United States
Environmental Protection
Agency
Prevention, Pesticides,
And Toxic Substances
(7506C)
EPA735-R-97-003
January 1998
r/EPA
Office Of Pesticide Programs
Annual Report For FY 1997
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TABLE OF CONTENTS
Foreword
The Office of Pesticides Programs: Moving Ahead
Implementing The Food Quality Protection Act
Partnerships
Reorganization
Risk Reduction
Outreach
Strengthening EPA's Science Base
Field Activities
International Activities
Technology
Page
1
2
4
10
12
14
16
19
22
24
Appendix A - Table and Figures of Fiscal Year 1997 Accomplishments
Appendix B - OPP Organizations and Contacts
Appendix C - EPA Regional Offices
Appendix D - List of Acronyms
Cover Photo by Shanaz Bacchus, EPA
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FOREWORD
Fiscal Year (FY) 1997 was truly a transition year for EPA's Office of Pesticide Programs (OPP).
Not only did our program take on the sweeping changes mandated by the passage of the Food Quality
Protection Act of 1996 (FQPA), but we also successfully carried out a comprehensive reorganization and
hiring plan to add over 100 new employees. These substantial changes to the pesticide program are setting
the stage for us to chart new territory and make meaningful improvements to the way pesticides are
regulated. In so doing, we will continue to work closely with our colleagues in the Regions and vital partners
in the States, Territories, and Tribal Organizations to further advance our efforts to protect the environment
and safeguard the health of the American public, especially infants and children, from pesticide risks.
Considering the extensive changes to the program's infrastructure and FQPA's mandate to
immediately implement its numerous requirements, the program over the last year has completed an
impressive number of regulatory actions. From the reregistration of 23 older chemicals to the registration
of 19 reduced risk active ingredients, as well as the addition of new partners and supporters to the Pesticide
Environmental Stewardship Program and advances in worker safety, the program continues to emphasize
the importance of reducing both the risk from and reliance on pesticides. These activities and countless
others are described in more detail throughout this report.
An important component of our efforts throughout FY 1997 was to expand even further our outreach
efforts with pesticide stakeholders through three separate advisory committees established under the Federal
Advisory Committee Act. The Federal Insecticide, Fungicide and Rodenticide (FIFRA) Scientific Advisory
Panel, the Pesticide Program Dialogue Committee and the Food Safety Advisory Committee held more than
ten large public meetings over the past year to solicit advice and feedback regarding pesticide scientific,
policy, and regulatory issues, including many of the early implementation mandates of FQPA. The
program's commitment to timely and meaningful public involvement will continue through the advisory
committee process.
Working in the Pesticide Program is a challenging and exciting endeavor. I encourage everyone to
take the time to review this report and to take advantage of the enormous amount of information available
on the World Wide Web (http://www.epa.gov/pesticides) describing our program's many efforts to protect
public health and the environment from pesticide risks.
I am impressed with the caliber of people who are dedicated to the important goals of the pesticide
program. I hope this report will help bring greater understanding about our accomplishments over the past
year and provide a snapshot of the many challenges that lie ahead.
'Acting Director
'rograms
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FY 1997 OPP ANNUAL REPORT
PAGE1
THE OFFICE OF PESTICIDE PROGRAMS: MOVING AHEAD
The mission of EPA's Office of
Pesticide Programs (OPP) is to protect
public health and the environment from the
risks posed by pesticides and to promote
safer means of pest control. Pesticides differ
from other substances regulated by EPA
because they are intentionally applied to
crops and other targets, rather than
byproducts of industry or other human
activity. Pesticides are likely to be found in
nearly every home and business in the
United States, from insect repellents to weed
killers to disinfectants to swimming pool
chemicals. They also are used in schools,
parks, hospitals, and other public places. It
is a challenging and complex undertaking to
run a consistent and equitable regulatory
program that achieves these goals.
The environment in which OPP
operates is constantly changing: new active
ingredients are developed for registration;
new uses are proposed; new standards are
applied to old pesticides; and new
information is received about the behavior
of pesticides in the field. Perhaps the most
significant change in recent history was
passage of a new statute, the Food Quality
Protection Act (FQPA) of 1996, which
dramatically redirected the program's
priorities and provided a new standard for
the assessment of pesticides used on our
food crops.
State and tribal agencies and
many other organizations, both public
and private, are vital partners. Meeting
our challenge requires that we get input from
and consider the needs of all Americans,
without delaying the achievement of public
health and environmental protection goals.
We also must be conscious of the
international implications of our decisions
and policies, and work to advance public
health and environmental protection on a
global scale.
OPP's Fiscal Year (FY) 1997 Annual
Report describes progress toward meeting
these challenges over the past year. The
report is organized according to several key
themes underlying OPP's work:
implementing FQPA, partnerships,
reorganization, risk reduction, outreach,
science, field programs, international
programs, and technology. The Appendix
presents the facts and figures on FY 1997
activities, documenting measurable, concrete
achievements over the past year.
Photo By Steve Delaney
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FY 1997 OPP ANNUAL REPORT
PAGE 2
IMPLEMENTING THE FOOD QUALITY PROTECTION ACT OF 1996
On August 3, 1-996, President
Clinton signed into law the FQPA, the most
significant piece of pesticide and food safety
legislation enacted in many years. FQPA
amended the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA), which covers
pesticide registration, use and training, and
the Federal, Food, Drug, and Cosmetic Act
(FFDCA), which regulates pesticide residues
in the food supply by requiring the setting of
maximum levels (called tolerances)
permitted in human and animal food.
Three important new changes in
FQPA were: 1) the reassessment of all
existing tolerances to ensure that they meet
the new safety standard; 2) developing and
implementing a program for screening and
testing pesticides for endocrine disruption
effects; and 3) improving the antimicrobials
registration process,
Tolerance Reassessment Under FQPA
A tolerance is the maximum legal
amount of a pesticide residue permissible on
food. FQPA requires that EPA reassess
within 10 years over 9,000 tolerances to
ensure that the tolerances meet the stringent
new "reasonable certainty of no harm"
standard, which includes consideration of:
• the aggregate exposure to the pesticide
(including exposure from
residential pesticide uses and drinking
water and dietary intake);
• the cumulative effects from pesticides
sharing a common mode of toxicity;
• whether infants and children are more
susceptible to the pesticide; and
» whether the pesticide mimics naturally
occurring estrogen, or otherwise disrupts
the human endocrine system.
FQPA AND PESTICIDES: FQPA gave EPA
unprecedented opportunities to provide greater
health and environmental protection by requiring
OPP to:
• apply more stringent safety standards for
pesticide residues in food;
• improve protection for all consumers,
particularly the young;
» maintain minor uses;
* give consumers greater access to information
about pesticides;
• accelerate registration of reduced risk
pesticides and complete the reregistration of
older pesticides; and
» encourage Integrated Pest Management (IPM)
techniques.
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FY 1997 OPP ANNUAL REPORT
PAGES
The law sets intermediate deadlines
for reassessment of these tolerances: 33
percent by August 1999, 66 percent by
August 2002, and 100 percent by August
2006.
In developing the reassessment
schedule, EPA is placing a priority on
pesticides believed to pose the greatest
potential risk to public health. These
pesticides are the organophosphates,
carbamates, and probable and possible
human carcinogens. Also included in this
first phase are the organochlorine pesticides,
high-hazard inert ingredients, and other
pesticide chemicals for which reregistration
is substantially complete.
Endocrine Disrupters
Endocrine disrupters are chemicals
that mimic the behavior of natural
hormones. There is substantial research and
discussion within the scientific community
regarding potential adverse impacts caused
by these chemicals. Additional research is
needed to determine the extent of risk and
identify those chemicals that may present a
problem. To address the information gap,
FQPA requires that EPA establish a
mandatory endocrine disrupter screening
and testing program for pesticides by August
1998 and implement the program by August
1999.
To assist in developing an endocrine
disrupter screening and testing program,
EPA established the Endocrine Disrupter
Screening and Testing Advisory Committee
(EDSTAC) in October 1996, under the
Federal Advisory Committee Act.
EDSTAC, which includes representatives
from industry, government, environmental
and public health groups, labor, and
academia, as well as other interested
stakeholders, is charged with recommending
an endocrine disrupter screening and testing
strategy responsive to the legislative
mandates of FQPA. The EDSTAC report
and recommendations are expected to be
issued in Spring 1998.
Antimicrobials Division
Antimicrobial pesticides are used to
control the growth of microorganisms. They
include public health antimicrobial
pesticides such as disinfectants used in
hospitals, households, and drinking water;
wood preservatives; pesticides that prevent
deterioration and fouling of such materials
as paint and metalworking fluids; and
certain pesticides that help prevent food
borne illness.
A turning point in improving the
antimicrobial pesticide registration process
occurred with the creation of a self-
contained Antimicrobials Division. This
new division performs all antimicrobial
regulatory services.
With this new division, EPA reduced
the antimicrobials registration backlog from
388 at the end of December 1996 to 87 at
the end of October 1997, a decrease of 77%.
At the same time, EPA met all the fast track
review goals for antimicrobials mandated by
the amended FIFRA, by creating an
Expedited Review Team that ensures fast
track actions are completed on time. These
accomplishments were possible largely
because the new Division controls its own
workflow.
