United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7506C)
EPA 735R96001
November 1996
Office of Pesticide Programs
Annual Report for 1996
Recycled/Recyclable « Printed with Vegetable Based Inks on Recycled Paper (20% Postconsumer)
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Foreword
I am particularly proud of the people in the Office of Pesticide Programs (OPP) this past year. They
continue to safeguard public health and the environment from pesticide risks while ensuring that pesticides are
regulated fairly and efficiently. In addition, OPP's partners in the regional offices, states and tribal pesticide
regulatory agencies play an important role in implementing and enforcing pesticide programs and policies.
OPP's Fiscal Year 1996 achievements are especially significant in that they were accomplished amidst a
government-wide shutdown, budget freezes, and the passage of a sweeping new law — The Food Quality
Protection Act of 1996. Moreover, the program continued extensive reinvention initiatives and planning efforts for
a major realignment.
OPP made over 6,000 regulatory decisions during the year, including the registration of 22 new active
ingredients and 27 Reregistration Eligibility Decisions. More than half of the newly registered active ingredients
are considered safer or reduced risk pesticides, continuing the trend over the past few years. While the new law
has undoubtedly affected the program's ability to make decisions on food-use chemicals and the shutdown and
budget crises meant fewer resources for the program, this record of solid achievement clearly reflects greater
efficiencies and a dedicated staff.
The new law, enacted August 3, 1996, and effective immediately, set in motion the creation of several
teams to deal with immediate policy and program implementation needs, as well as long term issues. A high-level
Food Safety Advisory Committee was established under the Federal Advisory Committee Act (FACA) to foster
improved communications and understanding among stakeholders and to help provide strategic direction to the
implementation efforts. In addition, a Pesticide Program Dialogue Committee was established under FACA this
past year to deal with long-term pesticide policy and program implementation issues. Examples of other
significant initiatives and accomplishments include: plans for a new Antimicrobial Division to reform and
expedite the registration of antimicrobial products with priority for those that have significant public health uses;
addition of more partners and supporters to the Pesticide Environmental Stewardship Program; deregulation of
low-risk active ingredients (e.g., garlic); continuous improvement and expanded outreach and training in the
Worker Protection program; and a redesigned Pesticides Program home page on the Internet.
The year ahead promises even greater challenges and opportunities as we implement the new law, realign
our program to meet the requirements of an Executive Order mandating a streamlined organizational structure,
and continue to deliver on our regulatory management obligations. The following pages provide a more in-depth
look at the complexity and accomplishments of OPP. I hope this report will serve as an important communication
and education tool and welcome your thoughts and recommendations on how we can improve it.
Daniel M. Barolo, Director
Office of Pesticide Programs
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Contents
Foreword
Page
Part I. The Office of Pesticide Programs: Meeting the Challenge 1
The Changing World of Pesticide Programs 3
New Legislation: The Food Quality Protection Act of 1996 4
Establishing the Antimicrobial Division 5
Endocrine Disrupters: Assessment and Analysis 6
Pesticide Program Dialogue Committee 6
Pesticide Publications and Information on the World Wide Web 7
International Partnerships 8
Safer Pesticides: Reducing Risks to Human Health and the Environment 11
Biopesticides and Pollution Prevention 12
Pesticide Environmental Stewardship Program (PESP) 13
Safer/Reduced Risk Pesticides 14
Negotiated Risk Mitigation in Special Reviews 14
Risk Reduction in Reregistration Eligibility Decisions (REDs) 14
Special Populations: New Initiatives to Ensure Protection of Children
and Agricultural Workers 15
Groundwater State Management Plans. 16
Continued Productivity Enhancements 19
Reinvention Initiatives to Enhance Productivity 20
Improving Customer Service 23
Continuing Strides in Agricultural Worker Protection and Applicator Training 23
Using Information Technology to Increase Access and Productivity 25
Part II. FY 1996 Accomplishments: Facts and Figures 27
Appendix A: OPP Organizational Structure and Contacts 41
Appendix B: How to Obtain More Information from OPP 43
Appendix C: List of Acronyms 45
Cover photographs by Strove Delaney, EPA
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FY1996 Annual Report
Pagel
Parti
The Office of Pesticide Programs: Meeting the Challenge
Introduction
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. This
is a challenging and complex undertaking.
Pesticides differ from other classes of chemicals
regulated by EPA because they are intentionally
applied, rather than byproducts of industry or
other human activity. Pesticide products and uses
are likely to be found in nearly every home and
business in the United States — from insect
repellents to weed killers to hospital disinfectants
to swimming pool chemicals — to name only a
few. They also are used in schools, parks, and
other public places.
The challenge for OPP, in carrying out its
responsibilities, is to consider both the risks
pesticides pose to human health and the
environment and the benefits they offer society.
Pesticides are useful because of their ability to kill
or control disease-causing organisms that threaten
humans, crops, ornamental and wild plants,
domestic animals, and wildlife. By their very
nature, however, most pesticides involve risks
because they are designed to be biologically active
and have a negative effect on living organisms.
OPP's programs and policies are
designed to meet the challenge of evaluating and
reducing pesticide risks and promoting safer
means of pest control. State and tribal agencies
and many other organizations, both public and
private, are vital partners in this effort. Quite
literally, pesticides and OPP's regulatory policies
touch every one who eats and breathes. Meeting
our challenge demands 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 1996 Annual Report
describes progress toward meeting these
challenges over the past year. Part I of the report
is organized according to three key themes
underlying OPP's work: (1) adapting to key
changes in our statutory framework, new scientific
developments, new technologies and increasing
global interdependence; (2) making significant
strides in reducing pesticide risks to health and the
environment; and (3) continuing progress in
increasing OPP productivity.
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Office of Pesticide Programs
Part n of the report presents the facts and
figures on Fiscal Year 1996 activities,
documenting measurable, concrete achievements
over the past year. Finally, the Appendices
provide details on how to obtain more information
and the organizational structure of OPP.
The World of Pesticide Programs at a Glance (figures are estimated and rounded-off)
Active Ingredients (AIs) 620 Pounds of AI used in U.S./Year 1 billion*
Registered Pesticide Products 20,000 U.S. Pesticide Sales/Year $9 billion
Tolerances (max. food residue limits) 9,000 Trained Farm Workers 2.5 million
Decisions/Year 6,000 Certified Pesticide Applicators 1.3 million
Publications Distributed/Year 400,000 Calls to the Pesticides Hotline/Year 20,000
* 1 billion pounds of conventional pesticides are used each year. Including wood preservatives and chlorine
and other disinfectants, approximately 4 billion pounds of pesticides are used each year.
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The Changing World of Pesticide Programs
Fiscal Year 1996 represented a year of
significant change for the Office of Pesticide
Programs. New legislation, new scientific
developments and technologies, Administration
initiatives to reinvent and streamline government,
and the increasing globalization of pesticide issues
have all spurred major changes in how OPP does
business.
* Landmark pesticide legislation, the Food
Quality Protection Act (FQPA), was signed by_
President Clinton on August 3. The new law
established a single consistent, health-based
standard for pesticide residues in food, with
particular emphasis on safety for infants and
children. Since many of the new statutory
requirements were effective immediately, OPP
initiated a major implementation effort that will
require the dedication of significant OPP staff and
"stakeholder" resources in the months ahead.
* Mechanisms for obtaining input from
major stakeholders and the public in implementing
the new law and improving OPP procedures
included public meetings of advisory bodies
focusing on strategic issues, consultation with
expert scientific advisory groups, and continued
reliance on the permanent Pesticide Program
Dialogue Committee chartered in FY'96. The
goal is to bring the expertise of all OPP
constituencies to bear on major program issues.
* Complementing the new legislation,
Administration initiatives to "reinvent"
government also led to significant changes and
productivity enhancements. OPP is creating two
new divisions, the Antimicrobial Division and the
Field and External Affairs Division, and is
streamlining management structures throughout
the program. The resulting structure will meet the
needs of the new law and the Administration goal
of more efficient and effective government
programs. (See Appendix A for an outline of the
planned new organizational structure.)
* Rising public and scientific concerns
about the possible effects of pesticides and other
man-made chemicals on the endocrine systems of
humans and other species led to the creation of
special initiatives to explore these issues further
and work toward the establishment of a
scientifically sound screening and testing program.
While OPP worked with other EPA offices and
public and private groups to begin this process
even before enactment of new legislation, the
FQPA contains ambitious new statutory deadlines
to expedite screening and testing of chemicals for
potential endocrine effects.
* Recognizing the importance of new
technologies in revolutionizing communications
and information dissemination, OPP continued
efforts to take advantage of the Internet and other
electronic mechanisms to help achieve program
goals.
* Promoting global environmental
protection and ensuring that international trade
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Office of Pesticide Programs
initiatives and agreements are consistent with the
high level of protection afforded by our pesticide
laws required OPP to intensify efforts to promote
the international "harmonization" of pesticide
standards. Greater harmonization will reduce
inconsistencies that raise both public and private
sector costs for data development and review, and
promote compliance with health and safety
standards.
