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United States Environmental Protection Agency Office of Pesticide Programs

Office of Pesticide Programs Annual Report for 1995

Publication Number: EPA 730-R-95-002
Date: December 1995
    
    ABSTRACT:      This Annual Report describes many of the efforts
    
                   and accomplishments of EPA's Office of Pesticide
    
                   Programs (OPP) during fiscal year 1995 (October 1,
    
                   1994 to September 30, 1995).
    
    
    
    NOTE:          The following electronic version does not contain
    
                   the full graphics of the original version. 
    
                   Information on obtaining a paper version
    
                   containing full graphics is provided in
    
                   the "Availability" section below.
    
    
    
    ORIGINATOR:    Environmental Protection Agency
    
                   Office of Pesticide Programs (7506C)
    
                   401 M Street, SW
    
                   Washington, DC 20460
    
    
    
    AVAILABILITY:  A limited number of paper copies are available
    
                   free of charge from the Communications Branch,
    
                   Office of Pesticide Programs, telephone 703-305-
    
                   5017 or fax 703-305-5558.
    
    
    
    FOR FURTHER INFORMATION:
    
    
    
                   For more information about this and other
    
                   pesticide publications, please contact:
    
    
    
                        Communications Branch (7506C)
    
                        Office of Pesticide Programs 
    
                        Environmental Protection Agency
    
                        401 M Street, SW
    
                        Washington, DC 20460
    
                        Ph:   703-305-5017
    
                        Fax:  703-305-5558
    
    
    
    ---------------------------------------------------------------
    
    
    
    
    
    
    
    U.S. Environmental Protection Agency
    
    Prevention, Pesticides and Toxic Substances (7506C)
    
    Publication Number: EPA 730-R-95-002
    
    December 1995
    
    
    
           Office of Pesticide Programs Annual Report for 1995
    
    
    
    
    
    
    
    
    
                                Foreword
    
    
    
         EPA's Office of Pesticide Programs (OPP) is making
    
    significant progress in carrying out its important
    
    responsibilities -- safeguarding public health and the
    
    environment from pesticide risks, and ensuring that pesticides
    
    are regulated fairly and efficiently. OPP's Fiscal Year 1995
    
    achievements are especially noteworthy as they were accomplished
    
    while the program was engaged in extensive reinvention
    
    initiatives, planning for a major realignment, and responding to
    
    pressures and concerns about impending budget actions.
    
    
    
         This was a banner year for both the registration and
    
    reregistration programs, with 40 new active ingredients
    
    registered and 40 Reregistration Eligibility Decisions (REDs)
    
    issued. To put these numbers in perspective, consider that
    
    historically, only about a dozen new active ingredients were
    
    registered annually. Dramatic improvements began to show in FY
    
    1994, when 30 new active ingredients were registered. The upward
    
    trend continued in FY 1995, with a record-breaking 40 new
    
    registrations accomplished. Impressively, well over half of the
    
    new registrations during the past two years are for "safer" or
    
    reduced risk products, many with lower use rates than
    
    conventional pesticides, and 35 are biopesticides. 
    
    
    
         During FY 95, the timeliness of EPA registration decisions
    
    improved substantially. Historically, it has taken on average
    
    four to six years to register a new pesticide. During the past
    
    year, average processing times were reduced as follows: reduced
    
    risk pesticides (8-16 months); biopesticides (3-16 months); and
    
    all other new active ingredients (3-52 months).
    
    
    
         OPP also accelerated its reregistration program for older
    
    pesticides, reaching its planned annual goal of 40 REDs in FY 95,
    
    for a grand total of 121 REDs. Combined with last year's total of
    
    34 REDs, this means an impressive 74 reregistration decisions --
    
    two-thirds of all REDs issued -- were accomplished in the last
    
    two years. These decisions were made following OPP's
    
    comprehensive review of literally thousands of scientific studies
    
    on the potential effects of pesticides and their fate in the
    
    environment. Based on this review, EPA took action to reduce
    
    pesticide risks by imposing many new requirements and
    
    restrictions as conditions of reregistration. While much work
    
    remains to be done, including REDs for many major pesticides with
    
    food-related uses, less than half of the original universe of
    
    older pesticides remain in the pipeline for review.
    
    
    
         Beyond the registration and reregistration programs, EPA
    
    implemented a number of other initiatives to protect public
    
    health and the environment. OPP worked to serve all of its
    
    customers by responding to requests for information and managing
    
    the distribution of hundreds of thousands of EPA-produced
    
    documents that help ensure safer pesticide practices in the home,
    
    in schools, in agriculture, and in industrial settings. Notably,
    
    the Worker Protection Standard became fully effective in 1995.
    
    This standard ensures that over three million agricultural
    
    workers have the training and equipment they need to protect
    
    themselves from pesticide risks on the job. At the same time, EPA
    
    continues to work to refine its rules to ensure appropriate
    
    flexibility in implementation, and to focus resources on true
    
    public health and environmental problems, by streamlining and
    
    "deregulating" wherever possible and establishing new alliances,
    
    such as the Pesticide Environmental Stewardship Program.
    
    
    
         A talented team of dedicated employees from across all OPP
    
    divisions made these accomplishments possible. In addition, EPA's
    
    partners in the regional offices and state and tribal pesticide
    
    regulatory agencies continue to play a key role in implementing
    
    and enforcing pesticide programs and policies. This Foreword
    
    highlights only a few of OPP's positive achievements over the
    
    past year. Others are described more fully in the following
    
    pages. The goal of the Annual Report is to provide a public
    
    accounting of our work for all of our constituencies. I hope that
    
    it will serve an important function in communicating the depth
    
    and breadth of OPP's responsibilities and accomplishments. 
    
    
    
    
    
                                       /signed/
    
    
    
                                  Daniel M. Barolo, Director
    
                                  Office of Pesticide Programs 
    
    
    
    
    
    
    
                             Introduction
    
    
    
         Protecting public health and the environment from the risks
    
    posed by pesticides is a challenging and complex undertaking. By
    
    their very nature, pesticides create some risk of harm to humans,
    
    animals or the environment because they are designed to be
    
    biologically active and have a negative effect on living
    
    organisms. At the same time, pesticides are useful to society
    
    because of their ability to kill potential disease-causing
    
    organisms and to control insects, weeds, and other pests.
    
    
    
         Over the past twenty years, EPA's Office of Pesticide
    
    Programs (OPP) has developed a number of programs structured to
    
    meet the challenge of evaluating and reducing pesticide risks and
    
    promoting safe pesticide use. These programs govern a wide
    
    variety of pesticide products and uses that are likely to be
    
    found in virtually every home and business in the United States -
    
    - from insect repellents to weed killers to hospital
    
    disinfectants to swimming pool chemicals -- to name a few. The
    
    health and environmental issues raised by pesticides in these
    
    many settings are varied and complex. In carrying out its
    
    responsibilities, OPP must consider both the need to minimize
    
    risks and the benefits that pesticides offer to society. State
    
    and tribal agencies and many other organizations, both public and
    
    private, are vital partners in this effort.
    
    
    
         While it would take many more pages to fully depict the
    
    extensive efforts and achievements of this program, this report
    
    attempts to describe many of the accomplishments of the Office of
    
    Pesticide Programs during the 1995 fiscal year (October 1, 1994
    
    to September 30, 1995).
    
    
    
                         Annual Report Structure
    
    
    
         While OPP staff are formally organized into eight divisions
    
    and a policy staff, this report is organized around the six major
    
    activity areas used in the resource planning process. In
    
    addition, the seventh chapter discusses some other special
    
    initiatives.
    
    
    
         1 - Registration
    
    
    
         Making decisions about the registration (licensing) of
    
    individual pesticide products, and assuring that decisions are
    
    consistent and up-to-date.
    
    
    
         2 - Reregistration
    
    
    
         Bringing the scientific data base for older pesticide active
    
    ingredients up to current standards, reassessing their regulatory
    
    status, mitigating risks, and documenting new decisions. Assuring
    
    that products containing eligible active ingredients are
    
    supported by valid data, are labeled correctly, and are
    
    reregistered.
    
    
    
    
    
         3 - Special Review
    
    
    
         Conducting in-depth assessments of pesticides suspected of
    
    posing unacceptable risks to public health or the environment.
    
    
    
         4 - Field Implementation and Communications
    
    
    
         Working with EPA regional offices, states, and tribal
    
    organizations to implement pesticide programs, communicating with
    
    the public about pesticide issues, and supporting compliance
    
    efforts.
    
    
    
         5 - Policy, Regulations, and Guidance
    
    
    
         Developing pesticide policies and regulations, including
    
    improvement of the quality of scientific information used to make
    
    decisions.
    
    
    
         6 - Information and Program Management
    
    
    
         Managing pesticide information (including automated
    
    information systems, computers and computer networks, and paper
    
    and microfiche collections) and administering programs (including
    
    human resources, facilities, finances, and budget planning).
    
    
    
         7 - Biopesticide, Risk Reduction, and Reinvention
    
         Initiatives
    
    
    
         Though integrated into the other six areas for budget
    
    purposes, these initiatives are given special attention in this
    
    report. They involve encouraging the introduction of a new
    
    generation of biological pesticides, reducing pesticide risks
    
    through environmental stewardship, and reinventing OPP
    
    organizations.
    
                                Contents
    
    Foreword
    
    
    
    Introduction
    
    
    
    Chapter 1: Registration
    
    
    
         Overview Of Registration
    
         New Registrations In 1995
    
         Other 1995 Registration Achievements
    
         Reinvention/Risk Reduction Activities
    
         Implementing Acetochlor Registration Conditions
    
         Ensuring The Effectiveness Of Antimicrobial Pesticides
    
         Efforts To Improve Pesticide Labels
    
         Pesticide Chemistry Laboratory Support For Registration
    
    
    
    Chapter 2: Reregistration
    
    
    
         Steps In Reregistering Pesticides
    
         1995 Reregistration Progress
    
         Assessing Exposure To Turf Pesticides
    
         Pesticide Chemistry Laboratory Support For Reregistration
    
         Reducing Pesticide Spray Drift
    
    
    
    Chapter 3: Special Review
    
    
    
         1995 Formal Special Reviews And Follow-up Activities
    
         Limited Reintroduction Of Aldicarb Use On Potatoes
    
    
    
    Chapter 4: Field Implementation and Communications
    
    
    
       A. Field Programs
    
         Implementing The Worker Protection Standard 
    
         Endangered Species Protection Program
    
         Protecting Ground Water
    
         Certification And Training Of Pesticide Applicators
    
    
    
       B. Communications, Public Response, and Coordination
    
         Outreach And Communications Strategies
    
         Responding To The Public
    
         Congressional Relations And Coordination With Other 
    
              Federal Agencies
    
         National Agricultural Pesticide Impact 
    
              Assessment Program (NAPIAP)
    
         International Coordination And Integration
    
         Regional, State, And Tribal Liaison
    
         Laboratory Tools
    
    
    
    Chapter 5: Policy, Regulations, and Guidance
    
    
    
         Improving Protection For Infants And Children
    
         Acute Dietary Risk Assessment Activities
    
         Activities Related To Implementation Of The "Delaney Clause"
    
         Revised Food And Livestock Feed Table
    
         "Reinvention" and Regulatory Reform: Ongoing Efforts to
    
              Clarify and Update Regulatory Policies and Requirements
    
         Ecological Risk Assessment and Ground-Water Study Guidance
    
         Community-Based Environmental Protection
    
         Improving Methods, Modeling, And Information Systems 
    
              for Environmental Assessments
    
         Legislative Proposals
    
         International Harmonization And Regulatory Coordination
    
         Technical Cooperation With Developing Countries
    
         International Trade And Environment Policy
    
    
    
    Chapter 6: Information and Program Management
    
    
    
         Operations, Maintenance And Integration Of The Primary 
    
              OPP Information Systems
    
         Electronic Dissemination Of Information
    
         Other Information Systems
    
         Pesticide Adverse Effects Information 
    
              Reporting/6(a)(2) Activities
    
         Ecological Incident Monitoring And Reporting
    
         Information And Records Management Activities
    
         Human Resources Management
    
         Resource Allocation And Financial Management
    
    
    
    Chapter 7: Biopesticide, Risk Reduction, and Reinvention
    
    Initiatives
    
    
    
         Creation Of The New Division
    
         Promoting Integrated Pest Management (IPM)
    
         Pesticide Environmental Stewardship Program (PESP)
    
         Biological Pesticide Regulatory Relief
    
         Reinventing And Streamlining OPP's Organization
    
    
    
    How To Obtain More Information
    
    
    
    Pesticide Program Contacts
    
    
    
    
    
                         Chapter 1: Registration
    
    
    
         This chapter describes the pesticide registration program,
    
    which provides the foundation for nearly all OPP activities. In
    
    addition to allowing the use of new pesticides, the registration
    
    program includes many activities related to the ongoing
    
    registration of existing pesticides, such as label changes in
    
    where and how they may be used in order to reduce risks or in
    
    response to requests by registrants. This chapter also describes
    
    several reinvention activities aimed at improving regulatory
    
    decisions, processes, and team structures. Also contained in this
    
    chapter are summaries of special programs ensuring the
    
    effectiveness of antimicrobial pesticides, improving pesticide
    
    labels, and the role of OPP's laboratories in pesticide
    
    registration.
    
    
    
    Overview Of Registration
    
    
    
         The Federal Insecticide, Fungicide, and Rodenticide Act
    
    (FIFRA) requires that before anyone can sell or distribute any
    
    pesticide in the United States, they must obtain a registration,
    
    or license, from EPA. The term pesticide means any substance or
    
    mixture of substances intended for preventing, destroying,
    
    repelling, or mitigating any pest, and any substance or mixture
    
    intended for use as a plant regulator, defoliant, or desiccant.
    
    When making a pesticide registration decision, EPA must ensure
    
    that the pesticide, when used according to label directions, will
    
    not cause unreasonable adverse effects to human health or the
    
    environment.
    
    
    
         Registration decisions are based primarily on EPA's
    
    evaluation of the test data provided by applicants. EPA has
    
    established a number of requirements, such as the Good Laboratory
    
    Practice Standards, that apply to both registrants and testing
    
    facilities to ensure the quality and integrity of pesticide data.
    
    
    
         Depending on the type of pesticide, OPP can require more
    
    than 100 different tests. Testing is needed to determine whether
    
    a pesticide has the potential to cause adverse effects to humans,
    
    wildlife, fish, and plants, including endangered species.
    
    Potential human risks, which are identified using laboratory
    
    tests in animals, include acute toxic reactions (such as
    
    poisoning and skin and eye irritation) as well as possible long-
    
    term effects (such as cancer, birth defects, and reproductive
    
    disorders). Data on the fate of pesticides in the environment are
    
    also required so that OPP can assess threats to ground and
    
    surface water or other risks.
    