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FY 1997 OPP ANNUAL REPORT
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To continue its streamlining
activities, EPA meets regularly with
antimicrobial pesticide stakeholders to
obtain their suggestions for lessening the
registration burden both on EPA and on
registrants, while ensuring the continued
safety and efficacy of registered pesticides.
PARTNERSHIPS
States, tribes, territories, public
health agencies, growers, and commodity
groups are vital partners in ensuring the safe
use of pesticides.
States
State Lead Agencies (usually, but not
always, state departments of agriculture) are
vital partners in pesticide regulation. In FY
1997, through the use of federal/state funded
cooperative agreements, states provided
essential activities in developing and
implementing the endangered species,
groundwater, and worker protection
programs, as well as in training and
certifying pesticide applicators. EPA
supported states for this work with about
$12 million in cooperative agreement funds
(in addition to a roughly equal amount of
funding for enforcement activities). In
addition, states were involved in numerous
special projects and investigations, including
emergency response efforts resulting from
widespread methyl parathion misuse which
is discussed later in this report.
• supported EPA's Tribal Lands
Environmental Science Scholarship
Program which provides scholarships to
Native American college students
working toward degrees in
environmental fields;
» supported development of a pesticide
integrated pest management course to be
taught at the Haskell Indian Nations
University in Lawrence, KS;
• funded a ground and surface water
course at Flathead Lake Biological
Station in Poison, MT, with participation
by tribes; and
* compiled a Tribal pesticide resource
document, consisting of existing Tribal
pesticide laws, memoranda of
understanding, and examples of
certification and training plans, to
provide a reference for tribes which want
to develop pesticide laws and programs.
OPP works closely with twenty tribes which
currently operate pesticide programs, and
with several tribes that use pesticides but
currently lack a pesticide regulatory
structure. In FY 1997, OPP:
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FY 1997 OPP ANNUAL REPORT
PAGES
TRIBAL FACTS
There are:
- 562 federally recognized Tribes.
- 38 million acres of tribal land that are
used for grazing.
- 8 million acres of tribal land that are
farmed.
- 6 million acres of tribal land that are
forested.
- 164,000 American Indians involved in
farming.
- 20 Tribes with pesticide programs.
- 4 Tribes with EPA approved Certification
and Training plans.
SPOTLIGHT ON TRIBES: During FY
1997, EPA Region 9 and the California
Department of Pesticide Regulation
encouraged a dialogue among pesticide
applicators, regulators, and Native Americans
on the impact of pesticide spraying on plants
important to Native Americans. Agreements
were made to stop roadside spraying and
move to mechanical control of weeds in
certain locations. Meanwhile, EPA Region 8
awarded a Community-Based Tribal Pesticide
Project to the Confederated Salish and
Kootenai Tribes of the Flathead Reservation
located in western Montana. Under this grant,
the Tribes will identify and monitor possible
pesticide residues on important cultural plants,
specifically bitterroot and camas and
formulate recommendations for minimizing
pesticide applications near cultural plant
communities.
Denise Davis splitting willow at the California
Basket Weavers Gathering. Photo by Hank
Meals
Territories
In FY 1997, OPP also provided
financial and technical assistance to the U.S.
Territories for developing and implementing
various pesticide programs.
Pesticide Program Dialogue Committee
In late 1995, the Pesticide Program
Dialogue Committee (PPDC) was
established under the Federal Advisory
Committee Act. This committee provides a
forum for a diverse group of stakeholders to
provide feedback to the pesticide program
on various regulatory, policy, and program
implementation issues. Membership
includes environmental and public interest
groups, pesticide user and commodity
groups, public health and academic
institutions, federal and state agencies, and
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FY 1997 OPP ANNUAL REPORT
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the general public. All PPDC meetings are
open to the public.
The group met four times from its
inception through the end of FY 1997 to
discuss a wide variety of topics, including:
reduced risk pesticides, labeling, measures
of success, minor uses, tolerance
reassessment, outreach, ecological
standards, endocrine disrupters, fees for
service, and several early implementation
issues resulting from the FQPA. In addition,
several PPDC work groups were established
with PPDC members and other external
parties to further facilitate the exchange of
ideas and to develop recommended options
for consideration at PPDC meetings.
A renewed two-year Charter for the
PPDC was approved and membership to the
PPDC is being renewed for many existing
members, while additional members are
being added to the group.
New Minor Use Program
Minor use pesticides are products
used on agricultural crops or sites, livestock,
or for protection of public health where the
total acreage in the United States is less than
300,000 acres, or the use of which does not
provide sufficient economic incentive to
registrants to generate the data required by
EPA to support registration. These
pesticides are often of major significance to
consumers and growers. Without these
small scale but vital pesticide uses, many of
the fruits, vegetables, and ornamentals that
we enjoy in the U.S., worth billions of
dollars, could not be grown successfully.
FQPA requires EPA to address
minor uses in a coordinated fashion. Thus,
in consultation with the Pesticide Program
Dialogue Committee, U.S. Department of
Agriculture, and growers concerned with
minor uses, EPA designed a new approach
to minor use pesticides. Under the new
program, EPA established a team of
representatives from throughout OPP which
reports to the Director of OPP. The minor
use team has three primary goals:
1) obtaining and using the best available
data to support minor use tolerances; 2)
working more closely with the minor use
grower community early in the regulatory
process; and 3) promoting the use of safer
pesticides for minor uses by urging
manufacturers to research and expedite
registrations for lower risk pesticides,
Stewardship Program
The Pesticide Environmental
Stewardship Program (PESP) is a voluntary
partnership between the pesticide user
community and EPA. Under PESP,
participants prepare and implement
strategies to reduce pesticide risk among
their constituents. The PESP involves:
» partners, who develop educational
programs on new, safer pest control
techniques, and research areas that
could lead to the development of
safer technologies;
• supporters, who help partners by
participating in research and
providing pesticide educational
information to the general public;
and
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FY 1997 OPP ANNUAL REPORT
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OPP, which provides both partners
and supporters with a liaison in EPA
to answer questions and address
pesticide issues and other EPA
activities.
SPOTLIGHT ON PESP: Measuring
success of integrated pest management
(IPM) strategies is a key component of
PESP. For example, under one project, a
three-year crop rotation system using
sustainable IPM tactics will be compared to
the traditional two-year cropping system for
northern plains wheat. The project, funded
by EPA Region 7, will examine indicators
of environmental health, including
comparisons of pest density and estimates of
arthropod and small mammal diversity and
abundance in the test fields and in the
surrounding area. Researchers will evaluate
the economic feasibility of the different
cropping systems and will coordinate closely
with wheat growers and grower
organizations. Results from this IPM project
will have broad application for dryland
wheat production in the northern plains,
particularly for areas affected by the Russian
wheat aphid.
The PESP program continued to
expand in FY 1997, adding 28 more Partners
and Supporters.
Photo by Steve Delaney
METHYL PARATHION MISUSE
Since 1994, EPA has responded to
several pesticide misuse incidents occurring
in Midwestern and Southern states. Those
incidents involved individuals who had
illegally sprayed homes and other buildings
with methyl parathion, a highly toxic
agricultural pesticide registered for outdoor
use only. Investigators found high levels of
methyl parathion residue in homes. Based
on urinalysis of residents, about 3,400
people have been relocated from their
residences.
Responding to this public health
emergency, which is the largest single
pesticide investigation ever undertaken
by EPA and the affected states, involved
tremendous interagency cooperation
between city, county, state and federal
agencies on a multitude of activities. Public
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FY 1997 OPP ANNUAL REPORT
PAGES
agencies have spent well over $72 million
to date in responding to this emergency
through environmental and biological
testing, relocation, decontamination, and
restoration.
The widespread misuse of methyl
parathion is a real public health threat,
particularly to infants and children.
Symptoms of direct exposure to high levels
of methyl parathion include headache,
dizziness, loss of coordination, muscle
twitching, tremor, nausea, vomiting,
abdominal cramps, diarrhea, and general
weakness, blurred vision, excessive
perspiration, and salivation.
In an effort to significantly reduce
the likelihood that such widespread misuse
will happen again, the multi-agency strategy
is focussing on incident response, product
modifications, outreach and prevention, and
enforcement and deterrence,
Incident Response
Three separate EPA regional offices,
seven state agencies, the U.S. Agency for
Toxic Substances and Disease Registry and
many county/local health officials were
involved in finding and testing thousands of
contaminated homes, conducting health
evaluations of residents, cleaning up the
homes, and relocating people. Information
on the health effects of methyl parathion was
distributed during the response and clean-up
phase. This information can be found on the
OPP Home Page on the Internet.
Product Modifications
In December 1996, Cheminova and
other registrants of methyl parathion
emulsifiable concentrate (EC) pesticide
products agreed to;
• recall unopened containers of
products in which methyl parathion
is the sole active ingredient;
• add an odoring agent to discourage
illegal indoor use;
• repackage the product into larger
containers that require special
equipment to access the contents;
• barcode packages for tracking
purposes; and
• limit concentration of methyl
parathion to five Ibs. per gallon or
less in all products containing methyl
parathion EC as the sole active
ingredient.
Outreach and Prevention
Cheminova agreed to launch an
education program to foster good product
stewardship by dealers and applicators.