Managing and enhancing the pesticide
regulatory system in this atmosphere of significant
change presents major challenges. The following
sections of this Chapter outline key initiatives
aimed at meeting these challenges and improving
public health and environmental protection for all
Americans and throughout the world.
New Legislation: The Food Quality Protection Act of 1996
EPA worked throughout the year to
secure the first major modernization of the
nation's pesticide/food safety laws in over 30
years. OPP prepared and reviewed proposed
legislation and participated in Congressional
hearings. The new Food Quality Protection Act
(FQPA) passed both the House of Representatives
and the Senate unanimously in late July and was
signed by the President on August 3,1996.
This landmark statute amends both major
pesticide laws: the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (FFDCA) in many
important ways. The most momentous reforms
include: setting a single health-based safety
standard for pesticide residues in food; providing
for Consumer Right-to-Know information at the
point of food purchasing decisions; and increasing
assurance that children and other sensitive
subpopulations are protected from pesticide risks.
The new law requires EPA to re-evaluate
over 9000 existing pesticide tolerances (maximum
food residue limits) within the next ten years to
ensure that all tolerances meet the stringent
standards of the FQPA. EPA also is charged with
establishing a registration renewal program for
updating pesticide registrations on a 15-year
cycle, to keep the safety data supporting
registrations up-to-date with current scientific
standards.
EPA takes great pride in its work to enact
the Food Quality Protection Act of 1996 with
broad bipartisan support. The new law will help
advance the scientific basis of risk assessment,
promote sound risk management decisions, and
ensure that the public is well protected into the
next century.
OPP has launched an ambitious initiative
to expedite implementation, including the
establishment of a new Food Safety Advisory
Committee to secure stakeholder input on strategic
issues and a number of implementation teams
focusing on key issues in the short term. We will
also rely on the continuing expertise of such
standing advisory groups as the FIFRA Scientific
Advisory Panel and the Pesticide Program
Dialogue Committee, along with other
mechanisms of obtaining public comment and
expert input.
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Establishing the Antimicrobial Division
As part of its overall streamlining efforts
and in response to the FQPA of 1996, OPP is
establishing a new Antimicrobial Division (AD) to
manage the registration and reregistration of non-
food use antimicrobial products. Division staff
will include health and environmental scientists
and risk assessors, as well as a core group of
registration and reregistration specialists. This
interdisciplinary approach will allow most
registration and reregistration activities to be
consolidated within a single division. The AD is
expected to be in place by early 1997.
Among the first priorities of the AD will
be implementing new requirements of the FQPA
that pertain to antimicrobial products. These new
provisions include establishing goals for review
periods for registration applications and the
development of new regulations clearly defining
antimicrobial pesticides, describing their use
patterns, and prescribing registration
requirements. EPA will also be considering how
to improve the cost-effectiveness of review
mechanisms and the potential for expanding self-
certification processes and notification procedures
(in lieu of pre-market approval) for some types of
actions.
The Division will report its progress each
year in an annual report. Another provision of the
FQPA exempts liquid chemical sterilants and
disinfectants used on medical devices from
regulation as pesticides and clearly places them
under the control of FDA, eliminating potentially
duplicative regulatory jurisdiction.
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Office of Pesticide Programs
Endocrine Disrupters: Assessment and Analysis
There is growing evidence that a number
of man-made chemicals may disrupt the endocrine
systems of wildlife and humans. These endocrine
or "hormone" disrupters may cause a variety of
reproductive, behavioral, and developmental
problems.
In FY1996 OPP collaborated with other
EPA offices to develop a report entitled
Environmental Endocrine Disruption: Effects
Assessment and Analysis Document. This
document provides an overview of the current
state of the science as it pertains to environmental
endocrine disruption, including the identification
of data gaps and high priority research needs to
improve our understanding of the potential for
pesticides and other chemicals to cause endocrine
Pesticide Program Dialogue Committee
A Pesticide Program Dialogue Committee
(PPDC) was established under the Federal
Advisory Committee Act in late 1995 and held its
first meeting in July 1996.
This committee was created as a forum
for a diverse group of representatives with a broad
range of interests and backgrounds to provide
feedback to the pesticide program regarding
regulatory, policy, and program implementation
issues. As such, the Committee's function is to
identify and evaluate proposed modifications to
current pesticide program policies and procedures
to reduce potential risks posed by pesticides,
and to facilitate the exchange of ideas and
information among stakeholders.
effects. The report articulates the Agency's
interim policy regarding its interpretation of the
existing data.
The Food Quality Protection Act (FQPA)
also focused on endocrine effects and mandated
work toward the expedited development of
screening and testing programs. EPA convened a
public meeting of experts to examine the issues
even before the new law was enacted, and has
formed a work group charged with implementing
the FQPA provisions. In FY 1997, EPA plans to
establish a formal advisory committee to aid in
these efforts.
Membership includes environmental and
public interest groups, pesticide industry, user and
commodity groups, public health and academic
institutions, federal and state government
agencies, etc. The first meeting was held in July
1996. Discussion focussed on the following
topics: endocrine disrupters; registration "fees for
service"; resistance management; and public
education and communications,. The Committee
intends to hold three or four meetings per year.
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Pesticides Publications and Information on the World Wide Web
EPA is steadily expanding its electronic
publishing via the Internet, and this past year
began phasing out older approaches in favor of
publishing on the World Wide Web. In FY 1996,
OPP redesigned its "home page" web site, giving
users a better guide to the information available
and a better idea of the work OPP does, hi order to
make Internet publication a standard part of
outreach and communication efforts, OPP
established a network of staff throughout the
program with responsibility for getting documents
onto the Internet.
OPP's web site is accessed from the EPA
home page address: www.epa.gov/internet. The
types of information available via Internet include
all Federal Register publications and press
announcements, reregistration eligibility decisions
(REDs), information on FQPA implementation
efforts, and fact sheets and publications of general
interest, such as the Citizen's Guide to Pest
Control and Pesticide Safety, OPP's Annual
Report, and the Catalog of OPP publications.
Comments and suggestions about the web site,
and what information OPP should post on the
Internet, can be sent to the following e-mail
address: eidoc.opp@epamail.epa.gov.
Two examples of the new information
made available via the Internet in FY 1996 include
the Pesticide Data Submitters List (PDSL) and
company, chemical, and product information
drawn from OPP's Pesticide Product Information
System. The PDSL is a compilation of names and
addresses of registrants who wish to be notified
and offered compensation for use of their data by
others seeking to market pesticide products. It
was developed to assist pesticide applicants in
fulfilling their obligations under FIFRA regarding
ownership of data used to support registration.
As a result of collaboration with the
California Department of Pesticide Regulation
(CDPR), the public can now access some of
OPP's Pesticide Product Information System.
From CPDR's web site, visitors can search this
database by company name, chemical name,
product name, EPA registration number, and
company numbers. Data are refreshed bi-weekly
by OPP staff. Visitors to OPP's web site will find
a link that will lead them to the CDPR site.
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Office of Pesticide Programs
International Partnerships
OPP's international partnerships aim to
develop common or compatible international
approaches to pesticide review, registration and
standard-setting. Partnerships with both
developed and developing countries allow 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 enhance
assurance that food imported into the U.S. is safe.
International partnerships can be grouped into
three broad categories: (1) policy, (2)
programmatic, and (3) capacity building.
Policy Coordination
By coordinating policies at global and
regional levels, governments seek international
harmonization on the sound management of
chemicals. InFY 1996, the Intergovernmental
Forum on Chemical Safety (IFCS) continued its
work to build international consensus on the need
to minimize use of twelve persistent organic
pollutants (POPs), which are mostly banned by
EPA but are still used in other countries. Action
will be taken on these findings and
recommendations early in 1997. IFCS also
shaped the negotiating process for turning 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.
OPP continued to provide support to the
work of the Codex Alimentarius Commission, a
joint program of the United Nations 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 own food safety
standards, and the U.S. is working to improve the
scientific basis and timeliness of Codex decisions,
as well as to boost public participation in
decision-making. OPP's work with Codex and in
World Trade Organization committees focused on
human, animal, and plant health protection
standards, is designed both to promote
harmonization and to ensure that international
agreements are consistent with the high level of
protection afforded by U.S. standards.
On a regional level, the North American
Free Trade Agreement (NAFTA) Commission on
Environmental Cooperation provided an important
forum for EPA's efforts to deal with persistent
organic pollutants. Canada, Mexico and the
United States developed draft plans to reduce the
use of DDT and chlordane throughout North
America. These pesticides, which are canceled in
the U.S. and Canada, continue to be used in
Mexico in its malaria control program (DDT) and
as a termiticide (chlordane). Residues are
persistent and may be transported long distances
in the atmosphere. These draft plans will serve as
models for global risk reduction efforts.
