, four-phase, or one-phase processes, depending on their characteristics. The most complex
set of these pesticides-the wood preservatives-are currently undergoing reregi strati on using the
six-phase process.
In addition to providing formal comment periods, the reregi strati on process continues to
include significant informal outreach opportunities to a range of stakeholders throughout the
process.
Comments on OIG Analysis and Conclusions on Past Decisions
The OIG reviewed a random sample of 29 reregi strati on eligibility decisions (REDs and
Interim REDs (IREDs)) from December 1996 to September 2004. The analysis shows that all
eight of the Interim REDs surveyed had formal public comment periods prior to signature. It
also shows that of the 21 REDs surveyed, four had formal comment periods prior to signature.
Based on the analysis, the OIG concludes that OPP has not consistently solicited public
participation. Even though OIG's analysis included these 29 decisions,
Table 3.3 does not reflect the Interim REDs, all of which featured two
formal public comment periods. This omission suggests that the Agency
provided fewer opportunities for public participation during this time
period.
The preliminary risk assessment process for most of the decisions surveyed was
completed prior to OPP adopting the more formalized public participation process for all
reregi strati on actions. If the analysis focused on approved REDs since OPP began to routinely
use its voluntary public participation process, the results would be very different. Of the 26
REDs issued for conventional pesticides from 2002 through 2004,
eighteen had two comment periods (six-phase process) and five had one
comment period (four-phase process) prior to the signature of the RED.
The remaining three were low-risk chemicals with a formal comment
period on the RED after signature.
The OIG analysis relies on "formal comment" periods as exclusive indications of public
participation and does not reflect the significant public outreach involved in many of the
decisions. Most reregi strati on decisions routinely included public outreach activities prior to the
RED signature. For example, in developing the diuron reregi strati on decision, OPP consulted
with state governments, utility companies, growers, and paint manufacturers. Both the terrazole
and chlorothanil decision process included input from golf course superintendents, as well as
other interested parties. The consultations mentioned here are a few
examples of the types of stakeholder involvement efforts associated with
making reregi strati on decisions. Unless the chemical had negligible risk
concerns, OPP has routinely consulted with major stakeholder groups
prior to making its reregi strati on decision.
See OIG Comment
in Appendix B,
Note 3
See OIG Comment
in Appendix B,
Note 4
See OIG Comment
in Appendix B,
Note 5
27
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In other cases, the RED itself announced a public involvement process. In another
example, OPP announced the initiation of an extensive public process for the Aluminum
Phosphide RED. Although the RED was signed, the Agency solicited public comment and
modified its decision based on that public input. The same is true for chlorophacinone and
diphacinone that were part of the 1997 Rodenticide Cluster RED. Again
OPP announced the formation of a public process for informing the
Agency. In this instance, the Agency convened a year-long advisory
subcommittee and took advice concerning young children and the
potential for accidental exposure to rodent control pesticides.
In fact, all the REDs surveyed by OIG actually provided a formal comment period after the RED
was signed, but before the RED was implemented. For example, in the case of oxyfluorfen and
MCPA [(4-chloro-2-methylphenoxy)acetic acid], the Agency received comments in response to
the REDs that led OPP to amend both REDs.
Similarly, new tolerances, including those for new uses of existing pesticides, are
established pursuant to the procedural rulemaking requirements in FFDCA section 408 which
provides for a public comment period. Since such decisions may require an aggregate exposure
assessment in order to make the safety finding under FFDCA, OPP has used such decisions as a
reassessment determination for a pesticide's tolerances. The public comment period provided for
setting new tolerances is relevant to your analysis of opportunities for public comment on
tolerance reassessment decisions. In fact, a significant number of tolerance reassessment
decisions (approximately 19% to date) have been made using this tolerance-setting rulemaking
process and have provided an opportunity for pre-release public comment.)
Given the variety of public participation methods employed by
OPP, the section heading in Chapter 3, "No Formal Public Comment
Periods Found Prior to 2002," does not accurately reflect the scope and
breadth of our public participation efforts prior to 2004. Since FQPA,
OPP has conducted extensive public involvement efforts.
Finally, OPP would like to note that we believe the term "registration" in the text of the
OIG Recommendation 3-1 is a typo since a "registration eligibility decision" does not exist.
III.B. OIG Recommendation 3-2:
"Develop guidance to determine which pesticide reregistration process (the six-phase or
four-phase process) should be implemented on individual pesticide reregistration eligibility
decisions."
OPP Response:
The draft report overstates the importance of setting additional "criteria" for conducting
public participation in OPP's reregistration program and neglects the Agency's current policy on
See OIG Comment
in Appendix B,
Note 6
See OIG Comment
in Appendix B,
Note 7
28
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public involvement by suggesting that further criteria are necessary for conducting legitimate
public participation (see Public Involvement Policy of the EPA, May 2003, EPA-233-B-03-002).
OPP's factors for determining the level of public participation are completely consistent with the
2003 Agency policy on public involvement. That policy instructs the methods for public
involvement, "may take a variety of forms, depending on the issues to be addressed, the timing
of the decision-making action, and the needs and resources of the
interested and affected public." Such flexibility has been incorporated
into the OPP policy and articulated by the various factors for determining
whether a reregi strati on case is conducted by a one-, four-, or six-phase
process.