    
    
         OPP processes a variety of registration applications,
    
    including: new pesticide active ingredients, new uses
    
    (applications for new uses of an already registered pesticide),
    
    "me-too's" (applications for registrations of pesticide products
    
    that are substantially similar or identical in their uses and
    
    formulation to currently registered products), and experimental
    
    use permits (which set specific terms under which prospective
    
    registrants may test pesticides outside of the laboratory prior
    
    to registration).
    
    
    
         Under section 18 of FIFRA, states may apply to EPA for an
    
    exemption or declare a crisis exemption for emergency use of a
    
    pesticide not registered for that use. Four types of emergency
    
    exemptions may be authorized. A specific exemption may be
    
    authorized in an emergency situation to avert significant
    
    economic loss, or significant risks to endangered species,
    
    beneficial organisms, or the environment. A quarantine exemption
    
    may be authorized in an emergency to control the spread of any
    
    pest new to or not known to be widely prevalent within the United
    
    States or its territories. An emergency public health exemption
    
    may be authorized to control a pest that will cause a significant
    
    risk to human health. In an emergency where there is not time to
    
    allow for EPA authorization of the applicable specific,
    
    quarantine, or public health exemption, a state may invoke a
    
    crisis exemption.
    
    
    
         Under section 24(c) of FIFRA, states may issue registrations
    
    for additional uses of currently registered pesticides to meet
    
    special local needs.
    
    
    
    New Registrations In 1995
    
    
    
         1995 was a banner year for OPP with the registration of 40
    
    new pesticide active ingredients, more than half of which are
    
    considered reduced risk pesticides, including biopesticides.
    
    Biopesticides include "microbial pesticides" (bacteria, viruses,
    
    or other microorganisms used to control pests) and "biochemical
    
    pesticides," such as pheromones (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.
    
    Many of these reduced risk pesticides were submitted under the
    
    voluntary Reduced Risk Pesticides Initiative. The following table
    
    describes the pesticide active ingredients registered for the
    
    first time in fiscal year 1995.
    
    
    
    
    
         New Pesticide Active Ingredients Registered in FY 1995
    
    
    
    -----------------------------------------------------------------
    
    Pesticide      Registrant     Pesticide      Use(s)    Biopest. 
    
    Name                          Type                     or Other
    
                                                           Reduced
    
                                                           Risk
    
                                                           Pesticide?
    
    -----------------------------------------------------------------
    
    
    
    AO-159         DuPont         Insecticide    Pets,          No
    
                                                 livestock
    
    -------------  -------------  -------------  --------  ----------
    
    Bt Corn        Ciba Seeds     Plant-         Field          Yes
    
                   and Mycogen    Pesticide      corn      (biopest.)
    
    -------------  -------------  -------------  --------  ----------
    
    Bt Potatoes    Monsanto       Plant-         Potatoes       Yes
    
                                  Pesticide                (biopest.)
    
    -------------  -------------  -------------  --------  ----------
    
    Bacillus       EcoGen Inc.    Microbial      Potatoes,      Yes 
    
    thuringiensis                 insecticide    tomatoes, (biopest.)
    
    subsp.                                       eggplants 
    
    kurstaki
    
    -------------  -------------  -------------  --------  ----------
    
    Beauveria      Mycotech       Microbial      Various        Yes 
    
    bassiana       Corp.          Insecticide    crops,    (biopest.)
    
    Strain GHA                                   rangeland,
    
                                                 pastures 
    
    -------------  -------------  -------------  --------  ----------
    
    Beauveria      Troy           Microbial      Ornamental     Yes
    
    bassiana       Biosciences    Insecticide    plants,   (biopest.)
    
    ATCC 74040                                   turf
    
    -------------  -------------  -------------  --------  ----------
    
    Candida        EcoGen Inc.    Microbial      Citrus         Yes
    
    oleophila                     fungicide      and pome  (biopest.)
    
                                                 fruits
    
    -------------  -------------  -------------  --------  ----------
    
    Celery         BIOSYS         Microbial      Vegets.        Yes
    
    Looper                        insecticide              (biopest.)
    
    Virus
    
    -------------  -------------  -------------  --------  ----------
    
    Chloreth-      DuPont         Insecticide    Corn           No
    
    oxyfos
    
    -------------  -------------  -------------  --------  ----------
    
    Cydia          Louis Falcon   Microbial      Fruits         Yes 
    
    pomonella                     Insecticide              (biopest.)
    
    -------------  -------------  -------------  --------  ----------
    
    (E)-5-Decenol  Consep Inc.    Insect         Fruits,        Yes
    
                                  pheromone      nuts      (biopest.)
    
    -------------  -------------  -------------  --------  ----------
    
    (E)-5-Decenyl  Consep Inc.    Insect         Fruits,        Yes 
    
    Acetate                       pheromone      nuts      (biopest.)
    
    -------------  -------------  -------------  --------  ----------
    
    Diethyl        Bear Country   Deterrent      Bears          No
    
    Sulfide        Products
    
    -------------  -------------  -------------  --------  ----------
    
    Difethialone   LiphaTech,     Rodenticide    Resid-         No
    
                   Inc.                          ential use
    
    -------------  -------------  -------------  --------  ----------
    
    1,4 Dimethyl-  D-I-1-4 Inc.   Plant Growth   Potatoes       Yes
    
    napthalene                    Regulator
    
    -------------  -------------  -------------  --------  ----------
    
    Dioctyl        Safe and Sure  Insecticide    Pets           No
    
    Sodium         Products
    
    Sulfosuccinate
    
    -------------  -------------  -------------  --------  ----------
    
    Fenbuconazole  Rohm and       Fungicide      Pecans         No
    
                   Haas Co.
    
    -------------  -------------  -------------  --------  ----------
    
    Flumiclorac    Valent         Herbicide      Corn           Yes
    
    Pentyl Ester 
    
    (Resource)
    
    -------------  -------------  -------------  --------  ----------
    
    Halosulfuron   Monsanto       Herbicide      Corn,          No
    
                                                 ornamental 
    
                                                 plants
    
    -------------  -------------  -------------  --------  ----------
    
    Hymexazol      Sumitomo       Fungicide      Seed           Yes
    
                   Chemical                      treatment
    
    -------------  -------------  -------------  --------  ----------
    
    Isobardac      Lonza, Inc.    Antimicrobial  Water          No
    
                                                 treatment 
    
    -------------  -------------  -------------  --------  ----------
    
    Mattch Bt K    Mycogen        Microbial      Fruits         Yes
    
                                  insecticide              (biopest.)
    
    -------------  -------------  -------------  --------  ----------
    
    Maxim          Ciba-Geigy     Fungicide      Seed           Yes
    
                                                 treatment
    
    -------------  -------------  -------------  --------  ----------
    
    Methyl         Dolphin Trust  Bird           Small fruits,  Yes
    
    Anthranilate                  Repellent      ornamental 
    
                                                 plants
    
    -------------  -------------  -------------  --------  ----------
    
    Neem Oil       W.R. Grace     Fungicide      Ornamental     Yes 
    
                   and Co.                       plants    (biopest.)
    
    -------------  -------------  -------------  --------  ----------
    
    Poly (N,N-     Calgon         Antimicrobial  Water          No
    
    dimethyl                                     systems
    
    diallyl 
    
    ammonium 
    
    chloride)
    
    -------------  -------------  -------------  --------  ----------
    
    Potassium      Church &       Fungicide      (Retail        Yes
    
    Bicarbonate    Dwight Co.                    pesticide 
    
    (baking soda)                                products not 
    
                                                 yet approved)
    
    -------------  -------------  -------------  --------  ----------
    
    Prallethrin    Sumitomo       Insecticide    Pets,          No
    
                                                 resid. uses
    
    -------------  -------------  -------------  --------  ----------
    
    Primisulfuron  Ciba-Geigy     Herbicide      Corn           No
    
    Methyl
    
    -------------  -------------  -------------  --------  ----------
    
    P. syringae    EcoScience     Microbial      Fruits         Yes 
    
    ESC 10         Corp.          fungicide      (post-    (biopest.)
    
                                                 harvest)
    
    -------------  -------------  -------------  --------  ----------
    
    P. syringae    EcoScience     Microbial      Fruits         Yes 
    
    ESC 11         Corp.          fungicide      (post-    (biopest.)
    
                                                 harvest)
    
    -------------  -------------  -------------  --------  ----------
    
    Pyridaben      Nissan         Insecticide    Ornamental     No
    
                   Chemical                      plants
    
    -------------  -------------  -------------  --------  ----------
    
    Pyriproxyfen   Mclaughlin     Insecticide    Pets           No
    
                   Gormley King 
    
                   Company
    
    -------------  -------------  -------------  --------  ----------
    
    Pyrithiobac-   DuPont         Herbicide      Ornamental     No
    
    sodium                                       plants
    
    -------------  -------------  -------------  --------  ----------
    
    Rimsulfuron    DuPont         Herbicide      Corn           No
    
    -------------  -------------  -------------  --------  ----------
    
    Sodium         Church &       Fungicide      (Retail        Yes
    
    Bicarbonate    Dwight Co.                    pesticide 
    
    (baking soda)                                products not 
    
                                                 yet approved)
    
    -------------  -------------  -------------  --------  ----------
    
    Sodium         Creative       Insecticide    Ornamental     Yes
    
    Carboxy-       Services Inc.                 plants
    
    methyl-
    
    cellulose
    
    -------------  -------------  -------------  --------  ----------
    
    Sodium         Asahi          Plant Growth   Cotton,        Yes
    
    5-Nitro-       Chemical       Regulator      rice, 
    
    guaiacolate    Manufacturing                 soybeans
    
    -------------  -------------  -------------  --------  ----------
    
    Tebufenozide   Rohm and       Insecticide    Walnuts        Yes
    
                   Haas Co.
    
    -------------  -------------  -------------  --------  ----------
    
    Undecylenic    Safe and Sure  Insecticide    Pets           No
    
    Acid           Products
    
    ----------------------------------------------------------------
    
    
    
    Other 1995 Registration Achievements
    
    
    
         Registering new pesticides for the first time is only one of
    
    an enormous number of pesticide registration actions that OPP
    
    carries out each year. Decisions made in 1995 are summarized in
    
    the following table. Both approvals and denials of the requests
    
    received by OPP are included in the number of decisions.
    
    
    
                      1995 Registration Activities
    
    
    
    ---------------------------------------------------------------
    
    Registration        Description of Activity           Number of 
    
    Activity                                              Decisions
    
    ------------------  --------------------------------  ---------
    
    Registrations of    First approval for use of               40
    
    new pesticides      pesticides not currently 
    
                        registered in the United States.
    
    
    
    Additional          Registrations for new products         832
    
    registrations       containing pesticide ingredients 
    
    for previously      already approved for proposed 
    
    registered          uses.
    
    pesticides
    
    
    
    Amendments to       Amendments, for example, to          3,614
    
    existing            reflect revised labels and 
    
    registrations       changed formulations for 
    
                        products already registered.
    
    
    
    New uses for        Approvals for uses of a                124
    
    previously          pesticide (such as on particular 
    
    registered          food crops) for which it has 
    
    pesticides          never been registered.
    
    
    
    Emergency           Decisions on granting emergency        400
    
    exemptions          exemptions to states or other 
    
    ("Section 18s")     federal agencies to allow use 
    
                        for a limited period of 
    
                        pesticides not registered for 
    
                        those particular uses.
    
    
    
    Experimental Use    Decisions on permits that allow        100
    
    Permits (EUPs)      pesticide producers to test new 
    
                        pesticide uses outside of the
    
                        laboratory; generally required
    
                        if more than 10 acres are to be
    
                        tested.
    
    
    
    Tolerances          Decisions on approving                 122
    
                        tolerances, or maximum allowable 
    
                        levels of a pesticide residues
    
                        in food or animal feed. Tolerances 
    
                        (or exemptions from tolerances) are 
    
                        required whenever a pesticide is 
    
                        registered for use on a food or 
    
                        feed crop.
    
    
    
    Temporary           Decision on tolerances                  34
    
    tolerances          for experimental purposes 
    
                        for an unregistered pesticide.
    
    
    
    Special Local       Registrations of pesticide             475
    
    Need                products by state agencies for 
    
    Registrations       specific uses not federally 
    
    ("Section           registered. (The pesticides must 
    
    24(c)s")            be federally registered for 
    
                        other uses.)
    
    ---------------------------------------------------------------
    
    
    
    
    
    Reinvention/Risk Reduction Activities
    
    
    
         Over the past several years, OPP has undertaken a major
    
    effort to overhaul its registration program, which in 1995 began
    
    to pay substantial dividends. The reinvention effort aims to
    
    accelerate the pace of decision-making and redirect staff
    
    activities to those most important in protecting health and the
    
    environment. This section describes the highlights of these
    
    initiatives.
    
     
    
         Agreement with California to Harmonize Pesticide Regulation
    
    
    
         OPP and the Department of Pesticide Regulation (DPR) of the
    
    California Environmental Protection Agency began an initiative in
    
    1994 to harmonize and simplify pesticide registration, and to
    
    exchange work products to reduce duplication of effort and
    
    expense. The first major milestone of this initiative was the
    
    signing of a Memorandum of Understanding (MOU) in May 1994.
    
    During 1995, significant progress was made in achieving the
    
    objectives of the MOU. For example, OPP and DPR began sharing the
    
    workload of reviewing acute toxicology studies, thereby reducing
    
    review cost and time. This should help OPP continue to reduce its
    
    current backlog of pending acute toxicity submissions. OPP also
    
    identified products intended for registration under FIFRA as well
    
    as in California. Other ongoing cooperative activities include
    
    harmonization of risk assessment methods, international
    
    standards, and registration of new active ingredients.
    
    
    
         Voluntary Reduced Risk Pesticide Initiative
    
    
    
         Since the inception of this initiative in 1993, OPP has
    
    received 20 reduced risk pesticide applications. OPP has accepted
    
    nine candidates (registering six so far), denied seven
    
    candidates, and is considering four. OPP is committed to
    
    expedited review of reduced risk applications and to making a
    
    registration decision within one year after a candidate has been
    
    granted reduced risk status. OPP issued a draft Pesticide
    
    Regulation (PR) Notice expanding the initiative to include new
    
    uses of pesticides that have been granted reduced risk status,
    
    and expects to finalize the notice by December 1995.
    
    
    
         Faster Approval of Minor Registration Changes
    
    
    
         In May 1995, OPP took a major step in reducing its workload
    
    in reviewing minor registration changes by issuing PR Notice
    
    95-2. The notice significantly expands the categories of minor
    
    changes, such as changes to labeling and packaging, that
    
    registrants can make without waiting for OPP approval. Under this
    
    program, OPP expects that as many as 500 amendments each year, or
    
    10% of the total, will be made by notifying OPP rather than
    
    requesting approval. For certain cases of minor changes not
    
    expected to change the potential risks of the products,
    
    registrants are not even required to notify OPP of the changes.
    
