Achieving  Results
               Through Commitment and Collaboration
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                       ||HltHH»
                'iscal Year 2003 Annual Report

                Office of Pesticide Programs

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2003 Annual Report, Office of Pesticide Programs
           Contents
           M
            essage
from the Director
          Section 1 !  Achieving Results Through Pesticide Registration . .  2

          Section 2i  Reducing Risk Through Reregistration and Tolerance
                      Reassessment 	  6

          Section 3i  Advancing the Science of Risk Assessment	9

          Section 4i  Providing the Public with Pesticide Information   . .

          Section O!  Col laborating with Partners to  Ensure Protection
                      and Safe Practices Through Field Programs  .... 14
          Section D!  Promoting  International Harmonization

          Homeland  Security	

          Appendices  Pesticide Program at a Glance
                       FY2003 Registration and Reregistration
                       Actions
                                                 . ...  19

                                                       21
                                                      ,22

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Dear Readers:

        The Office of Pesticide Programs (OPP) made significant progress in fiscal year 2003 in carrying out our many
important responsibilities. Our program's success represents the collective efforts of not only the many hardworking, diverse
employees within OPP but also our partners in the EPA regional offices and state and tribal pesticide regulatory agencies.

        OPP manages a large workload and faces complex issues. As a steward of public health and the environment, OPP
stands at the gateway to a multibillion dollar pesticide market. We must ensure that pesticides are regulated fairly and
efficiently while reducing pesticide risks  and promoting safe pesticide use. OPP  also must help ensure that pesticide users have
essential tools to meet their pest control needs in safe, environmentally sound ways.

        We continued our excellent track record in 2003—meeting and often exceeding our many regulatory commitments.
We nearly exceeded the program's all-time record of new pesticide registrations with  a total of 31 new chemicals registered. In
keeping with the Government Performance and Results Act objective of reducing exposure to more toxic pesticides, well over
half of the pesticides registered in 2003 were biopesticides or reduced-risk conventional pesticides. These accomplishments
were impressive, as the program had just completed a  significant amount of work associated with meeting the August 2002
tolerance reassessment deadline of the Food Quality Protection Act of 1996 (FQPA). Moreover, 43 reregistration actions were
completed in 2003, and these were based on some of the most complex regulatory science assessments ever performed at EPA.
A solid foundation is in place to continue the important work associated with meeting the ultimate FQPA deadline of August
2006, at which time we expect to have completed reassessments of more than 9,000 tolerances.

        Clearly, OPP's accomplishments for 2003 are the result of carefully integrated work planning, adherence to schedules,
and teamwork. The successful launch of our comprehensive, interactive database system (OPPIN) provides us with one
integrated system encompassing all major pesticide regulatory and scientific data. With this important new resource, we are
saving time, and we are able to better track our decisionmaking processes, decrease data entry tasks, and improve access to
critical decision documents. Our investment in this system  will benefit our program for years to come.

        The following pages provide brief summaries  of many more accomplishments made in FY 2003 throughout OPP. These
summaries touch on topics such as field programs, endangered species, worker protection, international harmonization, policy
development, and outreach to our stakeholders. By addressing all of these important issues, OPP lays the foundation for our
overall success. Our continuing efforts to find more efficient processes and to work more collaboratively have enabled us to get
more done, and the more we are able to  do, the more environmental protection we achieve.

        By managing for results, we have set a strategic course that allows us to measure our progress to determine the success
of our programs and  make necessary adjustments to improve our performance and reach our goals and objectives.

        I look forward to your continued cooperation and support. I want particularly to thank the dynamic team of
professional employees within OPP for their dedication and hard work in making this past year successful. We thank our
regional, state, and tribal partners, as well as the many other stakeholders who participated in our open decisionmaking process.
The year ahead presents even greater challenges and opportunities as we move forward with implementation of the Pesticide
Registration Improvement  Act of 2003 (which became effective in early 2004). I hope this report will help provide greater
understanding of our accomplishments during the past year and serve as an important communication and education tool for
all of our stakeholders.
                                                                                      James J. Jones, Director

                                                                                  Office of Pesticide Programs
                                                                     U.S. Environmental Protection Agency

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                 Achieving   Results  Through
                 Pesticide  Registration
                              ntM

     The United States Environmental Protection
     Agency (EPA) evaluates pesticides to ensure that
     they will meet stringent federal safety standards
designed to protect human health and the environment.
Registering a pesticide requires a considerable investment
of resources for both the registrant and EPA. EPA places a
high priority on registering lower-risk pesticides, pesticides
with public health benefits, and pesticides that are of par-
ticular economic importance to crop producers. To enable
OPP to make an informed regulatory decision on potential
risks, the applicant of a new pesticide must provide data,
typically from more than 100 different studies conducted
according to EPA guidelines. Prior to making a registra-
tion decision, OPP considers and evaluates the pesticide's
ingredients; the site or crop where it is to be used; use
directions; storage and disposal practices; supporting scien-
tific data, including efficacy of the public health products;
and risks to the environment
and human health.

   In FY 2003, EPA registered
31 new chemical ingredients, of
which three were antimicrobial,
14 were biopesticides, nine were
conventional chemicals, and five
were reduced-risk conventional
chemicals. Among the new
active ingredient registrations are
four that provide alternative uses to organophosphate pes-
ticides and one that is considered an alternative to methyl
bromide. Four of the new registrations were the result of
joint review under the North American Free Trade
Agreement (NAFTA).

Pesticide  Registration  Highlights

New Plant-Incorporated Protectant for Controlling
Corn Rootworm
After an intensive, multiyear scientific analysis, EPA
approved the use of a new biopesticide, MON 863, to
control the highly destructive corn rootworm, which is
responsible for the single largest use of conventional pes-
ticides (organophosphates, carbamates, and pyrethroids)
in the United States. At roughly 80 million planted
acres, corn is the largest crop grown in the United
                   States. This new product will
                   provide corn growers with a safe,
                   nonchemical pest control alter-
                   native that can reduce reliance
                   on traditional insecticides. Use
                   of this new biopesticide will
                   reduce the amount of chemical
                   pesticide introduced into the
                   environment and reduce expo-
                   sure of agricultural workers and
                   others to chemical pesticides.

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                                                 Achieving Results Through Commitment and Col laboration
Developed by Monsanto, MON 863 corn makes its
own insecticide, a protein called CrySBbl B that
controls the corn rootworm. This is the first plant-
incorporated protectant (PIP) registered for use
against a soil insect pest.

