United States
    Environmental Protection
Prevention, Pesticides
And Toxic Substances
EPA 735R96001
November 1996
     Office of Pesticide  Programs
     Annual  Report for 1996
Recycled/Recyclable  Printed with Vegetable Based Inks on Recycled Paper (20% Postconsumer)



        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



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


FY1996 Annual Report
  The Office of Pesticide Programs: Meeting the Challenge

        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

        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.

Page 2
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.

FT 1996 Annual Report
             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

 *       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

*      Promoting global environmental
protection and ensuring that international trade

Page 4
                     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
       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

       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.

FY1996 Annual Report
                                        Page 5
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

        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.

Page 6
                     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

        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.

FY1996 Annual Report
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.

                     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

        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

FY1996 Annual Report
                                        Page 9
made significant programmatic progress in FY

        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

        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

        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.

Page 10
                     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.

FY1996 Annual Report
                                   Page 11
       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
       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.

Page 12
                    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.

FY1996 Annual Report
                                       Page 13
Making A Difference Through Partnerships: The Pesticide Environmental Stewardship
        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.

Pago 14
                     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

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

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.

Page 16
                     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

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


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.

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.

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"

        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

        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

        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

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:
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
        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

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
        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
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

        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.

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.

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.


 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
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.

Page 28
Office of Pesticide Programs
                    Table I. New Pesticide Active Ingredients Registered in FY1996
Pesticide Name
Cams Chemical
Bear Country
Bayer Corp
Chem Co.JLtd
Ciba-Geigy Corp.
Rhone-Poulenc AG
Johnson &
Johnson, Inc.
Zeneca Ag
Pesticide Type
Use Only
Recreational Areas
Farm animals, dogs, cats,
non-food/feed storage
Corn & Sorghum
Fruits, nuts and melons
Turf, dogs, cats, golf
course turf
Farm animals, pests,
poultry, egg handling
equipment, pulp & paper
Sugar Beets
Preservative used in
adhesives, coatings, paints,
resin emulsions,
metalworking cutting
Biopesticide or
Reduced Risk

FY1996 Annual Report
Page 29
Pesticide Name
Bt Cotton
Jojoba oil
Oil of Melaleuca
solids and
solubles of)
Meat meal
Red pepper
Monsanto Bt
Lavandin Oil
IJO Products
Turtle Apiary
Ecogen, Inc.
Abbott Laboratories
Abbott Laboratories
Northrup King
S.C. Johnson &
Pesticide Type
Plant Pesticide
Mosquito Attractant
Plant pesticide
Plant pesticide
Preservative used in
adhesives, coatings, paints,
resin emulsions
All terrestrial food crops
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
Biopesticide or
Reduced Risk

Page 30
Office of Pesticide Programs
                       Table II. Registration Decisions vs. Targets in FY 1996
Old Chemicals
(Fast Track)
Old Chemicals
(Non-Fast Track)
(Fast Track)
(Non-Fast Track)
New Uses
New Chemicals
Experimental UsePermits
Temporary Tolerances
Emergency Exemptions
(Section 18s)
Special Local Needs
Rifrtcch Tsfotificfltion
application for a new product containing an
active ingredient (AI) contained in a
currently registered product; requires no data
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
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


 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
            To Go
                Table III. Reregistration Eligibility Decisions (REDs) Completed in FY 1996
Bacillus Popilliae
Colletotrichum gloeosporioides*
Dibromodicyanobutane (DBDCB)
 Furanone or Tanol Derivatives
 Gibberellic Acid
 Hydroxyethyl Octyl Sulfide
 Hydroxypropyl methanethiosulfonate
 Mepiquat Chloride*
Oil of Pennyroyal
Paraquat Bichloride*
Polyhedral Inclusion Bodies (NPV)*
Tridecenyl Acetates
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.

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*
TVDB of Pesticide
Consumer Applied
1 %
1 %
Aqricultural Use
>1 %
Commercial Use
Total Percent
 * 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.

 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
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.

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
                      Number of Studies Received
                      Number of Studies Reviewed
                      Number of Studies Awaiting Review
                       Environmental Fate
                                              Ecological Effects
        Residue Chemistry
Re-Entry Non-Dietary

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.

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

 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

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.
                           Figure V. OPP Laboratory Accomplishments
                                                 1  ECMs

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.

Page 40
                      Office of Pesticide Programs
Pesticide Environmental Stewardship Program (PESP)
                                 Table VII. PESP Partners and Supporters
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
Utilicorp United
VA, MD, DE Association of Electric Cooperatives
Vegetation Managers, Inc.
West Virginia Power
Wisconsin Ginseng Growers Association
Wisconsin Public Service Corporation

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

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
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

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
Fax: 308-7026
Environmental Fate and Effects Division
Fax: 305-6309
Health Effects Division
Fax: 305-5147
Information Resources and Services
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)

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

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).

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.

FT 1996 Annual Report
                                           Page 45
                      Appendix C.  List of Acronyms

 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
 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