    In addition, the notice creates an accelerated process for
    
    reviewing minor formulation changes in 45 days instead of 90
    
    days. Besides reducing OPP's workload, this action will allow
    
    registrants to make changes much more quickly.
    
    
    
         Exemption of Effluent Discharge Statements for Small
    
         Container Products
    
    
    
         On May 1, 1995, OPP issued PR Notice 95-1 exempting small
    
    containers (less than five gallons liquid or 50 pounds dry
    
    weight) from previously-required effluent discharge labeling.
    
    This reduces the burden on small container products with labels
    
    that lack space for these statements. Effluent discharge
    
    statements continue to be required for larger containers used in
    
    the industrial/commercial sector.
    
    
    
         Encouraging Water Soluble Packaging (WSP)
    
    
    
         Water soluble packaging allows a pesticide product to be
    
    transferred from its original container to the tank from which it
    
    will be applied with a minimal risk of spills or splashes. It
    
    also eliminates the need for rinsing the original container.
    
    Because of these benefits to pesticide handlers and the
    
    environment, OPP began to implement a streamlined process for
    
    registering WSP products in 1995. Registrants who wish to market
    
    a registered product in water soluble packaging can do so using
    
    the same registration number and by notifying OPP rather than
    
    waiting for OPP approval.
    
    
    
         Other Reinvention Initiatives in Progress
    
    
    
         Other efforts to improve the registration process in 1995
    
    included:
    
    
    
       o Exploring the possibility of allowing registrants to self-
    
         certify the results of product-specific acute toxicity tests
    
         rather than requiring OPP review.
    
    
    
       o Working to finalize a rule proposed in 1994 under section
    
         25(b) of FIFRA that would exempt a number of pesticides from
    
         regulation because they do not pose risks warranting
    
         regulation.
    
    
    
       o Developing guidance to standardize and simplify procedures
    
         for certain registration applications.
    
    
    
       o Preparing a proposal to streamline the registration of
    
         different sizes of rodent control pesticide products.
    
    
    
       o Developing a proposal to allow self-certification by
    
         registrants of certain "me-too" products.
    
    
    
    Implementing Acetochlor Registration Conditions
    
    
    
         In registering the pesticide acetochlor in 1994, OPP
    
    embarked on a new approach by setting strong standards to protect
    
    ground and surface water. The approach establishes clear criteria
    
    that trigger voluntary suspension or cancellation of the
    
    registration if water quality is adversely affected. In
    
    particular, the Acetochlor Registration Partnership (ARP) is
    
    required to conduct extensive monitoring programs to ensure that
    
    use of this herbicide will not adversely affect ground or surface
    
    water.
    
    
    
         During the past year, OPP worked with the partnership and
    
    State Lead Pesticide Agencies to implement the registration
    
    agreement. The ARP established 175 monitoring wells, 25 in each
    
    of the seven major use states (Illinois, Indiana, Iowa, Kansas,
    
    Minnesota, Nebraska, and Wisconsin). The ARP also established 175
    
    surface water monitoring sites at drinking water supply
    
    facilities in 12 states, and began biweekly monitoring in March.
    
    Detections of acetochlor in ground water were reported in eight
    
    wells, which the ARP is investigating. Acetochlor was found in
    
    approximately 20% of the surface-water samples collected,
    
    generally well below the 2 ppb annual trigger. Also, the ARP
    
    began work on a second monitoring program, initiating two of
    
    eight prospective ground-water studies in Wisconsin and in Ohio.
    
    Four additional studies will begin in 1996, and the last two in
    
    1997.
    
    
    
         The Agreement between the ARP and OPP has already produced
    
    results. In the first year of use, the ARP has restricted the use
    
    of acetochlor on sandy soils to reduce the risk of ground-water
    
    contamination. OPP has validated the ARP's multi-residue method
    
    for detecting acetochlor and is reviewing the ARP's acetochlor-
    
    specific detection method. Finally, an ARP evaluation found that
    
    commercially available, low-cost methods may be useful in
    
    screening for the presence of acetochlor and similar compounds in
    
    water.
    
    
    
         Recently, OPP made available to the public a map indicating
    
    areas throughout the country where acetochlor has been sold
    
    between March 1994 and January 1995. This county level usage
    
    information will be made available to the public annually by OPP
    
    and can be used to target monitoring by states and others.
    
    
    
    Ensuring The Effectiveness Of Antimicrobial Pesticides
    
    
    
         Antimicrobial products are used to control "germs" such as
    
    bacteria and fungi (molds and mildews) that can cause odors, food
    
    spoilage, or infections. They are used in homes, hospitals,
    
    cafeterias, restaurants, and many other institutions. Over the
    
    past several years, OPP has implemented a comprehensive strategy
    
    to ensure the efficacy of antimicrobial pesticides, placing
    
    highest priority on those that have significant public health
    
    uses. During 1995, OPP accomplished many of its research goals
    
    under a comprehensive Antimicrobial Program Strategy. Highlights
    
    include:
    
    
    
         Test Methodology Research Cooperative Agreements
    
    
    
         Substantial progress was made in each of the five research
    
    cooperatives. Three cooperatives finalized most of the research
    
    to improve the existing test methods used to determine
    
    antimicrobial product efficacy. New sporicidal, virucidal and
    
    tuberculocidal test methods have been developed and are in the
    
    process of being validated through collaborative studies. Another
    
    agreement focused on bacterial cell injury and proposed a
    
    protocol for determining the level of injury sustained during
    
    typical efficacy test conditions.
    
    
    
         Antimicrobial Complaint System Cooperative Agreement
    
    
    
         Through the National Pesticide Telecommunications Network
    
    (NPTN), the Antimicrobial Complaint System (ACS) handles phone
    
    inquiries and complaints regarding EPA-registered antimicrobials.
    
    The ACS responded to over a thousand calls in 1995.
    
    
    
         Antimicrobial Product Testing Program
    
    
    
         In 1995, the Antimicrobial Product Testing Program was
    
    converted from a contract to an OPP-managed program. Product
    
    efficacy testing of tuberculocides and hospital disinfectants is
    
    now being conducted at OPP's new Microbiology Laboratory in
    
    Cincinnati. The laboratory will continue to evaluate selected
    
    hospital disinfectant and tuberculocidal product claims in
    
    support of OPP's Testing Program to ensure the efficacy of
    
    antimicrobial pesticides. The laboratory will also assist in
    
    enforcement actions where efficacy claims cannot be confirmed.
    
    
    
    Efforts To Improve Pesticide Labels
    
    
    
         Labeling is one of OPP's most important tools for achieving
    
    its mission of protecting human health and the environment. No
    
    other pesticide document or publication has a more direct impact
    
    on risk reduction or the potential to prevent pollution. Over
    
    time, however, some labels have become cluttered and confusing.
    
    OPP has taken several steps to address labeling concerns and has
    
    accomplished the following:
    
    
    
         Computer Software to Standardize Precautionary Labeling. 
    
    Precautionary statements are those portions of a pesticide label
    
    that summarize a product's hazards, provide first aid
    
    instructions, and list storage and disposal instructions. In
    
    1995, OPP began developing a computer program which displays the
    
    correct precautionary labeling statements for a product based on
    
    acute toxicity studies. This system could be used by both OPP and
    
    registrants to assure accurate and appropriate precautionary
    
    labeling. This could help reduce review time and rejection of
    
    applications with incorrect labeling. OPP expects to distribute
    
    the software in early 1996.
    
    
    
         Label Review Manual. In December 1994, OPP completed and
    
    made available its first comprehensive Label Review Manual, a
    
    document to be used by OPP staff in reviewing and determining the
    
    acceptability of pesticide labeling. The manual is available to
    
    the public.
    
    
    
         Label Policy Directory. In October 1994, OPP launched an
    
    electronic "on-line" Labeling Policy Directory that allows OPP
    
    staff to quickly search and access labeling policy information
    
    via computer. Portions of the directory will soon be made
    
    available to the public.
    
    
    
         Labeling Coordination. OPP issued a draft PR Notice
    
    establishing an annual compliance date for implementing most EPA-
    
    mandated labeling changes, and describing current approaches to
    
    coordinating labeling issues and related streamlining efforts.
    
    After review of public comments, OPP plans to issue a final
    
    notice in 1996.
    
    
    
         Total Release Fogger Labels. OPP continued to work to
    
    improve the labels of total release foggers, sometimes called
    
    "bug bombs." The aerosol propellants found in these indoor
    
    fumigants can cause fires or explosions if the products are not
    
    used properly. OPP expects to issue final labeling requirements
    
    in 1996.
    
    
    
    Pesticide Chemistry Laboratory Support For Registration
    
    
    
         OPP's pesticide registration program is supported by two
    
    pesticide chemistry labs: the Analytical Chemistry Laboratory
    
    (ACL) in Beltsville, Maryland, and the Environmental Chemistry
    
    Laboratory (ECL) in Bay St. Louis, Mississippi. The labs support
    
    registration through the food tolerance and environmental
    
    chemistry methods validation programs, which ensure that
    
    pesticide residues can be accurately measured in food and the
    
    environment.
    
    
    
         The ACL has the lead responsibility for the food tolerance
    
    methods validation program. In fiscal year 95, ACL validated a
    
    record 65 food tolerance methods out of a total of 102 submitted
    
    or carried-over from 1994 (see table below). In addition, the ACL
    
    developed a new method for detecting residues of multiple
    
    sulfonylurea pesticides in water using capillary zone
    
    electrophoresis. Scientists are enthusiastic about the method and
    
    additional work is underway at both EPA and industry labs to
    
    determine the suitability of the method for monitoring pesticide
    
    residues.
    
    
    
         The ECL has lead responsibility for the environmental
    
    chemistry methods validation program. The demand for
    
    environmental chemistry methods testing increased dramatically in
    
    1995 (see second table below). The primary emphasis of this
    
    program is to evaluate those methods associated with studies for
    
    environmental fate, exposure, and ecological effects. The ECL
    
    completed 35 validations in 1995, including three expedited
    
    methods for acetochlor. ECL continued to evaluate new, low-cost
    
    technology for detecting pesticide residues using immunoassay
    
    tests, completing review of eight tests in 1995. 
    
    
    
    
    
    --------------------------------------------------------------
    
                      Tolerance Method Validations
    
    --------------------------------------------------------------
    
                   FY 91     FY 92     FY 93     FY 94     FY 95
    
                   -----     -----     -----     -----     -----
    
    Carried-         7         6         7         9        23
    
    over
    
    Requests
    
    
    
    New             26        18        31        63        79
    
    Requests
    
    
    
    Completed       27        17        29        49        65
    
    --------------------------------------------------------------
    
    
    
    
    
    
    
    --------------------------------------------------------------
    
               Environmental Chemistry Method Validations
    
    --------------------------------------------------------------
    
                   FY 91     FY 92     FY 93     FY 94     FY 95
    
                   -----     -----     -----     -----     -----
    
    Carried-         0         3         9        17        23
    
    over
    
    Requests
    
    
    
    New              6        10        16        17        54
    
    Requests
    
    
    
    Completed        3         4         8        11        35
    
    --------------------------------------------------------------
    
                        Chapter 2: Reregistration
    
    
    
         Pesticide reregistration is one of OPP's most vital
    
    programs. OPP is required by 1988 amendments to federal pesticide
    
    law to review and, as warranted, reregister all existing
    
    pesticide products that contain active ingredients initially
    
    registered before November 1, 1984. The goal is to update
    
    labeling and use requirements and reduce potential risks
    
    associated with older pesticide active ingredients -- those first
    
    registered when the standards for government approval were less
    
    stringent than they are today. This comprehensive reevaluation of
    
    pesticide safety in light of current standards is critical to
    
    protecting human health and the environment. 
    
    
    
         This chapter discusses OPP's progress in reregistering
    
    pesticides, as well as some related initiatives. These include
    
    efforts to develop additional information on pesticide exposure
    
    to people who enter treated lawn and turf areas and to reduce the
    
    risks posed by pesticide spray drift.
    
    
    
    Steps In Reregistering Pesticides
    
    
    
         Through the pesticide reregistration program, now in its
    
    final phase, OPP is reviewing studies submitted to support each
    
    reregistration case (or group of related pesticide active
    
    ingredients). After examining the health and environmental
    
    effects, OPP employs measures to mitigate risks most effectively.
    
    This evaluation and risk mitigation process is complete when OPP
    
    is satisfied that the pesticide, used in accordance with approved
    
    labeling, will not pose unreasonable risks to human health or the
    
    environment.
    
    
    
         OPP's regulatory conclusions about each case are presented
    
    in a Reregistration Eligibility Decision document, or RED. Later,
    
    once product-specific data and revised labeling are submitted and
    
    approved, OPP reregisters products containing the eligible
    
    pesticide(s). A product is not reregistered, however, until all
    
    of its active ingredients are eligible for reregistration.
    
    
    
    1995 Reregistration Progress
    
    
    
         OPP is making significant progress in reregistering
    
    pesticides. During fiscal year 1995, OPP completed 40
    
    Reregistration Eligibility Decisions, or REDs, a record in terms
    
    of both the number and magnitude of the decisions. Working with
    
    the Special Review program (described in chapter 3), the
    
    reregistration program is employing a variety of measures to
    
    reduce the most serious pesticide risks. These include use
    
    phaseouts, voluntary cancellations, restricted use
    
    classifications, ground-water label advisories, and strengthened
    
    requirements to better protect pesticide handlers and other
    
    workers. New label guidance for aerial applications, requirements
    
    for vegetative buffer strips bordering areas treated with
    
    pesticides, and reduced application rates are reducing risks to
    
    wildlife.
    
    
    
         For example, the Picloram RED Team worked with state
    
    representatives and the registrant to reduce use rates in order
    
    to decrease risks to nontarget plants. The Ethalfluralin RED Team
    
    strengthened personal protective equipment and restricted entry
    
    intervals to reduce risks of cancer and developmental effects to
    
    workers, and required buffer strips to mitigate threats to
    
    aquatic wildlife. 
    
    
    
         With this year's accomplishments, OPP has completed a total
    
    of 121 REDs covering 30 percent of the cases to be reregistered,
    
    including glyphosate, metolachlor, picloram, and other major
    
    pesticides. About 1,000 tolerances (maximum legally permissible
    
    levels of pesticide residues in foods) have been reassessed, and
    
    many are being revised to better ensure food safety. About 750
    
    products have completed the process and have been reregistered. 
    
    
    
         Looking to the future, more pesticides with food uses and
    
    other significant human exposures are scheduled for
    
    reregistration eligibility decisions during fiscal year 1996. For
    
    the first time, OPP expects that the number of candidates ready
    
    for decisions in FY 1996 will exceed the resources available to
    
    complete those decisions.
    
    
    
         Some of the principal accomplishments of the reregistration
    
    program during fiscal year 1995 and cumulatively are summarized
    
    below.
    