Programmatic Activities
Policy coordination sets the stage for
more concrete programmatic activities, based
upon agreed-upon priorities and scopes of work.
Through the Organization for Economic
Cooperation and Development (OECD) and the
North American Free Trade Agreement (NAFTA)
Technical Working Group on Pesticides, OPP
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FY1996 Annual Report
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made significant programmatic progress in FY
1996.
Organization for Economic Cooperation
and Development (OECD). Building upon work
by the European Union, OECD members are
working to develop harmonized procedures for
electronic data submission and documentation of
the reviews that support pesticide regulatory
decisions. Staff exchanges help scientists better
understand each other's approaches to pesticide
assessment and promote greater confidence in
harmonization.
FY 1996 also marked a year of significant
accomplishment in updating and harmonizing
pesticide testing guidelines with those of the
OECD. Final guidelines were issued on applicator
exposure and post-application exposure, microbial
and biochemical pest control agents, residue
chemistry, and physical chemistry. Additional
draft guidelines were prepared and are under
review.
Also through OECD, OPP worked toward
a,three year risk-reduction program (1997-1999),
harmonizing regulation of biocides (non-
agricultural pesticides), and the establishment by
the year 2000 of internationally harmonized
labeling. The U.S. is participating in an OECD
advisory group to develop proposals for a
common hazard classification scheme that
encompasses acute toxicity, reproductive effects,
cancer, serious chronic effects, mutagenic effects,
and aquatic toxicity.
The North American Free Trade
Agreement (NAFTA) Technical Working Group.
In 1996 Mexico became a full partner with
Canada and the U.S. in harmonization activities
through NAFTA. EPA is working with Mexico
and pesticide registrants to establish reciprocal
residue limits for pesticides used on peppers,
strawberries, and squash.
U.S.-Canada cooperation produced a
number of concrete advances: a bilateral
agreement regarding the protection and exchange
of confidential business information; a plan to
allow residue field trial data from one country to
be used by the other (a similar Mexican proposal
is pending.); work sharing to review certain data
on pheromones, microbial pesticides, and new
active ingredients; coordinated reviews and
decisions on three fungicides and the use of
Integrated Pest Management (IPM) techniques to
control late blight in potatoes; and the
establishment of harmonized residue limits for
several pesticides used on apples, potatoes,
canola, carrots, cranberries and oats.
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Office of Pesticide Programs
Capacity-Building Activities
To achieve global environmental
protection goals, it is essential to work with
developing countries to assist them in building
their capacity to regulate pesticides and manage
chemical production, distribution, use, and
disposal. In cooperation with other U.S. and
international agencies, OPP initiated a number of
significant activities in FY1996.
One major achievement was the
development of a training course on the
management and disposal of obsolete pesticides in
developing countries. This course will be given
first in a Central American country in early 1997.
Consistent with resources available from
U.S. and international donor organizations, OPP
also provides technical assistance on a bilateral
and regional basis to build capacity in developing
countries. For example, in FY 1996, EPA began
work with the Indonesian Ministry of Agriculture
on improving the regulation of pesticides in
Indonesia. This partnership will form the basis for
a regional pesticide information network to be
shared by seven Asian countries. EPA also
initiated a partnership with the Japanese National
Institute of Health Sciences to improve global
access to international sources of pesticide data
and OPP data bases.
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Safer Pesticides: Reducing Risks to Human Health
and the Environment
Over one billion tons of pesticide products
are used each year in the United States. New, safer
products are replacing older, more traditional
pesticides on the farm, as well as in the backyard.
A challenge for the Office of Pesticide Programs is
to ensure that pest control and pesticide use become
increasingly safer each year.
To meet this challenge, OPP is promoting
safer pesticides and a pollution prevention ethic,
creating public-private partnerships to reduce
pesticide use and risk, and implementing risk-
reduction through negotiated agreements, Special
Review, and Reregistration Eligibility Decisions
(REDs). Special emphasis is placed on potentially
at-risk populations, including infants and children
and agricultural workers. Many of these efforts
have been given added impetus as a result of the
Food Quality Protection Act, which specifically
directed EPA to expedite safer pesticides and
incorporate additional factors into pesticide
assessments. OPP also is intensifying its efforts to
educate pesticide users on the availability of
alternative means of pest control, and on how to
minimize pesticide risks to themselves and the
environment
A common thread running through many of
OPP's initiatives to reduce pesticide use and risks is
facilitating the development and adoption of
Integrated Pest Management (IPM) strategies.
IPM seeks to reduce the use of pesticides by taking
advantage of all available alternative pest
management options, substituting mechanical,
physical, or biological pest controls for chemical
controls whenever possible. IPM also promotes the
adoption of safer, less environmentally persistent
pesticides. More toxic pesticides are applied only
as a last resort.
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Office of Pesticide Programs
Biopesticides and Pollution Prevention
In FY 1996, OPP established a permanent,
interdisciplinary Biopesticides and Pollution
Prevention Division (BPPD), after evaluating
BPPD's success as a pilot division in speeding
review of safer, biological pesticides.
Biopesticides include microbial pesticides (bacteria,
viruses, or other microorganisms used to control
pests) and biochemical pesticides, such as
phcromones (insect mating attractants), insect or
plant growth regulators, and hormones used as
pesticides. Biopesticides generally pose less risk to
human health and the environment than
conventional chemical pesticides, because they are
quite specific to the target pest.
During 1996, ten new biopesticides and
associated products were registered. An example of
one such biopesticide is a nematicide that can
replace some uses of methyl bromide, a highly toxic
broad-spectrum conventional pesticide scheduled
for phase-out under the Clean Air Act due to its
potential to deplete stratospheric ozone.
Modern biotechnology has enabled the
production of new plant-pesticides, for example,
new types of agricultural plants that have been
altered to produce proteins toxic to insects that
destroy crops. In FY 1996, EPA registered com
and cotton plant-pesticides. Such plant-pesticides
reduce the need for conventional pesticide
applications, thereby reducing production costs as
well as risks to workers and non-target insects,
since only insects feeding on the crop are affected.
Pollution prevention is accomplished by
reducing reliance on toxic broad spectrum
pesticides. As IPM programs are more widely
adopted, farmers and homeowners will be less
dependent on the use of conventional pesticides to
control disease and insect outbreaks. The use of
biopesticides and the incorporation of IPM
programs and other risk reduction measures is the
basis of EPA's Pesticide Environmental
Stewardship Program (PESP), as described in the
following section.
Phcromonc pesticides are used to attract the
spincd soldier bug, here seen feeding on a
Mexican bean beetle larva, one of the most
damaging soybean insect pests.
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Making A Difference Through Partnerships: The Pesticide Environmental Stewardship
Program
The Pesticide Environmental Stewardship
Program (PESP) was launched in December 1994.
PESP is a voluntary program that forms
partnerships with pesticide users to reduce health
and environmental risk and implement pollution
prevention strategies.
There are two categories of membership in
PESP, "Partner" and "Supporter." Partners are
agricultural producer organizations and other
pesticide users who agree to devise and implement
risk reduction strategies. Supporters include
organizations that, while they are not pesticide users
themselves, exert significant influence on pesticide
use (for example, food processing companies who
negotiate pesticide use restrictions in contracts with
their suppliers). All PESP participants make a
commitment to reduce pesticide risk and develop a
strategy to achieve risk reduction goals. For a
complete list of Partners and Supporters, see Part II,
Page 40 of this report.
PESP partners and supporters are making a
difference. For example, PESP participants in the
Mint Industry Research Council are reducing risks
through a number of innovative techniques,
including reducing the spread of insect pests by
promoting the use of disease-free rootstocks to
establish new fields. Other PESP partners, such as
the New England Vegetable and Berry Growers
Association, are developing IPM standards and
certification programs. The U.S. Department of
Defense has made a commitment to develop
alternative pest control strategies to reduce its
pesticide use by 50% by the year 2000.
Through PESP, EPA also funds small "seed
money" grants to partners and other organizations
to foster the development and implementation of
pollution prevention/risk reduction strategies. Eight
PESP partner grants were awarded in FY 1996
through the National IPM Foundation for
Education, and 14 EPA regional grants were
awarded to support original research and promote
IPM and PESP goals. Additional projects were
supported through partnerships with the U.S.
Department of Agriculture's "Agriculture in
Concert for the Environment" program.
For more information on PESP, please call
the PESP Infoline at 1-800-972-7717.
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Office of Pesticide Programs
Safer/Reduced Risk Pesticides
In 1993, EPA launched a new initiative to
expedite the review of lower risk pesticides.
Under this program, OPP gives priority review to
pesticides that satisfy criteria as likely to meet
pest control needs and present lower risks to
human health and the environment.