OPP's May 2004 notice on the public participation process clearly describes and is
completely consistent with the Agency's Public Involvement Policy. The notice describes
the factors for determining whether a chemical goes through a one-, four- or six-phase
process. The factors include the magnitude of risk identified in the preliminary risk assessment,
the degree of uncertainty in the preliminary assessment, the existence of unusual issues pertinent
to the risk assessment and the level of public interest. When the Agency began using the process
for conventional chemicals (specifically the organophosphates), it made virtually all RED
decisions following the full six-phase public participation process. All REDs and IREDs
completed in FY 2002 involved the six-phase process. Over time and with experience, OPP
received very few comments for some draft REDs during a second public comment period. OPP
concluded that for certain pesticides, an additional comment period would be of little, if any,
value to the decision. Therefore, it would be an inefficient use of resources and unnecessarily
delay OPP's and the registrants' implementation of any newly required risk mitigation measures
to protect the public's health and/or the environment. Consequently, by 2004, OPP was able to
provide adequate public comment and save resources by using the modified four-phase or one-
phase processes. The Agency's website shows the planned comment periods for the next six
months. However, the plan may change over time for specific pesticides, based on public
comment and the results of OPP's preliminary risk assessments.
In the May 2004 notice, the basic framework for using different length public processes
was given as, "level of risk, extent of use, overall complexity of the issues, and amount of public
concern associated with each individual pesticide." The Agency outlines the factors for using
the four-phase process as applying in a case of a pesticide having, "highly refined risk
assessments, limited use, low risk concerns, few complex issues, and/or low public interest." In
clarifying the conditions for the one-phase process, the Agency further carefully elaborated on
the factors and meaning of low-risk pesticides as those that, "pose no or few risk concerns . . .
[or] show low levels of (non-target) toxicity and/or pass through screening models and show
very low levels of risk . . . [or] do not raise complex issues or public concerns."
IV. "Chapter 4 - Additional Opportunities Exist to Enhance Public Confidence"
In Chapter 4 , OIG focused upon OPP's guidance on involving the public in FQPA
related processes and decisions. They identified two areas where they stated that guidance is
needed: gathering data to identify and assess major subgroups of consumers; and responding
See OIG Comment
in Appendix B,
Note 8
29
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promptly and directly to petitions and requests from all external stakeholders. OPP's responses
to the recommendations in Chapter 4 are provided below.
IV.A. OIG Recommendation 4-1:
"Develop guidance that provides a defined methodology for identifying additional
subpopulations in a systematic manner, as well as a strategy for collecting and
disseminating information about subgroups. Continue to work with ORD to develop a
research agenda focusing on exposures to major identifiable subgroups."
OPP Response:
OPP plans to continue to work with ORD to develop a research agenda that seeks to
identify meaningful exposures to pesticide residues. That information is important to OPP in
carrying out its responsibility to ensure that pesticide tolerances provide a reasonable certainty of
no harm to consumers and major identifiable subgroups of consumers.
The OIG report does not explain what it means by "a defined
methodology for identifying additional subpopulations in a systematic
manner." OPP is unwilling at this time to commit to developing such a
methodology without an understanding and agreement of this
recommendation. Moreover, given the multitude of factors involved in
risk assessment under the FQPA, OPP is concerned that any such methodology that did much
more than merely restate the statutory factors relevant to major identifiable subgroups - e.g.,
"dietary consumption patterns," "aggregate levels of exposure," and "variability of sensitivities"
- would run the risk of inadvertently excluding critical information about a major identifiable
subgroup. Instead, we think we should proceed by considering any and all available information
that might define a subgroup and that might provide insights into differences in dietary
consumption, aggregate exposure, or sensitivity. The approach to such an analysis and the
conclusions reached would depend on the type of data available, which will vary from case to
case. The numerous examples that we provided to the OIG illustrate a range of ways in which
we have approached this responsibility. OPP agrees with the OIG that we should be transparent
in our explanation of our decisions whether or not a particular group is a "major identifiable
subgroup" and provide for public comment opportunities on our decisions. We also agree that
these decisions should be based on consistent principles and reflect sound science and we believe
we have and continue to be transparent by inviting and including public input.
Although the draft report attempts to describe OPP's risk assessment process for
consumers, including major identifiable subgroups of consumers, several significant problems
are evident. First, the Report appears to present stakeholders' concerns as fact, rather than
opinion or perception. This may be a simple editing fix and we have separately provided line-
by-line comments to address this problem (see Attachment 4). If this is more than an editing
problem and OIG asserts the stakeholders' unsubstantiated claims as facts, then OPP strongly
objects to this Report since it provides no basis to support such conclusions.
See OIG Comment
in Appendix B,
Note 9
30
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Also, the Report often misstates how OPP considers residential exposures to pesticides.
The Report accurately notes that OPP breaks down exposure estimates in the residential setting
into estimates for four separate subgroups; however, parts of the Report state that OPP only has
identified subgroups based on food consumption information. We believe it is extremely
important that the OIG Report correctly describe OPP's consideration of subgroup exposure in
the residential setting. Additional information on this topic is provided below.
We find the Report's discussion of the nine examples of OPP's consideration of
subgroups to be confusing and misleading. OPP provided the OIG with several examples where
subgroups were considered in risk assessment or regulatory actions. Some of these examples
involved subgroups beyond those routinely considered. Others were examples of where
consideration of children's subgroups caused EPA to take action to protect children. The OIG
Report misleadingly combines all of these examples together without providing an adequate
explanation of the reason for presenting the examples or even accurately describing the
examples. The Report also inaccurately states that OPP lacked data on
some of the subgroups. Finally, the discussion in Chapter 4 and Table 4.1
confusingly refer to "changes in tolerance levels" as if that is the only
manner in which we protect subgroups.