Other efforts are being initiated to
prevent such widespread misuse from
happening again. OPP led an effort with
Regional Offices, ATSDR, Office of
Enforcement and Compliance Assurance
(OECA), and the Office of Communication,
Education and Public Affairs to develop a
communication and outreach strategy which
will increase awareness of pesticide risks,
available safer alternatives, and sources of
information. The outreach effort focusses
on medical professionals, grassroots groups,
and consumers.
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FY 1997 OPP ANNUAL REPORT
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Several key accomplishments to date
include:
• production by Cheminova, a methyl
parathion registrant, of a widely-
distributed public service
announcement for radio and
television that urges people to read
labels, not to use outdoor-only
pesticides indoors, and to hire only
licensed applicators;
• development of a poster and
brochure promoting safer methods of
roach control;
• a joint letter from OPP and OECA
published in the National Pest
Control Association newsletter, that
asks for industry assistance in
identifying unscrupulous pesticide
applicators and;
• publication of an article in the
American Academy of Pediatrics
newsletter regarding methyl
parathion as an aggravating factor of
asthma in children.
Additional outreach efforts will be
implemented in FY 1998, including working
with the National ParentTeachers
Association to communicate information on
safer pest control methods.
Enforcement and Deterrence
To date, 23 individuals have been
arrested for their illegal pesticide operations
and face prison terms if convicted. One
defendant has already received a six and
one-half year sentence, the longest sentence
ever issued in the United States for an
exclusively environmental crime. EPA will
continue to vigorously prosecute any person
who places people at such risk.
OECA, in cooperation with Regions
4 and 5, developed a National Urban and
Residential Pesticide Control and
Enforcement Program that is currently being
implemented by States nationally. This
program is designed to prevent future
diversion and illegal structural application of
agricultural pesticides by detecting points of
diversion of methyl parathion or other
restricted use pesticides from the agricultural
sector and initiating appropriate enforcement
action against the culpable parties.
-rl
Photo by Steve Delaney
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FY 1997 OPP ANNUAL REPORT
PAGE 10
REORGANIZATION
In FY 1997, OPP implemented the
organizational realignment it had been
planning for several years. Under this
realignment, OPP:
• reduced the number of supervisors
by roughly half, with a reduction
from four or five to only two levels
of supervision within each division.
Nearly all branches in OPP were
recast at a new standard size of 12-15
employees, headed by a single
supervisor. This flattening created
new opportunities for additional
branch chiefs while it eliminated the
former branch subdivisions.
defined a single team in each
division to provide all administrative
and support functions. This provides
increased efficiency and career
opportunities for specialists in
administrative and support fields.
consolidated information
management functions in a new
Information Resources and Services
Division.
combined the former Policy and
Special Projects Staff with the Field
Operations Division to form a new
Field and External Affairs Division.
created multi-disciplinary branches
with a self-contained science review
function. This puts the primary
reviewers much closer to the
regulatory decision process, reduces
the number of pass-throughs and
sign-offs required to reach a
decision, and encourages
collaborative work among specialists
in different disciplines.
created a new Antimicrobials
Division that combines risk
assessment and risk management
functions for antimicrobial pesticides
in a single organization. The
division carries out both regulatory
and science functions. The new
division has improved the efficiency
and accountability for the
antimicrobials program, and it is
continuing to work with stakeholders
to achieve further streamlining
improvements.
See the Appendix for a summary of
each Division's area of responsibility.
In FY 1998, OPP will continue to
examine other ways to structure staff and
processes to deliver services to the public.
The new Antimicrobials Division assures that
disinfectants and certain sterilants used in operating
rooms kill germs that cause infection. Photo by
Steve Delaney
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FY 1997 OPP ANNUAL REPORT
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OFFICE OF PESTICIDE PROGRAMS
OFFICE OF
PESTICIDE
PROGRAMS
IMMEDIATE
OFFICE OF THE
DIRECTOR
FIELD &
EXTERNAL AFFAIRS
DIVISION
BIOPESTICIDES &
POLLUTION PREVENTION
DIVISION
REGISTRATION
DIVISION
ENVIRONMENTAL
FATE & EFFECTS
DIVISION
RESOURCES
MANAGEMENT
STAFF
INFORMATION
RESOURCES & SERVICES
DIVISION
ANTIMICROBIALS
DIVISION
SPECIAL REVIEW &
REREGISTRATION
DIVISION
HEALTH
EFFECTS
DIVISION
BIOLOGICAL &
ECONOMIC ANALYSIS
DIVISION
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FY 1997 OPP ANNUAL REPORT
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RISK REDUCTION
In FY 1997, EPA continued to
pursue pesticide risk reduction in a variety
of ways, including expediting the
registration of reduced risk products, placing
conditions on registrations to reduce risk, re-
registering older pesticides to meet today's
safety standards, using special review
authority to remove or change problem uses,
and working with our partners in the field.
Reduced Risk Products
EPA's emphasis on the registration
of new reduced risk pesticides continued in
FY 1997 with the registration of 19 reduced
risk active ingredients.
Reduced risk pesticides fall into two
classes - conventional reduced risk
pesticides and biological pesticides.
Conventional reduced risk pesticides are
those that have low impact on human health,
low toxicity to non-target organisms (birds,
fish, and plants), low potential for
groundwater contamination, lower use rates,
low pest resistance potential, and are
compatible with IPM. The number of
conventional reduced risk pesticides
registered by EPA has steadily increased
each year. These include reduced risk
fungicides, herbicides, and insecticides for a
variety of crop and non-crop uses. Reduced
risk pesticides are registered in about one-
third the time required to register a
conventional non-reduced risk pesticide.
The average time required to register a new
reduced-risk pesticide is about 14 months,
compared to 38 months for a conventional
pesticide.
Biological pesticides, naturally
occurring substances with pesticidal
properties, are considered reduced risk
because they work by non-toxic means. In
FY 1997, the average time required to
register a biological pesticide was 11
months. Biological pesticides fall into three
broad categories. Microhialpesticides
contain a bacterium, fungus, virus,
protozoan or alga as the active ingredient.
Approximately 50 microbial pesticide active
ingredients have been registered by EPA.
The most widely known of these are
varieties of the bacterium, Bacillus
thuringensis or Bt, which can control certain
moths, beetles, and mosquitoes. Plant-
Pesticides are pesticidal substances
produced in a plant and contain the genetic
material necessary for the production of
those substances. To date, seven plant-
pesticide registrations have been issued.
Biochemical Pesticides include growth
regulators and pheromones.
Reregistration
Under FIFRA, EPA must review the
human health and environmental effects of
all pesticide active ingredients initially
registered before November 1, 1984, to
determine whether they meet today's
standards. The reregistration process is
addressing the potentially riskiest pesticides
first. Those active ingredients that meet the
standards are declared "eligible" for
reregistration, as explained in a
Reregistration Eligibility Decision (RED)
document. REDs are designed to provide
guidance to registrants for the reregistration
of individual pesticide products, and usually
spell out various mitigation measures that
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FY 1997 OPP ANNUAL REPORT
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are required for the products containing a
particular chemical to be reregistered. All
23 REDs completed this fiscal year contain
risk mitigation measures. For details, please
see Table V.
The 171 REDs completed through
the end of FY 1997 represent over 60% of
the total volume of pesticide active
ingredients used annually in the U.S. The
remaining REDs are expected to be
completed by 2002.
Special Review
A Special Review is conducted on a
pesticide when the Agency believes it poses
an unacceptable risk to human health and/or
the environment. In FY 1997, agreements
were reached with the registrants of six
chemicals through the Special Review
program, in order to reduce potential
pesticide risk.
These chemicals were:
• flowable carbofuran, a broad spectrum
carbamate pesticide used against soil and
foliar pests of field, fruit and vegetable
crops;
• methyl parathion, an organophosphate
insecticide used to control boll weevils
and other biting or sucking insect pests
of agricultural crops, primarily cotton;
SPOTLIGHT ON SPECIAL REVIEW: In
response to EPA concerns about exposure of
agricultural workers to methamidophos, an
insecticide used on a variety of crops, Bayer
Corporation and Valent USA, the
methamidophos registrants, deleted all uses
except cotton, potatoes, and tomatoes from
methamidophos labels. The registrants also
agreed to implement closed mixing and
loading systems for all methamidophos
products registered in the United States. EPA
accepted these measures as interim risk
mitigation; the remaining methamidophos
uses will be evaluated during the reregistration
phase. Also, in March 1997, Rhone Poulenc,
in an effort to reduce dietary risk posed by
iprodione on peaches, agreed to reduce the
number of applications per use season from
four to three, and to restrict application timing
to the stage prior to petal fall, thereby
increasing the pre-harvest interval (PHI) from
7 to 90 days. Although the reduction of risk
resulting from these changes is not precisely
quantifiable at this time, field data indicate
that 99% of the residue is the result of the last
application, and the company is conducting
new field trials to reflect the new use rates.
These label changes, as negotiated, were
approved in April 1997, with relabeling of
existing stocks to be completed by December
1997.