Microbial Fungicide Aspergillus  flavus AF36
Registered for  Use on Cotton
In FY 2003,  EPA conditionally registered Aspergillus
flavus AF36  for use on cotton to reduce aflatoxin
contamination. Aflatoxin is a naturally occurring
toxic metabolite from the growth of some strains of
Aspergillus flavus. By aggressively competing with
those strains that produce aflatoxin, Aspergillus
flavus AF36  reduces aflatoxin contamination. AF36
does not produce aflatoxin. Aflatoxin contamina-
tion of cottonseed causes significant economic losses
annually because cottonseed is a preferred feed for
dairy cows. When cows are fed contaminated seed,
their milk sometimes contains aflatoxin residues in
excess of Food and Drug Administration (FDA)
limits, resulting in discarded milk and quarantined
dairy. There are no chemicals registered specifically
for the control of aflatoxin-producing strains of
Aspergillus flavus. Aspergillus flavus is a common fun-
gus that is most often found where crops such as
cottonseed, corn, and peanuts are grown under
stressful conditions, such as drought.

Bardac 22C50  as New CCA Alternative
OPP registered Bardac 22C50 as an alternative to
chromated copper arsenate  (CCA), a wood preser-
vative that contains the known human carcinogen
arsenic. As of December 30, 2003, CCA registrants
voluntarily phased  out some uses of CCA; therefore,
it cannot be used to treat most wood used in resi-
dential settings. Bardac 22C50 is a 50-percent
concentrate of didecyl dimethyl ammonium carbon-
ate and didecyl dimethyl ammonium bicarbonate,
and it is to be applied only  by wood-preserving
plants to pressure-treat wood articles. It can be used
alone or in combination with other EPA-registered
wood preservatives.

Two New Use Registrations as Alternatives to
Methyl Bromide
The registration of methyl bromide replacement
products is a high priority for EPA. This past year,
OPP registered the use of s-metolachlor and tri-
floxysulfuron as fumigants on tomatoes. These
registrations will help growers transition away from
methyl bromide.

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2003 Annual Report, Office of Pesticide Programs
   Tickicide to Manage Lyme Disease Vectors
   EPA registered 4-Poster™ Tickicide, a low-toxicity
   permethrin product, for control of deer ticks in Lyme
   disease vector-control programs. The product is for
   use only in the 4-Poster™ deer treatment device,
   which was developed and patented by the USDA.
   USDA has licensed the device to the American
   Lyme Disease Foundation. The product will be used
   in federal, state, and community-based Lyme disease
   vector-control programs and on public and private
   game preserves. The device consists of a feed bin,
   which attracts deer, and rollers impregnated with
   permethrin. As a deer feeds on corn in the bin, per-
   methrin is applied to its ears, head, neck, and
   shoulders, where most feeding adult ticks are
   attached. Deer ticks are vectors for Lyme disease,
   which is currently the most frequently acquired vec-
   tor-borne disease in the United States.

   New Conventional Active Ingredient to Control
   the Invasive Brown Tree Snake
   EPA has granted a registration to  USD As Animal
   and Plant Health Inspection Service (APHIS) for
   the new active ingredient acetaminophen. It will be
   used to control the invasive brown tree snake in
   Guam and the Commonwealth of the Northern
Marianas Islands. The brown tree snake is responsi-
ble for the extirpation of most of the islands' native
terrestrial vertebrates, the extinction of nine of 12
native forest birds, and more than 1,200 power fail-
ures on Guam that lead to food spoilage and
computer failures, interfering with business and mili-
tary operations. Brown tree snakes also pose a public
health concern on these islands. Hospitals in Guam
have treated more than 200 victims, including many
infants and toddlers who were bitten while sleeping.

Increasing  Efficiency and
Productivity Through the
Registration  Process
OPP strives to meet stakeholder needs and
continually identify process efficiencies to increase
productivity. To this end,  a number  of new ways of
doing business have evolved over time and are wor-
thy of being highlighted in this report. The FY 2003
activities highlighted below have improved OPP's
ability to meet stakeholder needs while saving
resources and time.

Minor Crop  Pesticide Registration
OPP broadened and strengthened partnerships with
stakeholders in the minor crops community. The
enhanced relationship between OPP and USD As
Interregional  Research Project Number 4 (IR-4) is
particularly significant. A prime motivator of this
partnership is EPAs need to meet the more stringent
food safety requirements of FQPA while continuing
to provide safe and affordable pest control tools to
minor crop farmers. The successful relationship
between EPA and USDA was further enhanced by
IR-4's early acceptance of reduced-risk technologies
and shared work plan development, which led  to the
achievement  of priority review status for many
minor uses. In FY 2003, applications for minor use
pesticides accounted for nearly 70 percent of all reg-
istration decisions for new uses. Since 2000, more
than 80 percent of IR-4's research efforts have
involved biopesticides and reduced-risk chemical use
pesticides. Other major factors in the success of the
minor use registration program include work-sharing
initiatives with the California Department of
Pesticide Regulation; the Alternative Risk
Integrated Assessment (ARIA) Team, which

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                                                  Achieving Results Through Commitment and Col laboration
assumes significant responsibilities in conducting col-
laborative risk assessments for reduced-risk chemicals;
and other partnering efforts within and outside EPA.

Emergency Exemption Pilot Indicates Increased
Efficiency
In FY 2003, OPP launched a pilot initiative to test a
more efficient and targeted review of pesticide emer-
gency exemption applications. The pilot involves two
revisions to the FIFRA section 18 emergency exemp-
tion process that permits states to: (1) recertify
emergency conditions that continue to exist in the
second and third years of use for certain eligible uses
and (2)  use a revised loss-based economic analysis for
determining significant economic losses. During
FY 2003, OPP found that the section 18 emergency
exemptions were re-certified under the pilot initiative
in an average turnaround time of nine days. OPP
expects  involvement in the program from numerous
states in FY 2004. The Agency expects to publish a
proposed rule during the fourth quarter of FY 2004  as
a step towards making these changes final.

Expedited Review  of Certain Experimental Use
Permits (EUPs)
In September 2003, OPP published Pesticide
Registration (PR) Notice 2003-2 to inform registrants
that the Agency had begun to expedite approval of
EUP applications for alternatives to methyl bromide
and organophosphates, and for active ingredients
with a registered reduced-risk pesticide use for which
EPA has already completed the tolerance assessment
or reassessment. Using the new expedited review
process, OPP issued an EUP for testing indoxacarb as
a conventional reduced-risk pesticide to control
insect pests in peaches. EPA issues PR Notices to
inform pesticide registrants and other interested per-
sons about important practices, procedures, and
regulatory decisions. Visit http://www.epa.gov/
PR Notices/#2003.
NAFTA Joint Review Efforts
Joint reviews and work sharing are fundamental ele-
ments in the harmonization of pesticide regulatory
programs, increasing the efficiency of the registration
process, strengthening the regulatory process and deci-
sions, and facilitating decisions for registration of
alternative pest control products. The program is con-
tinuing to evolve as the regulatory programs and
applicants build upon their experiences. In FY 2003,
OPP and Canada's Pest Management Regulatory
Agency (PMRA) worked together to complete reviews
and decisions for four new conventional chemical reg-
istrations. There was a total of 48 food uses  and two
nonfood uses associated with these registrations.