When OPP concludes a tolerance reassessment and finds a risk of con
common risk mitigation strategy it would pursue would be termination of the
termination of specific uses. EPA does not ordinarily change the pesticide's 1
risk mitigation measure. For termination of a food crop use, the associated
tolerance(s) would also be terminated. Often, the necessary risk mitigation
is to revise or terminate other uses that are contributing to exposure, such as
residential uses, to protect children. No tolerances are associated with such
uses. Attachment 2 provides examples of mitigation measures taken in response to risks of
concern identified during reregi strati on and/or tolerance reassessment. To the extent the OIG
wants to present information pertaining to significant actions to protect children's subgroups that
information, we have included that information in another attachment (see Attachment 3).
Finally, there are a number of minor misstatements of fact and law for which we are
separately providing suggested edits (please refer to Attachment 4). Additionally, for general
reference we are including the following discussion of OPP's consideration of subgroups.
Subgroups Assessed by OPP
See OIG Comment
in Appendix B,
Note 10
ern, the most
lesticide's use or
iterance level as a
See OIG Comment
in Appendix B,
Note 11
As a part of every pesticide risk assessment, OPP considers a large variety of
consumer subgroups according to well-established procedures. Those subgroups include
several age-groupings of children, among other groups. These evaluations of subgroup risks
have been deciding factors in every major risk reduction measure taken post-FQPA, with risks to
children generally being the key factor. EPA also has embarked on several data-gathering
exercises to determine if additional subgroups should be included in its routine analysis.
31
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The types of subgroups of consumers assessed by OPP in its pesticide risk assessments
can be broken into two main categories: (1) subgroups based on dietary consumption patterns;
and (2) subgroups based on activity patterns in a residential setting.
For pesticides with food/feed-crop uses and dietary consumption,
OPP evaluates pesticide risks for every pesticide in food for each of the
following subgroups. These subgroups are based on extensive data on food
consumption patterns:
IK si«c "roup:
IK scsison:
IK ethnic si si lus:
IK region:
Infants <1, nursing
Winter
Hispanics
Northeast
Infants <1 non-
Spring
Non-hispanic whites
Midwest
nursing
Summer
Non-hispanic black
Southern
Infants
Autumn
Non-hispanic, non-
Western
Children 1-2
white, non-black
Children 3-5
Children 6-12
Youths 13-19
Adults 20-49
Adults 50+
Females 13-49
Children 1-6
Children 7-12
Females 13+,
pregnant, not nursing
Females 13+ nursing
Females 13-19, not
pregnant, not nursing
Females 20+ not
pregnant, not nursing
Females 13-50
Males 13-19
Males 20+
OPP conducts exposure and risk assessments for each of these subgroups using models that have
been extensively and scientifically peer-reviewed.
Further, although exposure to smaller, specialized subgroups is not routinely assessed by
OPP, OPP is able and does perform such exposure assessments when conditions or
circumstances warrant. Recent examples include analyses of triclopyr and lindane for exposures
to certain Native Americans. In addition, OPP has contributed both financial resources and
expertise toward the development of specialized dietary and aggregate exposure software for
Native Americans (Tribal Lifeline™). In 2002, OPP initiated a contract to develop and modify
the Lifeline software in such a way that expanded consideration could be given to Native
See OIG Comment
in Appendix B,
Note 12
32
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Americans living on reservations and practicing traditional Native American lifestyles (including
diet). Specifically, this contract was initiated to better and more accurately represent exposure
scenarios for two specific Native American communities, and to explore the options and
approaches for complete representation of Native American communities. The software contract
provides for consideration of the exposure scenarios of people living Native American lifestyles.
Traditional diets based on hunted meats and gathered vegetables, seasonal changes of lodging,
use of sweat lodges and other unique exposure scenarios are now part of the risk assessment
model. As this model is developed, OPP intends to make more extensive use of it in instances
for which we believe more generic models and approaches are not sufficient.
In addition to subgroups based on dietary patterns, OPP also uses several subgroups to
assess differential risks from non-dietary exposure due to variation in behavior patterns. For
each pesticide that has a registered residential use, OPP assesses the exposure
and risk for the following subgroups, as appropriate for the use(s):
applicator (adult)
post-application adult
post-application youth
post-application toddler
These subgroups take into account, for example, that a young child's post-application exposure
to a pesticide may be substantially different than an adult's exposure, due to their different
behavior, such as the tendency of young children to spend significant periods of time on the floor
or lawn and to engage in hand-to-mouth activities.
Finally, OPP is continually evaluating and gathering data on whether risks to other
subgroups should be specifically assessed. For example, several environmental and other
organizations have argued that farm children face heightened pesticide exposures and have
petitioned the Agency to assess farm children as a separate subgroup (i.e., the "Farm Children
Petition"). OPP has comprehensively evaluated the available data on this
question and determined that the available data do not support identifying
farm children as a separate subgroup because their exposure to pesticides is
not significantly different than non-farm children.
Strategy for collecting and disseminating information about subgroups
OPP agrees with this recommendation. We are working with ORD's National Center
for Environmental Assessment to have this information incorporated and distributed as part of
EPA's Exposure Factors Handbook (next edition in 2007). OPP has also provided this
information to exposure model developers.
Collaborative research efforts
With regards to the recommendation that OPP continue to work with ORD to develop a
research agenda focusing on exposures to major identifiable subgroups, OPP acknowledges the
See OIG Comment
in Appendix B,
Note 13
See OIG Comment
in Appendix B,
Note 14
33
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value of such collaboration. OPP has and will continue to work with ORD on science issues
related to exposure to subgroups. OPP and ORD are well beyond the planning stage, as
documented in Attachment 3. This attachment highlights OPP's and ORD's major collaborative
efforts, past and present, to improve the human health risk assessment process under FIFRA and
FFDCA. Many of these collaborations relate directly to scientific challenges posed by FQPA
including the understanding and characterization of pesticide exposure to subgroups.