    
    
         Annual and Cumulative Completion of REDs
    
    
    
         The number of REDs completed per fiscal year has been
    
    increasing steadily since the accelerated reregistration program
    
    began. This number reached 40 in fiscal year 1995 for a
    
    cumulative total of 121 completed REDs. A target of 40 more REDs
    
    has been set for 1996.
    
    
    
                        Number of REDs Completed:
    
    
    
                                  FY91:   13
    
                                  FY92:   15
    
                                  FY93:   19
    
                                  FY94:   34
    
                                  FY95:   40
    
                                          --
    
               Cumulative through FY95:  121
    
    
    
                             FY96 Goal:   40
    
                  FY96 Cumulative Goal:  161
    
    
    
         Status of Reregistration Cases
    
    
    
         OPP has completed a total of 121 REDs, representing nearly
    
    one third of the 382 chemical cases currently supported for
    
    reregistration. Meanwhile, 230 of the original 612 cases are
    
    unsupported (meaning that the registrants have decided not to
    
    complete and submit the studies required for reregistration).
    
    Cases that remain unsupported have been or will be cancelled. OPP
    
    therefore has 261 more REDs to complete, less than half of the
    
    original cases from 1988.
    
    
    
         Anatomy of the 121 REDs Completed
    
    
    
              ...Or, What "121 REDs Completed" Means...
    
    
    
         The 121 REDs completed cover 170 pesticide active
    
    ingredients, 4,633 products, and 957 tolerances. They represent
    
    about 30% of all supported reregistration cases (a case consists
    
    of one or more related pesticide active ingredients); 30% of all
    
    food use pesticides (supported List A cases); and 17% of original
    
    List A tolerances reassessed. 
    
    
    
         As described in the table below, the completed REDs
    
    represent about two-thirds of the total quantity of pesticides
    
    used (by volume) in the United States. They include over two-
    
    thirds of all homeowner-applied pesticides, about one third of
    
    all pesticides used in agriculture, and two-thirds of all
    
    pesticides used commercially, by industry and government. 
    
    
    
                  Amount of Pesticide Usage (by Volume)
    
                       Covered By REDs Completed*
    
    
    
    ---------------------------------------------------------------
    
                   Homeowner    Agriculture  Commercial/    TOTAL
    
                   Applied                   Industrial 
    
                                             and 
    
                                             Government     
    
    -------------  -----------  -----------  -----------  ---------
    
    Fungicides     50% to 55%   60% to 65%    4% to 7%    40 to 48%
    
    
    
    Herbicides     20% to 25%   30% to 35%   16% to 30%   28 to 32%
    
    
    
    Insecticides   10% to 15%    1% to 2%     3% to 5%     8 to 10%
    
    
    
    Anti-             99% +        99% +        99% +        99%
    
    microbials
    
    
    
    TOTAL              68%         32%          65%          65%
    
    ---------------------------------------------------------------
    
    
    
         * Please note that the REDs completed for two antimicrobial
    
         cases -- bleach (sodium and calcium hypochlorite) and
    
         chlorine -- account for a large proportion of the usage of
    
         antimicrobials and the overall usage of pesticides covered
    
         by the REDs completed so far. Note, too, that the pounds
    
         used may not indicate the relative percent of market share
    
         or number of applications. 
    
    
    
         REDs Completed in 1995
    
    
    
         The following table summarizes the 40 REDs completed in FY
    
    1995:
    
    
    
    ----------------------------------------------------------------
    
    Pesticide Case      Pesticide      Use(s)              Eligible
    
                        Type                               for Rereg-
    
                                                           istration?
    
    ----------------------------------------------------------------
    
    Agrobacterium       Fungicide      Fruit, nut, and     All uses
    
    radiobacter         Insecticide    ornamental trees
    
                                       (nursery stock)
    
    ------------------  -------------  ------------------  ---------
    
    Aliphatic           Antimicrobial  Indoors             All uses
    
    Alcohols            Fungicide      (including 
    
    (ethanol and        Insecticide    homes),
    
    isopropanol)        Plant Growth   agriculture
    
                          Regulator
    
    ------------------  -------------  ------------------  ---------
    
    Alkyl               Antimicrobial  Fuel oil            All uses
    
    Imidazolines   
    
    ------------------  -------------  ------------------  ---------
    
    Amitraz             Insecticide    Cotton, pears       All uses
    
                                       livestock, dogs
    
    ------------------  -------------  ------------------  ---------
    
    Ancymidol           Plant Growth   Ornamental plants   All uses
    
                          Regulator
    
    ------------------  -------------  ------------------  ---------
    
    Asulam              Herbicide      Sugarcane, turf,    Some uses
    
                                       ornamental plants,
    
                                       and other non-
    
                                       cropland uses
    
    ------------------  -------------  ------------------  ---------
    
    Benzocaine          No longer      Medicine (regu-     (Not
    
                        considered     lated by Food       appli- 
    
                        a pesticide    and Drug Admini-    cable)
    
                                       stration, not EPA)
    
    ------------------  -------------  ------------------  ---------
    
    O-Benzyl-           Antimicrobial  Various indoor      All uses
    
    Chlorophenol                       uses, including
    
                                       agricultural, 
    
                                       food, and medical
    
                                       facilities
    
    ------------------  -------------  ------------------  ---------
    
    Bis(trichloro-      Antimicrobial  Water systems,      Some uses;
    
    methyl)sulfone                     industrial uses,    one use
    
                                       chemical products   awaiting
    
                                                           additional
    
                                                           info.
    
    ------------------  -------------  ------------------  ---------
    
    Bromohydroxy-       Antimicrobial  Paints, adhesives,  All uses
    
    acetophenone                       and other
    
    (BHAP)                             chemicals
    
    ------------------  -------------  ------------------  ---------
    
    Bronopol            Antimicrobial  Water systems,      All uses
    
                                       industrial uses,
    
                                       chemical products
    
    ------------------  -------------  ------------------  ---------
    
    Chlorhexidine       Antimicrobial  Livestock           All uses
    
    Diacetate                          facilities
    
    ------------------  -------------  ------------------  ---------
    
    Chlorpropham        Herbicide      Potatoes, spinach,  Some uses;
    
                        Plant Growth   ornamental plants   others
    
                          Regulator                        awaiting
    
                                                           additional
    
                                                           info.
    
    ------------------  -------------  ------------------  ---------
    
    4-Chlorophenoxy-    Plant Growth   Food industry       All uses
    
    acetic Acid           Regulator    (bean sprouts)
    
    (4-CPA)   
    
    ------------------  -------------  ------------------  ---------
    
    Cyanazine           Herbicide      Corn, cotton,       No: use
    
                                       sorghum             are being
    
                                                           phased out
    
    ------------------  -------------  ------------------  ---------
    
    Cytokinin           Plant Growth   Various crops,      Some uses;
    
                          Regulator    ornamental plants,  others
    
                                       forestry            awaiting
    
                                                           additional
    
                                                           info.
    
    ------------------  -------------  ------------------  ---------
    
    DCPA                Herbicide      Various crops,      All uses
    
                                       ornamental plants,
    
                                       lawns
    
    ------------------  -------------  ------------------  ---------
    
    Dimethoxane         Antimicrobial  Industrial uses,    All uses
    
                                       chemical products
    
    ------------------  -------------  ------------------  ---------
    
    Diquat Dibromide    Herbicide      Potatoes, seed      All uses
    
                                       crops, non-crop
    
                                       areas
    
    ------------------  -------------  ------------------  ---------
    
    Dowicil 100         Antimicrobial  Industrial uses,    All uses
    
                                       paints, textiles
    
    ------------------  -------------  ------------------  ---------
    
    Ethalfluralin       Herbicide      Various vegetable   Some uses;
    
                                       and grain crops     others
    
                                                           awaiting
    
                                                           additional
    
                                                           info.
    
    ------------------  -------------  ------------------  ---------
    
    Ethephon            Plant Growth   Cotton, various     All uses
    
                                       other crops,
    
                                       ornamental plants
    
    ------------------  -------------  ------------------  ---------
    
    Fenitrothion        Insecticide    Ornamental plants,  Some uses
    
                                       greenhouses,
    
                                       indoors (including
    
                                       homes)
    
    ------------------  -------------  ------------------  ---------
    
    Fosamine Ammonium   Herbicide      Rights-of-way,      Some uses
    
                                       industrial sites,
    
                                       fencerows
    
    ------------------  -------------  ------------------  ---------
    
    Linuron             Herbicide      Soybeans, other     Some uses
    
                                       crops, ornamental
    
                                       plants
    
    ------------------  -------------  ------------------  ---------
    
    Methyl Nonyl        Animal and     Residences,         All uses
    
    Ketone              Insect         ornamental plants
    
                        Repellent
    
    ------------------  -------------  ------------------  ---------
    
    Metolachlor         Herbicide      Various crops,      Some uses
    
                                       lawns, ornamental
    
                                       plants, rights-of-
    
                                       way, forestry
    
    ------------------  -------------  ------------------  ---------
    
    Nabam               Antimicrobial  Water systems,      All uses
    
                                       other industrial
    
                                       uses
    
    ------------------  -------------  ------------------  ---------
    
    Nuranone            Insect         Agricultural and    All uses
    
                        (Japanese      ornamental plants
    
                        beetle) 
    
                        Pheromone 
    
    ------------------  -------------  ------------------  ---------
    
    Picloram            Herbicide      Rights-of-way,      All uses
    
                                       forestry, 
    
                                       rangelands,
    
                                       pastures, small
    
                                       grain crops
    
    ------------------  -------------  ------------------  ---------
    
    Polybutene          Bird and       Roosting sites,     All uses
    
                        Squirrel       other indoor and
    
                        Repellent      outdoor locations
    
    ------------------  -------------  ------------------  ---------
    
    Prometryn           Herbicide      Celery, cotton,     All uses
    
                                       dill
    
    ------------------  -------------  ------------------  ---------
    
    Propamocarb         Fungicide      Ornamental plants,  Some uses
    
                                       lawns, turf, golf
    
                                       courses
    
    ------------------  -------------  ------------------  ---------
    
    Sodium              Predator       Sheep, goats        All uses
    
    Fluoroacetate       (coyote)
    
    (1080)              Poison
    
    ------------------  -------------  ------------------  ---------
    
    Sodium Omadine      Antimicrobial  Industrial uses,    All uses
    
                                       chemical products
    
    ------------------  -------------  ------------------  ---------
    
    Starlicide          Bird Poison    Bird feeding and    All uses
    
                                       roosting areas 
    
    ------------------  -------------  ------------------  ---------
    
    Terbuthylazine      Algicide       Water systems,      All uses
    
                        Antimicrobial  fountains,
    
                                       aquaria
    
    ------------------  -------------  ------------------  ---------
    
    Tetrachlorvinphos   Insecticide    Livestock, pets,    Some uses
    
                                       various other sites
    
    ------------------  -------------  ------------------  ---------
    
    Trichlorfon         Insecticide    Various crops,      Some uses
    
                                       other indoor and
    
                                       outdoor sites
    
    ------------------  -------------  ------------------  ---------
    
    Trifluralin         Herbicide      Various crops,      Some uses
    
                                       ornamental plants
    
    ----------------------------------------------------------------
    
    
    
    
    
         Risk Reductions Achieved Through FY 1995 REDs
    
    
    
         The 1995 REDs include many changes intended to reduce risks
    
    to people and the environment. Some of the risk reduction
    
    measures achieved in the 40 REDs completed this fiscal year are
    
    summarized in the following table:
    
    
    
    ----------------------------------------------------------------
    
     Number of REDs   Risk Reduction Measures Required By RED
    
    ----------------  ----------------------------------------------
    
            2         Voluntary cancellation of all or many uses.
    
                      (Cyanazine voluntary cancellation of all
    
                      production for domestic use effective 12/31/99;
    
                      use of existing stocks will be phased out in
    
                      stages, and entirely by 1/1/03. Fenitrothion
    
                      voluntary cancellation of all uses except ant &
    
                      roach bait treatments.)
    
    
    
           14         Some uses deleted or not currently eligible
    
                      for registration.
    
    
    
            5         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.
    
    
    
           27         Personal Protective Equipment (PPE)            
    
                      requirements for pesticide applicators
    
                      strengthened or confirmed.
    
    
    
           21         Restrictions that limit entry of workers into
    
                      treated areas (including Restricted Entry
    
                      Intervals/REIs) strengthened or confirmed.
    
    
    
           19         Amount, frequency, or rate of application is
    
                      reduced, limited, or specified.
    
    
    
           40         Use Directions on labeling strengthened or 
    
                      made more specific, or Additional Restrictions
    
                      imposed.
    
    
    
           25         User safety measures required.
    
    
    
           10         Label Advisory or other measures to protect
    
                      ground or surface water required.
    
    
    
           18         Environmental Hazard statements to reduce
    
                      ecological risks strengthened.
    
    
    
           12         Tolerances revised (reduced, revoked, or newly
    
                      approved).
    
    ----------------------------------------------------------------
    
    
    
    
    
         Tolerances Reassessed
    
    
    
         As part of reregistration, OPP is reassessing pesticide
    
    tolerances, or maximum residue limits in food and feed. A
    
    pesticide must have a tolerance (or be granted an exemption from
    
    the tolerance requirement) for each different type of food or
    
    animal feed on which it may be used. The number of tolerances for
    
    the List A pesticides (which represent the most significant food
    
    use pesticides) was about 5,600 in November 1988, when the
    
    accelerated reregistration program began. Since then, almost
    
    1,000 (or 18%) of the List A pesticide tolerances have been
    
    reassessed as part of the reregistration process. 
    
    
    
         Several hundred more tolerances are associated with List A
    
    active ingredients no longer supported for reregistration. These
    
    active ingredients ultimately will be cancelled and their
    
    tolerances revoked. Meanwhile, OPP is actively revoking
    
    tolerances as warranted by the tolerance reassessment decisions
    
    reflected in the REDs. 
    
    
    
         Status Of Studies Received
    
    
    
         Registrants have responded to Data Call-Ins and other
    
    requirements by submitting over 20,000 studies in support of
    
    reregistration. Reviews of these studies provide the basis for
    
    OPP's reregistration decisions. By end of fiscal year 1995, OPP
    
    had reviewed almost 13,000 of these studies, including over 7,000
    
    of the 9,500 studies received for List A pesticides. The
    
    cumulative numbers of studies received, reviewed, and awaiting
    
    review by scientific discipline are shown in the following tables
    
    for the List A pesticides and for all pesticides undergoing
    
    reregistration. 
    