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SECTION   2
                 Reducing   Risk  Through
                 Reregistration  and
                 Toleranc&Reassessrnerit
     The process of ensuring that older pesticides meet
     current safety standards is as important as registering
     newer, reduced-risk pesticides. The reregistration
and tolerance reassessment process includes consideration
of all routes of exposure to a pesticide, as well as the cumu-
lative effects of pesticides that have a common mechanism
of toxicity. By the end of FY 2003, EPA had completed
reviewing 458 of the 612 pesticides subject to reregistra-
tion. Of the 9,721 tolerances subject to reassessment,
EPA had completed 6,626, which puts the Agency on
track to meet the August 2006 deadline for completing
tolerance reassessment.

Reducing Risk with New Protective Measures for
Carbaryl
EPA completed a thorough assessment of the carbamate
pesticide carbaryl, a widely used agricultural and residen-
tial insecticide. Carbaryl can cause cholinesterase
inhibition in humans  (i.e., it can overstimulate the nerv-
ous system causing nausea, dizziness, confusion, and at
extreme exposures, could cause respiratory paralysis and
death). EPA did not identify concerns related to dietary
exposure. To protect homeowners, children, agricultural
workers, and the environment, EPA is requiring regis-
trants and applicators  to adopt new risk mitigation
measures. EPAs actions include eliminating most pet care
and aerosol products. Registrants agreed not to produce
new technical carbaryl labeled for certain residential lawn
uses until EPA could consider the data being submitted to
refine the risks of concern. Exposures of people who apply
carbaryl in agriculture and those who enter treated areas
will be reduced by canceling certain agricultural uses and
REREGISTRATION DECISIONS CONSIST OF
THE FOLLOWING TYPES OF ACTIONS:
Reregistration Eligibility Decision (RED):
  When EPA completes the review and risk man-
  agement decision for a pesticide that is subject
  to reregistration (one initially registered before
  November 1984), the Agency generally issues a
  RED. The RED summarizes the risk assessment
  conclusions and outlines any risk-reduction
  measures necessary for the pesticide.
        eregistration Eligibility Decisior
  An IRED is issued for pesticides that require
  both a reregistration eligibility decision and a
  cumulative assessment. IREDs do not become
  final until EPA completes a cumulative risk
  assessment and risk manaqement decision
Tolerance Reassessment Decision (TRED):
  A TRED is issued for a pesticide that requires a
  cumulative assessment but does not require a
  cides first registered after 1984, pesticides that
  previously had REDs, and pesticides with impor
  tolerances only).

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                                                  Achieving Results Through Commitment and Col laboration
application methods, reducing maximum application
rates, eliminating aerial application for certain crops,
requiring more personal protective equipment and
engineering controls, and extending restricted-entry
intervals for many crops. These new mitigation
measures, detailed in the Interim Reregistration
Eligibility Document (IRED), will be implemented
and will take effect through the product reregistra-
tion process.

Adopting Innovative Measures for Atrazine
In January 2003, EPA announced an innovative and
aggressive program to protect vulnerable community
drinking water systems from contamination by
atrazine, the most widely used herbicide in the
United States. The Agency concluded that atrazine
may continue to be used, provided registrants and
applicators take new precautions  and implement spe-
cific new measures to reduce potential drinking
water contamination risks.

    EPA also incorporated the provisions of the
atrazine IRED into an agreement with the  principal
registrant of atrazine. Under this  agreement, the reg-
istrant is required to conduct a specialized testing
program in vulnerable watersheds on a weekly basis
to monitor "raw" and finished drinking water during
high-use periods for this pesticide. Detections of
atrazine above the level of concern will result in
                                                    actions ranging from required use of best manage-
                                                    ment practices to use cancellations. In this way, EPA
                                                    is allowing flexibility to account for local conditions
                                                    while assuring that the Agency's safety standards
                                                    are met. Atrazine manufacturers must bear the
                                                    costs involved with this program as part of their
                                                    product stewardship.

                                                        On October 31,  2003, EPA released an adden-
                                                    dum to the IRED that focused on the potential
                                                    effects of atrazine on amphibian endocrinology and

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2003 Annual Report, Office of Pesticide Programs
               development, ecological monitoring and risk
               mitigation in sensitive watersheds, and the
               potential association between atrazine expo-
               sure and the incidence of prostate cancer and
               other cancers in humans. Concurrent with
               the release of the revised atrazine IRED, EPA's
               Office of Water also published a revised draft
               aquatic life criteria document for atrazine.

                   EPA has found that atrazine is not likely
               to be carcinogenic to  humans but will explore
               this issue further with the SAP in the future,
               when additional data  are received and
               reviewed. Atrazine has been associated with
               causing imbalances in hormonal levels in lab-
               oratory animals, possibly disrupting
               reproductive and developmental processes,
               and affecting ecosystem structure in the envi-
               ronment. Although atrazine does not pose
               risks through food, the Agency's drinking
               water, residential, occupational, and ecologi-
               cal risk assessments for atrazine indicate risks
               of concern. EPA considered human health
               effects and the exposure levels that created
               risk concerns in developing risk mitigation
               measures for atrazine.

               Addressing Worker  and Ecological Risks
               Through Methyl Parathion IRED
               In FY 2003, OPP signed an IRED for methyl
               parathion (an organophosphate insecticide)
               addressing unacceptable worker and ecologi-
               cal risks associated with agricultural uses.
               Methyl parathion can cause cholinesterase
               inhibition in humans  (i.e.,  it  can overstimu-
               late the nervous system causing nausea,
dizziness, confusion, and at extreme exposure,
respiratory paralysis and death). To protect
agricultural workers and the environment, the
Agency is requiring registrants and applicators
to adopt new risk mitigation measures that
would reduce these risks of concern to accept-
able levels. Mitigation measures include
reducing application rates and the number of
applications for several crops; prohibiting
mixing/loading/handling in areas prone to
runoff or movement into aquatic environ-
ments or wetlands (except applications to
rice); requiring closed delivery systems for aer-
ial applications of the microencapsulated
formulation; requiring engineering controls
for applications of the microencapsulated for-
mulations; prohibiting use of human flaggers;
and extending re-entry intervals for some
uses. Previous actions addressed human health
risks. These new mitigation measures detailed
in the IRED will be implemented through the
product reregistration process.

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              Science
                    Advancing
                                          Assessment
  n 2003, OPP continued to advance the science needed
  to understand and accurately assess the potential risks
  that pesticides can pose to public health and the envi-
ronment. The Agency developed and implemented new
science policy guidance documents and new techniques
for conducting human health and ecological risk assess-
ments. EPA's efforts to advance the science of risk
assessment are conducted in the spirit of collaboration
with risk assessment experts (within EPA and outside the
Agency)  and include opportunities for input from all
stakeholders.