• copper and zinc naphthenate, which are
wood preservatives;
» vinclozolin, a fungicide used for the
control of several types of fungi in vines,
strawberries, vegetables, fruit, and
ornamentals. It was also used on turf
grass;
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FY 1997 OPP ANNUAL REPORT
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iprodione, a fungicide used on
vegetables, ornamentals, root crops,
cotton, and sunflowers; and
methamidophos, an insecticide used on a
wide variety of fruits and vegetables.
Risk reduction measures included
voluntary cancellation of some/all uses,
expanding the duration of the pre-harvest
interval, special packaging and engineering
controls, and spray drift labeling. (See the
Appendix for all mitigation measures
developed through the special review
process in FY 1997).
OUTREACH
Because the use of pesticides affects
virtually everyone in the United States, it is
especially important that EPA provide
useful information to citizens about
pesticide registration and use. In FY 1997
OPP expanded its outreach efforts by
developing a consumer brochure, working
on label improvements, and creating a Home
Page on the World Wide Web.
Consumer Brochure
OPP began work in FY 1997 on a
brochure to inform consumers about
pesticide residues on food as required by
FQPA. This brochure is designed for
supermarkets to distribute to the public. It
will include basic information on the risks
and benefits associated with pesticides and
recommendations for ways consumers can
reduce their dietary exposure to pesticide
residues. In addition, the brochure will list
benefits-based tolerances if they are set
(tolerances that do not meet the "reasonable
certainty of no harm" standard, but are
retained because the loss of a particular use
would pose even higher risks to public
health, or the loss would significantly
disrupt the food supply). The brochure will
be available in August 1998 and annually
thereafter.
As part of the development process,
OPP is working with stakeholders through
the Pesticide Program Dialogue Committee,
and is conducting consumer research and
focus groups.
Better Pesticide Labeling
In FY 1997, EPA continued to work
on improving pesticide labels, revising
labeling procedures, and increasing
accessibility of label information.
IMPROVING PESTICIDE LABELS -
The Consumer Labeling Initiative (CLIJ, a
joint project with several Federal and State
agencies, industry, and other interested
parties, began in FY 1996. Its goal is to
foster pollution prevention and improve
consumer understanding of safe use,
environmental, and health information on
household consumer product labels. During
its first year, the CLI conducted basic
research on consumer behavior and
attitudes, including one-on-one interviews
with consumers; issued three Pesticide
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FY 1997 OPP ANNUAL REPORT
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Registration Notices which permitted the
use of chemical common names and phone
numbers on labels; and tested revised First
Aid statements with consumers.
SPOTLIGHT ON OUTREACH: Education
and outreach to ordinary consumers can be an
effective means of reducing risks from
pesticide use. For example, runoff from urban
and suburban users probably accounts for a
significant portion of pesticide detection in
wells and waste water plants. Proper use of
pesticides, as part of an overall strategy of pest
prevention, is crucial in order to decrease
runoff of pesticides. The Fort Worth Water
Department's Clean Water Program (FWWD)
initiated an educational effort, funded by EPA
Region 6, directed at urban residents to
provide information about proper pesticide use
and avoiding excessive application of
pesticides. The Water Department met with
area pesticide retailers to educate employees
about IPM practices which they can convey to
their customers to ultimately reduce
pesticides. Also, brochures regarding
pesticide alternatives were mailed to citizens
with water bills. The FWWD has passed the
water quality tests from November 1996
through September 1997. The Department
credits this success to its education program.
IMPROVING INFORMATION FLOW -
Pesticide label information must be
accessible in order for it to be effective.
Progress continued on a number of fronts in
disseminating label information, including:
• revision of the Label Review Manual,
which provides one source for existing
regulations, policies, and other
information concerning labels;
• creation of the Pesticide Product Label
System (PPLS), which is a CD-ROM
that provides users with a visual image
of all EPA-stamped and accepted
pesticide labels; and,
• announcement of the Labeling Change
Coordination Policy which will help
streamline the Agency's processing of
labeling changes, improve the
coordination of EPA's labeling
activities, and lessen the economic
impact on registrants and supplemental
distributors who make labeling changes
throughout the year.
OPP and the Internet
OPP's Website continued to expand
in FY 1997. The Website can be found at
http://www.epa.gov/pesticides. The web is
being utilized to provide practical
information to consumers on the use of
pesticides, as well as providing information
to states, businesses, and children.
Photo by Steve Delaney
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FY 1997 OPP ANNUAL REPORT
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STRENGTHENING EPA'S SCIENCE BASE
One of the Agency's core challenges
has been to consistently improve the quality
and soundness of the science used to support
regulatory decision making. In March 1995,
EPA issued a policy committing the Agency
to the core values of clarity, transparency,
reasonableness, and consistency within the
context of sound science and regulatory
actions. In FY 1997, OPP implemented this
policy in several ways.
Ecological Risk Assessment Methods
In response to a recommendation
from the FIFRA Scientific Advisory Panel
(SAP), OPP began improving its ecological
risk assessment by developing probabilistic
risk assessments. Such an assessment would
address the magnitude and probability of the
expected impact as well as the uncertainty
and variation involved in the provided
estimates. OPP began a new initiative to
achieve this goal by forming aquatic and
terrestrial technical workgroups, which are
composed of experts drawn from
government agencies, academia, contract
laboratories, environmental advocacy
groups, and industry.
These workgroups will identify and
develop probabilistic tools and
methodologies for terrestrial and aquatic
assessments. They will also identify
developmental information and validation
needs to ensure that the assessment process
supports environmental decisions that are
scientifically defensible, and will participate
in nationally recognized professional
meetings, such as the American Chemical
Society and the Society for Environmental
Toxicology and Chemistry.
Human Health Risk Assessments
AGGREGATE RISKS - OPP developed
interim guidance for performing aggregate
exposure assessments for chemicals as
required under FQPA. This guidance
describes an approach to combining
exposures to chemicals by multiple routes,
from or through the diet, from water, and
from other nonoccupational sources.
EPA's interim decision logic is based
on the concept that the total level of
acceptable risk to a pesticide is represented
by the pesticide's Reference Dose (RfJD).
This is the level of exposure to a specific
pesticide that a person could receive every
day over a seventy-year period without
significant risk of a long-term or chronic
non-cancer health effect. The analogy of a
"risk cup" is being used to describe
aggregate exposure estimates. The full cup
represents the total RfD and each use of the
pesticide contributes a specific amount of
exposure that adds a finite amount of risk to
the cup. As long as the cup is not full,
meaning that the combined total of all
estimated sources of exposure to the
pesticide has not reached 100% of the RfD,
EPA can consider registering additional uses
and setting new tolerances. If it is shown
that the risk cup is full, no new uses could
be approved until the risk level is lowered.
This can be done by the registrant providing
new data which more accurately represent
the risk or by implementing risk mitigation
measures.
While this explanation is focused on
chronic non-cancer risk, the Agency will use
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FY 1997 OPP ANNUAL REPORT
PAGE 17
a similar logic to assess acute risk and
cancer risk.
This process was reviewed publicly
by the SAP in March 1997, The SAP found
the approach to be a good first step toward
developing a policy. They provided several
recommendations for next steps in the
development process. OPP has continued to
work toward development of a final policy
on aggregate exposure, both internally and
with the public and regulated community.
CUMULATIVE RISK - OPP also
developed an approach to determine whether
two or more pesticide chemicals are acting
by a common mechanism of toxicity and
thus are candidates for cumulative risk
assessment. The proposed approach
considers all available information on a
group of candidate chemicals using a
weight-of-evidence approach. OPP
presented its approach and a case study
clustering a group of structurally similar
pesticides in draft form to the FIFRA SAP in
March of 1997. This policy is being
finalized.
DRINKING WATER EXPOSURE - As a
result of FQPA, OPP is required to factor
exposure to pesticide residues in drinking
water into tolerance decision making.
During FY 1997 EPA developed and
implemented an interim approach for
addressing this pathway of exposure for
those pesticides which have some potential
to reach groundwater and/or surface water.
The interim approach relies heavily on
modeling (i.e., the estimation of pesticide
concentrations in surface water and
groundwater), because EPA lacks
comprehensive drinking water monitoring
data for most pesticides (comprehensive
costs of collecting such data are enormous).
OPP continues to evaluate options for
improving its interim approach (so that its
model-based estimates are more accurate),
as well as options for obtaining additional
drinking water monitoring data. OPP has
presented its interim approach to a Working
Panel of the International Life Sciences
Institute (ILSI) and is planning to present
some options for improvement to the
approach to the FIFRA Scientific Advisory
Panel in December 1997.
ACUTE DIETARY RISK OPP is
currently reviewing probabilistic risk
assessments of acute dietary risk from short
term exposure. These assessments more
closely approximate the likely risk to the
public from acute dietary exposures to
pesticides, by considering the probability of
different combinations of exposure. The
introduction of this methodology into
worker and residential exposure assessments
is also being explored.