IV.B. OIG Recommendation 4-2:
"Respond to petitions and requests from external stakeholders without further delay.
Develop a policy that stresses the importance of Agency response to external comment in a
timely manner."
OPP Response:
We agree with the spirit of the recommendation that petitions should be responded to in a
timely manner and we would admit that we have been frustrated that it has taken an extensive
period of time to address some FQPA petitions. Very little in the implementation of a ground-
breaking statute like the FQPA has been easy or quick. We object strongly, however, to the
recommendation to respond to petitions "without further delay" if, for no other reason, than
because EPA has either already responded to the petitions mentioned in the report or a court has
upheld our response schedule as reasonable. We also object to the report's conclusions about
"unreasonable delay;" as explained below, they have not been adequately supported. The
unfortunate fact is that we believe that most of our disagreement with this section of the Report
could have been resolved if only the OIG staff would have been willing to meet with us to
discuss these concerns, or at least to discuss our comments on their draft Report. When we first
learned of the OIG's conclusion regarding petition responses, we strongly
objected to it noting that the OIG was drawing a broad conclusion based on
a single petition (the 1998 Farm Children Petition) and without seeking
OPP's explanation for the timing of its response. While the draft report is
marginally better in how it deals with the Farm Children Petition, it compounds the original error
by now raising other petitions which the OIG has not discussed with OPP. Because the OIG
insists on pushing ahead without stopping to learn the facts or discuss the flaws in their analysis,
OPP reluctantly must commit to the written record the serious deficiencies in this section of the
Report.
Overview
OPP objects to the accuracy and fairness of this whole section of the Report. We
perceive OIG as having two criticisms of OPP practice with regard to Administrative Procedures
Act (APA) petitions. First, that OPP has not responded in a timely manner to such petitions and
second, that OPP's responses have not been direct (i.e., OPP has not sent a letter directly to
petitioners announcing its response). Although these may very well be valuable issues for the
OIG to evaluate, this section is replete with serious flaws:
See OIG Comment
in Appendix B,
Note 15
34
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1. As mentioned, the main recommendation from this section - that
OPP should respond to petitions without further delay - is
unsupported by fact. Each of the petitions cited in the Report have
either been responded to or a court has upheld the timing of OPP's
response schedule.
2. Although this section of the report purports to evaluate OPP's
handling of FQPA petitions, it never discusses or considers OPP's
approach to addressing such petitions.
3. The Report's conclusion that OPP has unreasonably delayed
responding to the 1998 Farm Children's Petition in violation of the
APA is devoid of any legal reasoning. In fact, the legal analysis
appears to have been prepared by individuals without legal training.
Needless to say, the Report contains no defensible basis for its
conclusion.
4. The Report's description of OPP's response to the Farm Children
Petition is rife with inaccuracies and mischaracterizations.
Each of these points is discussed in turn below.
The Referenced Petitions Have Been Responded To
The OIG Report recommends that OPP respond to petitions and requests without further
delay. We find this recommendation confusing, to say the least, given the status of the petitions
discussed in the report. The only petition clearly identified in the Report is the 1998 Farm
Children Petition filed by NRDC and a host of other organizations. EPA released a point-by-
point response to this petition in May, 2004. 69 FR 30042, 30069-30070 (May 26, 2004). The
Report also vaguely references petitions on the children's safety factor and on wood
preservatives. EPA is aware of two petitions concerning the children's safety factor, one filed by
NRDC and other environmental organizations and one filed by representatives from the pesticide
and food industry. EPA responded to both of these petitions in the course of developing its 2002
policy statement on the children's safety factor and included a discussion of the issues raised by
the petitions in the response to comment document for that policy. Finally, OPP has received a
petition to cancel various wood preservatives. OPP has decided to respond to that petition in the
course of making a FIFRA reregi strati on decision on these pesticides. In a case challenging the
timing of EPA's schedule for response to this petition, a federal district court ruled in favor of
OPP holding its approach was reasonable. Beyond Pesticides v. Johnson.
2005 Lexis 4895 (D.D.C. March 21, 2005) (finding a 4 year delay in
responding to a petition to cancel was not unreasonable). Thus, the OIG's
recommendation to respond to petitions "without further delay" has no
basis.
See OIG Comment
in Appendix B,
Note 16
See OIG Comment
in Appendix B,
Note 17
See OIG Comment
in Appendix B,
Note 18
See OIG Comment
in Appendix B,
Note 19
See OIG Comment
in Appendix B,
Note 20
35
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EPA's Approach to Addressing FQPA Petitions
Because the OIG Report does not discuss OPP's approach to addressing petitions, we
have attempted to encapsulate it here. When allocating its resources, OPP's top FQPA priority is
completing the 10 year tolerance reassessment program explicitly mandated by Congress in
FQPA. With this goal as its top priority, OPP has often managed petitions by folding the
response to them into more generalized actions in support of tolerance reassessment or other
required actions that are part of the tolerance reassessment program. Thus, OPP has dealt with
petitions concerning the children's safety factor and aggregate exposure in the context of the
science policy papers and response to comment documents on those topics. Similarly, OPP
responded to the Farm Children Petition as a part of the response to objections filed in a
tolerance preceding that raised the same issues. (Earlier, OPP had provided preliminary
responses to the petition both in is letter acknowledging receipt of the petition and in the
response to comment document for OPP's children's safety factor policy
document.). Such an approach has led to a lapse of time between the filing
of a petition and the OPP response. Before concluding that any particular
length of time is unreasonable, however, OPP believes it is necessary for the
OIG to consider both OPP's need to combine issues for efficiency purposes in meeting its
tolerance reassessment deadlines and the complexities of the issues presented by the petition.