Improving Hazard Assessment Through New Testing
Paradigm
EPA continued its work with international governments,
academia, industry, and the Health and Environmental
Science Institute's International Life Sciences project to
improve and update the toxicity testing of pesticides to
ensure that data supporting pesticide registrations will rep-
resent the current state of science. The goal of the
International Life Sciences project is to design a science-
based assessment strategy that will:

• Maximize the useful information collected during the
  testing of a pesticide by focusing on the most critical
  data needed for a risk assessment;

• Reduce the number of animals needed for testing; and

• Incorporate a better explanation for why a pesticide is
  toxic on a molecular level.
Developing Physiologically Based Pharmacokinetic/
Pharmacodynamic (PBPK/PD) Modeling
FQPA requires EPA to consider the cumulative effect to
human health that can result from exposure to pesticides
and other substances that have a common mechanism of
toxicity.  EPA is currently involved in a research effort to
develop a case study on using PBPK/PD modeling in
cumulative risk assessments. Such models could greatly
improve the estimation of risk from a pesticide by increas-
ing our understanding of how the toxicity of the pesticide
and the effects from exposure to the pesticide relate to
one another.

Improving Benchmark Dose  Software for Better
Understanding of Toxicity
OPP is collaborating with the  EPA's Office of Research
and Development (ORD) to upgrade the Agency's bench-
mark dose software. Benchmark dose modeling enables a
more refined identification of the amount of pesticide
needed to cause an effect.

Advancing Ecological  Risk Assessment
OPP continued to move forward with implementing an
initiative to refine the  ecological risk assessment process.
In 2003, OPP developed preliminary refined risk assess-
ment models (Level II) for assessing ecological risk to
terrestrial and aquatic organisms from the use of pesti-
cides. These refined models incorporate probabilistic tools
and methods that provide information on the likelihood

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2003 Annual Report, Office of Pesticide Programs
               of ecological impact as well as the magnitude
               or severity of the potential effect from the use
               of pesticides. These models can produce an
               assessment that provides a distribution or
               range of values instead of one fixed value. In
               FY 2004, the Agency will ask the Scientific
               Advisory Panel to peer review these models.

               Enhancing Coordination with Other
               Agency Programs
               OPP worked closely with the Office of Water
               (OW) and the ORD on cross-cutting science
               issues associated with characterizing risk to
               human health and the environment from the
               use of pesticides. OPP designed environmen-
               tal monitoring programs and approaches for
               species extrapolation,  created common crite-
               ria for regulation and monitoring of
               individual pesticides, and shared data on the
               occurrence of pesticides in drinking water
               monitored under the Safe Drinking Water
               Act. In  addition, OPP and OW collaborated
               on identifying research priorities for ORD.
               OPP and OW urged ORD to develop and
               evaluate exposure models and environmental
               fate methods for use in the drinking water
component of human health risk assessments
and for use in refined ecological risk assess-
ments.

Improving Risk Assessments for Crop
Consultants
To address potential pesticide risk to crop
consultants, EPA began collaborating with
the National Association of Independent
Crop Consultants to develop accurate infor-
mation on crop advisors' "time in field" for a
variety of crops. Crop consultants provide
pest management information to their farm-
ing clients based on observations of pest
conditions in the fields. Consultants' exposure
to pesticide residues varies with the character-
istics of the crop and the time spent in the
fields. Development and use of this informa-
tion will  enable OPP to improve its exposure
and risk estimates for this worker population.

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                                                                            *l   -


                       roviding  the  Public
                       rith   Pesticide   Information
  n 2003, OPP continued to provide timely pesticide
  information to stakeholders and the public using various
  outreach tools. One major tool OPP uses for delivering
the latest news and program decisions is the Pesticide
Program Update, which is distributed via e-mail to regis-
trants, advocacy organizations, and others on its electronic
mailing list. Since last year, the number  of contacts on
this list has increased from 4,000 to 6,500, and OPP has
issued 108 updates. OPP also leads EPA  in providing quick
responses to public inquiries, responding to nearly 6,000
inquiries last year from the public through traditional let-
ters and Web mail. Nearly 500,000 people visited OPP's
newly designed Web site at http://www.epa.gov/
pesticides, which features seasonal messages with safety
information on lawn care, mosquito control, and general
pest control. If you are interested in receiving these
updates, please visit the Pesticide Web site at
http://www.epa.gov/oppfead l/eb/csb_page/form/fQrmhtml.

"Lock it Up" Pesticide Safety Campaign
In early fall 2003, the Pesticide Program launched the
"Lock it Up" campaign, which primarily targets parents
and concerned citizens in urban areas, to encourage safer
pesticide storage practices. In developing the campaign
poster, OPP collaborated with the American Association
of Poison Control Centers and the National Safety
Council. Poison control centers  in more than 25 states
requested 23,000 copies of the poster. The safe storage
message was also displayed in healthcare facilities, and 500
Washington, DC, Metropolitan Area Transit Authority
buses and subway train stations carried "Lock it Up"
posters.
Community Involvement For Poison Prevention
OPP has partnered with the National Poison Prevention
Week Council (NPPWC) over the years to conduct many
                                                                                              11

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2003 Annual Report, Office of Pesticide Programs
   public outreach campaigns that raise awareness about
   the importance of safe pesticide use and storage. In
   FY 2003, OPP joined forces with the National Safety
   Council to increase awareness about the danger to
   children of accidental poisoning from pesticides and
   household products. The new Poison Prevention: Read
   the Label First! Community Action Kit includes materi-
   als to help communities heighten awareness about
   preventable poisonings caused by the improper use
   and storage of household chemicals. OPP distributed
   the kits and other poison prevention materials to
   poison centers and community groups during
   National Poison Prevention Week.

   Safety Awareness Outreach to the Hispanic
   Community
   OPP, the Self-Reliance Foundation, and the
   Hispanic Radio Network teamed up to produce one-
   minute radio  segments in Spanish on pesticide safety
   issues. These  messages targeted  migrant farmworkers
   and their families and were used to reinforce the
   dangers of taking pesticide residues home on cloth-
   ing, the symptoms of pesticide poisoning, and the
   danger of heat stress. In addition, OPP ran a pesti-
   cide safety article in the Spanish-language
   newspaper Medio Ambiente Saludable, which serves
more than 1.5 million people in Los Angeles,
Chicago, New York, San Juan, Orlando, and Miami.