OTHER PROJECTS - In FY 1997 OPP
also:
• presented draft guidance on Data
Requirements for Import Tolerances
to the SAP;
» developed guidelines on conducting
domestic animal safety studies,
which are required prior to
registration of a pesticide product
proposed for direct application to
domestic animals; and
• drafted Residential Exposure
Assessment Standard Operating
Procedures for conducting residential
exposure assessments for both
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FY 1997 OPP ANNUAL REPORT
PAGE 18
handler and post-application
exposures when pesticide-specific
and/or site-specific field data are
limited,
EPA Analytical, .Support
ASSISTANCE - OPP assisted State and
Federal laboratories with a variety of
complex analytical projects. For example, in
support of the Mediterranean fruit fly
quarantine eradication program, OPP
provided Florida State and USDA labs with
water check samples to allow them to
monitor for malathion and malaoxon in the
environment. The laboratories also provided
reference standards, analytical methods, and
other assistance to state laboratory
personnel, OPP laboratories also
successfully responded to an urgent request
for assistance from USDA and FDA to help
discover the source of dioxin contamination
in chickens which came from clay in feed.
THE ENVIRONMENTAL SCIENCE
CENTER - Construction continued on a
new EPA laboratory facility in Ft. Meade,
Maryland. The Region 3 Annapolis
laboratories, the OPP Beltsville Analytical
Chemistry Laboratory, and the OPP
Cincinnati Microbiology Laboratory will co-
locate to the new facility upon completion in
December 1998. The OPP wings will house
the current operations of the two OPP
laboratories as well as the analytical grade
standards repository which will be
transferred from the Office of Research and
Development (ORD). This will result in
cost savings and facility/equipment
modernization.
SPOTLIGHT ON ANALYTICAL
METHOD DEVELOPMENT: In FY 1997,
reports surfaced in the Pacific Northwest that
sulfonylurea (SU) herbicides were suspected
of causing damage to non-target plant life,
As a class, SU herbicides are effective in very
small quantities, relative to other types of
registered compounds. But, the fact that less
active ingredient is being applied contributes
to the difficulty in detecting the SUs in the
environment. EPA formed a task force with
industry to develop better analytical methods
of detecting these effects on nontarget species,
which will enable the EPA to better monitor
the effects of the SUs on the environment. The
task force developed five new analytical
methods for soil and water. Responding to
adverse effects through cooperative
investigations with industry is a good example
of public-private, cross-disciplinary efforts.
EFFICACY TESTING - Before EPA will
register a public health pesticide, it reviews
the submitted efficacy data to be sure that
the pesticide will be effective. In FY 1997,
work continued on evaluating:
• technologies to more quickly
determine efficacy of antimicrobia
pesticides; and
• the efficacy of about 800 registered
hospital disinfectants, 154 of which
are registered for controlling the
tuberculosis bacterium.
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FY 1997 OPP ANNUAL REPORT
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FIELD PROGRAMS
EPA's Certification and Training,
Endangered Species, Groundwater, and
Worker Protection programs continued to be
developed and implemented in FY 1997 by
OPP, regional offices and state, tribal and
territorial regulatory offices.
Certification and Training
When OPP designates some or all
uses of a pesticide as "restricted use," the
pesticide may only be used by, or under, the
direct supervision of specially trained,
certified applicators. Certification programs
are conducted in accordance with national
standards set by OPP. All states require
commercial applicators to be recertified,
generally every three to five years. Some
states also require recertification or other
training for private, non-commercial
applicators.
In 1997, OPP established the
Certification and Training Advisory Group
that completely reviewed the requirements
for certified applicators. The group is
reconsidering all aspects of applicator
certification and will make
recommendations for improvements on an
annual basis. Other activities included the
biennial pesticide applicator training
workshop, and continued work on pesticide
drift management and application
technology.
In 1996, the most recent year for
which figures are available, over 81,000
private and 66,000 commercial applicators
were certified; and more than 129,000
private and 121,000 commercial applicators
were recertified. There are a total of
approximately 950,000 private and 360,000
commercial applicators currently certified
nationwide.
In addition to traditional pesticide
applicator training, the state Cooperative
Extension Services initiate specialized
training for various groups. For example,
training is provided to private applicators on
the proper use of personal protective
equipment (PPE) and application equipment
calibration, how to handle spill and injury
situations, farm family safety, how to
prevent drift and pesticide and container
disposal. Other specialized training is
provided to public works employees on
grounds maintenance, pesticide control
operators on proper insect identification and
weed control for agribusiness.
Photo by Steve Delaney
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FY 1997 OPP ANNUAL REPORT
PAGE 20
SPOTLIGHT ON ENDANGERED
SPECIES: In the arid Trans-Pecos area of
West Texas, two endangered fish, the
Comanche Springs pupfish and the Pecos
gambusia, are occasionally getting into the
agricultural irrigation ditches near their
natural habitat. As a result, EPA proposed
pesticide use limitations for a fairly large area
adjacent to the springs. A regional
agriculture-wildlife team initiated a
cooperative effort to prevent major impacts
from these limitations to agricultural
irrigation. The Team suggested creation of an
artificial pond in Balmorhea State Park which
would provide additional habitat for the
endangered fish. The pond was constructed
with tourism in mind. An underwater viewing
area was installed to provide tourists the
opportunity to safely view the endangered
fish. Hundreds of thousands of endangered
fish have propagated since the pond was
completed. The project not only prevented
extensive pesticide regulations while
benefiting fish and wildlife, but it also
stimulated a variety of economic and
educational activities. A video documenting
the approach used to develop the park was
produced and is shown to other state, local and
federal agencies as a success story of a
cooperative team effort.
Endangered Species
The Endangered Species Protection
Program, currently a voluntary program, is
designed to protect endangered species from
exposure to pesticides through the
implementation of chemical-specific county
bulletins. In FY 1997, OPP printed and
distributed 89 bulletins and sent 22 draft
bulletins to states for review. OPP also
continued significant efforts with the
registrants' FIFRA Endangered Species Task
Force to develop an information
management system on endangered species
that would markedly enhance endangered
species risk assessments and species location
data for registration and reregistration
actions.
In addition to continuing work with
risk assessors in OPP to address selected
endangered species concerns, the program
developed risk profiles on more than 300
listed plant species in FY 1997.
The Endangered Species Protection
Program also has begun to provide
information electronically on the Internet
and through a faxback number (800-447-
3813).
Groundwater
In FY 1997, states, tribes and EPA
regions participated as equal partners in
developing the ground water protection rule,
which is intended to implement risk-
reduction measures for pesticides in ground
water. OPP always considers states and
tribes to be its regulatory partners.
However, in the past, states and tribes were
not permitted to assist in regulation
development after the close of the formal
comment period, due to laws governing how
the federal government develops regulations.
With the Ground Water State/Tribal
Management Plan Proposed Rule, OPP
gained approval for states and tribes to work
with us beyond the close of the comment
period. In 1997, ten states and three tribes
joined OPP's traditional regulatory review
group to notify them when pesticides are
applied. Employers also must provide
washing supplies if workers are likely to
come into contact with pesticides, and
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FY 1997 OPP ANNUAL REPORT
PAGE 21
provide and maintain protective equipment.
Implementation of the WPS is lowering the
risk of pesticide poisonings among
agricultural workers and pesticide handlers.
SPOTLIGHT ON COMPLIANCE: A
FIFRA cooperative agency since 1979, the
New Mexico Department of Agriculture has
long believed that the risks from potential or
actual pesticide misuse are greater in the
urban/suburban sector than in the
rural/agricultural sector, due to the population
density, but needed data to support that theory.
Beginning in FY 1997, state inspectors used a
standardized inspection checklist to cover
FIFRA and State regulatory requirements,
including compliance with label site,
application within certification category,
application rate and method, equipment
integrity, and disposal. Overall, about 33
percent of all urban pesticide use inspections
show some violation, although most are not
"use", or label violations. This compares to a
violation rate of about 15 percent in the
agricultural sector. The most common
violations found in urban/suburban application
sites are record-keeping (45%), unlabeled or
mis-labeled rodenticide bait stations (17%),
and unused or inadequate personal protective
equipment (12%). Compliance Assistance
activities designed to reduce these violations
include training seminars for non-certified
commercial applicators, state participation in
training activities for certified applicators, and
post-inspection reviews provided to
applicators and service technicians by
pesticide inspectors at the end of a formal
inspection.
Worker Protection Standard
OPP's Worker Protection Standard
(WPS) for agricultural pesticides represents
a major strengthening of national efforts to
safeguard agricultural workers. WPS
requires agricultural employers to ensure
that employees receive basic pesticide safety
training and in FY 1997, OPP issued the
National Dialogue Report - Part I, a
summary and transcript of the nine public
meetings held in FY 1996. Part II, a
strategic plan for the further efforts on the
WPS will be issued in FY 1998.
OPP also continued to refine WPS
requirements to increase flexibility and to
remove unnecessary restrictions (e.g.,
issuing a proposal to modify glove
requirements and an exception to rose
growers for harvest activities).
Photo by Carol Parker
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FY 1997 OPP ANNUAL REPORT
PAGE 22
INTERNATIONAL ACTIVITIES
OPP continued to provide leadership
in FY 1997 in international efforts to
harmonize pesticide standards and
regulatory procedures. OPP's objective is to
promote improved environmental protection
world-wide and to ensure that international
trade initiatives and agreements are
consistent with the high level of protection
afforded by EPA's pesticide laws.
In FY 1997, partnerships with both
developed and developing countries allowed
OPP to promote public health and
environmental protection on a global scale,
share the work of reviewing data with other
countries, reduce trade barriers and
regulatory burdens, and help ensure that
imported food is safe. FY 1997
international efforts can be grouped into
three broad categories: (1) policy, (2)
programmatic, and (3) capacity building.