    
    
               Status Review Status For List A Pesticides
    
    
    
    --------------------------------------------------------------
    
    Study Type                     Received    Reviewed   Awaiting
    
                                                           Review
    
    -----------------------------  ----------  ---------  --------
    
    Residue Chemistry                2,962       2,309       653
    
    Environmental Fate               2,242       1,440       802
    
    Reentry Non-Dietary                214          59       155
    
    Toxicology, Non-CORT**           1,580       1,278       302
    
    Toxicology, CORT*                  766         684        82
    
    Ecological Effects               1,822       1,483       339
    
    ALL DISCIPLINES                  9,586       7,253     2,333
    
    --------------------------------------------------------------
    
    
    
    
    
                 Status Review Status For All Pesticides
    
            Undergoing Reregistration (Lists A, B, C, and D)
    
    
    
    --------------------------------------------------------------
    
    Study Type                     Received    Reviewed   Awaiting
    
                                                           Review
    
    -----------------------------  ----------  ---------  --------
    
    
    
    Residue Chemistry                4,760       3,102      1,658
    
    Environmental Fate               3,916       2,194      1,722
    
    Reentry Non-Dietary                283          67        216
    
    Toxicology, Non-CORT**           5,292       3,061      2,231
    
    Toxicology, CORT*                1,913       1,238        675
    
    Ecological Effects               4,529       3,249      1,280
    
    ALL DISCIPLINES                 20,693      12,911      7,782
    
    --------------------------------------------------------------
    
    
    
    * Tox., CORT -      Chronic feeding, carcinogenicity
    
                        (oncogenicity), reproduction, and
    
                        developmental toxicity (teratology) studies.
    
    ** Tox., Non-CORT - Studies other than CORT studies that measure
    
                        the toxicity of pesticides.
    
    
    
    
    
         Product Reregistration
    
    
    
         While REDs are OPP's major reregistration output, much of
    
    the real world impact of eligibility decisions and risk reduction
    
    measures occurs after the RED is issued, once products are
    
    reregistered. As of October 1995, about 2,200 products have
    
    completed this concluding phase. OPP has reregistered about 750
    
    of these products, granted 1,175 voluntary cancellations, amended
    
    20 existing registrations, and suspended 300. An additional 600
    
    products have just entered this phase, and decisions are pending
    
    on another 1,750. Activity in this important area is increasing
    
    rapidly and will accelerate during the next several years.
    
    
    
         Process Improvements
    
    
    
         Some innovations that have helped improve OPP's
    
    reregistration and Special Review processes and products during
    
    FY 1995 include the following:
    
    
    
         SRRD Peer Review Committee -- The Special Review and
    
    Reregistration Division (SRRD) Peer Review Committee, comprised
    
    of both staff and managers, is reviewing draft RED documents and
    
    Special Review Position Documents (PDs) to ensure clarity and
    
    consistency in addressing risk and regulatory issues. 
    
    
    
         Policy Capture Workgroup -- This workgroup is developing a
    
    means of capturing electronically the issues addressed, policies
    
    established, and risk mitigation measures required by key
    
    regulatory decisions, primarily REDs and Special Review Position
    
    Documents. 
    
    
    
         RED Process Improvement Committee -- This committee
    
    developed "A þHow toþ Guide for REDs" providing guidance on RED
    
    schedules, team responsibilities, and meetings.
    
    
    
         RED Document Improvement Workgroup -- This workgroup is
    
    considering new, more comprehensible ways to present and
    
    disseminate the large body of information currently contained in
    
    a complete RED document package. 
    
    
    
         Pesticide Use and Usage Data Outputs -- OPP is improving the
    
    compilation of pesticide use and usage information by
    
    consolidating information into a single database. While still in
    
    the developmental stage, it has already provided efficiencies by
    
    allowing quick access to a preliminary overview of pesticide use
    
    parameters. In a related effort, OPP is piloting a new matrix
    
    format to provide key pesticide usage parameters to be used in
    
    the development of REDs. These efforts will continue to be
    
    refined.
    
    
    
    Assessing Exposure to Turf Pesticides 
    
    
    
         OPP began a cooperative effort in 1995 with 35 pesticide
    
    manufacturers (the Outdoor Residential Exposure Task Force),
    
    California EPA, and Health Canada to obtain information on
    
    exposure to applicators and residents from pesticides used on
    
    home lawns. In March, OPP issued a Data Call-In for data which
    
    will be used to evaluate exposure to pesticides undergoing
    
    reregistration, as well as new pesticides being registered for
    
    the first time. The goal of the effort is to develop generic
    
    exposure data for different types of pesticide formulations so
    
    that exposure to lawn-care pesticides can be predicted without
    
    requiring data on specific compounds. This effort will save
    
    industry and OPP time and resources. Since the project is a joint
    
    effort with California and Canada, the findings from the required
    
    studies will be used to support pesticide registrations by their
    
    respective regulatory agencies as well. OPP expects the task
    
    force to begin submitting its initial findings in 1997 and to
    
    complete the effort in 1999.
    
    
    
    Pesticide Chemistry Laboratory Support For Reregistration
    
    
    
         In addition to supporting the pesticide registration
    
    program, as described in chapter 1, OPP's pesticide chemistry
    
    labs provide reregistration support. The labs work to confirm
    
    that the methods described by registrants for detecting pesticide
    
    residues in food and in the environment are effective. The
    
    Analytical Chemistry Laboratory (ACL) received 23 requests to
    
    validate food tolerance methods for reregistration in 1995, a
    
    marked increase from the seven requested in 1994, and validated
    
    nine methods. The Environmental Chemistry Laboratory (ECL)
    
    completed 20 analytical method validations for pesticides in soil
    
    and water under the reregistration program in 1995.
    
    
    
    Reducing Pesticide Spray Drift
    
    
    
         Aerial or ground application of pesticides may lead to off-
    
    target drift and result in exposure to workers, nearby residents,
    
    nontarget plants, and other ecological resources. During 1995 OPP
    
    continued its work with the Spray Drift Task Force (SDTF), an
    
    industry consortium conducting research into the factors which
    
    contribute to and can control spray drift. During 1995, the task
    
    force submitted its research results to OPP. OPP began a
    
    comprehensive scientific review of the data in 1995 and the
    
    review will continue during 1996. 
    
    
    
         In 1995, OPP continued its work with EPA's Office of Re-
    
    search and Development to develop computer models which will
    
    estimate the potential for off-target pesticide drift and suggest
    
    methods for reducing drift. Also, in conjunction with the SDTF
    
    and following input from some state and pesticide applicator
    
    groups, OPP developed a set of Best Management Practices (BMPs)
    
    for aerial pesticide application. During 1995, the BMPs were
    
    added to REDs, new chemical registrations, and other OPP actions
    
    involving aerial pesticide applications.
    
                        Chapter 3: Special Review
    
    
    
         Special Review is EPA's formal process for determining
    
    whether the use of a pesticide poses unreasonable risks to people
    
    or the environment. In making this determination, EPA must
    
    consider the pesticide's risks and benefits. Special Review is
    
    designed to allow formal public input to the decision-making
    
    process. A Special Review can result in a decision to cancel,
    
    restrict, or continue the pesticide uses in question. 
    
    
    
         The Special Review process is set in motion when EPA has
    
    reason to believe that the use of a registered pesticide poses
    
    significant risks to people or the environment. Over 100
    
    pesticides or groups of closely related pesticides have been
    
    evaluated through Special Review. While reregistration applies to
    
    all older pesticides, Special Reviews apply to those pesticides
    
    of particularly serious concern.
    
    
    
    1995 Formal Special Reviews And Follow-up Activities
    
    
    
         Triazines and the Cyanazine Phaseout
    
    
    
         OPP initiated a Special Review for these related herbicides
    
    in November 1994. Up to 121 million pounds of atrazine,
    
    cyanazine, and simazine are used yearly on food crops including
    
    corn, and on cotton and turf. Atrazine currently is one of the
    
    two most widely used agricultural pesticides in the U.S. (based
    
    on pounds of active ingredient applied per year) and cyanazine
    
    ranks among the top five agricultural pesticides. In initiating
    
    the Special Review, the Agency determined that the triazines may
    
    pose significant risks of cancer due to exposure to residues in
    
    food and drinking water and through exposure when mixing,
    
    loading, and applying these pesticides. Growers, professional
    
    agricultural and lawn care applicators, and some homeowners
    
    appear to be at risk from using one or more of these products.
    
    OPP is also concerned about the risks to the environment from the
    
    large amount of triazines used. 
    
    
    
         Because each of the three pesticides appear to have similar
    
    potential to cause adverse effects, and because they can be used
    
    to some degree interchangeably, OPP decided to address their
    
    risks simultaneously. The announcement of the Special Review
    
    prompted over 87,000 public comments, all of which have been
    
    screened. The substantive comments are now being evaluated. The
    
    Agency's risk and benefit analyses, including responses to the
    
    comments, should be published by the end of 1996.
    
    
    
         In August 1995, the primary registrant, DuPont, agreed to
    
    completely phase out production of cyanazine for domestic use and
    
    to voluntarily cancel its registration effective December 31,
    
    1999. (The other formulator of cyanazine is now compelled to
    
    follow suit). Use of remaining stocks will be allowed through
    
    2002, but maximum use rates will drop incrementally in 1997,
    
    1998, and 1999. OPP believes that a significant reduction in
    
    potential risks from exposure to cyanazine will result from these
    
    reductions in cyanazine production and use. Additionally,
    
    beginning in 1998, all applications must be made from within a
    
    closed cab (meaning that the driver of the vehicle applying the
    
    pesticide is enclosed in a cab designed to significantly reduce
    
    the exposure to pesticides being applied). The Agency expects to
    
    terminate the Special Review of cyanazine in 1996.
    
    
    
         Lindane
    
    
    
         In March 1994, the Agency proposed not to initiate a Special
    
    Review of lindane. The proposal was prompted by a review of
    
    studies in which laboratory animals were exposed to this
    
    organochlorine insecticide. Initially, OPP was concerned about
    
    risks to humans based on an effect on kidney function in male
    
    rats; the kidney effect is a serious and uncommon one that is
    
    usually associated with exposure to petroleum products. Further
    
    research showed that the lindane effect was particular to male
    
    rats, not female rats or any other species tested, and unlikely
    
    to occur in humans. OPP formally closed the Special Review for
    
    kidney effects in July 1995. Comments on the 1994 proposal,
    
    however, identified lindane as a potential disrupter of the
    
    endocrine system, so the Agency is now developing a strategy for
    
    evaluating that effect in lindane and three other organochlorine
    
    pesticides that are candidates for reregistration.
    
    
    
         Propoxur
    
    
    
         In January, the Agency proposed not to initiate a Special
    
    Review of propoxur, an insecticide once suspected of posing an
    
    unreasonable cancer risk to residents and pest control
    
    professionals. Propoxur is used to control indoor pests such as
    
    ants and cockroaches and also to control fleas on pets. In its
    
    proposal, OPP reported that the cancer risk has diminished since
    
    the Special Review was first suggested in 1988 because the
    
    registrants voluntarily dropped the uses which caused the
    
    greatest concern. OPP also reported that a reevaluation of
    
    exposure data and the cancer potency of propoxur indicated that
    
    the remaining uses are likely to present only negligible risks.
    
    OPP expects to complete its review of comments and issue a final
    
    decision in FY 1996.
    
    
    
         Carbofuran
    
    
    
         The uses of granular carbofuran on corn, sorghum, and rice
    
    were marked for phaseout by 1994 because of risks to wildlife,
    
    which were substantiated by large and widespread bird kills in
    
    and around treated fields. Birds of prey (such as eagles),
    
    waterfowl, game birds, and songbirds were all affected. The
    
    registrant appealed the decision, and in March 1995, the Agency
    
    rejected the reinstatement of uses on corn and sorghum while
    
    extending the use on rice for two years. The rice decision was
    
    based on a continued lack of alternatives to control the rice
    
    water weevil, a serious rice pest, and on the vigorous approach
    
    rice growers took to adopt environmental stewardship practices to
    
    protect wildlife at risk. These practices included working with
    
    the State of California and other agencies to identify and avoid
    
    times and sites where carbofuran application poses the greatest
    
    risk to threatened species, such as the bald eagle and the giant
    
    garter snake. The rice growers organization also supported a user
    
    education program and the development of publications for the
    
    program. The Agency is currently negotiating with the registrants
    
    of liquid carbofuran formulations to mitigate wildlife risks.
    
    
    
         Dichlorvos
    
    
    
         OPP issued a proposal to minimize the cancer and
    
    neurological risks of the insecticide dichlorvos (DDVP) in
    
    September 1995. Dichlorvos is used to control pests in the home,
    
    on livestock and manure, and in warehouses. The Agency is
    
    proposing to cancel some uses of dichlorvos, including all
    
    residential uses and use on stored food. Additional uses could be
    
    cancelled unless certain changes, such as restrictions on reentry
    
    into treated areas and prohibition of use except by licensed
    
    applicators wearing protective clothing, are incorporated into
    
    product labels. Public comment on the proposal will be accepted
    
    for 90 days.
    
    
    
    Limited Reintroduction Of Aldicarb Use On Potatoes
    
    
    
         When excessive residues of aldicarb appeared on potatoes in
    
    1990, the Agency halted its sale and use in potato production. In
    
    September 1995, the Agency reapproved this use for farmers using
    
    positive displacement equipment -- a new technology designed to
    
    control application rates more precisely and prevent spills and
    
    leaks. Use on potatoes is permitted only in Oregon, Idaho,
    
    Washington, Montana, northern Florida, and parts of Utah and
    
    Nevada, where the risk of ground-water contamination is believed
    
    to be low. Several other measures to reduce risks have also been
    
    imposed: furrow irrigation is prohibited; use after planting is
    
    prohibited; and the minimum interval between aldicarb application
    
    and potato harvest has been extended from 90 days to 100 days in
    
    Florida and 150 days elsewhere. Additionally, anyone wishing to
    
    apply aldicarb must receive special training in product
    
    stewardship. The reinstatement of use on potatoes is supported by
    
    data from the registrant showing that residue levels under the
    
    new application technology are within safe limits. Federal
    
    agencies will continue to monitor potatoes for aldicarb residues.
    
    The Special Review of aldicarb on the issue of ground-water
    
    contamination is still proceeding.
    
    
    
    
    
            Chapter 4: Field Implementation and Communication
    
    
    
         The first three chapters of this report have focused largely
    
    on OPP's work to ensure that individual pesticides are
    
    appropriately licensed, that decisions are made in a timely
    
    manner, and that the conditions of registration reflect up-to-
    
    date scientific standards. This chapter turns to the important
    
    area of field implementation and communication: OPP's work with
    
    pesticide users and others to ensure safe pesticide use practices
    
    are implemented in the field and to provide organizations and
    
    individual citizens with the information they need to make
    
    environmentally sound pesticide decisions. These efforts
    
    complement the pesticide regulatory programs described in the
    
    first three chapters and are critical to achieving our nation's
    
    health and environmental protection goals.
    