Since 1993, OPP has received 26 reduced
risk pesticide applications. Of these, eight have
been registered, with an average review time of 14
months, compared to 38 months for most
conventional pesticides. Ten applications have
been denied, and three are currently pending
registration. (Reduced risk pesticides registered in
FY1996 are listed in Part H, Table I.) EPA is in
the process of expanding its reduced risk initiative
to include not only new pesticide active
ingredients, but also new, safer uses of already-
registered reduced risk pesticides.
The Food Quality Protection Act of 1996
explicitly mandates the continuation and
enhancement of EPA's reduced risk pesticide
initiative. The new law requires OPP to expedite
review of new registrations and registration
amendments that may reasonably be expected to
reduce the risks of pesticides to human health or
nontarget organisms; reduce the potential for
contamination of groundwater, surface water, or
other valued resources; or broaden the availability,
adoption, or effectiveness of integrated pest
management strategies. FQPA implementation
will integrate these considerations into OPP's
registration priority program.
Negotiated Risk Mitigation in Special Reviews
OPP continued to use negotiated
agreements to expedite the reduction of pesticide
risks in FY 1996. Following are three examples
of the kinds of agreements achieved.
Cyanazine: In FY 1995, as the result of OPP's
Special Review investigation into the potential
cancer risks of cyanazihe and other triazine
compounds (atrazine and simazine),. registrants
agreed to implement worker protection safeguards
and phase-out cyanazine sales and use by 1999.
Based on these actions, EPA terminated its
Special Review of cyanazine in July 1996.
Special review of the other triazines is continuing.
Propargite: Based on studies showing that this
miticidc causes tumors in laboratory rats and
residue data indicating unacceptable dietary risks
to consumers, propargite registrants agreed to
eliminate use on ten fruit and vegetable crops.
These use deletions reduce risk to a negligible
level and became effective in August 1996.
Molinate: hi FY 1996, OPP successfully
negotiated risk reduction measures for the rice
herbicide molinate, based on concerns about
reproductive risks to workers. The agreement
requires more protective equipment (including
chemical-resistant gloves, respirators, and
coveralls) and handling systems that reduce
exposure during loading. Additional studies have
been required and may result in further
restrictions.
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FY1996 Annual Report
Page 15
Risk Reduction in Reregistration Eligibility Decisions (REDs)
Many older pesticides were first
registered before today's stringent testing and
safety standards were in place. In 1988, Congress
required EPA to undertake a comprehensive
reregistration review of all pesticides first
registered before November, 1984, to ensure that
they meet current standards. Reregistration
Eligibility Decisions (REDs) summarize the
findings of OPP's reregistration review of these
older chemicals. (REDs completed in FY 1996 are
listed in Part H, Table III.)
Nearly all REDs include some provisions
to reduce risks to pesticide handlers, the public, or
the environment. Among the 27 REDs completed
by OPP in Fiscal Year 1996, the following are two
examples of the kind of significant and innovative
risk reduction measures being implemented
through reregistration.
Coumaphos (pre-FQPA): An insecticide used on
cattle, goats, horses, sheep, and swine, coumaphos
is known primarily for its use by the Department
of Agriculture (USDA) in dip vats located along
the U.S./Mexico border, to control ticks that carry
Texas Cattle Fever. EPA has been concerned
about risks to pesticide handlers, wildlife,
groundwater, and other ecosystem effects.
Disposal of spent solution from these vats has
been a long-standing environmental problem.
Thanks to a new bioremediation method
developed by USDA's Agricultural Research
Service (ARS) and supported by the registrant, the
risks associated with disposal of coumaphos waste
are being effectively mitigated. The
bioremediation process developed by ARS uses
bacteria naturally present in dip vats to detoxify
the waste. In the RED, EPA is requiring this
process, or, as a second choice, the use of lined
pits for spent dip vat solutions. To reduce risks to
handlers of coumaphos, the RED establishes
baseline protective equipment requirements.
Other packaging and labeling requirements will
lower risks to handlers, birds, and aquatic
invertebrates.
Bromacil (post-FQPA): Based on the data
required in reregistration, EPA was concerned
about the effects of bromacil on pesticide
handlers. A herbicide used on citrus and
pineapple crops and for a variety of non-food
uses, bromacil causes thyroid, adrenal, and thymus
effects and is classified as a possible human
carcinogen. Bromacil also has been detected in
groundwater and may pose risks to birds, reptiles,
and mammals. EPA's reregistration decision
document for bromacil reduces application rates
by over 50%, from a maximum rate of 32 pounds
to 12 pounds per acre. To reduce risks to workers,
the RED requires additional protective equipment,
including chemical resistant gloves, and restricts
the number of acres that may be treated in one
day. Additional label warnings to reduce potential
contamination of water resources and exposure of
nontarget organisms are also required by the RED.
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Office of Pesticide Programs
Special Populations: New Initiatives to Ensure Protection of Children and
Agricultural Workers
Infants and Children
The Food Quality Protection Act of 1996
(FQPA) emphasizes the need to ensure protection
of potentially sensitive or highly-exposed
populations from pesticide risks, including infants
and children. This issue will be a high priority for
FQPA implementation. OPP currently analyzes
food consumption and residue data to assess risks
for more than twenty subpopulations, based on
age, gender, ethnicity, and region.
In response to the 1993 National
Academy of Sciences Report on Pesticides in the
Diets of Infants and Children, the Agency
continued to upgrade its testing requirements and
analytical capabilities in FY 1996, including the
issuance of a new policy for acute dietary
exposure assessment.
Preparations also were made to
determine the need for additional uncertainty or
"safety" (margin of exposure) factors to protect
children and the usefulness of in utero testing to
detect possible effects of pesticide exposure "in
the womb." These were presented to the FIFRA
Scientific Advisory Panel in early FY 1997.
The new law mandates improved data
collection efforts to support EPA decision-
making. The quality and timeliness of the data
supporting OPP's pesticide risk assessments
remain of some concern in terms of dietary
consumption patterns and actual residue levels.
EPA will be working with the Departments of
Agriculture and Health and Human Services and
others to improve the quality of these data.
Agricultural Workers
EPA also continued to focus on
pesticides that appear to pose the greatest risks
to agricultural workers, using data from the
State of California and the Americain
Association of Poison Control Centers. These
efforts resulted in the cancellation of all uses of
mevinphos in FY 1995. In FY 1996, successful
risk mitigation measures were negotiated for the
pesticide methomyl, including reduced
application rates, more precautionary label
language, longer re-entry intervals after
applications, and deletion of uses that accounted
for disproportionate numbers of poisonings.
EPA is continuing to work with registrants of
carbofuran and methamidiphos to reduce worker
risks.
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FY1996 Annual Report
Page 17
Future Partnerships: Groundwater State Management Plans
OPP laid the foundation for a new
approach to groundwater protection in FY 1996,
issuing a proposed groundwater protection rule
based on the adoption of State Management
Plans (SMPs). The proposed regulation focused
on five pesticides frequently found in ground
water as initial SMP candidates. The SMP
approach is based on the notion that states are
knowledgeable and equal partners in designing
and implementing risk-reduction measures for
pesticides in ground water.
Groundwater SMPs will join an array
of national measures to reduce the risks to
humans from contaminated ground water. EPA
expects to issue a final SMP rule in FY 1997.
.. -J
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FY1996 Annual Report
Page 19
Continued Productivity Enhancements
Despite two prolonged government
closings during the winter and new responsibilities
following the passage of the FQPA in the summer,
FY 1996 marked another highly productive year.
The Office of Pesticide Programs registered 22
new pesticide active ingredients, more than half of
which are considered reduced risk pesticides.
These decisions include the approval of twelve
new chemicals, including three reduced risk
chemicals, and ten biopesticides. Overall, there
were over 5,000 individual decisions concerning
pesticide registrations.
OPP completed 27 Reregistration
Eligibility Decisions (REDs), many of which
included significant measures to reduce pesticide
risks to human health and the environment. In
addition, the Office met its target of completing
10 Special Review decisions in FY 1996.
More detail on these achievements is
contained in Part II of this report. Wile these
figures are lower than FY 1995's record high
number of new active ingredients and REDs
completed, they compare favorably with the
program's historical levels of activity and reflect in
part the need to adjust program policies to
implement the new law. FY 1997 is expected to
be a transitional year as new policies and
procedures are implemented in a reorganized OPP.
FY 1996 also was characterized by
continued "reinvention" efforts designed to
streamline processes, build partnerships, and
increase automation in ways that enable OPP to be
more responsive and productive.
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Page 20
Office of Pesticide Programs
Reinvention Initiatives to Enhance Productivity
The Office of Pesticide Programs initiated
many new projects aimed at reinventing registration
and reregistration processes to provide services faster,
smarter and more efficiently, resulting in benefits to
registrants and the public. In fact, OPP was
recognized for its success in simplifying the process of
registering pesticide products when it received the
prestigious "Hammer" Award from Vice President Al
Gore's National Performance Review.