Policy Coordination
INTERGOVERNMENTAL FORUM ON
CHEMICAL SAFETY (IFCS) - In FY
1997, the IFCS continued to build
international consensus on the need to
minimize use of twelve persistent organic
pollutants. Intergovernmental negotiations
on a global control mechanism will begin in
1998. IFCS has also been instrumental in
building consensus to turn the UN Prior
Informed Consent (PIC) procedures into a
legally-binding instrument. PIC procedures
relate to international information exchange
on the export and import of banned and
severely restricted chemicals.
CODEX - OPP supported the work of the
Codex Alimentarius Commission, a joint
program of the UN Food and Agriculture
Organization and World Health
Organization that sets international
standards for pesticide residues in foods.
Many countries rely on Codex in setting
their national food safety standards. The
U.S. is working with the organization to
improve the scientific basis and timeliness
of Codex decisions, and to boost public
participation in the Codex decision-
making process.
NORTH AMERICAN COMMISSION
ON ENVIRONMENTAL
COOPERATION - On a regional level, the
North American Commission on
Environmental Cooperation provided an
important forum for EPA's efforts to deal
with chemical pollutants of concern to
Canada, Mexico, and the United States. The
Commission approved regional action plans
to reduce the use of DDT and chlordane
throughout North America.
Program Activities
In FY 1997, OPP expanded its
harmonization and cooperation work
through the Organization for Economic
Cooperation and Development's (OECD)
Pesticide Forum. Building upon work by the
European Union, OECD members are
developing harmonized procedures for
electronic data submission and standardized
data submission and evaluation formats.
OPP began participation in a three-year
OECD risk-reduction program (1997-1999),
to harmonize the regulation of biocides and
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FY 1997 OPP ANNUAL REPORT
PAGE 23
to establish internationally harmonized
chemical classification and labeling by the
year 2000.
Cooperative work with Canada and
Mexico under the North American Free
Trade Agreement Technical Working Group
on Pesticides increased in FY 1997. The
first joint review of a reduced risk chemical
pesticide is currently in progress in the U.S.
and Canada, and the joint review process has
now been extended to microbial and
pheromone products. Significant progress
has been made in the harmonization of data
requirements between Canada and the
United States.
Capacity-Building Activities
To improve environmental
protection world-wide, industrialized
countries with well-established regulatory
programs are working with developing
countries to help improve their ability to
regulate pesticides and to manage chemical
production, distribution, use, and disposal.
In 1997, OPP activities included:
• development of a training course on
the management and disposal of
obsolete pesticides in developing
countries. The course was first
delivered in Honduras in May 1997
and is expected to be used
throughout Central America;
• working with the Indonesian
Ministry of Agriculture to improve
the regulation of pesticides in
Indonesia. One objective of this
work is to develop a regional
pesticide information network to be
shared by seven Asian countries;
coordinating efforts with
international development agencies
in Central America for harmonizing
pesticide standards and building
institutional capacity for pesticide
regulation; and
helping Central American countries
strengthen regulatory institutions for
improved control over the
importation, distribution, use and
disposal of pesticides and promote
policies for safe pesticide use,
practices.
I
Photo by Steve Delaney
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FY 1997 OPP ANNUAL REPORT
PAGE 24
TECHNOLOGY
In FY 1997, OPP continued to take
advantage of innovations in technology in
order to achieve greater efficiencies by
purchasing state-of-the-art computers,
integrating its numerous databases, and
providing more opportunities for electronic
submission by registrants and states.
Computer Infrastructure Improvement
OPP invested significantly in
improving its computer infrastructure.
Approximately 50 percent of existing
inventory was replaced by new Pentiums
installed on desktops, and an additional 50
percent were upgraded with additional
memory and enhanced operating systems.
All Local Area Network (LAN) file servers,
routers, and gateways were upgraded with
new hardware. All file servers were
reconfigured to conform to Agency
standards.
Database Integration
OPP made significant progress
toward integrating its main databases
containing information about pesticide
products, chemicals, companies and studies.
Groundwork has been laid to migrate this
information from a mainframe computer to
the Local Area Network, into a fully
relational database, a step that will provide
OPP staff with more flexible and more
convenient access.
registration documents and information.
This effort is being done in cooperation with
the Canadian Pest Management Regulatory
Agency, the Canadian Crop Protection
Institute, the European Community and the
European Crop Protection Association.
EPA is adapting for Agency use a system
called Computer Aided Dossier and Data
Supply (CADDY) developed by the
European Commission and the European
pesticide industry.
SPOTLIGHT ON TECHNOLOGY: Under
the federal certification program, all persons
applying restricted use pesticides must be
certified under an EPA-approved program,
which is generally administered by states.
Since thousands of people are certified
annually, the states shoulder a large
administrative burden. Technology is rapidly
turning the certification process into a more
manageable job. For example, upgraded
software was distributed to Region 8's
pesticide state lead agencies and pesticide
coordinators (Extension Services) under the
new title Parsystem. This new program is an
integrated system designed to assist in the
development of tests, scoring and analyzing of
tests, maintaining records, managing grades,
and tracking attendance. In addition, Virginia
currently has similar technology in operation,
and the remainder of Region 3 states are
considering implementation of this system for
private applicator testing.
Electronic Submission
OPP began work to develop
computer software which will allow the
electronic submission of pesticide
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FY 1997 OPP ANNUAL REPORT PAGE 25
APPENDIX A
TABLES AND FIGURES OF OPP'S FISCAL YEAR 1997 ACCOMPLISHMENTS
Table 1 Pesticide Active Ingredients Registered in FY 1997
Table II Registration of Safer Chemicals
Table III Registration Decisions versus Targets in FY 1997
Figure I Reregistration Eligibility Decisions (REDs) Issued in FY 1997
Figure II Product Reregistration Status
Table IV Risk Reduction Through Special Review
Table V Risk Reduction Measures Required in FY 1997 Registration
Figure III Outcome of 6(a)(2) Submissions Warranting Expedited Review
Eligibility Decisions
Table VI Pesticide Environmental Stewardship Program Partners and Supporters
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FY 1997 OPP ANNUAL REPORT
PAGE 26
TABLE I
PESTICIDE ACTIVE INGREDIENTS REGISTERED
IN FY 1997
Of the 28 new active ingredients registered, 19 are reduced risk pesticides (including 15
biopesticides) and 2 are antimicrobials. (For purposes of this chart, reduced risk pesticides are
those that have low risk to human health, low toxicity to non-target organisms (birds, fish, and
plants), low potential for groundwater contamination, lower use rates, low pest resistance
potential, are compatible with IPM, or are biopesticides; non reduced risk pesticides have been
evaluated, they do not pose unreasonable adverse affects, but may have the potential to cause
greater harm than reduced risk pesticides if not used properly.)
•• P1STICIDENAME ,
acetic acid
alpha-metolachlor
AVG
azoxyst robin
bacillus cereus
BtK
burkholderia cepacia isolate
cis-1 1-tetraclecenyl acetate
clofencoet
copper octanoate
cyclanilid
daza technical
dekaib Bt com
German cockroach pheromone
halofenozide
imazamox
iron phosphate
Lepinox-genetically altered Bt
Plant Extract 620
poly ox in
primicarb
silver oxide
spinosad
sulfentrazone
suttocide A
thiazapyr
trans-1 1-tetradecenyl acetate
YieldgardBt corn
TBPE
herbicide
herbicide
plant growth regulator
fungicide
plant growth regulator
microbial insecticide
fungicide
pheromone
herbicide
fungicide
fungicide
insecticide
plant-pesticide insecticide
pheromone
insecticide
herbicide
molluscacide
insecticide
plant growth regulator
fungicide
insecticide
disinfectant
insecticide
herbicide
preservative
herbicide
pheromone
plant-pesticide insecticide
CMSS • -.
biopesticide
conventional
biopesticide
conventional
biopesticide
biopesticide
biopesticide
biopesticide
conventional
conventional
conventional
biopesticide
biopesticide
biopesticide
conventional
conventional
biopesticide
biopesticide
biopesticide
biopesticide
conventional
anti microbial
conventional
conventional
anti microbial
conventional
biopesticide
biopesticide
,;;;•>« ,'^lpg.
ornamental turf
all metalachlor uses
apples and pears
fruits and vegetables
cotton
field crops
vegetables/ornamentals
technical
wheat
field, fruit, and ornamental
cotton
technical
corn
cockroach control
turf
soybeans
home, gardens
technical
fruits and vegetables
turf
alfalfa
swimming pools
cotton, turf
soybeans
preservative
citrus
technical
com
RBWJCHIIUSI^S
yes
yes
yes
yes
yes
yes
yes
yes
no
no
no
yes
yes
yes
no
yes
yes
yes
yes
yes
no
n/a
yes
no
n/a
no
yes
yes
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FY 1997 OPP ANNUAL REPORT
PAGE 27
TABLE II
REGISTRATION OF SAFER CHEMICALS
The proportion of pesticide active ingredients that are considered to be safer (including
biological chemicals) than conventional chemical pesticides has steadily increased over the past
several years, as the chart below indicates.