    
    
                            A. Field Programs
    
    
    
         OPP managed four major field programs in FY 1995. These
    
    programs are aimed at protecting agricultural workers, endangered
    
    species and ground water from pesticide risks, and ensuring that
    
    applicators of potentially more hazardous pesticides are
    
    appropriately trained and certified in their use. In all of these
    
    programs, OPP relies heavily on cooperative relationships with
    
    regional offices, state and tribal pesticide regulatory agencies,
    
    other public and private organizations, and individuals. Only
    
    through the combined efforts of all of these groups can EPA's
    
    field programs be successfully implemented. 
    
     
    
    Implementing The Worker Protection Standard
    
    
    
         OPP's Worker Protection Standard (WPS) for agricultural
    
    pesticides became fully effective on January 1, 1995. The
    
    Standard represents a major strengthening of national efforts to
    
    safeguard agricultural workers. It requires agricultural
    
    employers to ensure that employees receive basic training in
    
    pesticide safety and to notify workers when pesticides are
    
    applied. Employers also must provide washing facilities and
    
    supplies if workers are likely to come into contact with
    
    pesticides, and provide and maintain protective equipment to
    
    reduce potential health risks due to pesticide exposure in
    
    agriculture. OPP believes that effective implementation of the
    
    WPS will substantially reduce the risk of pesticide poisonings
    
    among agricultural workers and pesticide handlers.
    
    
    
         In 1995, OPP carried out a number of WPS activities in
    
    collaboration with EPA's ten regional offices. In addition, OPP
    
    continued to refine requirements to maximize effective protection
    
    for workers in a wide variety of agricultural settings, while
    
    ensuring appropriate flexibility in implementation. Highlights of
    
    OPP's 1995 efforts include:
    
    
    
       o Ongoing work with pesticide registrants to ensure that the
    
         labeling of all agricultural pesticides was revised to
    
         convey stronger worker protection requirements, such as
    
         restrictions on entry into treated areas and use of personal
    
         protective equipment. The goal of ensuring that all end-
    
         users received the required WPS labeling by October 1995 was
    
         achieved, without creating undue burdens on the pesticide
    
         industry.
    
    
    
       o Work with the states, USDA's Cooperative Extension Service,
    
         and the agricultural community to help employers obtain the
    
         information and assistance they need. OPP created or funded
    
         1,100,000 grower compliance manuals, 2,700,000 safety
    
         training manuals, 685,000 safety posters, 11,500 safety
    
         training videos, and 6,000 grower compliance video/slide
    
         sets that were made available free or at low cost to farmers
    
         and farmworkers.
    
    
    
       o Implementation of a voluntary program to issue training
    
         verification cards to agricultural workers and pesticide
    
         handlers upon completion of WPS training. This will promote
    
         safety training and help agricultural employers fulfill
    
         their responsibilities by making it easier for them to
    
         verify that their workers have been trained. To date,
    
         2,500,000 training verification cards have been distributed
    
         to the 42 states, Puerto Rico, and two tribes participating
    
         in the program.
    
    
    
       o Workshops, periodic meetings, and ongoing discussions with
    
         agricultural groups and farmworker organizations affected by
    
         the WPS. These discussions enabled OPP to identify key
    
         concerns, resolve problems and improve implementation. 
    
    
    
       o Implementation of a process for considering requests for
    
         exceptions to WPS requirements. Under the WPS, OPP may
    
         approve exceptions if the benefits outweigh the costs
    
         (including any health risks attributable to the exception).
    
         In 1995, OPP denied an exception to the WPS early entry
    
         restrictions for uses of chlorothalonil in certain states,
    
         because the information supplied to OPP did not justify the
    
         exception.
    
    
    
       o Issuing several final rules that strengthened WPS safety
    
         training requirements, but reduced certain requirements in
    
         situations where the restrictions were not necessary to
    
         achieve WPS objectives. For example, OPP reduced
    
         requirements for crop advisors who have already been through
    
         comprehensive training, for irrigation activities and other
    
         work that results in only limited contact with pesticides,
    
         and for situations involving use of relatively low risk
    
         pesticides.
    
    
    
    Endangered Species Protection Program
    
    
    
         The primary goal of OPP's Endangered Species Protection
    
    Program (ESPP) is to protect federally listed threatened and
    
    endangered species from the direct and indirect impacts of
    
    pesticide use, while minimizing regulatory burdens on pesticide
    
    users. OPP's current ESPP is an interim non-regulatory program. A
    
    final program will be established that reflects any necessary
    
    changes once Congress enacts legislation reauthorizing the
    
    Endangered Species Act.
    
    
    
         During this interim period, the ESPP relies primarily on the
    
    development and dissemination of county-specific pamphlets that
    
    describe voluntary measures pesticide users can take to avoid
    
    affecting endangered species. In 1995, OPP began developing the
    
    pamphlets internally, ending dependence on contractors. A total
    
    of 277 pamphlets have been completed and are being distributed
    
    with state assistance in 25 states and Puerto Rico. OPP also
    
    developed additional fact sheets on endangered species in FY
    
    1995, bringing the total to 59, and continued to operate a toll-
    
    free endangered species hotline. 
    
    
    
         In implementing the ESPP, OPP works closely with EPA
    
    regions, states, and other federal agencies. The ESPP allows
    
    states to develop plans to protect species in their states in a
    
    manner suited to local conditions. At present, 20 states have
    
    developed plans, which may include detailed assessments and site-
    
    specific protection measures as well as provisions for agreements
    
    with landowners to protect species on their property. During
    
    1995, OPP completed a status review of the plans, and (working
    
    with the U.S. Fish and Wildlife Service) approved the first two,
    
    prepared by North Dakota and Kansas. Several other states are
    
    close to approval. 
    
    
    
         Other FY 1995 highlights include:
    
    
    
       o Continuing cooperative efforts with the Wyoming Department
    
         of Agriculture, U.S. Fish and Wildlife Service (FWS), and
    
         EPA's Region 8 to locate and protect the Wyoming toad. Local
    
         landowners again agreed to delay pesticide applications
    
         until their lands were searched for the presence of toads.
    
         Although reintroductions of this endangered species are
    
         being made in wildlife refuges, it appears that the toad no
    
         longer exists elsewhere in the wild, and all of the searched
    
         lands were cleared for pesticide use.
    
    
    
       o Initiation of efforts to clarify the roles of OPP and
    
         federal land management agencies to protect species.
    
         Procedures have been worked out with the National Park
    
         Service and are being developed with the Department of
    
         Defense and the U.S. Forest Service.
    
    
    
       o Cooperation with pesticide manufacturers, who have formed a
    
         task force to provide extensive and valuable information
    
         about where endangered species are located, relative to
    
         pesticide use sites on private lands.
    
    
    
       o Verification with the FWS of the accuracy of OPP's
    
         comprehensive national database of the county-by-county
    
         location of endangered species. This database is available
    
         to other EPA offices and federal agencies, and to the public
    
         upon request.
    
    
    
    Protecting Ground Water
    
    
    
         Protection of ground water from pesticide contamination is
    
    the focus of OPP's third major field program. Ground water is a
    
    priority concern for both human health and environmental
    
    protection reasons. It is the source of drinking water for about
    
    half of the U.S. population, and because it flows into lakes and
    
    rivers it helps supports fish and wildlife habitats and
    
    commercial activity.
    
    
    
         The centerpiece of OPP's ground-water strategy is a
    
    cooperative effort with the states and EPA regions to develop
    
    State Management Plans (SMPs) to prevent ground-water pollution
    
    from pesticides. Forty-eight states have submitted draft
    
    "generic" SMPs, designed to create capacity for protecting ground
    
    water regardless of the particular pesticides used. The other two
    
    states are developing pesticide-specific plans in lieu of a
    
    generic plan. In 1995, EPA regions concurred (with comments) on
    
    three of the state plans, and are expected to concur on the
    
    remaining plans by the end of 1996. In 1995, OPP completed much
    
    of the work on the next major step, a proposed rule requiring
    
    SMPs for five widely-used herbicides frequently detected in
    
    ground water. OPP consulted extensively with state officials
    
    during 1995, so the proposed rule is expected to have broad
    
    support among the states when published for comment in 1996.
    
    
    
         Another important feature of OPP's strategy has been to
    
    evaluate a pesticide's potential to contaminate ground water
    
    whenever OPP makes registration and reregistration decisions,
    
    with an emphasis on early mitigation of ground-water risks, as
    
    first implemented in 1994. The Agency is also continuing to track
    
    evidence of ground-water contamination through its Pesticides in
    
    Ground Water Database. In 1992, the Agency proposed a rule to
    
    establish specific criteria for classifying a pesticide as
    
    "restricted use" if any of its ingredients has the potential for
    
    contaminating ground water on a widespread basis. Restricted use
    
    pesticide products may be purchased and used only by certified
    
    pesticide applicators or individuals under their supervision. OPP
    
    believes that these specialized requirements will reduce the
    
    potential for ground-water contamination. In 1995, OPP completed
    
    much of the work on the final rule, which will be published in
    
    1996.
    
    
    
    Certification And Training Of Pesticide Applicators
    
    
    
         When OPP designates some or all uses of a pesticide as
    
    "restricted use," then the pesticide may only be used by or under
    
    the direct supervision of specially trained and 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, to maintain
    
    their certification. States also sometimes require
    
    recertification or other training for private applicators.
    
    
    
         Over one million applicators are currently certified
    
    nationwide, including over 900,000 private applicators and about
    
    350,000 commercial applicators. In 1994, the most recent year for
    
    which figures are available, more than 80,000 private and 60,000
    
    commercial applicators were certified. More than 120,000 private
    
    and 120,000 commercial applicators were recertified in the same
    
    year. In addition, several hundred thousand applicators attended
    
    training sessions to learn or review appropriate methods for
    
    applying pesticides, in some cases as part of receiving or
    
    maintaining certifications.
    
    
    
         In FY 1995, OPP continued work to revise national standards
    
    to better ensure continued competency of certified applicators.
    
    To assist state, territorial and tribal governments in conducting
    
    certification programs, OPP also funded 64 cooperative agreements
    
    and provided support to state extension coordinators through the
    
    U.S. Department of Agriculture. Other activities included support
    
    for train-the-trainer and pesticide applicator workshops;
    
    development of training materials on improving pesticide drift
    
    management and application technology; and methods for evaluating
    
    behavioral and attitudinal changes in applicators as a result of
    
    certification and training programs.
    
    
    
          B. Communications, Public Response, and Coordination
    
    
    
         Few organizations serve a wider "public" than OPP.
    
    Communications efforts must be tailored to the needs of a broad
    
    spectrum of constituents who are affected by or interested in OPP
    
    actions and policies: other EPA offices and regions, state and
    
    tribal agencies, individual citizens, environmental and public
    
    interest groups, industry and trade associations, pesticide
    
    users, health professionals, academia, foreign governments and
    
    international organizations, Congress and other federal agencies,
    
    and the media. 
    
    
    
         Appropriate outreach activities are vital to OPP's efforts
    
    to ensure that groups and individuals have the information they
    
    need to make responsible decisions about pesticides and promote
    
    public health and environmental protection goals. The challenge
    
    is to make information widely available, easily accessible, and
    
    suited to the needs of OPP's many "publics." To accomplish this,
    
    OPP issues announcements and publications for both general and
    
    scientific audiences, provides information by telephone and
    
    electronic network, responds to written requests for information,
    
    maintains a public docket for walk-in visitors, holds public
    
    meetings, and presents speeches and Congressional testimony. This
    
    section describes some of the ways OPP provides information and
    
    obtains valuable public input. Additional information on
    
    electronic information dissemination is found in chapter 6.
    
    
    
    Outreach And Communications Strategies
    
    
    
         In 1995, OPP issued approximately 65 announcements informing
    
    the public of major regulatory and policy decisions, continuing
    
    an upward trend from 1994. Each announcement is planned using a
    
    communications strategy, which often entails a press notice and
    
    additional outreach materials, such as fact sheets or questions
    
    and answers. In addition, OPP issued background materials to
    
    respond to inquiries arising out of media reports on pesticide-
    
    related issues. 
    
    
    
         Public demand for pesticides information increased
    
    dramatically in FY 1995. Directly and through the National Center
    
    for Environmental Publications and Information, OPP managed
    
    distribution of over 700,000 copies of publications, a four-fold
    
    increase over FY 1994.
    
    
    
         OPP is working with others inside and outside EPA to
    
    increase public awareness of available information resources on
    
    pesticides and ensure the most cost-effective, timely
    
    distribution of educational materials. One key accomplishment in
    
    FY 1995 was the production of an updated catalogue of pesticide
    
    publications. The catalogue was distributed in "hard copy" in
    
    1995; it will be posted electronically and updated annually in
    
    the future. 
    
    
    
         Significant new publications developed in FY 1995 include
    
    joint publication with the Occupational Safety and Health
    
    Administration of a Guide to Heat Stress for Agricultural Workers
    
    and a major update and expansion of OPP's core consumer
    
    publication, Citizen's Guide to Pest Control and Pesticide
    
    Safety, to be printed and distributed in FY 1996. 
    
    
    
         Protecting children from pesticide poisoning continues to be
    
    an important focus of outreach efforts. In collaboration with the
    
    Poison Prevention Council and the Consumer Product Safety
    
    Commission, OPP participated in Poison Prevention Week and other
    
    activities, distributing thousands of copies of fact sheets to
    
    medical establishments and the general public. Fact sheet topics
    
    included child safety and using insect repellents safely (both in
    
    English and Spanish).
    
    
    
    Responding To The Public
    
    
    
         Freedom of Information Act (FOIA) Requests
    
    
    
         OPP responds to technical or complicated requests for
    
    information from the public under the Freedom of Information Act
    
    (FOIA). OPP continues to receive the highest number of FOIA
    
    requests of any program within EPA, and in fiscal year 1995
    
    received 1,537 requests and completed 1,235 responses. The
    
    majority of requestors receive all of the records requested, with
    
    the most common requests being for science reviews of
    
    registration data, administrative files for pesticide products,
    
    and reregistration information.
    
    
    
         OPP Public Docket
    
    
    
         OPP has established four dockets to house the regulatory
    
    notices, background documents, and public comments on OPP
    
    activities. These consist of the Federal Register, Special
    
    Review, Registration Standard, and Special Program Dockets. The
    
    docket now has the capability to accept the electronic submission
    
    of public comments. The most active docket action was the
    
    Triazines Special Review, which received over 87,000 public
    
    comments. Over 2,000 requests for docket information received by
    
    letter, telephone, and in person were filled in fiscal year 1995.
    
    
    
         National Pesticides Telecommunications Network (NPTN)
    
    
    
         NPTN is a national service accessible by a toll-free
    
    telephone number that provides objective information about
    
    pesticides upon request to anyone in the United States, Puerto
    
    Rico, and the Virgin Islands. The service operates Monday through
    
    Friday from 6:30 a.m. to 4:30 p.m. (Pacific Time). NPTN provided
    
    services to more than 17,000 callers during fiscal year 1995,
    
    including approximately 1,700 calls concerning pesticide
    
    incidents. The remaining calls were requests for general
    
    information on pesticide products and issues concerning health,
    
    safety, and use.
    