Streamlining Registration Reviews, Self-
Certification and Exemptions
A number of important productivity gains
\vcrc achieved in the registration program in FY 1996.
Highlights included:
* OPP significantly expanded the categories of
low risk, minor pesticide registration
amendments that may be accomplished
without waiting for formal EPA review and
approval (self-certification) and created an
accelerated process for Agency review of
minor formulation changes.
* A final rule exempted 31 active ingredients (in
71 products) under FIFRA Section 25(b)
because of their low risk. The exempted
products included many common food
ingredients, such as garlic. They will no
longer be regulated under FIFRA when they
are used alone or in combination with inert
ingredients that EPA has found to be safe.
* OPP also made great strides in expediting the
review of the approximately 900 acute
toxicity data submissions received each year,
bringing the backlog down from 400 to nearly
zero and reducing review times from 30
months to 4 months.
* Working with the California Department of
Pesticide Regulation, EPA launched "work-
sharing" programs for simple registration
amendments and acute toxicity data. These
activities aim to avoid unnecessary
duplication of work by California and EPA
and significantly shorten review times. EPA
saved considerable resources by sharing the
acute toxicity review workload with California
(30 reviews in FY 96).
* A parallel review of a new pesticide active
ingredient, tebufenozide, was conducted by
EPA and Canada. The goal was to identify,
through a real example, the similarities and
differences between the Canadian and U.S.
pesticide regulatory systems. Based on this
cooperative review experience, EPA and
Canada are exploring work-sharing
opportunities under the NAFTA Technical
Working Group, as described in Chapter 1.
Other internal efficiencies resulted from the
continued activities of the Product Manager
Automation Team (PMAT). PMAT helped implement
electronic time-accounting for OPP staff, improving
accuracy and reducing error rates. The group also
enhanced staff performance by creating easily
accessible templates and standard language for use in
registration notices, fact sheets, and other frequently
used forms and documents.
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FY1996 Annual Report
Page 21
In the coming fiscal year, OPP expects to
build on these achievements. The Agency will explore
and seek public comment on additional opportunities
for self-certification of, for example, product
chemistry data. EPA also is collecting data on why
applications for "me-too" products are found to be
deficient, following the example of the successful
rejection rate analyses performed in the reregistration
program. ("Me-too" pesticides include registration
applications and amendments that do not require data
review and are identical or substantially similar to
existing registered products in composition and
labeling.) Once this analysis is complete, OPP will
consider options for self-certification of "me-too"
products.
Finally, OPP is considering proposing
additional exemptions under FIFRA Section 25 (b) to
deregulate low risk chemicals and/or uses, such as
antimicrobial products that claim only to eliminate
odor-causing bacteria.
Reregistration and Special Review
RED Document Improvement. As part of a
continuing effort to improve the format, content, and
readability of RED documents, an OPP team
developed and began piloting a user-friendly version
of portions of the standard RED package. Others
revised the RED document format and language to
reflect the new FQPA provisions. Efforts to more
clearly communicate worker protection aspects of our
decisions are underway.
Special Review and Reregistration Division
Peer.Review Committee. This committee, comprised
of both managers and staff, continued to review draft
RED documents and Special Review Position
Documents, considering cross-cutting policy and
regulatory questions to ensure greater clarity and
consistency.
State and Regional Review ofREDs. OPP
began an initiative to include States and EPA Regional
Offices in the review of some draft REDs in order to
make the best possible use of their expertise and
interests, especially their familiarity with local
pesticide use.
Coalition on Drift Minimization. OPP began
participating in this new government/industry/user
effort to identify and implement measures to reduce
off-target spray drift through education, research, and
regulatory means.
Improving Pesticide Labels and Labeling
Procedures
Clear and effective product labeling is critical
to protecting the public from pesticide risks. No other
pesticide document or publication has a more direct
impact on reducing risks, preventing pollution, and
promoting safer use. OPP took several steps to
improve both the labels themselves and the processes
for their review and approval.
Consumer Labeling Initiative (CLI). The
goal of the CLI, launched on March 22, 1996, is to
foster pollution prevention, empower consumer
choice, and improve consumer understanding
through clear, consistent and useful environmental,
health, and safety information on household
consumer product labels.
The project is coordinated by a joint task
force consisting of representatives from EPA, Food
and Drug Administration (FDA), Consumer Product
Safety Commission, Federal Trade Commission, and
certain states. It also features partnerships with
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Page 22
Office of Pesticide Programs
interested companies and trade organizations. In FY
1996, CLI activities focused on qualitative research
to improve our understanding of labeling issues and
the development of a report and recommendations to
Administrator Carol Browner.
Labeling Coordination. OPP issued a draft
notice that would establish an annual compliance date
for implementing most OPP-mandated labeling
changes. The notice also described the Labeling
Unit's role in coordinating labeling issues and related
streamlining efforts. EPA is currently reviewing the
comments received on the notice. In another effort
to improve coordination and consistency in labeling
policy, the Agency also began work to update the
Label Review Manual, first issued in December
1994. A second edition should be available in early
FY 1997.
Improving Accessibility and Updating
Labeling Technology OPP converted its microfiche
collection of pesticide product labels to compact disk
format. The labels on compact disk, searchable by
registration number and EPA company number, will
be available to the public via the National Technical
Information Service (NTIS). The collection will be
updated quarterly to reflect newly registered products
as well as label changes.
EPA also continued to maintain and post its
electronic "on-line" Labeling Policy Directory on
OPP's LAN. A listing of new documents is being
sent to interested outside parties on a regular basis,
and specific documents are made available upon
request. Finally, EPA initiated a limited pilot project
to test the electronic submission and review of labels.
Forming Partnerships to Monitor Ecological Incidents
OPP worked with other federal and state
agencies and industry to develop the Fish and Wildlife
Incident Monitoring Protocol. If accepted by the
American Society of Testing and Materials, the
protocol will be published and distributed world-wide
to improve the rate and quality of incident reporting.
OPP's Ecological Incident Information System (EIIS),
which can be used to assess the ecological impacts of
pesticides, is now available to the public on the World
Wide Web. The address is:
www.epa.gov/indicator/county/pest/pest.html.
Improving Customer Service
The Office of Pesticide Programs (OPP) is
committed to improving the quality of service we
provide to a broad spectrum of customers. We are
improving communication with our customers, and we
arc enhancing our understanding of their needs and
circumstances.
To assess current services, OPP conducted a
series of baseline customer surveys. The surveys
targeted the following groups: pesticide registrants;
producers and formulators; environmental and public
interest groups; the general public; and EPA regional
offices and states. ( The surveys by no means covered
the entire spectrum of diverse customers affected by
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FY1996 Annual Report
Page 23
pesticide regulatory and implementation issues, and
OPP continues to assess customer satisfaction via
other mechanisms, including stakeholder meetings and
the Pesticide Program Dialogue Committee.) The
information gained from these surveys assisted OPP in
drafting new customer service standards. The
Employee Advisory Group is developing a plan to
implement customer service standards across OPP in
1997.
In addition, OPP worked closely with OPPT
to complete the OPPTS Community Based
Environmental Protection Tools Catalogue, which
was distributed to Regional Offices to review and use.
Designed to provide more effective cooperation with
our partners in protecting human and ecological
communities, this catalogue improves access to
OPP's technical expertise, analytical tools, and data
bases.
Continuing Strides in Agricultural Worker Protection and Applicator Training
Implementing The 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 to notify them when
pesticides are applied. Employers also must provide
washing supplies if workers are likely to come into
contact with pesticides, and provide and maintain
protective equipment. Effective implementation of the
WPS will substantially lower the risk of pesticide
poisonings among agricultural workers and pesticide
handlers.
To date, roughly 2.5 million agricultural
workers have been trained. OPP created or funded the
distribution of over 1 million compliance manuals for
growers; nearly 3 million safety training booklets;
700,000 safely posters; 20,000 safety training videos;
and 8,000 grower compliance video/slide sets. OPP
also implemented a voluntary program to verify
completion of WPS training.
hi FY 1996, OPP conducted nine public
meetings and 30 field site visits in major agricultural
areas across the country (Florida, Mississippi,
Washington, Texas, California, Pennsylvania,
Missouri, and Indiana). Information from these
meetings and site visits will be used to develop
strategies to improve WPS administration.
OPP also continued to modify WPS
requirements to increase flexibility and remove
unnecessary restrictions, issuing two proposed and
two final regulation changes in the past fiscal year.
Expanding efforts to reach diverse audiences more
effectively, OPP worked with the Hispanic Radio
Network in FY 1996 to develop and broadcast ten
WPS safety information programs, reaching 120
market areas nationwide.
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Page 24
Office of Pesticide Programs
Certification And Training Of Pesticide Applicators
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 by states, territories, and tribes 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 1995, the most recent year for which
figures arc 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.