Using  Information Technology to
Increase  Access  and Productivity

New  Information  Network Launched
OPP successfully combined all of its major data sys-
tems (including regulatory and scientific data
systems, workflow tracking systems, and electronic
document management systems) into one integrated
system called the Office of Pesticide Programs
Information  Network (OPPIN). Launched in FY
2003,  OPPIN consolidates information formerly
stored on several mainframe systems, the OPP Local
Area Network  (LAN), stand-alone computers, and
paper  documents. The new network will:

•  Decrease  OPP's data entry burden,

•  Increase OPP's analytical capabilities,

•  Better track OPP's decisionmaking processes,

•  Improve access to critical decision documents,
   and

•  Enhance availability of pesticide regulatory infor-
   mation within OPP (this information will be
   available to  the public in the future).

These changes allow OPP to charge pesticide prod-
uct registrants a fee for approximately 90 categories
of pesticide registrations, including new active ingre-
dients and new pesticide products.

Electronic Submissions
OPP is implementing electronic data submission
and review tools to improve the efficiency  and
effectiveness of its regulatory processes. In  FY 2003,
OPP received 35 new electronic data submissions.
These improvements apply to information  delivery,
review, and exchange, as well as to  archiving func-
tions.  The approach enables OPP to use current
technology, consider the needs of data submitters
and reviewers,  and address legal requirements asso-
ciated with both the pesticide program and
information  technology  choices.

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National Pesticide  Medical Monitoring Program
Through a cooperative agreement between EPA and
Oregon State University, the National Pesticide
Medical Monitoring Program was established in
FY 2003. This program provides informational assis-
tance on the health effects of pesticides in humans.
It is led by a physician who specializes in medical
toxicology. In FY 2003, the program received more
than 400 requests for assistance that were related to
human exposure to pesticides. The National
Pesticide Medical Monitoring Program received
inquiries from healthcare providers, public health
agencies, and the general public.

National Pesticide  Information  Center
1-800-858-7378
The National Pesticide Information Center (NPIC) is
a cooperative effort between EPA and Oregon State
University. NPIC is a unique toll-free service that
provides objective, science-based information on a
variety of pesticide-related subjects, including pesti-
cide products, recognition and management of
pesticide poisonings, toxicology, and environmental
chemistry. In FY 2003, NPIC responded to more than
24,000 inquiries about pesticides or pesticide-related
issues. Two recent additions to NPIC's Web site are
general and medical case profiles, intended to convey
educational and pesticide resource information to the
general public and to healthcare providers.
New Storage and Disposal Information on
the Web
In FY 2003, OPP launched a Web site to provide
information (in English and Spanish) on pesticide
storage and disposal for consumers, farmers, regis-
trants, and developing countries. In addition, the
site includes dozens of links to comprehensive stor-
age and disposal guidance developed by state
extension staff, state regulatory agencies, federal
agencies (EPAs Chemical Security Site is particular-
ly useful), industry, and professional associations.

Third Edition of Pesticide Product Label Review
Manual Is Online
OPP made the third edition of Label Review Manual
(LRM) available online at http://www.epa.gov/
oppfeadl/labeling/lrm. This document updates the
edition released in 1996 and serves as a training tool
and resource for OPP employees responsible for
reviewing pesticide product labels. The goal of the
manual is to improve the quality and consistency of
labels. State label reviewers, registrants, and others
interested in producing readable, unambiguous pesti-
cide product labels may also use the manual. The
manual serves as an instructional aid for interpreting
existing statutes and regulations and drafting labels.

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    SECTION   5
                    «
                          
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                                                  Achieving Results Through Commitment and Col laboration
lie comment on this notice to obtain input on
consultation approaches, county bulletins, public
participation, and compliance assistance and enforce-
ment, and is refining its approach to implementation
based on these comments and other activities.

Developing Endangered Species CIS Bulletins
In FY 2003, OPP entered into an agreement with
the U.S. Geological Survey's (USGS's) cartography
program to convert 200 existing bulletins and devel-
op bulletins for additional counties using Geological
Imaging Services' (GIS's) mapping tools. The GIS-
based bulletins will allow more efficient updating
and will allow interactive Web-based applications to
be developed for the public.

Responding to Endangered Species Lawsuits
In FY 2003, OPP was subject to the following
Endangered Species lawsuits:

•  Washington Toxics Coalition v. EPA
   The U.S. District Court for the Western District
   of Washington ordered EPA to  review 54 pesti-
   cide active ingredients and, where these pesticides
   could pose a risk to listed salmonids, consult with
   NMFS to determine measures that might be nec-
   essary to mitigate that risk. In FY 2003, OPP
   completed reviews on half of the active ingredi-
   ents. OPP will review the remaining 27 active
   ingredients on schedule in 2004.

•  Californians for Alternatives to Toxics v. EPA
   In FY 2002, EPA entered into a consent decree
   on a schedule to review and consult with  FWS
   and NMFS on the risks posed by 18 pesticide
   active ingredients to seven California Pacific
   salmonid and steelhead and 33  forest plant
    PROCESS FOR  PROTECTING ENDANGERED AND
    THREATENED SPECIES
    OPP uses sound science to assess the potential risk of
    pesticide use to  listed species and consults with scientist:
    at the Fish and Wildlife Service (FWS) and the National
    Marine Fisheries Service (NMFS). FWS administers the
    Endangered Species Act (ESA) for most species.  NMFS
    administers the ESA for certain listed marine and
    anadromous  species. FWS or NMFS issues  a biological
    and EPA implements use limitations that are either spec-
    ified in its opinions or developed from those opinions.
    Use limitations are likely to be achieved by:
    • Adding a generic label statement.
    • Developing county bulletins that contain maps of
                            and other ma-
PJioto by Carol Parker
         le variety of methods).
   species. In FY 2003, as required by the consent
   decree, OPP reviewed seven of the pesticides on
   schedule. These seven pesticides were also identi-
   fied in Washington Toxics Coalition v. EPA.

Protecting Pesticide Workers
Through Improved  Training
One of OPP's highest priorities is to protect people
who work with or around pesticides because they
potentially have the highest risk for pesticide expo-
sure. EPA places strong emphasis on assuring the
health of workers whose jobs require mixing, load-
ing, or applying pesticides. The Agency also is
committed to strengthening national efforts to safe-
guard farmworkers and their families. EPA's Worker
Protection Standard, first implemented in 1992, has
resulted in safety education and training efforts
across the country.  In FY 2003, OPP focused on
improving the content and delivery of training for
the worker community.

Agricultural Worker Training  in Mexico
In FY 2003, to address potential pesticide risks to
agricultural workers, OPP collaborated with a con-
sortium of interested parties from Mexico to develop

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2003 Annual Report, Office of Pesticide Programs
   PJioto by Carol Parker
   a pesticide safety training program under NAFTA.
   This project, the National Program Against the
   Risks of Pesticide Use, provided training (including
   courses) to individuals who go into the field and
   onto farms to train agricultural workers. To date,
   more than 2,000 workers have been trained under
   the program. The program has been expanded to
   include training for the medical community.