For petitions that call on OPP to make broad policy pronouncements, it makes little sense when
OPP is already in the process of formulating policy on issues related to the petition to abort its
policy-making process to first respond to a petition. FQPA policy development, not unlike
rulemaking, tends to be a fairly arduous process in which both public and intra- and inter-agency
comment as well as peer review is sought and considered. When OPP receives a petition, it
incorporates the issues raised as part of its on-going regulatory work, as appropriate, and in
accordance with its on-going priorities. Similarly, for petitions that raise complex factual and
scientific issues, the reasonableness of the time in responding depends on an analysis of the
complexity of the issues presented.
Because the OIG does not even take into account OPP's approach to
addressing petitions, its evaluation of OPP's performance with regard to
responding to petitions has little value.
The OIG's Legal Conclusion on Unreasonable Delay is Without Support
The OIG's conclusion that EPA unreasonably delayed its response
to the Farm Children's Petition in violation of the Administrative
Procedures Act (APA) is unfounded. The OIG's analysis fails to identify
the appropriate legal test for unreasonable delay, ignores almost all relevant
facts, and misses the most relevant legal precedent.
The OIG concluded that it was unreasonable for OPP to take six years to respond to the
Farm Children petition and additionally, that it was unreasonable for OPP to spend one year to
address extensive supplemental material submitted in support of the petition. Those conclusions
were based on nothing more than the time involved in responding to the petition. In full
See OIG Comment
in Appendix B,
Note 21
See OIG Comment
in Appendix B,
Note 22
See OIG Comment
in Appendix B,
Note 23
36
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disregard of all legal precedent, the OIG did not consider the substantial competing demands on
OPP's time - i.e., the mandatory tolerance reassessment deadline - or the complexity of the
issues presented in the petition and the carefulness and detail of OPP's response. It is axiomatic,
however, that an evaluation of the reasonableness of the timing of an agency action requires a
fact-driven inquiry. Oil Chem.. & Atomic Workers v. OSHA. 145 F.3d 120, 123 (3rd Cir. 1998)
(resolution of unreasonable delay claim in "a particular case is fact-intensive."). Indeed,
unreasonable delay cases uniformly follow a well-established multi-factor test in assessing the
reasonableness of the timing of the agency's action. See, e.g.. In re: International Chemical
Workers Union. 958 F.2d 1144, 1149-1150 (D.C. Cir. 1992) (describing a four factor test);
Qwest Communications Int'l. Inc. v. FCC. 398 F.3d 1222, 1238 (10th Cir. 2005) (adding a fifth
factor: "consideration of the complexity of the task envisioned by a court's remand order").
Instead of investigating the relevant facts surrounding the Farm Children's Petition, the
OIG relies only upon broad statements from a single judicial decision without analyzing the
either the facts of that decision or the court's multi-factor test for making unreasonable delay
determinations. See In re: American Rivers and Idaho Rivers United. 372 F.3d 413 (D.C. Cir.
2004). Even a cursory analysis of the American Rivers decision would have shown a significant
factual difference between that case and the present situation in that the agency there defended
primarily by arguing it was not obligated to respond to the petition at issue. Id. at 418, 420
("FERC offers no "plea of administrative error, administrative convenience, practical difficulty
in carrying out a legislative mandate, or need to prioritize in the face of limited resources."").
Equally damaging to the OIG's legal conclusion is its failure to consider much more relevant
precedent. Just recently, a federal district court upheld a lengthy OPP delay
in responding to a petition, based on a similar justification to OPP's reason jn AppendjX B
for delaying its response to various FQPA petitions. See Beyond Pesticides Note 24
v. Johnson. 2005 Lexis 4895 (D.D.C. March 21, 2005). In that case, a four
year delay in responding to a petition to cancel was not considered "unreasonable" because EPA
was coordinating response to the petition with FIFRA reregi strati on. Ironically, the OIG scolds
EPA for not responding to this very petition.
See OIG Comment
These flaws render the OIG's legal analysis completely meritless. in Appendix B,
Note 25
Factual Inaccuracies and Mischaracterizations
The Report contains numerous inaccurate statements and mischaracterizations concerning
OPP's response to the Farm Children Petition. First, in the second paragraph in this section, the
OIG states: "The agency addressed many aspects of the 1998 NRDC petition in the Federal
Register order . . . ." By using the term "many", the OIG report implies that some or even a
majority of the issues in the petition were not addressed. In fact, in responding to the petition,
OPP individually examined each of its six requests and responded to each one of them. OPP also
exhaustively discussed the data relied upon by the Petition. Any implication by the OIG that
EPA did not fully address the 1998 NRDC petition is wholly without a factual basis.
Second, this same paragraph also notes that "NRDC was not immediately mailed a copy
of the ruling ..." Although that is true, the statement is very misleading in that it creates an
37
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impression thatNRDC was not aware of the document containing OPP' petition response.
NRDC certainly had actual notice that the document had been published since EPA's General
Counsel's office had discussions with NRDC concerning the Order immediately following its
entry. Moreover, we think it is important to mention that the main issue discussed in this Order
was the exposure of farm children to pesticides. It is not as if OPP placed its petition response in
some random document that NRDC was not likely to see.
Third, this paragraph further states "NRDC received word that the Imidacloprid decision
served as a response to the petition on August 23, 2005, one year after the publication of the
decision in the Federal Register." This is inaccurate on several levels. Any reasonable person
would recognize as a "response" a document the provided a detailed response and analysis of
each of the six demands in the Farm Children Petition and explicitly stated "[a]l though EPA
prior to this action has not issued a formal response [to the Petition], . . ."