In 1996, OPP continued to work to revise its
national standards to ensure the continued competence
of certified applicators. To assist state, territory and
tribal governments in conducting certification
programs, OPP funded 64 cooperative agreements and
provided support to state extension coordinators
through USDA. Other activities included "train-the-
trainer" and pesticide applicator training workshops,
development of training materials for improving
pesticide drift management and application
technology, and assessing behavioral and attitudinal
changes in applicators as a result of certification and
training programs.
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FY1996 Annual Report
Page 25
Using Information Technology to Increase Access and Productivity
A key to increased productivity is the
adoption of new computer technologies that allow
OPP to respond faster to customer needs and improve
both internal and external communication. Our
increasing use of the World Wide Web, as described in
Chapter 1, reflects OPP's commitment to these goals.
OPP is working with regulated industry to
facilitate the electronic submission of pesticide
registration documents and information. In the course
of its investigations, OPP learned of a system called
Computer Aided Dossier and Data Supply (CADDY)
under development by the European Commission and
the European pesticide industry. CADDY will rely
initially on CD-ROM technology for submission of
pesticide information to member countries. OPP is
developing partnerships wititi Europe in the
development and use of CADDY. In the long run,
international harmonization of requirements,
expectations and submission formats will benefit
EPA, the private sector, and the public.
OPP is also standardizing electronic formats
for some of the data in registration submissions in
order to facilitate analysis by OPP scientific reviewers.
The Office is moving more of its major data systems
to the OPP local area network (LAN) to provide staff
with more convenient access. In addition, OPP has
adopted compact disk format as the archival medium
for all studies, replacing microfiche.
In the future, OPP is planning to establish.a
Computer Resource Center to help keep OPP staff
abreast of the latest technology. The center will
consist of a fully equipped classroom for hands-on
formal training and a room housing unusual or
specialty software and equipment. In addition, a loan
center will allow staff to borrow equipment, manuals,
and training materials.
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FY1996 Annual Report
Page 27
Part II
FY 1996 Accomplishments: Facts and Figures
Index of Tables and Figures
Table I
Table II
Figure I
Table III
Table IV
Table V
Figure II
Figure IE
Figure IV
Table VI
Figure V
Figure VI
Table VH
New Pesticide Active Ingredients Registered in FY 1996
Registration Decisions vs. Targets in FY 1996
Status of Original Reregistration Cases
Reregistration Eligibility Decisions (REDs) Completed in FY 1996
Amount of Pesticide Usage Covered by REDs Completed through FY 1996
Risk Reduction Achieved Through FY 1996 REDs
Review Status of List A Pesticides
Product Reregistration Status for 149 REDs Completed as of October 1, 1996
Special Review Decisions vs. Targets in FY 1996
Risk Reduction and Data Gathering through Special Review in FY 1996
OPP Laboratory Accomplishments (FY 1993 - FY 1996)
Outcome of 6(a)(2) Submissions Warranting Expedited Review
Pesticde Environmental Stewardship Program (PESP) Partners and Supporters
Page
28
30
31
31
32
33
34
35
36
37
38
39
40
New Pesticide Registrations
In FY 1996, OPP registered 22 new pesticide active ingredients, more than half of which are considered
reduced-risk pesticides. These decisions include the approval often biopesticides and twelve new chemicals, which
include three reduced risk, chemicals. The table on the following pages lists active ingredients for which decisions
were made (and two where applications were withdrawn) in Fiscal Year 1996.
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Office of Pesticide Programs
Table I. New Pesticide Active Ingredients Registered in FY1996
Pesticide Name
Potassium
Permanganate
Butancthiol
Aztec
Sumilar
Maxim
Cadre
Mefcnoxam
Fipronil
Cidex
Upbeet
Proincxal
Registrant
Cams Chemical
Company
Bear Country
Products
Bayer Corp
Sumitomo
Chem Co.JLtd
Ciba-Geigy Corp.
American
Cyanamid
Ciba-Geigy
Rhone-Poulenc AG
Johnson &
Johnson, Inc.
DuPont
Zeneca Ag
Products
Pesticide Type
Disinfectant
Repellent
Insecticide
Miticide
Insecticide
Miticide
Fungicide
Herbicide
Fungicide
Insecticide
Miticide
Disinfectant
Herbicide
Miticide
Fungicide
Use(s)
Manufacturing
Use Only
Recreational Areas
Corn
Farm animals, dogs, cats,
non-food/feed storage
areas
Corn & Sorghum
Peanuts
Fruits, nuts and melons
Turf, dogs, cats, golf
course turf
Farm animals, pests,
poultry, egg handling
equipment, pulp & paper
mills
Sugar Beets
Preservative used in
adhesives, coatings, paints,
resin emulsions,
metalworking cutting
fluids.
Biopesticide or
Reduced Risk
Pesticide?
No
No
No
No
Yes(RR)
Yes(RR)
Yes(RR)
No
No
No
No
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FY1996 Annual Report
Page 29
Pesticide Name
Busanll04
Bt Cotton
l-octen-3-ol
Jojoba oil
Oil of Melaleuca
Bt (CRYMAX)
Myrethecium
verrucaria
(killed
fermentation
solids and
solubles of)
Meat meal
Red pepper
Verticillium
lecanii
NKBtcorn
Monsanto Bt
corn
Lavandin Oil
Registrant
Buckman
Labs
Monsanto
Armatron
IJO Products
Turtle Apiary
Laboratory
Ecogen, Inc.
Abbott Laboratories
Lakeshore
Enterprises
Lakeshore
Enterprises
Abbott Laboratories
Northrup King
Monsanto
S.C. Johnson &
Sons
Pesticide Type
Microbiocide
Plant Pesticide
Mosquito Attractant
Insecticide
Miticide
Insecticide
Nematicide
Repellent
Repellent
Insecticide
Plant pesticide
Plant pesticide
Repellent
Use(s)
Preservative used in
adhesives, coatings, paints,
resin emulsions
Cotton
Non-food
All terrestrial food crops
(Application
Withdrawn)
All terrestrial food crops
All terrestrial food crops
and ornamentals
Deer, rabbits and raccoons
Deer, rabbits and raccoons
(Application withdrawn)
Field com
Corn (field, sweet and
pop)~seed increase only
Moths
Biopesticide or
Reduced Risk
Pesticide?
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
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Office of Pesticide Programs
Table II. Registration Decisions vs. Targets in FY 1996
CATEGORY
Old Chemicals
(Fast Track)
Old Chemicals
(Non-Fast Track)
Amendments
(Fast Track)
Amendments
(Non-Fast Track)
New Uses
New Chemicals
Experimental UsePermits
(EUPs)
Tolerances
Temporary Tolerances
Inerts
Emergency Exemptions
(Section 18s)
Special Local Needs
(24c)
Rifrtcch Tsfotificfltion
TOTALS
DESCRIPTION
application for a new product containing an
active ingredient (AI) contained in a
currently registered product; requires no data
review
application for a new product containing an
AI in a currently registered product; requires
data review
application to change an existing registration
(e.g., formula or labelling); requires no data
application to change an existing registration;
requires data review
application for registration of a use not
currently included in the registration
application for registration of a product
containing an AI not contained in a currently
registered product
permit required to conduct field trials
(residue tests) to support the registration of a
newAI
Safe pesticide residue level allowed on food
Tolerance for a pesticide under an EUP;
must be established if the crop will be eaten
approval of toxicology data for new inert
ingredients to be used in pesticide products
approval of a State's request to use an
unregistered pesticide when no registered
product is available
approval of a State's request for a specific
use that is not currently registered
special EUP for a biolotrical cesticide
TARGET
DECISIONS
595
85
2,150
215
50
24
123
65
36
13
247
390
5
3,998
FINAL
DECISIONS
701
200
3,104
154
117
24
85
106
35
38
452
373
5
5,394
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FY1996 Annual Report
Page 31
Reregistration Progress
Overall Status of Reregistration
Of the 614 reregistration cases ! (representing 1,138 active ingredients or AIs) that were eligible for
reregistration in 1988,232 are no longer supported (they have been suspended and/or voluntarily canceled).
Reregistration Eligibility Decisions (REDs) have been completed 2 for 148 ~ almost 40% -- of the 382 remaining
cases. The 27 REDs competed in FY 1996 are listed below in Table III.
Figure I. Status of Original Reregistration Cases
614
Original
Cases
148
134.
M#re
To Go
382
Cases
232
Unsupported
Cases
Table III. Reregistration Eligibility Decisions (REDs) Completed in FY 1996
Amitrole
Bacillus Popilliae
Bromacil*
Cloprop
Colletotrichum gloeosporioides*
Coumaphos
Cryolite
Desmedipham
Dibromodicyanobutane (DBDCB)
4,4-Dimethyloxazolidine
Furanone or Tanol Derivatives
Gibberellic Acid
Hydroxyethyl Octyl Sulfide
Hydroxypropyl methanethiosulfonate
Mepiquat Chloride*
Methylisothiazolinone
(MitinFF
Norflurazon
Oil of Pennyroyal
p-Chloro-m-cresol
Paraquat Bichloride*
Phosphamidon
Polyhedral Inclusion Bodies (NPV)*
S-Kinoprene*
Strychnine
Tridecenyl Acetates
Virelure*
1 This number, originally 611 cases, rose to 614 when several active ingredients were separated to become individual cases.