   Train-the-Trainer Pilot Project
   In FY 2003, EPA, farmworker associations, training
   organizations, academia, county extension services,
   and grower groups participated in a workgroup
   that initiated a train-the-trainer pilot in three
   states—Florida, New Jersey, and Washington. The
   workgroup drafted a training manual and materials
   that workers could use to conduct pesticide safety
   training for their fellow workers. The workgroup
   evaluated the effectiveness of the training by target-
ing specific components to be measured by workers,
trainers, and master trainers (i.e., those who train
trainers). The goal of this pilot is to develop a
nationally adaptable train-the-trainer model that
ensures consistency and quality in Worker
Protection Standard pesticide safety training.

Pesticide Applicator Core Exam
In 2003, through a NAFTA project, OPP and
Canada's Pest Management Regulatory Agency com-
pleted the development of a pesticide applicator
core exam. The core exam addresses key tasks per-
formed by all applicators, regardless of the type of
applications performed. A committee of pesticide
applicators, representing different regions of the
United States and Canada, developed an outline of
necessary tasks, decided the number of questions and
difficulty level for each task, and drafted  exam ques-
tions. After more than two years of dedicated work,
the committee produced an exam of 90 questions to
be used by pesticide state lead agencies and
Canadian provinces to determine the competency of
pesticide applicators.

National Agricultural Aviation Research and
Education Foundation  (NAAREF)
In 2003, EPA entered into a five-year cooperative
agreement with NAAREF to reduce pesticide drift
               G THE TRAIN-THE-TRAINER
    PROJEC
                                                           In 2003, EPA collaborated with the University
                                                           of Washington's Pacific Northwest
                                                           Agricultural Safety and Health Center
                                                           (PNASH) to develop the appropriate means
                                                           of evaluating the train-the-trainer project in
                                                           the  three pilot states at the master trainer,
                                                           trainer, and worker levels. The PNASH
                                                           report details and analyzes the methods,
                                                           outcomes, training sites, trainer demograph-
                                                           ics, program format, training materials, work-
                                                           er demographics, ability of the program to
                                                           impart key  knowledge to participants, and
                                                           participant  evaluations administered at vari-
                                                           ous stages of the project.
   PJioto by Carol Parker

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                                                  Achieving Results Through Commitment and Col laboration
incidents by developing an educational program
targeted at professional aerial applicators. The
NAAREF educational program focuses on providing
the latest pesticide drift prevention technology.
NAAREF will work with the National Agricultural
Aviation Association (NAAA), the Professional
Aerial Applicators Support System (PAASS), state
departments of agriculture, and the American
Association of Pesticide Control Officials to present
a comprehensive drift-prevention educational pro-
gram at annual, regional,  and state meetings with
the goal of reaching a majority of aerial applicators
across the country. For more information, visit
http://www.agaviation.org/paass.htm.

Working with  States,  Stakeholders,
and Other Agencies

Collaborating with State Regulatory Partners
In FY 2003, OPP, EPAs regional offices, and the
Office of Enforcement and Compliance Assurance
collaborated with state  regulatory partners to resolve
issues raised by members of the State FIFRA
Research and Evaluation  Group (SFIREG) and the
Association of American  Pesticide Control Officials
(AAPCO). These individuals and organizations had
concerns about section 18's state laboratory capabili-
ties for analysis of new pesticide products, genetically
engineered plants, termiticide labeling, mosquito
adulticide labeling, the minimum age requirement
for approval of a state certification
program, electronic labeling, and pesticides and
terrorism. For more information, visit
http://aapco.ceris.purdue.edu/index.htm.

Providing Pesticide Training to Regulators
In an effort to fulfill training needs of regional,
state, and tribal regulators on pesticide regulatory
issues, OPP hosted five Pesticide Regulatory
Education Program (PREP) courses in FY 2003.
Representatives from more than  23 states attended
the courses on the reregistration and worker protec-
tion programs, bioengineered crops and invasive
species, West Nile virus,  homeland security,  and
state FIFRA laboratory issues.
Reorganizing the Environmental
Stewardship Program
Environmental stewardship is a prominent theme in
EPAs strategic plans and OPP's goals. OPP is meet-
ing its stewardship goals by forming hundreds of
voluntary partnerships with stakeholders from across
the country who are working to reduce the risk of
pesticides and promote the use of Integrated Pest
Management (IPM).  In 2003, OPP created a new
Environmental Stewardship Branch (ESB) dedicated
to reducing pesticide  risk through partnerships and
other nonregulatory means. ESB  provides leadership,
guidance, and resources for voluntary partnership
programs nationwide. ESB manages the following
voluntary partnership programs:

•  Pesticide Environmental Stewardship
   Program (PESP)
   This is a voluntary partnership between EPA and
   the pesticide user community to reduce the risk
   from the use of pesticides. PESP has 136 mem-
   bers, including agricultural companies, structural
   pest control companies, schools, food  processing
   firms,  landscaping companies,  and local govern-
   ments. The PESP  Update Report on 2003 Activities
   provides information on PESP activities and
   accomplishments.  Visit  http://www.epa.gov/
   oppbppdl/PESP/publications/vol6se.pdf for
   more information.

•  Strategic Agriculture Initiative (SAI)
   SAI is a partnership with all 10 EPA regions  to
   demonstrate and facilitate the  adoption of farm
   management practices that transition farmers away
   from the highest-risk pesticides. In 2003, EPA pro-
   vided  $1.8 million in grants to help growers across
   the nation transition to  lower-risk pesticides.

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2003 Annual Report, Office of Pesticide Programs
     IPM in Schools Initiative
     This initiative encourages school officials to adopt
     IPM practices to reduce children's exposure to
     pesticides. More than 2 million children have
     been positively affected by new IPM practices in
     their schools. In 2003, the schools program issued
     a new publication (National School Update) that.
     provides news on current activities, feature arti-
     cles, and success stories on IPM in schools.

     Lawns and the Environment  Initiative
     This initiative encourages environmentally
     responsible lawn and landscaping practices for
     creating and maintaining residential landscapes.
     OPP is part of a voluntary coalition comprised of
     representatives from the lawn care and landscap-
     ing industry, environmental groups, and
     government agencies. The mission of the initia-
     tive is to develop consensus-based guidelines for
     responsible lawn and landscaping practices and to
     educate and encourage the public to adopt them.
   • Environmental Indicators Project
     OPP is working with partners to generate a set of
     effective environmental indicators using changes in
     bird populations. The project involves developing
     a computer program that calculates and displays
     environmental indicators for bird  populations.