69 FR 30042, 30046 (May 26, 2004) (emphasis added). Moreover, in the
context of litigation with NRDC on a similar issue, EPA filed papers in
court in the Spring of 2005 noting that it had responded to the Farm
Children Petition.
See OIG Comment
in Appendix B,
Note 26
The "Directness" of OPP's Response to Petitions
Finally, as noted above, the OIG is critical of OPP for not directly mailing petition
responses to petitioners. Again, however, the OIG fails to discuss or consider OPP's approach to
publishing its petition responses. OPP's approach has been to include its response to petitions in
broadly-distributed public documents that have been available on OPP's website or in the
Federal Register. OPP has not attempted to hide its responses. On the
contrary, it has included them in documents likely to get the broadest public
distribution. If the OIG believes that OPP should take additional steps and
send a letter directly to the petitioners, OPP will consider such steps to
further transparency.
See OIG Comment
in Appendix B,
Note 27
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Appendix B
OIG Comments on Agency's Response
1. With the enactment of FQPA, the need for extensive broad public involvement was clear.
OPP acknowledges in its response that, at a minimum, public participation should include
at least one pre-signature public comment period for all pesticides except those
presenting the lowest risks. According to OPP's public participation process, formal
public comment periods are the primary method by which OPP allows for public
participation. Allowing for public comment after a decision is made does not allow for
the same type of stakeholder confidence as soliciting pre-signature public participation.
Additionally, allowing formal public comment periods prior to the release of a final
decision document may preclude the Agency from having to amend decisions once they
are made. We believe that proactively requesting public comment encourages
stakeholder confidence in Agency decisions. Without OPP actively seeking pre-signature
public comment, the public may continue to raise concerns regarding the transparency of
the Agency decisions.
According to the Agency's response, OPP believes that our reliance upon formal public
comment periods does not accurately reflect all outreach involved in the decision-making
process. Although there are other methods by which OPP can solicit some degree of
participation, pre-signature public comment periods published in the Federal Register
remain the most open and transparent method of involvement. While targeting specific
stakeholders may add value to the decision making process, OPP can reduce the
perception of bias by favoring formal public comment over informal outreach
opportunities.
2. See Comment 1.
3. Table 3.3 clearly states that it comprises only final reregi strati on eligibility decisions.
The 8 interim reregi strati on eligibility decisions highlighted by OPP are discussed in the
first paragraph of that section: "Similarly, we reviewed one third (eight total) of the post-
FQPA interim reregi strati on eligibility decisions and found that all of these decisions had
formal comment periods prior to the issuance of the interim decision in accordance with
the new policy." In no way does the table suggest that the Agency provided fewer
opportunities for public participation during this time period for the interim reregi strati on
eligibility decisions; it accurately reflects the number of public comment periods allowed
for all final reregi strati on eligibility decisions signed during this time period.
4. Our sampling methodology included in the selection universe reregi strati on decisions
made since the enactment of FQPA. Two of the five key principles of FQPA
implementation focused on openness and public involvement. Evaluating public
participation from FQPA's passage through the present should reflect OPP's dedication
to these principles. OPP states that we do not accurately reflect current conditions
because we evaluated public comment from FQPA's outset. FQPA was passed in 1996;
however, according to OPP, it did not implement the draft public participation policy
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until 2002. This policy was not finalized until 2004. The scope of our review was from
the passage of FQPA to the present. To focus solely on the years covered by the draft
and final policies, we would have ignored at least 6 years of decision-making by OPP.
This omission would lead to an inaccurate picture of public participation in OPP since
FQPA's passage. We acknowledge in various places in our report the progress EPA has
made since 2002. We reviewed over one third of the universe of decisions made since
FQPA. We reported on the positive results found in reviewing the interim reregi strati on
eligibility decisions. In meetings with OPP staff, our sampling methodology was
discussed and vetted by those involved in the reregi strati on process. We believe that our
decision to examine public comment periods from FQPA passage in 1996 through the
end of the field work process most accurately depicts OPP's work in implementing
FQPA.
OPP expressed concerns that our sample does not accurately reflect its 2000 draft change
in policy. OPP provided statistics related to the decisions made between 2002 and 2004.
According to OPP, of the 26 reregi strati on eligibility decisions finalized during that
period, 18 had two comment periods, 5 had one, and 3 had none. However, OPP's
numbers, as provided within the Agency's response, are potentially confusing to the
public. According to the Agency's Web site of the 26 reregi strati on eligibility decisions
OPP discussed, 11 are interim reregistration eligibility decisions. This lack of distinction
between interim reregistration eligibility decisions and reregistration eligibility decisions
may be confusing to the public and thus reduce public confidence and the transparency of
the process.
5. See Comment 1. Additionally, we are concerned that of all the stakeholder groups OPP
mentioned as involved in public outreach activities prior to the reregistration eligibility
decision signature but outside the realm of public comment, no public health or
environmental advocacy groups are discussed. Targeting outreach at pesticide
manufacturers and growers may miss out on a segment of the interested population. OPP
stated that it has routinely consulted with major stakeholder groups prior to making its
registration decisions. However, this would lead the public to believe that all stakeholder
groups, including environmental and public health advocacy organizations, are consulted
during OPP's decision-making process.
6. OPP states that it took the advice of a subcommittee formed to examine the potential for
accidental exposure of young children to rodent control pesticides by issuing safety
regulations in 1998. However, EPA revoked these protections in 2001. In August 2005,
a Federal judge rejected the Agency's reversal, finding that its justification was without
merit.
7. OPP objects to the section heading, "No Formal Public Comment Periods Found Prior to
2002." This heading, however, was removed prior to our providing OPP a revised draft
report.