    
    
         National Pesticide Medical Monitoring Program (NPMMP)
    
    
    
         The NPMMP, located at Oregon State University, provides
    
    information and referrals on clinical toxicology questions and
    
    analytical services for biological and environmental samples.
    
    Health care professionals and possible victims of pesticide
    
    poisonings are major users of the service. NPMMP handled 452
    
    incidents in FY 1995.
    
    
    
         Other Letters and Inquiries
    
    
    
         Rising public interest in pesticides and their effects on
    
    people and the environment is reflected in the hundreds of
    
    letters and telephone inquiries that OPP receives annually. In
    
    1995, OPP prepared responses for senior EPA officials to over
    
    1,600 letters, ranging from highly complex Congressional
    
    inquiries to postcard write-in campaigns. In addition to the
    
    docket letters described above, OPP received over 30,000 cards
    
    and letters supporting alternatives to animal testing and nearly
    
    1,000 letters on biotechnology issues. The triazines Special
    
    Review (involving ground-water issues) was the next most popular
    
    topic, with over 70 letters. Other frequent subjects included the
    
    Worker Protection Standard, pesticides and children, the Delaney
    
    clause and other food safety issues. Over the past year, OPP laid
    
    the groundwork to be one of the first EPA offices to adopt a new
    
    automated correspondence control and information storage and
    
    retrieval system. This will enhance efficiency and allow improved
    
    responsiveness to OPP's many customers.
    
    
    
    Congressional Relations And Coordination With Other Federal
    
    Agencies
    
              
    
         Congressional interest and oversight of pesticide and food
    
    safety issues continues at a high level. Over 450 of the letters
    
    described above were responses to Congressional inquiries. In
    
    addition, OPP prepared testimony and briefing materials for four
    
    Congressional hearings on pesticide issues and activities,
    
    including implementation of the Worker Protection Standard and
    
    proposals for major changes in legislation governing pesticide
    
    regulation and food safety. 
    
    
    
         OPP continued to assist the General Accounting Office and
    
    EPA's Inspector General with several ongoing evaluations of
    
    pesticide program activities, including implementation of the
    
    Worker Protection Standard, activities to address alternatives to
    
    the pesticide methyl bromide (scheduled for phaseout under the
    
    Clean Air Act), management of the fees paid by pesticide
    
    registrants, incident monitoring and follow-up, the progress of
    
    reregistration of older pesticides, and a review of the effect of
    
    environmental laws and regulations on U.S. agriculture and other
    
    industry.
    
    
    
         Pesticide and pest control issues often involve the
    
    jurisdiction of several federal agencies. To promote efficiency
    
    and consistency of federal effort, OPP coordinates many of its
    
    activities with those agencies through Memoranda of Understanding
    
    and less formal working groups. Some of the areas of common
    
    activity are: FDA -- food safety and antimicrobial pesticides
    
    (such as hospital disinfectants); USDA -- food safety and farm-
    
    related regulations (such as worker protection and pesticide
    
    storage and disposal); Consumer Product Safety Commission --
    
    labeling issues; Department of Interior -- endangered species;
    
    Occupational Safety and Health Administration -- worker
    
    protection; Customs and Coast Guard -- import and export issues;
    
    Department of Defense -- pest control on military installations;
    
    and Department of Transportation -- harmonization of safety
    
    standards for hazardous chemicals.
    
    
    
         One example of OPP federal coordination in 1995 was its
    
    interagency agreement with the U.S. Geological Survey (USGS).
    
    This agreement will allow OPP to access USGS monitoring data and
    
    information on water quality trends, thereby enhancing OPP's
    
    ability to assess ground and surface water vulnerability to
    
    pesticide contamination and to make sound regulatory decisions to
    
    protect water resources.
    
    
    
    National Agricultural Pesticide Impact Assessment Program
    
    (NAPIAP)
    
    
    
         OPP played a significant role in the independent panel
    
    review of NAPIAP, a USDA program. Recognizing significant changes
    
    in the demands for information and in regulatory priorities,
    
    tight budgets, and government reinvention, the panel was charged
    
    with evaluating NAPIAP in the context of USDA's overall pesticide
    
    and pest management information function. The panel's report
    
    highlighted 13 key findings and recommendations. The report
    
    reaffirmed NAPIAP's primary mission to provide science-based
    
    benefits information that contributes to EPA's pesticide
    
    regulatory decisions. The report recommended improving benefits
    
    information by establishing formal procedures and assessment-
    
    specific protocols, and continuing to improve communications and
    
    cooperation between USDA and EPA. OPP is continuing to work with
    
    USDA to address these recommendations.
    
    
    
    International Coordination And Integration
    
    
    
         This section describes OPP's efforts to inform foreign
    
    governments about changes in the status of pesticides in the U.S.
    
    and major OPP programs. The purpose of these efforts is to help
    
    foreign governments, especially those that have not yet developed
    
    extensive pesticide regulatory and information-gathering
    
    programs, make informed choices about the use of pesticides in
    
    their countries. Not only do these efforts benefit citizens of
    
    foreign nations, but they also benefit Americans by helping to
    
    ensure the safety of imported food and other commodities treated
    
    with pesticides. In addition, these efforts help to protect
    
    wildlife, like migratory birds, that cross international borders.
    
    
    
         Export Notification for Unregistered Pesticides
    
    
    
         For all exports of pesticides not registered in the United
    
    States, section 17(a) of the Federal Insecticide, Fungicide, and
    
    Rodenticide Act (FIFRA) requires the U.S. exporter to obtain a
    
    statement from the buyer acknowledging that the product is not
    
    registered. The exporter must submit this statement to OPP, and
    
    OPP forwards a copy to the importing government. In 1995, OPP
    
    transmitted approximately 2,000 export notifications for about
    
    260 pesticide active ingredients to the governments of more than
    
    125 importing countries. Since 1992, reporting has increased by
    
    more than 150% for exports containing active ingredients approved
    
    in other U.S. products, but where the particular export
    
    formulation is not registered by OPP. In 1994, such pesticides
    
    comprised more than half of the unregistered pesticide exports. 
    
    
    
          Reinventing EPA's Pesticide Export Notification Program
    
    
    
         In September 1995, as part of the effort to reinvent
    
    government, OPP made options for revising its pesticide export
    
    notification policies available for public comment. The key
    
    option would take a risk-based approach in determining when
    
    export notices would be required, significantly reducing the
    
    number of exports subject to notification. After consideration of
    
    comments, OPP will revise its current requirements. In addition,
    
    the European Union (EU) has recently announced plans to revise
    
    its pesticide export regulations. This announcement presents an
    
    opportunity for the United States to work with the EU in
    
    developing complementary export notification programs.
    
    
    
         Information Exchange with Foreign Countries
    
    
    
         Another provision of FIFRA, section 17(b), requires OPP to
    
    share information with health and environmental agencies in other
    
    countries. Under this requirement, OPP sends notices to other
    
    governments on important regulatory decisions made in the United
    
    States related to pesticides, food safety, and pest management.
    
    In 1995, OPP transmitted 31 notices covering a range of
    
    regulatory actions, such as initiation of the triazine Special
    
    Review and the new agricultural Worker Protection Standard.
    
    Notifications are distributed directly to pesticide regulatory
    
    authorities in approximately 140 countries. 
    
    
    
         Prior Informed Consent (PIC)
    
    
    
         OPP continues to actively participate in this joint program
    
    developed by the United Nations Environment Programme (UNEP) and
    
    the U.N. Food and Agriculture Organization (FAO) to promote the
    
    safe management of chemicals in international trade. PIC
    
    establishes a mechanism whereby importing countries can receive
    
    information about pesticides and industrial chemicals and then
    
    make informed decisions on whether to allow, restrict, or
    
    prohibit future imports. In 1995, OPP prepared a discussion paper
    
    for FAO/UNEP on determining which pesticides pose particular
    
    concerns under conditions of use in developing countries,
    
    reviewed draft FAO/UNEP Decision Guidance Documents prepared to
    
    assist importing countries, and responded to requests from other
    
    countries for additional information. 
    
    
    
         Work progressed internationally toward making PIC a legally
    
    binding instrument. Formal negotiations toward an international
    
    treaty are expected in FY 1996. 
    
    
    
         International Visitors
    
    
    
         OPP arranges briefings with key U.S. officials for foreign
    
    visitors interested in U.S. pesticide policies and scientific
    
    evaluation procedures. During the past fiscal year, OPP hosted 85
    
    visitors, including representatives from Australia, Brazil,
    
    Canada, Chile, Denmark, France, Hong Kong, Indonesia, Japan,
    
    Latvia, Malaysia, South Korea, Moldova, New Zealand, Russia,
    
    Taiwan, the United Kingdom, and Venezuela.
    
    
    
    Regional, State, And Tribal Liaison
    
    
    
         Regional Coordination
    
    
    
         EPA's 10 regional offices are OPP's primary connection to
    
    state, territorial, and tribal governments. They negotiate
    
    cooperative agreements for OPP's field programs, assist in
    
    developing and implementing programs, and oversee accomplishments
    
    and commitments made by the states, territories and tribes.
    
    Regional staff communicate OPP's programs and policies to the
    
    public and in turn provide OPP with public input. 
    
    
    
         State and Territorial Programs
    
    
    
         States and territories are true partners with EPA in
    
    protecting human health and the environment from pesticide risks.
    
    They assist in developing and implementing field programs, and
    
    they enforce OPP's regulations and pesticide labeling and use
    
    requirements. To further these common goals, OPP supports a
    
    cooperative agreement with the Association of American Pesticide
    
    Control Officials for the State FIFRA Issues Research and
    
    Evaluation Group (SFIREG). In 1995, SFIREG continued to meet
    
    periodically with OPP to develop pesticide programs and discuss
    
    implementation and enforcement issues of concern to the states
    
    and territories.
    
    
    
         Tribes
    
    
    
         Native American tribal governments have sovereign rights and
    
    certain specific assurances from the federal government under
    
    treaties. The capacity of tribal governments to carry out
    
    environmental regulatory programs varies significantly from tribe
    
    to tribe, and the challenge for OPP is to accommodate tribal
    
    differences while ensuring that basic health and environmental
    
    protections are achieved for all Native Americans.
    
    
    
         OPP is working with tribes to assist them in building
    
    capacity to conduct regulatory and field programs for pesticides.
    
    In 1995, OPP helped fund an environmental scholarship program to
    
    assist college students studying environmental sciences and
    
    interested in addressing Native American issues. OPP also
    
    sponsored a Native American intern to work on these issues and
    
    learn more about how EPA works, supported efforts by the Native
    
    American Higher Education Consortium to develop college-level
    
    courses related to pesticide safety, and developed and piloted a
    
    seminar on Native American culture and history for OPP staff.
    
    
    
         OPP is also addressing specific issues uniquely affecting
    
    Native Americans. In 1995, OPP continued work with other state
    
    and federal authorities to address potential pesticide exposure
    
    by members of the California Indian Basketweavers Association
    
    (CIBA). CIBA members are concerned about potential exposure to
    
    pesticides from contact with native plant materials used in
    
    traditional basketweaving. 
    
    
    
    Laboratory Tools
    
    
    
         Pesticide Chemistry Laboratories (PCLs) in Beltsville,
    
    Maryland, and Bay St. Louis, Mississippi, support EPA regions and
    
    states with technical reference standards, technical assistance,
    
    and laboratory services. (Technical reference standards are
    
    pesticide samples of known concentration that can be used, for
    
    example, in verifying the formulations of pesticides being
    
    offered for sale.) In FY 1995, OPP distributed 735 technical
    
    reference standards to the regions and states, and PCLs responded
    
    to 76 requests for assistance. Most of the requests came from
    
    chemists in other federal, state or private labs. OPP's PCLs are
    
    the primary repository for all food tolerance, product, and
    
    environmental chemistry methods, as described in chapters 1 and
    
    2.
    
    
    
         In 1995, OPP also drafted an Environmental Chemistry Methods
    
    Manual describing how to detect pesticides in soil and water.
    
    When finalized, it will include introductory chapters, formatted
    
    methods developed by EPA or pesticide registrants, and technical
    
    appendices. OPP is planning wide distribution and will make the
    
    manual available to public and private labs for a fee.
    
    
    
             Chapter 5: Policy, Regulations, and Guidelines
    
    
    
         OPP makes many individual decisions in its registration,
    
    reregistration, and special review programs. To guide these
    
    decisions and inform its many stakeholders, OPP develops
    
    regulations, policy documents, guidelines and analyses covering
    
    scientific, legal, and international matters. Active public
    
    participation and feedback is critical to the development of
    
    practical pesticide policies. Regulations are published for
    
    notice and comment in the Federal Register. When final, they are
    
    incorporated in the Code of Federal Regulations. OPP makes other
    
    policy and guidance documents available through a variety of
    
    mechanisms, such as the Government Printing Office, direct
    
    mailings, and increasingly, through electronic dissemination.
    
    This chapter highlights some key areas of progress over the last
    
    fiscal year.
    
    
    
    Improving Protection For Infants And Children
    
    
    
         OPP has made substantial progress implementing
    
    recommendations in the 1993 report of the National Academy of
    
    Sciences (NAS), Pesticides in the Diets of Infants and Children.
    
    The report made recommendations to improve protection of infants
    
    and children in four areas: toxicology, risk assessment, residue
    
    chemistry, and food consumption.
    
    
    
         Toxicology
    
    
    
       o To better assess newborn and pre-adolescent toxicity, EPA's
    
         Scientific Advisory Panel (SAP) peer reviewed in 1995 a
    
         number of data requirements developed by OPP.  The
    
         requirements are for assessing the potential effects of
    
         pesticides on immune function, the nervous system,
    
         reproduction and development, and the visual system.  The
    
         requirements will be proposed in 1996 as part of
    
         comprehensive revisions to OPP's data requirement
    
         regulations (40 CFR Part 158).
    
    
    
       o Test guidelines for each of these areas have been developed
    
         (neurodevelopmental, neurotoxicity) or will be completed in
    
         1996 (reproductive/developmental, visual system).
    
    
    
       o The National Toxicology Program at the Department of Health
    
         and Human Services (HHS) completed a pilot study on the use
    
         of an additional thyroid test which is now being evaluated
    
         by OPP.
    
    
    
         Risk Assessment
    
    
    
       o EPA is revising its guidelines for assessing the cancer
    
         risks posed by chemicals to take into account all available
    
         biologically-based information.
    
    
    
       o OPP is phasing in the evaluation of multiple routes of
    
         pesticide exposure (such as from food, drinking water, and
    
         household use) and combined exposures to multiple pesticides
    
         which have the same mechanism of action (that is, they cause
    
         the same toxic effect in the same way). For example, in the
    
         Special Review of the triazine family of pesticides, the
    
         potential combined risks from consumption of these chemicals
    
         in food and drinking water is being considered along with
    
         application exposure via agricultural and residential use.
    