40
35
o30
525
£20
215
210
«• 5
0
NUMBER OF PESTICIDE REGISTRATIONS
by Category
n
n. _n
84 85 86 87 88 89 90 91
YEAR
92 93 94 95 96 97
Category
Biologicals
Conventional Chemicals
Safer Chemicals
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FY 1997 OPP ANNUAL REPORT
PAGE 28
TABLE III
REGISTRATION DECISIONS VERSUS TARGETS IN FY 1997
The following table summarizes, by action, the number of decisions that were made in the Office
of Pesticide Programs verses the target, or goal that the program anticipated could be made. The
target numbers are determined by anticipating market influences and taking into account past
trends.
REGISTRATION
CATEGORY
Me-too's (Fast Track)1
Me-too's (Non-Fast Track)
Amendments (Fast Track)
Amendments (Non-Fast Track)
New Uses
New Active Ingredients
Experimental Use Permits
Tolerances
Temporary Tolerances
Inerts (non-active ingredients)
Section 18 Decisions
Section 18 Tolerances
Special Local Needs
Biotech Notification
TOTALS
OPP TOTAL
Targets
625
163
3100
141
104
21
66
67
40
33
398
0
235
3
4996
Decisions
589
352
3273
387
84
28
14
43
2
25
384
87
290
5
5564
'The term "me-too" product refers to a pesticide product that is identical or substantially similar
to another pesticide product that is currently registered by EPA.
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FY 1997 OPP ANNUM, REPORT
PAGE 29
FIGURE I
REREGISTRATION ELIGIBILITY DECISIONS (REDs) COMPLETED IN FY 1997
EPA presents the results of its reregistration reviews in Reregistration Eligibility Decision
(RED) documents. EPA has completed REDs for 171 cases (groups of related active
ingredients). Twenty-three of these REDs were completed during FY 1997. In addition, 231
cases have been canceled. Out of a universe of 612 reregistration cases, 402 cases (66%) have
completed the process, leaving 210 REDs (34%) to be completed by the year 2002.
cases completed
cases remaining
cases cancelled
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FY 1997 OPP ANNUAL REPORT PAGE 30
FIGURE II
PRODUCT REREGISTRATION STATUS
While REDs are OPP's major reregistration output, much of the real world impact of
eligibility decisions and risk reduction requirements does not occur until products are reregistered.
As of October 1997, OPP has reregistered 923 products, granted 1,818 voluntary cancellations,
amended 55 registrations, and suspended about 146 products. In addition, about 2,500
reregistration decisions are pending, and 1,148 of these products have recently entered this final
phase.
suspended £ pending
reregistration |j amendments
cancelled
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FY 1997 OPP ANNUAL REPORT
PAGE 31
TABLE IV
RISK REDUCTION THROUGH SPECIAL REVIEW
The following chart shows risk mitigation measures developed in FY 1997 through the
special review process.
FY 97 RISK REDUCTION THROUGH SPECIAL REVIEW BRANCH
Risk Mitigation
Measures
Use Reduction
Voluntary
Cancellation,
Some/ All Uses
Pre-Harvest Interval
Added
Special Packaging/
Engineering Controls
Stronger Use
Directions
Spray Drift Labeling
Environmental
Safeguards
Reduction of Risk to
Children
Other Special
Measures
Pesticide
Carbofuran
(Flowable)
Risks to
workers and
wildlife
X
X
X
X
X
Copper &
Zinc
Naphthenate
Malodorous
Off-Gassing
X
X
X
Iprodione
Dietary risk,
especially m
reaches
X
X
Methamido
-phos
Risks to
workers
X
X
Methyl Parathion
Organophosphate,
acute human
poisoning risks
X
X
X
Vinclozolin
Dietary and
residential
risks
X
X
X
-------
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Limit Amount, Frequency, Timing of Use
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Application Restrictions
Restricted Use Pesticide
Personal Protective Equipment/ Re-entry Interval
User Safety Requirements, Recommendations
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Ground or Surface Water Safeguards
Spray Drift Labeling
Other Environmental Safeguards
Ecological Safeguards
Other
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tn
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FY 1997 OPP ANNUAL REPORT
PAGE 34
FIGURE III
OUTCOME OF 6(A)(2) SUBMISSIONS
FIFRA Section 6(a)(2) requires registrants to notify OPP of any studies, incidents or
other information indicating adverse effects of registered pesticides. This information helps OPP
decide what action, if any, is necessary to reduce the risks posed by a particular pesticide.
Incidents. In FY 1997, the volume of reported incidents increased over the prior year.
OPP received approximately 1,800 submissions containing more than 12,000 incidents.
Studies. OPP screened 375 adverse effects submissions consisting of studies and
preliminary reports of possible adverse effects. About 15 percent of these submissions warranted
expedited review and are further tracked.
The outcome of expedited reviews since 1992 are as follows. About 40 percent will result,
or has resulted, in regulatory action (either immediate through label changes, or long-term
through re-registration eligibility decisions or special review), about 30 percent needed no action,
and about 27 percent are still being reviewed for possible regulatory action. Detailed information
regarding the screening decisions and outcome of submissions warranting expedited review is
available in the OPP Public Docket.
no action
other
label change
review initiated
REDs and SRs*
more data needed
* The risk issues
presented by these
data are addressed by
an upcoming
Reregistration
Eligibility Decision
(RED) or Special
Review.
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FY 1997 OPP ANNUAL REPORT
PAGE 35
TABLE VI
PESTICIDE ENVIRONMENTAL STEWARDSHIP PROGRAM
PARTNERS AND SUPPORTERS
EXISTING PARTNERS
American Corn Growers Association
American Electric Power Service Corp.
American Mosquito Control Association
American Nursery and Landscape Assoc.
Arizona Public Service
Atlantic Electric
California Citrus Research Board
California Pear Advisory Board
California Pear Growers
California Tomato Board
Carolina Power & Light
Cranberry Institute
Delmarva Power
Duke Power Company
Eastern Utilities
Edison Electric Institute
Florida Fruit & Vegetable Association
Global Integrated Pest Management
Golf Course Superintendents Association
Hawaii Agriculture Research Center
Hood River Grower-Shipper Association
Mint Industry Research Council
Monroe County School Corporation
National Potato Council
New England Vegetable & Berry Growers
New York State Gas & Electric
Northern Indiana Public Service
Corporation
Northwest Alfalfa Seed Grower Assoc.
New Oregon Wheat Growers League
Owen Specialty Services, Inc.
Pear Pest Management Research Fund
Pebble Beach Company
Pennsylvania Electric
Pennsylvania Power & Light
Pennsylvania Rural Electric Association
Pineapple Growers Association of Hawaii
Processed Tomato Foundation
Professional Lawn Care Association of
America
South Dakota Cattlemen's Association
Sun-Maid Growers of California
Tennessee Valley Authority
Texas Pest Management Association
U.S. Apple Association
U.S. Department of Defense
Utilicorp United
VA, MD & DE Association of Electric
Cooperative
Vegetation Managers, Inc.
West Virginia Power
Winter Pear Control Committee
Wisconsin Ginseng Growers Association
Wisconsin Public Service Corporation
EXISTING SUPPORTERS
Aqumix, Inc.
Bay Area Storm Water Management
Agencies
Campbell Soup Company
Del Monte
Farm*A*Syst / Home*A*Syst
Gempler's Inc
NEW PARTNERS
Almond Board of California
American Pest Management, Inc.
California Pistachio Commission
California Prune Board
Central Maine Power Company
Chevy Chase Village
City of Davis, CA
Delta Pest Control
Environ "Pest Elimination" Inc.
Filmore Citrus Protective District
Griggs County 319 Water Quality Project
Hawaiian Electric Company
Lodi-Woodbridge Wine Grape Comm.
Michigan Cherry Committee
New Orleans Mosquito Control Board
New York Berry Growers Association
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FY 1997 OPP ANNUAL REPORT PAGE 36
Northwest Alfalfa Seed Grower Assoc,
New Oregon Wheat Growers League
Owen Specialty Services, Inc.
Pacific Coast Producers
Pear Pest Management Research Fund
Pennsylvania Electric
Pennsylvania Power & Light
Pennsylvania Rural Electric Association
Pest Police Pest Control
Pineapple Growers Association of Hawaii
Planet Pest Products Corporation
Processed Tomato Foundation
Professional Lawn Care Association of
America
Redi National Pest Elimination
Reliable Pest Control
Sanitary Exterminating Co.
South Dakota Cattlemen's Association
South Texas Cotton and Grain Association
Sun-Maid Growers of California
Sunkist Growers
Tennessee Valley Authority
Texas Pest Management Association
U.S. Apple Association
U.S. Department of Defense
U.S. Public Health Service - CDC
University of Georgia
Utilicorp United
VA, MD & DE Association of Electric
Cooperative
Vegetation Managers, Inc.
West Virginia Power
Winter Pear Control Committee
Wisconsin Ginseng Growers Association
Wisconsin Public Service Corporation
NEW SUPPORTERS
Association of Applied Insect Ecologists
Audubon Cooperative Sanctuary System
-------
FY 1997 OPP ANNUAL REPORT PAGE 3 7
APPENDIX B
OPP DIVISIONS AND CONTACTS
Office of the Director
(703) 305-7090
Marcia Mulkey, Director
Stephen Johnson, Deputy Office Director
Responsible for overall management of the Office of Pesticide Programs.