8. See Comment 1. We recognize that the Agency has a public involvement policy that
allows public involvement to take many forms. As we reported, we agree that it is
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important for OPP to have the flexibility to utilize various public participation processes
(six-phase, four-phase, or one-phase). However, we believe that it is essential that OPP
staff have clear criteria to use in assessing which phase is selected. In meeting with OPP
staff, we were informed that the decision as to the level of public comment to employ is
typically left to the discretion of OPP staff, and that it is usually a "judgment call."
Additionally, such criteria would clearly articulate to the public and other interested
stakeholders OPP's justification for deviation from the six-phase process, which allows
the greatest opportunity for public comment.
9. While the Agency agreed with the recommendation to develop a strategy for collecting
and disseminating information about subgroups, we believe it is imperative that the
Agency first have a methodology in place describing at a minimum how it will identify
additional subgroups on a case-by-case basis. We recommended that OPP document the
methodology by which it currently considers additional subgroups who might potentially
receive greater exposure than one of the standard subgroups. Additionally, providing this
methodology to the public would increase transparency and public confidence in OPP's
work.
10. We requested that OPP identify instances where pesticide tolerance setting decisions
specifically incorporated the needs of subgroups, particularly in terms of non-dietary
exposure pathways. Specifically we requested documents regarding: OPP's
methodology for considering subpopulations, examples of instances in which
subpopulation considerations changed the tolerance-setting process, and any changes in
the non-dietary risk assessment process to take subpopulations into greater consideration.
The information we received did not detail specific instances of OPP action to protect
subpopulations from pesticide exposures; instead, we received reregi strati on eligibility
decision and interim reregi strati on eligibility decision documents and policy decisions,
the majority of which focused on dietary exposures and did not incorporate changes in
the decision due to consideration of these subgroups. Based on our interviews with OPP
staff, we assumed it was reasonable to consider the nine examples provided as the
universe of decisions in which OPP addressed the question of major identifiable
subgroups of consumers other than infants and children.
OPP agreed with our recommendation to work with ORD to develop a research agenda
focusing on exposures to major identifiable subgroups. We anticipate the goal of the
research agenda would be to generate information on subgroups that OPP currently does
not have. This research could be used to benefit future decision making.
The statement that OPP is referring to as confusing is no longer in the report. In addition,
the table heading was revised to more accurately reflect actions taken by OPP to protect
subgroups.
11. See Comment 10. OPP objected to our examination of tolerance changes as a mechanism
of reflecting impact and results from FQPA implementation. However, in meetings with
high-level OPP staff, they recommended looking at individual registration eligibility
decisions pre- and post-FQPA to ascertain the differences resulting from FQPA. We
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were informed that there is rarely a chemical that goes through this process without some
additional restriction on its use related to FQPA. Therefore, the reregi strati on eligibility
decisions and tolerance reregi strati on eligibility decisions will evidence pre-FQPA and
post-FQPA differences, especially the additional analyses related to safety factor
decisions. We were told that looking at individual reregi strati on eligibility decisions and
tolerance reregi strati on eligibility decisions "would be perfect" in illustrating the
analytical and outcome differences related to FQPA. We will be addressing the impact of
FQPA in an upcoming report.
12. We reported that OPP traditionally used a dietary exposure model that examines at least
27 different subgroups, which is consistent with the table provided in the Agency's
response. Moreover, during our field work, we specifically asked for the methodology
OPP uses in identifying and assessing subgroups in regard to non-dietary exposure. As
we reported, in evaluating residential exposures, OPP evaluates four additional
subgroups, including toddlers, youth, young adults, and applicators. While we did not
evaluate individual decisions or the methodology used by OPP in conducting
assessments, we recognized that there is still controversy as to whether additional
subgroups should be examined. Additionally, in some instances, additional data will be
needed to determine the susceptibility of such subgroups. We agree with OPP that the
identification of subgroups is complicated and requires additional information and
research. We will examine the extent to which OPP has "extensive data on food
consumption patterns" in the forthcoming report on opportunities to improve data quality.
13. According to a 2000 GAO report, "As part of its implementation of the Food Quality
Protection Act, EPA is revising the way it assesses residential pesticide exposures to
better account for farm children's exposures. Among other things, in setting tolerances,
EPA will consider pesticides that are tracked into homes and pesticide exposures children
receive through spray drift in agricultural areas. As of November 1999, EPA had not
completed its revision of methods to assess residential pesticide exposures." However,
OPP standard procedures do not necessarily address take-home and spray drift exposures
in assessing the potential for residential, non-occupational exposures to children.
14. One of the goals of FQPA was to improve existing data on the potential pesticide
exposure to infants and children, and on the outcomes of these exposures. OPP agreed
with our recommendation to work with ORD to collect and disseminate information
about subgroups. Where gaps exist, OPP needs to ensure that the research agenda
addresses these gaps.
15. OPP stated that a number of issues it has with our report could have been alleviated if we
were "willing to meet with [them] to discuss these concerns." However, we met with
OPP staff after the draft report was issued to discuss concerns and later provided OPP a
revised draft. Additionally, OIG staff had several phone conversations with OPP staff
and legal counsel between OPP's receipt of the revised draft report and OPP providing
Agency comments. Furthermore, we extended the customary draft comment period to
twice its normal length to further accommodate OPP. The meetings and conversations
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discussed above were in addition to numerous discussions with OPP staff at various
levels throughout our evaluation.
16. OPP strongly objected to the recommendation that OPP should respond to petitions
"without further delay." However, that wording was removed prior to our providing OPP
a revised draft report.
17. The focus of our evaluation was on the responsiveness of OPP to stakeholder petitions
and requests. We did not focus on OPP's approach to addressing petitions; rather, we
focused on one consequence of OPP's approach, which we concluded is contrary to the
Agency's policy of openness and transparency.