   Partnering with  Tribes
   In FY 2003, OPP, the Office of Enforcement and
   Compliance Assurance (OECA),  and EPA regional
   representatives provided assistance to tribes through
   the Tribal Pesticide Program Council on tribal prior-
   ities such as homeland security, human health
   concerns, water issues, and tribal authority.
PJioto by Karen Rudek
EPA/APHIS/Navajo Nation Memorandum
of Understanding
EPA entered into a Memorandum of Understanding
(MOU) with the Navajo Nation and the Animal and
Plant Health Inspection Service. This MOU, the first
of its kind, is a pilot program that would provide farm-
ers on Navajo land with the authority to use
unregistered pesticides when emergency conditions
exist, similar to EPAs Emergency Exemption program
for states.

Environmental Chemistry Lab Analyses Target
Special Dietary Risks for  Native Americans
in New England
OPP's Environmental Chemistry Laboratory—in part-
nership with the Bureau of Indian Affairs, USGS, and
the Department of Health and Human Services'
Agency for Toxic Substances and Disease Registry—
is providing support to EPA Region 1 by conducting
dioxin analyses on 20 moose and deer livers for
Native American tribes led by the Passamaquoddy
Tribe Indian Township. The data from these analyses
will be used to evaluate possible exposure scenarios for
Native Americans in the region. The presence of per-
sistent, bioaccumulative toxic pollutants (PBTs) in
moose and deer livers and local fish has raised con-
cerns about dietary risks to Native Americans in New
England. Moose and deer liver is a significant food
source for members of the New England tribes. In
addition, OPP is conducting ecological and human
health risk assessments with Penobscot Nation mem-
bers to address the Bureau of Indian Affairs' concern
that fish caught in the Penobscot River might be a
source of contamination.

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       The United States is a world leader when it comes
       to evaluating chemicals of concern. The overall
       goals of OPP's international efforts are to promote
improved health and environmental protection worldwide
and to ensure that international trade initiatives and other
agreements are consistent with the high level of protec-
tion afforded by U.S. laws. With the expansion of
international trade in agriculture and chemical products,
it is no longer possible to separate domestic and interna-
tional issues. A global approach is often required.

Organization for Economic Cooperation
and Development
In FY 2003, OPP worked with its governmental counter-
parts from NAFTA countries and from  the Organization
for Economic Cooperation and Development (OECD)
member countries in Europe, North America, Asia, and
the Pacific to move closer toward global harmonization of
processes and pesticide registration requirements.

    In 2003, OPP and the Canadian Pest Management
Regulatory  Agency continue to improve efficiencies in
work sharing. Working together, scientists from both pro-
grams completed the development of templates for writing
reviews of submitted pesticide studies of all disciplines.
These templates promote consistency in format and con-
tent of reviews, thereby facilitating work sharing.
    By harmonizing pesticide-related activities, EPA hopes
to promote benefits from shared scientific and technical
expertise, lessen the resource burden on governments and
the regulatory community, and maintain high standards
for the protection of human health and the environment.

Globally Harmonized System to Improve
Pesticide Labels
After more than a decade of international negotiations
involving government, industry, and other stakeholders,
the United Nations Economic and Social Council formal-
ly approved the Globally Harmonized System (GHS) of
Classification and Labeling of Chemicals in July 2003.
The GHS is a common and coherent approach to defining
and classifying chemical hazards and communicating
information on labels and safety data sheets. When imple-
mented on a global basis, the GHS is expected to enhance
protection of human health and the environment world-
wide, reduce the need for duplicative testing and
evaluation of chemicals, and facilitate international trade
by promoting greater consistency in regulatory require-
ments for classifying hazards and communicating hazard
information on labels and safety data sheets.
                                                                                                                19

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2003 Annual Report, Office of Pesticide Programs
   NAFTA Technical Working Group
   The NAFTA Technical Working Group issued a new
   five-year strategy entitled The North American
   Initiative: The Next Five Years. This initiative lays out
   major harmonization objectives for the United
   States, Canada, and Mexico. For more information,
   visit http://www.epa.gov/ oppfeadl/international/naf-
   tatwg/twgstrategy.pdf.

   North America Commission  for Environmental
   Cooperation Task Force on Lindane
   In FY 2003, OPP was named chair of the North
   American Commission for Environmental
   Cooperation (CEC) Task Force on Lindane and led
   the first meeting of the task force to begin developing
   a North American Regional Action Plan to reduce
   and/or eliminate the risks posed by lindane. The
   CEC task force will collaborate with all stakeholders
   to finalize the action plan in 2005. CEC is an inter-
   national organization created by Canada, Mexico,
   and the United States under the North American
   Agreement on Environmental  Cooperation. CEC
   was established to address regional environmental
   concerns, help prevent potential trade and environ-
   mental conflicts, and promote the effective
   enforcement of environmental laws.

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           "iomeland   Security
In FY 2003, OPP—along with other Agency program offices—
made significant progress and contributions to a variety of
homeland security initiatives. OPP continued with its collabo-
ration with other key federal departments and agencies,
including the Departments of Agriculture, Health and Human
Services, and Defense, to develop and enhance coordination of
communications and other activities for protecting human
health, the environment, and the nation's infrastructures for
agriculture, food, water, air,  and buildings. OPP played a lead
role with other agencies in the advancing the development and
validation of antimicrobial efficacy methods for biological
agents. Effective methods are necessary to ensure antimicrobial
pesticides are efficacious against pathogens, such as anthrax,
that may contaminate environmental surfaces in buildings or
elsewhere. The program gained important experience partici-
pating in homeland security  exercises with other EPA offices,
including our regional offices, and other agencies. This experi-
ence was critical to helping OPP and others prepare for
potential terrorist threats.


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         The  Pesticide  Program
         aLaJ3lanc
                   *    *,
                            mm.
W'i »  •
  V  iii
                                                     -9*.
       OPP's mission is to protect human health,
       safeguard the environment from unrea-
       sonable adverse effects resulting from the
use of pesticides, and assure that there is a reason-
able certainty of no harm from pesticides in the
diet of all Americans, especially children. OPP reg-
ulates pesticides under the authority of two federal
statutes: the Federal Insecticide, Fungicide, and
Rodenticide Act and the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality
Protection Act of 1996 (FQPA).

The Federal  Insecticide,  Fungicide,
and Rodenticide Act (FIFRA)
FIFRA is a product-licensing statute. Many provi-
sions of FIFRA provide regulatory tools for EPA to
use to fulfill the intent of the law:

Registration - Generally, pesticide products for use
in the United States must be registered or licensed
by EPA, based on a scientific evaluation, prior to
manufacture, transport, and sale.

Labeling - All pesticide products must have a label
that describes, among other things, the content,
directions for use, safety precautions, and disposal
requirements.
      Data Call-in - Since 1978, FIFRA has provided
      strong authority for EPA to require data (results
      from pesticide testing), enabling OPP to evaluate
      the potential hazards and exposures from pesticide
      products and the efficacy of public health pesticides.

      Restricted-Use Pesticides - Certain high-risk pesti-
      cides are restricted for use only by trained and
      state-certified applicators.