Antimicrobials Division
(703)308-6411
Frank T. Sanders. Director
William Jordan, Associate Director
Responsible for all regulatory activities associated with antimicrobial pesticides, including
product registrations, amendments, and reregistrations.
Biological and Economic Analysis Division
(703) 308-8200
Sherri Sterling, Acting Division Director and Associate Director
Responsible for assessment of pesticide use and benefits: operation of analytical chemistry and
antimicrobial testing laboratories.
Biopesticides and Pollution Prevention Division
(703) 308-8712
Janet Andersen, Director
F. Kathleen Knox, Associate Director
Responsible for risk/benefit assessment and risk management functions for microbial pesticides;
tolerance reassessment; biochemical pesticides; plant pesticide and Pesticide Environmental
Stewardship Program.
Environmental Fate and Effects Division
(703) 305-7695
Joseph Merenda, Director
Denise Keehner, Associate Director
Responsible for evaluating and validating environmental data submitted on pesticide properties
and effects.
Field and External Affairs Division
(703) 305-7102
Anne Lindsay, Director
Jay Ellenberger, Associate Director
Responsible for program policies and regulations; legislation and Congressional interaction;
regional, state, and tribal coordination and assistance; international and field programs; and
communication and outreach activities.
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FY 1997 OPP ANNUAL REPORT PAGE 38
Health Effects Division
(703) 305-7351
Margaret Stasikowski, Director
Stephanie Irene, Associate Director
Randolph Perfetti, Associate Director
Responsible for reviewing and validating data on properties and effects of pesticides, as well as,
characterizing and assessing exposure and risks to humans and domestic animals.
Information Resources and Services Division
(703) 305-5440
Linda Travers, Director
Richard Schmitt, Associate Director
Responsible for information support; Public Docket; records computer support; FIFRA section
6(a) (2) issues; pesticide incident monitoring; and National Pesticides Telecommunications
Network,
Registration Division
(703) 305-5447
Jim Jones, Director
Peter Calkins, Associate Director
Responsible for product registrations, amendments, reregistrations, tolerances, experimental use
permits, and emergency exemptions for all pesticides not assigned to BPPD or AD.
Special Review and Reregistration Division
(703) 308-8000
Lois Rossi, Director
Jack Housenger, Associate Director
Responsible for Reregistration Eligibility Decisions (REDs), product reregistration; tolerance
reassessment; and Special Reviews.
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FY 1997 OPP ANNUAL REPORT
PAGE 39
APPENDIX C
EPA REGIONAL OFFICES
EPA Region 1
JFK Federal Building
Boston, MA 02203
Telephone: (617) 565-3420
Fax:(617)565-3415
EPA Region 2
2890 Woodbridge Ave
Edison, NJ 08837
Telephone: (212) 637-3000
Fax:(212)637-5046
EPA Region 3
841 Chesnut Building
Philadelphia, PA 19107
Telephone: (215) 566-5000
Fax:(215)566-5103
EPA Region 4
Atlanta Federal Center - 12th Floor
61 Forsyth Street, S.W.
Atlanta, GA 30303
Telephone (404) 562-9900
Fax:(404)562-8174
EPA Region 5
77 W. Jackson Blvd.
Chicago, II 60604
Telephone: (312) 353-2000
Fax:(312)353-1120
EPA Region 6
1445 Ross Ave
Dallas, TX 75202
Telephone: (214) 665-6444
Fax:(214)665-2146
EPA Region 7
726 Minnesota Ave
Kansas City, KS 66101
Telephone: (913) 551-7000
Fax:(913)551-7976
EPA Region 8
999 18th Street, Suite 500
Denver, CO 80202
Telephone: (303) 312-6312
Fax:(303)312-6363
EPA Region 9
75 Hawthorne Street
San Francisco, CA 94105
Telephone: (415) 744-1305
Fax:(415)744-1073
EPA Region 10
1200 Sixth A venue
Seattle, WA 98101
Telephone: (206) 553-0149
Fax: (206) 553-0163
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FY 1997 OPP ANNUAL REPORT PAGE 40
THIS PAGE INTENTIONALLY LEFT BLANK
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FY 1997 OPP ANNUAL REPORT
PAGE 41
APPENDIX D
LIST OF ACRONYMS
AD
ARS
BPPD
BEAD
CADDY
CDPR
CLI
DDT
EFED
EIIS
FDA
FEAD
FFDCA
FIFRA
FQPA
HED
IFCS
IPM
IRSD
LAN
NAFTA
NTIS
OECD
OPP
PDSL
PESP
PIC
POPs
PPDC
RD
RED
SRkD
USDA
WPS
Antimicrobials Division
Agricultural Research Service
Biopesticides and Pollution Prevention Division
Biological and Economic Analysis Division
Computer Aided Dossier and Data Supply
California Department of Pesticide Regulation
Consumer Labeling Initiative
Dichloro diphenyl trichloroethane (DDT)
Environmental Fate and Effects Division
Ecological Incident Information System
Food and Drug Administration
Field and External Affairs Division
Federal Food, Drug and Cosmetic Act
Federal Insecticide, Fungicide, and Rodenticide Act
Food Quality Protection Act
Health Effects Division
Intergovernmental Forum on Chemical Safety
Integrated Pest Management
Information Resources and Services Division
Local Area Network
North American Free Trade Agreement
National Technical Information Service
Organization for Economic Cooperation and Development
Office of Pestcide Programs
Pesticide Data Submitters List
Pesticide Environmental Stewardship Program
Prior Informed Consent
Persistent Organic Pollutants
Pesticide Program Dialogue Committee
Registration Division
Reregistration Eligibility Decision
Special Review and Reregistration Division
United States Department of Agriculture
Worker Protection Standard
-------
EPA REGIONAL OFFICES
PESTICIDES PROGRAM PHONE NUMBERS
REGION 1 (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island,
Vermont). Phone 617-565-3225 / Fax: 617-565-4940
REGION 2 (New Jersey, New York, Puerto Rico, Virgin Islands). Phone 732-
321-6765 / Fax: 732-321-4081
REGION 3 (Delaware, District of Columbia, Maryland, Pennsylvania, Virginia,
West Virginia). Phone 215-566-2111 / Fax:215-566-2124
REGION 4 (Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina,
South Carolina, Tennessee). Phone 404-562-8956 / Fax 404-562-8973
REGION 5 (Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin). Phone 312-
886-5220 / Fax 312-353-4788
REGION 6 (Arkansas, Louisiana, New Mexico, Oklahoma, Texas). Phone 214-
665-7240 / Fax 214-665-7263
REGION 7 (Iowa, Kansas, Missouri, Nebraska). Phone 913-551-7033 / Fax 913-
551-7165
REGION 8 (Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming).
Phone 303-312-6020 / Fax 303-312-6064
REGION 9 (Arizona, California, Hawaii, Nevada, American Samoa, Guam).
Phone 415-744-1087 / Fax 415-744-1073
REGION 10 (Alaska, Idaho, Oregon, Washington). Phone 206-553-1173 / Fax
206-553-1775
PESTICIDES AT A GLANCE
Number of Active Ingredients: 865
Number of Tolerances (maximum food residue limits): 9,500
Pounds of Al Used in U.S./Year: About one billion pounds of conventional
pesticide active ingredient are used each year. Including wood preservatives,
chlorine, and other disinfectants, approximately 4.5 billion pounds of active
ingredients are used each year
Total U.S. Pesticides Sales/Year: $9 billion
Number Certified Pesticide Applicators: 1.3 million
-------
FOR INFORMATION ON PESTICIDES
U.S. Environmental Protection Agency, Office of Pesticides Programs,
Communications Services Branch (703-305-5017) - Provides recent press
announcements and copies of non-technical brochures and fact sheets on
pesticide issues,
National Pesticides Telecommunications Network (800-858-7378 or
http://www.ace.orst.edu/info/nptn) - Provides general information about pesticides,
including toxicology. The network is available to anyone in the United States,
Puerto Rico, and the Virgin Islands (Open 7 Days a Week, 6:30 am to 4:30 pm
Pacific Time).
National Antimicrobial Information Network (800-447-6349 or Email
nain@ace.orst.edu) - Provides information on antimicrobials (Monday-Friday,
7:30am-4:30pm Pacific Time).
OPP Public Docket - Provides regulatory notices, background documents, and
public comments on OPP activities. The Docket is open to the public from 8:00
a.m. to 4:30 p.m., Monday through Friday, and is located in Room 119 of Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, Virginia (near the Crystal City
Metro station).
EPA Pesticide Registration Kits - (703-305-6549) To get the forms necessary to
apply for registration of a pesticide.
Pesticide Information Network (703-305-5919) - Provides current and historic
pesticide information, 24 hours a day, seven days a week.
Internet (http://www.epa.gov.) - Provides instant access to various fact sheets
for laypeople, Federal Register publications, Reregistration Eligibility Decisions
(REDs) and RED fact sheets, information on registrants from the Pesticide Data
Submitters List, company and product information from the Pesticide Product
Information System, and other documents.
-------
vvEPA
United States
Environmental Protection Agency
(7506C)
Washington, DC 20460
Official Business
Penalty for Private Use
$300
------- |