18. See Comment 16. The Agency stated that conclusions drawn by the OIG were "devoid
of any legal reasoning." However, this language was revised prior to our providing OPP
with a revised draft report. We conducted a policy - not a legal - analysis of the
Agency's responsiveness. In conducting our policy analysis, we determined that the
responses by OPP to the petitions in question were inconsistent with the intent of Agency
policy regarding transparency. While "OPP's approach has been to include its response
to petitions in broadly-distributed public documents that have been available on OPP's
website or in the Federal Register," we believe that OPP should take additional steps and
specifically identify each such policy iteration as a response to a specific petition. OPP
should mail a copy of these responses directly to the petitioners as a means to increase
clarity and public confidence.
19. OPP states that our description of OPP's response to the Farm Children Petition is "rife
with inaccuracies and mischaracterizations." This section was modified and edited
significantly to address what OPP viewed as inaccuracies and mischaracterizations. At
this time, we believe we have reported the condition accurately.
20. See Comment 16.
21. See Comment 18.
22. See previous discussions in Comments 19-22.
23. We did not in any version of our report conclude that OPP's lack of responsiveness
"violated" APA. We did not conclude in the draft report that OPP had an unreasonable
delay. Also, we only conducted a policy review and analysis of these issues; we did not
conduct a formal legal analysis. See previous discussions in Comments 16-19.
24. See Comments 16-23. Additionally, in numerous interviews, we heard a variety of
opinions on the validity and finality of the imidacloprid order as a response to the Farm
Children Petition. The overall perception among the petitioners was that the imidacloprid
decision does not resolve the petition. Moreover, OPP has never commented on the
impact of the delay on current and future pesticide decisions. Our focus within the report
was on the perception of OPP's unresponsiveness.
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25. Again, the OIG did not conduct a legal analysis, but rather a policy analysis on the impact
of OPP's practices on public confidence and perceptions. See previous discussions in
Comments 16-24.
26. See comments 18-24.
27. OPP believes that we imply its responses to petitions have been hidden. The OIG
evaluation was not a review of OPP's approach in responding to petitions but rather its
responsiveness and the impact of the approach taken by OPP. According to the Agency's
response, OPP has included responses to petitions in broad public distributions, such as
policy documents or individual pesticide decision. However, this approach is not clear
and transparent to petitioners and the public as to when and how the petitioners' concerns
were addressed. For example, we found various opinions regarding the status of the
petition during the course of this evaluation. It was unclear as to whether the Agency had
responded to the petition. Apparently recognizing that, OPP issued a letter on August 23,
2005, to the petitioners informing them that the Imidacloprid order was in response to
their petition. In the Agency's response, OPP agreed to consider taking additional steps
in responding to petitions to further transparency.
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Appendix C
FQPA Major Science Papers Receiving
Public Comment Periods
Draft Toxicology Data Requirements for Assessing Risks of Pesticide Exposure to
Children's Health
Draft Exposure Data Requirements for Assessing Risks of Pesticide Exposure to Children
Standard Operating Procedures (SOPs) for Residential Exposure Assessment
Guidance for the Submission of Probabilistic Human Health Exposure Assessments to the
Office of Pesticide Programs
Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment
Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern
The Use of Data on Cholinesterase Inhibition for Risk Assessments of Organophosphorous
and Carbamate Pesticides
The Role of Use-Related Information in Pesticide Risk Assessment and Risk Management
Consideration of the FQPA Safety Factor and Other Uncertainty Factors in Cumulative
Risk Assessment of Chemicals Sharing a Common Mechanism of Toxicity
Drinking Water Screening Level Assessment, Part A: Guidance for Use of the Index
Reservoir in Drinking Water Exposure Assessments
Standard Operating Procedure for Incorporating Screening-Level Estimates of Drinking
Water Exposure in Aggregate Risk Assessments
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Appendix D
Results on Public Participation for Sampled
Final Reregistration Eligibility Decisions
Universe: All OPP Final Reregistration Eligibility Decisions,
October 1996-February 2005
Chemical
Date of
Final Decision
(Month/Year)
Was Formal Public Participation
Solicited Prior to
Issuance of Final Decision?
Aluminum phosphide
9/1998
NO
Chlorophacinone
7/2004
NO
Chlorothalonil
9/1998
NO
Cycloate
9/2004
YES
Deet
4/1998
NO
Dichlobenil
9/1997
NO
Diclofop-methyl
9/2000
NO*
Diphacinone and salts
9/1997
NO
Diuron
9/2003
YES
Folpet
9/1999
NO
MCPA
9/2004
YES
Oxyfluorfen
10/2002
YES
Pebulate
9/1999
NO
Pendimethalin
4/1997
NO
Terbacil
9/1997
NO
Terrazole
9/2000
NO*
TFM
9/1999
NO
Thiobencarb
9/1997
NO
Thiodicarb
9/1998
NO
Triclopyr Salts and Esters
9/1997
NO
Troysan
12/1996
NO
* Risk assessment was made available via a Federal Register notice but, according to the
notice, no formal comment period was granted.
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Appendix E
Distribution
Office of the Administrator
Acting Assistant Administrator for Prevention, Pesticides, and Toxic Substances
Director, Office of Pesticide Programs
Acting Director, Office of Children's Health Protection
Associate Director, Field and External Affairs, Office of Pesticide Programs
Agency Followup Official (the CFO)
Agency Followup Coordinator
Audit Coordinator, Office of Prevention, Pesticides, and Toxic Substances
Audit Liaison, Office of Research and Development
Audit Liaison, Office of Pesticide Programs
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Inspector General
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