      Enforcement - FIFRA contains enforceable provi-
      sions on the manufacture, sale, distribution, and use
      of pesticides.

      Emergency Exemption Authority -  In certain pest
      emergency cases, FIFRA permits approval of unreg-
      istered uses of registered products on  a time and
      geographically limited basis.

      Reregistration - All pesticides registered before
      November 1, 1984, must be reevaluated to ensure
      that they meet today's more stringent safety standards.

      Registration Review - FIFRA requires the Agency
      to establish a program to periodically reassess all pes-
      ticide registrations, with a goal of every 15 years.

      Suspension or Cancellation - Through appeals and
      adjudicatory processes, some or all of a pesticide
      product's uses can be suspended or canceled to pre-
      vent unreasonable adverse effects.

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                                                  Achieving Results Through Commitment and Col laboration
Minor Use Program - FIFRA requires EPA to
establish a program that gives special consideration
and support to minor uses of pesticides that are of
low value to pesticide producers but of high value
to farmers. Minor use crops, including most fruits
and vegetables, are those grown on less than
300,000 acres.

The  Federal  Food,  Drug,
and  Cosmetic  Act (FFDCA)
FFDCA provides EPA with the authority to set tol-
erances (maximum allowable residue levels) for
pesticides in or on foods and animal feed. Key ele-
ments of FFDCA include:

Tolerance reassessment - All tolerances that were
in place as of August 1996 must be reassessed.  EPA
has completed 68 percent of the total tolerance
reassessment decisions and is on schedule to com-
plete tolerance reassessment by August 2006.

Reasonable Certainty of No Harm Safety Standard -
FFDCA includes a health-based safety standard for
pesticide residues in both raw and processed foods.
"Reasonable certainty of no harm" is the general
safety standard, both for tolerances under FFDCA
and registration of pesticides with food uses under
FIFRA.

Special Protection of Children - EPA must make an
explicit determination that tolerances are safe for
children. FQPA requires an additional ten-fold safety
factor, unless there is sufficient reliable information
to support application of a different safety factor.

Cumulative Risk and Common Mechanism of
Toxicity - EPA must consider the cumulative effects
of substances that share a common mechanism of
toxicity.

Benefit-Based Tolerances - Under very limited con-
ditions,  EPA may retain a tolerance for a pesticide
that does not meet the new safety standard if it is
deemed to be in the public interest. No such toler-
ances have been issued.

Right-to-Know - The Agency must develop infor-
mation to educate the public about the risks and
benefits associated with using pesticides on foods.
EPA must also list any tolerances that are set based
on benefits considerations and  explain ways con-
sumers can reduce their exposure to pesticides in or
on food.

Endocrine Disrupters - Due to concern  that some
chemicals might disrupt the human endocrine hor-
mone system, EPA must develop an endocrine
screening and testing program to evaluate potential
adverse  effects from pesticides and other chemicals.

Aggregate Exposure Assessment - The Agency con-
siders aggregate exposure to pesticides from food,
drinking water, and home and garden use in deter-
mining allowable levels of a pesticide residue in food.

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2003 Annual Report, Office of Pesticide Programs
                 FY 2003  Office  of  Pesticide  Programs  Output Summary
                                   Final  Counts as of October 15, 2003
                                        Verified by OPP Divisions
                               FY 2003 New Active Ingredients
Number
     Total New Active Ingredients Registered
          Total new uses associated with new active ingredients = 91
     Conventional Chemicals (includes three OP alternatives and one methyl bromide alternative)
          New uses associated with new conventional active ingredients =41
     Conventional Reduced-Risk Chemicals (included 1 OP alternative)
          New uses associated with new conventional reduced risk active ingredients = 32
     Biopesticides
          New uses associated with new biopesticide active ingredients =15
     Antimicrobials
          New uses associated with new antimicrobial active ingredients = 3
  31
  14
                            FY 2003 New Uses for Existing Active Ingredients
     Total New Uses (food and nonfood)
     Total New Food Uses
     Total New Nonfood Uses
     New Biopesticide Nonfood Uses
     New Biopesticide Food Uses
     New Antimicrobials Nonfood Uses
     New Antimicrobials Food Uses
     New Conventional Nonfood Uses
     New Conventional Food Uses
     New Conventional Reduced-Risk Nonfood Uses
     New Conventional Reduced-Risk Food Uses
     New Methyl Bromide Alternative Uses
     New OP Alternative Uses
     Total Tolerances Established for New Uses (for new & existing active ingredients)
     Total Major Crops Associated with New Uses (for new & existing active ingredients)
     Total Minor Crops Associated with New Uses (for new & existing active ingredients)
   334
   307
    27
     3
    98
     6
     0
    17
   145
     1
    64
     1
    29
   538
   119
 1,428

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                                              Achieving Results Through Commitment and Col laboration
FY 2003 Section
18 Emergency Exemptions
Exemption Requests Received
Exemptions Granted
Exemptions Withdrawn
Exemptions Denied
Crises Declared
Tolerances Established for Section 18s
Number
431
344
56
6
67
19
Average Processing Time = 38 days
FY 2003 Special Local Needs Accepted (section 24(c))
      Total for FY 2003:      576

FY 2003 Experimental Use Permits
      Total for FY 2003:       25
FY 2003 Temporary Tolerances
      Established for EUPs:     3

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2003  Annual Report,  Office of Pesticide Programs
FY 2003 Reregistration Risk Management Decisions Completed
REDs
Interim REDs
Tolerance Reassessment

Decisions
Total REDs Completed Through FY 2003
Number
13
3
13
227
FY 2003 Product Reregistration Actions Completed
Product Reregistration Actions
Product Amendment Actions
Product Cancellation Actions
Product Suspension Actions
Total Product Reregistration Actions for FY 2003
53
40
213
5
311
FY 2003 FQPA Tolerance Reassessment Summary
Class
Organophosphates
Carbamates
Organochlorines
Carcinogens
High Hazard Inerts
Other
Total
Total # of Tolerances
to be Reassessed
1,691
545
253
2,008
5
5,219
9,721
Total Reassessed Since
August 3, 1996
1,127
303
253
1,301
3
3,639
6,626
Percent Reassessed
66.65
55.60
100.00
64.79
60.00
69.73
68.16

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                                               Achieving Results Through Commitment and Col laboration
                   FY 2003 Fast-Track and Nonfast-Track Decisions
Me-Too Product Registrations
Amendments
Total
Fast-Track Decisions
         417
        5,193
        5,610
Nonfast-Track Decisions
         326
         640
         966

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2003  Annual Report,  Office of Pesticide Programs


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                                                         Achieving Results Through  Commitment and  Collaboration
Recycled/Recyclable—Printed with vegetable oil based inks on 100% postconsumer, process chlorine free recycled paper.

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