2 The 148 completed REDs include some cases voluntarily canceled as a result of the reregistration review.
* Indicates RED was issued after August 3,1996, under the provisions of the FQPA.
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Page 32
Office of Pesticide Programs
Pesticide Usage Covered by REDs
The 148 REDs completed through the end of FY 1996 represent about 60% of the 4.2 billion pounds of
pesticide active ingredients used annually in the United States. A significant portion of this volume is represented by
chlorine, hypochlorites (bleach), pine oil, sulfur, petroleum oil, aliphatic alcohols, and coal tar/creosote.
REDs account for 30% of the remaining 1.6 billion pounds of conventional pesticides, antimicrobials, and
wood preservatives used each year in the U.S. Looking at these conventional pesticides by market segment,
completed REDs cover an estimated 33% of the consumer-applied pesticides, almost 24% of pesticides used in
agriculture, and about 35% of pesticides applied by commercial applicators for residential and commercial pest
control. This year's usage estimates are more accurate than previous years' because they are based on better data --
more categories of pesticides and data bases, and more recent and complete data.
Table IV. Amount of Pesticide Usage (by Volume) Covered by REDs Completed through FY 1996*
i
TVDB of Pesticide
Antimicrobials/
JAIgicides
Biologicals
Fungicides
Herbicides/Growth
Regulators
Insecticides/Fumi-
gants/Nematicides
Repellents
Rodenticldes/
Molluscicides
Wood
Preservatives
TOTAL
Consumer Applied
100%
100%
1 %
24%
12%
1 %
65%
0%
33%
Aqricultural Use
3%
0%
6%
37%
>1 %
n/a
0%
0%
24%
Commercial Use
57%
24%
3%
30%
14%
14%
18%
0%
35%
Total Percent
60%
28%
5%
36%
4%
2%
18%
0%
30%
* Excludes pine oil, chlorine, sodium, and calcium hypochlorites (bleach), aliphatic alcohol, sulfur, petroleum oil, and coal
tar/crcosotc. RED's completed account for 78% of-these large volume pesticides. Also, pounds used may not indicate the
relative percent of area treated or number of applications.
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FY1996 Annual Report
Page 33
Risk Reduction Achieved Through FY 1996 REDs
The REDs completed in FY 1996 include many changes intended to reduce risks to human health and the
environment. Some of the risk reduction measures achieved in these 27 REDs are summarized below.
Table V. Risk Reduction Achieved Through FY 1996 REDs
Number of REDs
6
8
3
20
11
21
16
6
4
9
14
11
Risk Reduction Measures Required by REDs
Voluntary Cancellation and/or Deletion of all or certain registrations, uses, or
formulations. Includes Amitrole (voluntary cancellation of liquid formulation and
deletion of ornamental plant nursery stock uses); Bacillus popilliae (all uses
voluntarily canceled); Cloprop (all uses voluntarily canceled); Oil of Pennyroyal
(last product voluntarily canceled); Paraquat Dichloride (some use patterns
deleted); and Phosphamidon (all uses voluntarily canceled)
Use Reduction.
Restricted Use Pesticide classification added or maintained, so that the pesticide may
be used only by or under the direct supervision of a certified applicator.
Personal Protective Equipment (PPE) requirements for pesticide handlers
strengthened or confirmed.
Restricted Entry Intervals (REIs) limiting entry of workers into treated areas
strengthened or confirmed.
Use Limits, Application Restrictions, Use Directions or Precautions added,
strengthened, or made more specific.
User Safety Requirements or Recommendations added.
Special Packaging or Engineering Controls required.
Ground Water or Surface Water Safeguards required.
Spray Drift Labeling required.
Other Environmental Safeguards required to reduce ecological risk.
Tolerances reassessed (reduced revoked or newlv aooroved^
For more detailed information on the risk reduction measures achieved from each of the individual REDs completed
in FY 1996, please refer to the Pesticide Registration Progress Report for FY 1996.
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Page 34
Office of Pesticide Programs
Status of Studies Received
Registrants have responded to Data Call In's and other requirements by submitting over 21,000 studies in
support of reregistration. By the end of FY 1996, OPP had reviewed over 14,500 of these studies, including more
than 8,000 of the over 10,000 studies received for List A pesticides (the most significant and/or food use pesticides).
The numbers of studies received, reviewed, and awaiting review by scientific discipline are shown below for the List
A pesticides.
Figure II. Review Status of List A Pesticides
Number of Studies Received, Reviewed, and Awaiting Review
3500
3000
2500
Number of Studies Received
Number of Studies Reviewed
Number of Studies Awaiting Review
Environmental Fate
Ecological Effects
Residue Chemistry
Re-Entry Non-Dietary
ToxCort"
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FY1996 Annual Report
Page 35
Product Reregistration
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 1996, about 2,500 products
have completed this concluding phase. OPP has reregistered over 900 of these products, granted about 1,450
voluntary cancellations, amended 44 registrations, and suspended about 150 products. In addition, about 1,300
reregistration decisions are pending, and 1,370 products have recently entered this final phase.
Figure III. Product Reregistration Status
for 148 REDs Completed as of October 1, 1996
158 Suspended
906 Reregistered
44 Amendments
13D5 Pending'
1459 Cancelled
* An additional 1371 products are covered by REDs issued since August 1995, for which a product reregistration
decision is not yet due under, FIFRA.
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Page 36
Office of Pesticide Programs
Special Review
OPP completed a total of 10 Special Review decisions during FY 1996, meeting its target for the fiscal year.
Figure IV. Special Review Decisions vs. Targets in FY 1996
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
O Special Reviews Scheduled H Special Reviews Completed
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FY1996 Annual Report
Page 37
Risk Reduction Achieved Through Special Review
The following Special Review activities have resulted in risk reduction through label amendments, or provide
information to OPP allowing the refinement of risk assessments to determine the need for further exposure reduction.
Table VI. Risk Reduction and Data Gathering through Special Review in FY 1996
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Page 38
Office of Pesticide Programs
OPP Laboratory Accomplishments
Food Tolerance Method Validations (TMVs)
In order for FDA, USDA and the states to take appropriate regulatory action when residues exceed that which
has been established by federal and state agencies, reliable chemical methods of analyses are required. Although the
pesticide registrants are responsible for developing such methods, EPA determines if the methods are suitable for
monitoring the nation's food supply. The Analytical Chemistry Lab, located in Beltsville, Maryland, is responsible
for validating these methods. In FY 1996 the total number of TMVs completed at the laboratory increased by 66%
from FY 1995. Of those, 27% of the TMVs were new uses of existing pesticides.
Environmental Chemistry Methods Validations (ECMs)
The Environmental Chemistry Laboratory in Mississippi determines the reliability and validity of pesticide
soil and water residue methods. The environmental chemistry mthods (ECM) are used by the EPA regions and states
to identify inadvertent pesticide residues in soil and water contaminated sites as well as being used for pesticide
monitoring studies. There was a 26% increase in ECM validations completed in FY 1996 compared to last year's
accomplishments.
Product Chemistry Method Validation (PCMs)
The Analytical Chemistry Laboratory in Beltsville, Maryland, periodically tests the composition of pesticide
products. This testing is known as product chemistry method (PCM) validation. The lab completed 27% more PCM
validations in FY 1996 than it completed last year.
120
Figure V. OPP Laboratory Accomplishments
FY93
FY94
FY95
TMVs
Legend
1 ECMs
FY96
PCMs
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FY1996 Annual Report
Page 39
Pesticide Adverse Effects Reporting
FIFRA Section 6(a)(2) requires registrants to report to OPP any studies, incidents, or other information
indicating new 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 1996, the volume of reported incidents increased over the prior year. OPP received approximately
1500 submissions containing more than 9,200 incidents.
Studies. OPP screened over 400 adverse effects submissions consisting of studies and preliminary reports of possible
adverse effects. Detailed information regarding the screening decisions and outcome of submissions warranting
expedited review is available in the OPP Public Docket.
Figure VI. Outcome of 6(a)(2) Submissions
Warranting Expedited Review
No Action 30%
More Data 14%
RED'S SSR's* 15%
Other 3%
Label Change 15%
Review Initiated 23%
* The risk issues presented by these data are addressed by an upcoming Reregistration Eligibility Decision (RED) or
Special Review.
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Page 40
Office of Pesticide Programs
Pesticide Environmental Stewardship Program (PESP)
Table VII. PESP Partners and Supporters
Partners
American Association of Nurserymen
American Corn Growers Association
American Electric Power (AEP) Service Corporation
American Mosquito Control Association (AMCA)
Arizona Public Service
Atlantic Electric
California Citrus Research Board
California Pear Advisory Board
California Pear Growers
California Tomato Board
Carolina Power & Light
Cranberry Institute
Dclmarva Power
Duke Power Company
Eastern Utilities
Edison Electric Institute
Florida Fruit & Vegetable Association
Global Integrated Pest Management
Golf Course Superintendents Association of America
Hawaii Agricultural Research Council
Hood River Grower-Shipper Association
Mint Industry Research Council
Monroe County School Corporation
National Potato Council
New England Vegetable & Berry Growers Association
New Orleans Mosquito Control Board
New York State Gas & Electric
Northern Indiana Public Service Company
Northwest Alfalfa Seed Growers Association
Orcgon-Washington-California Pear Bureau
Oregon Wheat Growers League
Owen Speciality 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
Sun-Maid Growers of California
South Dakota Cattelmen's Association
Tennessee Valley Authority
Texas Pest Management Association
U.S. Apple Association (International Apple Institute)
U.S. Department of Defense
U.S. Public Health Service, Centers for Disease Control and
Prevention
Utilicorp United
VA, MD, DE Association of Electric Cooperatives
Vegetation Managers, Inc.
West Virginia Power
Wisconsin Ginseng Growers Association
Wisconsin Public Service Corporation
Supporters
Aqumix, Inc.
Bay Area Stormwater Management Agencies Association
Campbell Soup Company
Del Monte
Farm*A*Syst/Home*A*Syst National Office
Gempler's, Inc.
General Mills, Inc.
Gerber Products Company
Glades Crop Care, Inc.
United States Golf Association
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FT 1996 Annual Report
Page 41
Appendix A. OPP Organization and Contacts
As part of its overall commitment to reinvention, the Office of Pesticide Programs (OPP) is
"flattening" its organizational structure. This reorganization will reduce the number of layers of supervision
and improve accountability for program performance. OPP is creating a new Antimicrobial Division, with
the full range of functions needed to assess and regulate antimicrobial pesticides; merging the existing Policy
and Special Projects Staff with the current Field Operations Division in a new Field and External Affairs
Division; consolidating resources management functions in the immediate staff of the Office Director; and
consolidating information management functions in a new Information Resources and Services Division. The
general responsibilities of OPP's remaining divisions will change little, but structural changes below the
division level will greatly increase reliance on interdisciplinary review groups. The new alignment will be in
place early in calendar 1997. Below is a summary of division responsibilities in the new structure. OPP
staff contacts follow.
Field and External Affairs Division (FEAD)
Program policies and regulations; legislation and Congressional interaction; International, Regional,
State, and Tribal coordination and assistance; general food safety issues; ground water activities;
publications and communications; endangered species; worker protection; certification and training
Information Resources and Services Division (IJRSD)
Information support; Public Docket; records; computer support; FIFRA Section 6(a)(2) issues;
pesticide incident monitoring, National Pesticides Telecommunications Network (NPTN)
Biological and Economic Analysis Division (BEAD)
Assessment of pesticide use and benefits; operation of analytical chemistry and antimicrobial testing
laboratories
Biopesticides and Pollution Prevention Division (BPPD)
Risk/benefit assessment and risk management functions for microbial pesticides, biochemical
pesticides, and plant-pesticides; Pesticide Environmental Stewardship Program (PESP)
Antimicrobial Division (AD)
Risk/benefit assessment and risk management for antimicrobial pesticides
Registration Division (RD)
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 (SRRD)
Reregistration Eligibility Decisions (REDs); Special Reviews
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Page 42
Office of Pesticide Programs
Environmental Fate and Effects Division (EFED)
Environmental hazard, exposure, and risk assessments
Health Effects Division (HED)
Human hazard, exposure, and risk assessments
Key OPP Management Contacts
(All telephone
Immediate Office
Fax: 308-4776
Biological and Economic Analysis Division
Fax: 308-8091
Biopestieides and Pollution Prevention
Division
Fax: 308-7026
Environmental Fate and Effects Division
Fax: 305-6309
Health Effects Division
Fax: 305-5147
Information Resources and Services
Division
Fax: 308-5984
Registration Division
Fax: 305-6920
Special Review and Reregistration Division
Fax: 308-8005
Field and External Affairs Division
(under development) Fax: 305-6244
Antimicrobial Division
(under development)
Daniel M. Barolo, Director
Penelope Fenner-Crisp, Deputy Director
Allen L. Jennings, Director
Janet L. Andersen, Acting Director
Joseph Merenda, Director
Margaret Stasikowski, Director
Linda Travers, Director
Stephen L. Johnson, Dkector
Lois A. Rossi, Director
Anne E. Lindsay, Dkector
Frank T. Sanders, Director
area codes are 703)
305-7090
305-7092
308-8200
308-8712
305-7695
305-7351
305-5440
305-5447
308-8000
305-7102
305-5440
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FY1996 Annual Report Page 43
Appendix B. How to Obtain More Information
The Office of Pesticide Programs (OPP) wishes to provide timely and consistent information to the
public. For additional information on subjects discussed in this report or other topics, the following sources
are available to you.
How to Obtain Information from EPA's Office of Pesticide Programs (EPA 735-F-96-004)
This document, which was last updated in July 1996, provides general guidance for obtaining a
variety of OPP records and publications. It provides key information and contacts for many
resources available to the public (including Pesticide Dockets, Freedom of Information Act, the
pesticide hotline, and on-line databases). Lists of OPP program contacts are included to help direct
public requests regarding specific chemicals or policy issues. It can be obtained from
Communications Branch (7506C)
Office of Pesticide Programs, U.S. EPA
401M Street, S.W.
Washington, D.C. 20460
(703-305-5017)
Communications Branch
Recent press announcements and copies of non-technical brochures and fact sheets on pesticide
issues can be obtained from the Communications Branch, as listed above.
OPP Public Docket
OPP's docket houses the 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 1132 of Crystal Mall #2,1921 Jefferson Davis Highway, Arlington, Virginia
(near the Crystal City metro station); telephone 703-305-5805.
Catalog of OPP Publications And Other Information Media (EPA 730-B-95-001)
Last updated in June 1995, this catalogue provides a listing of hundreds of pesticide publications,
including science chapters and facts sheets. It is available from EPA's Public Information Center,
401 M Street, S.W., Washington, DC 20460 (Telephone 202-260-2080); or the National Center for
Environmental Publications and Information (NCEPI), P.O. Box 42419, Cincinnati, OH 45242-2419
(Telephone 1-800-490-9198 or 513-891-6561; Fax 513-891-6685).
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Page 44
Office of Pesticide Programs
National Pesticides Telecommunications Network (NPTN)
Accessible by a toll-free telephone number, NPTN provides general information about pesticides.
The network is available to anyone in the United States, Puerto Rico, and the Virgin Islands (Monday
- Friday, 6:30 a.m. to 4:30 Pacific Time) at 1-800-858-7378.
Pesticide Information Network (PIN)
The PIN is an interactive database system containing current and historic pesticide information. It is
free and operational 24 hours a day, seven days a week. It can be reached via modem and
communications software at 703-305-5919.
OPPHome Page on the World Wide Web
OPP's web site is accessed from the EPA home page address: http://www.epa.gov.
The following information is available: Federal Register publications, reregistration eligibility
decisions (REDs), information on registrants from the Pesticide Data Submitters List, company and
product information from the Pesticide Product Information System, information, on Food Quality
Protection Act implementation efforts, and fact sheets and publications of general interest, such as
the Citizen's Guide to Pest Control and Pesticide Safety and this report.
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FT 1996 Annual Report
Page 45
Appendix C. List of Acronyms
AD
ARS
BBPD
CADDY
CDPR
CLI
DDT
EIIS
FDA
FIFRA
FEAD
FFDCA
FQPA
IFCS
IPM
LAN
NAFTA
NTIS
OECD
OPP
PDSL
PESP
PIC
POPs
PPDC
REDs
USDA
WPS
Antimicrobial Division
Agricultural Research Service
Biopesticides and Pollution Prevention Division
Computer Aided Dossier and Data Supply
California Department of Pesticide Regulation
Consumer Labeling Initiative
Dichloro diphenyl trichloroethane (DDT)
Ecological Incident Information System
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Field and External Affairs Division
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Intergovernmental Forum on Chemical
Safety
Integrated Pest Management
Local Area Network
North American Free Trade Agreement
National Technical Information Service
Organization for Economic Cooperation and Development
Office of Pesticide Programs
Pesticide Data Submitters List
Pesticide Environmental Stewardship Program
Prior Informed Consent
Persistent Organic Pollutants
Pesticide Program Dialogue Committee
Reregistration Eligibility Decisions
United States Department of Agriculture
Worker Protection Standard
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