         In addition, OPP now routinely addresses the potential for
    
         additive risks from drinking water and food in making
    
         reregistration decisions. Evaluation of exposure to children
    
         and other potentially sensitive subpopulations is a routine
    
         aspect of dietary risk assessments in both the registration
    
         and reregistration programs. 
    
    
    
         Food Consumption
    
    
    
       o To provide more reliable information regarding exposure to
    
         pesticides in foods, OPP will be using USDA's Food Grouping
    
         System in standardizing the "recipes" used to convert foods
    
         "as eaten" (for example, pizza) to raw agricultural
    
         commodities (for example, wheat, and tomatoes). In addition,
    
         OPP is revising its commodity list which, upon completion,
    
         will be transmitted to USDA so all recipes can be
    
         standardized based on the new commodity list by the end of
    
         1996.
    
    
    
       o USDA requested additional funds to carry out a supplemental
    
         food consumption survey, but monies were not appropriated.
    
         OPP is working with USDA and HHS, as part of the Food
    
         Consumption Working Group, to design future surveys.
    
    
    
         Residue Chemistry
    
    
    
       o A design for a National Pesticide Residue Monitoring
    
         Database is complete and could be implemented in FY 1997, if
    
         funds were available.
    
    
    
       o OPP completed a market basket feasibility study for
    
         monitoring pesticides in the top 20 foods eaten by children.
    
    
    
       o OPP routinely uses actual field trial data to estimate
    
         potential residues in treated food. Guidance specifying
    
         number of field trials per crop was peer reviewed by the SAP
    
         and completed in 1995. 
    
    
    
    Acute Dietary Risk Assessment Policies
    
    
    
         Acutely toxic pesticides are those which could cause illness
    
    or injury based on short term exposure to excessive residues. For
    
    example, high residues of such a pesticide in food could cause
    
    illness to some people after a single serving of the food. Unlike
    
    potential chronic effects, which are evaluated based on likely
    
    consumption of foods containing varied residue levels over many
    
    years, acute effects must be evaluated based on the possibility
    
    of excessive exposure to "high residue" foods within a relatively
    
    short period. Using average residue values in evaluating health
    
    risks would not provide an adequate margin of safety for
    
    consumers in the case of acutely toxic pesticides.
    
    
    
         In FY 1995, OPP developed new, refined guidance for
    
    determining potential risks posed by acutely toxic pesticide
    
    residues in food. The policy optimizes the use of available
    
    residue data and takes a tiered approach, proceeding from worst
    
    case assumptions to more realistic assumptions. The new approach
    
    incorporates recommendations from the National Academy of
    
    Sciences report on Pesticides in the Diets of Infants and
    
    Children and was presented to the OPP's Science Advisory Panel
    
    for expert peer review in October 1994. The new policy
    
    standardizes OPP risk assessment for acutely toxic pesticides,
    
    enabling the agency to compare risks more directly and to make
    
    sound, protective tolerance decisions. 
    
    
    
    Activities Related To Implementation Of The "Delaney Clause"
    
    
    
         Following a 1992 decision by the Ninth Circuit Court of
    
    Appeals, OPP has made progress implementing the Delaney clause of
    
    the Federal Food, Drug and Cosmetic Act (FFDCA). The Delaney
    
    clause prohibits the establishment of food additive regulations
    
    or maximum residue limits for processed foods for any pesticide
    
    that induces cancer in humans or test animals. In FY 1995, EPA:
    
    
    
       o Proposed in January to revoke six food additive regulations
    
         involving four pesticides found to induce cancer, continuing
    
         the orderly process of making decisions on existing food
    
         additive regulations potentially subject to the Delaney
    
         clause initiated in July, 1994.
    
    
    
       o Obtained a court approval in February of a settlement with
    
         the Natural Resources Defense Council and others (NRDC
    
         settlement) to take a number of actions within certain time
    
         frames to comply with the Delaney clause as interpreted in
    
         the Ninth Circuit decision.
    
    
    
       o Articulated commonsense, science-based policies for defining
    
         when pesticide residues concentrate in processed food and
    
         when processed food is considered "ready to eat." These new
    
         policies, published in June, responded to certain issues
    
         raised by the National Food Processors Association and
    
         others. Although established as a result of Delaney actions,
    
         the policies apply to the tolerance setting process in
    
         general. A significant consequence of these policies is that
    
         fewer food/feed additive tolerances will be needed for
    
         processed foods, due to more realistic assumptions of the
    
         likelihood of residues in processed foods.
    
    
    
       o Began applying these new policies in a number of specific
    
         tolerance decisions. For example, in August, EPA proposed to
    
         revoke tolerances for trifluralin in mint oils since mint
    
         oils are not "ready to eat," and residues in ready-to-eat
    
         foods made with mint oils would not be higher than the raw
    
         agricultural commodity tolerances. In September, the Agency
    
         proposed the revocation of 36 livestock feed additive
    
         regulations involving 16 pesticides. Of these, 34 proposed
    
         revocations were based on a determination that they were no
    
         longer needed (e.g., the residues were found not to
    
         concentrate in ready-to-eat processed feed), while two
    
         revocations were proposed because the tolerances violate the
    
         Delaney clause. With this action, EPA completed initial
    
         proposals on all existing food additive regulations that had
    
         been identified as potentially subject to Delaney. Final
    
         decisions will be made on these proposals between December
    
         1995 and March 1997.
    
    
    
    Revised Food And Livestock Feed Table
    
    
    
         OPP has issued a revised version of its Food and Livestock
    
    Feed Table (Table 2 of Subdivision O of the Pesticide Assessment
    
    Guidelines, entitled "Raw Agricultural and Processed Commodities
    
    and Feedstuffs Derived from Field Crops"). This table lists raw
    
    and processed human foods and livestock feeds (derived from field
    
    crops) for which tolerances are established and residue data are
    
    required. 
    
    
    
         Changes to the table were needed to reflect significant
    
    changes in livestock feeding practices in recent years. Some
    
    commodities formerly listed (such as barley bran and tomato
    
    paste) are no longer considered to be significant feed items and
    
    have been dropped from the table. Residue data and tolerances are
    
    no longer required for these commodities. This new information on
    
    feeding practices improves the accuracy of exposure assessments
    
    for residues in livestock-derived foods. OPP has already begun
    
    using the new table in making tolerance decisions. 
    
    
    
    "Reinvention" and Regulatory Reform: Ongoing Efforts to Clarify
    
    and Update Regulatory Policies and Requirements
    
    
    
         FY 1995 was a year of significant progress in a number of
    
    ongoing efforts to update and reform core OPP policies in order
    
    to improve the quality of pesticide regulatory decision-making
    
    and make OPP's requirements clearer and more consistent.
    
    
    
         Comprehensive Review of Existing Regulatory Burdens
    
    
    
         In the spring of 1995, President Clinton directed all
    
    federal agencies to reduce regulatory burdens and signed into law
    
    a new Paperwork Reduction Act. In response to the President's
    
    call, OPP mounted a concentrated effort to review every
    
    regulation on the books, with the goals of eliminating outdated
    
    or unnecessary rules and reducing reporting and recordkeeping
    
    requirements where appropriate. All interested stakeholders had
    
    the opportunity to become involved in this effort, through public
    
    meetings and solicitation of written comments. 
    
    
    
         OPP reported back to the President in June, 1995, and
    
    announced a number of new initiatives designed to streamline and
    
    reduce burdens posed by pesticide regulation. Highlights included
    
    steps to exempt low-risk pesticides from regulation, eliminate
    
    regulatory overlap between EPA and the Food and Drug
    
    Administration for certain products, and permit minor changes in
    
    the conditions of pesticide product registrations without prior
    
    OPP approval. OPP is also exploring other approaches to reducing
    
    regulatory burdens, including implementation of self-
    
    certification programs for certain registration requirements.
    
    Finally, as described in more detail in chapter 4, OPP is
    
    reviewing current policies with a view toward "reinventing" its
    
    export notification programs. 
    
    
    
         Tolerances and Food Safety
    
    
    
         In FY 1995, OPP continued to work on proposals for
    
    reinventing its processes for establishing tolerances and
    
    estimating risks to consumers (including children) from exposure
    
    to pesticide residues in food. 
    
    
    
         A major component of this effort was the opening up of OPP's
    
    current procedures for wider public review and comment. Based on
    
    the comments received, OPP has already taken steps to incorporate
    
    improved statistical techniques into dietary exposure analyses
    
    and to consider average field trial residues in determining the
    
    need for separate tolerances for processed foods. 
    
    
    
         OPP is continuing to assess the comments received and
    
    expects to announce a number of additional changes in FY 1996.
    
    Some of the changes under consideration are designed to take into
    
    account factors known to reduce pesticide residues in foods
    
    between the time crops are harvested and eaten (e.g., washing and
    
    peeling) when setting tolerances. Other proposals involve
    
    gathering more data on pesticide usage and actual residues on
    
    crops in order to make more accurate estimates of dietary
    
    exposure, harmonizing terminology with current international
    
    practices, improving OPP's ability to track total dietary
    
    exposure for food use pesticides, and developing materials to
    
    improve public understanding of the tolerance-setting process.
    
    The goal is to establish tolerances that more closely reflect
    
    real exposure to residues in food and to make the tolerance-
    
    setting process more open and accessible to the public. 
    
    
    
         Revised Pesticide Registration Data Requirements (40 CFR
    
         Part 158)
    
    
    
         As part of the Administration's regulatory reform
    
    initiative, OPP has undertaken a comprehensive review and
    
    updating of its pesticide data requirements, found in Title 40
    
    Part 158 of the Code of Federal Regulations. 
    
    
    
         In 1995, OPP submitted a draft proposal to the Scientific
    
    Advisory Panel (SAP) for peer review. Among other provisions, the
    
    proposal includes significant regulatory relief for biological
    
    pesticides, sets forth data requirements for clearance of inert
    
    ingredients of pesticides, and provides more explicit criteria
    
    for when specific types of studies are required for agricultural
    
    uses of pesticide chemicals. For the most part, the SAP endorsed
    
    the proposed changes, except for a provision to require
    
    comparative performance testing. Based on the SAP response, OPP
    
    plans to issue a proposed rule for full public comment in 1996. 
    
    
    
          In addition, OPP made significant advances in laying the
    
    groundwork for revising data requirements for biocides and other
    
    non-agricultural pesticides and tailoring them to reflect
    
    specific use and exposure conditions. Collaboration with Canada
    
    and the European Union to promote international harmonization of
    
    data requirements and testing strategies for non-agricultural
    
    pesticides also began during this fiscal year.
    
    
    
         Draft Guideline for Independent Laboratory Validation of
    
         Environmental Chemistry Methods
    
    
    
         OPP published a draft data reporting guideline that requires
    
    registrants to obtain independent laboratory validation of
    
    methods used to detect pesticide residues in soil and water. The
    
    guideline applies to nine environmental fate, exposure and
    
    ecological effects studies that OPP requires of pesticide
    
    registrants. The guideline is based on OPP's findings that a
    
    large number of existing detection methods were incomplete,
    
    inadequately documented and insufficiently effective, while other
    
    methods used outdated technology no longer available in EPA
    
    laboratories. These new guidelines will save OPP resources and
    
    reduce delays in reviewing methods. A revised draft is planned to
    
    be published in the Federal Register in early 1996.
    
    
    
         Guideline Harmonization and Updating
    
         
    
         In another regulatory reform initiative, OPP is nearing
    
    completion of a multi-year project to harmonize its pesticide
    
    chemical test guidelines with those of the EPA's Office of
    
    Pollution Prevention and Toxics, California, and the Organization
    
    for Economic Cooperation and Development (OECD), an international
    
    organization that includes most major industrialized countries
    
    among its members. 
    
    
    
         OPP's test guidelines outline how studies should be designed
    
    and conducted in order to satisfy OPP's regulatory requirements
    
    and support pesticide registration. Greater clarity and
    
    consistency in test requirements will eliminate duplicative or
    
    redundant testing and provide greater assurance that pesticide
    
    studies reflect the best, most current science. As harmonization
    
    and updating efforts are completed, the test guidelines are being
    
    consolidated into a single cataloguing system and will be made
    
    available through the Government Printing Office beginning in
    
    1996.
    
    
    
         EPA currently has 340 guidelines, organized into 10
    
    categories based on scientific discipline. Once the Agency has
    
    reviewed a guideline and developed an updated/harmonized version,
    
    the revised guideline is subject to peer review and international
    
    notification where appropriate, prior to publication. 
    
    
    
         Accomplishments in FY 1995 included:
    
    
    
       o Guidelines harmonized and/or updated
    
              Toxicology (57)
    
              Nontarget Organisms (45)
    
              Residue Chemistry (18)
    
              Physical Chemistry (25)
    
    
    
       o Guidelines Peer Reviewed
    
              Residue Chemistry (18)
    
              Physical Chemistry (25)
    
    
    
       o Guidelines Ready for Republication
    
              Applicator Exposure (7)
    
              Post Application Exposure (9)
    
              Microbial Pest Control Agents (44)
    
              Biochemical Pest Control Agents (7)
    
    
    
    OPP plans to publish all remaining test guidelines after
    
    appropriate peer review and public comment during 1996.
    
    
    
         Methyl Bromide Alternatives
    
    
    
         Methyl bromide is a broad spectrum pesticide which is
    
    effective in controlling insects, fungi, nematodes, and weeds
    
    when used to fumigate soil, structures, and commodities. However,
    
    it has also been found to contribute to depletion of the ozone
    
    layer. Consequently, under the Clean Air Act, EPA has prohibited
    
    the production and importation of methyl bromide after January 1,
    
    2001. In light of this phaseout, EPA is cooperating with the U.S.
    
    Department of Agriculture, commodity groups, and others to give
    
    priority to the development, registration, and adoption of
    
    alternatives to methyl bromide, including both chemical and non-
    
    chemical pest control strategies. 
    
    
    
         In 1995, OPP issued two formal policy statements: a
    
    commitment to giving priority review to methyl bromide
    
    alternatives, and a requirement that applications for "emergency
    
    exemptions" involving methyl bromide use demonstrate efforts to
    
    develop alternative means of pest control. In keeping with its
    
    overall policy of reducing pesticide use and risk, OPP also
    
    supported the Port of San Diego's efforts to develop an
    
    innovative technology to capture and reuse methyl bromide in its
    
    quarantine fumigation operation. This method has the potential to
    
    decrease use and emissions of methyl bromide.
    
    
    
         Other Ongoing Regulatory Improvement Initiatives
    
    
    
    OPP made significant progress on a number of additional
    
    regulatory improvement initiatives during 1995, including work
    
    toward publication of several key proposed and final rules:
    
    
    
       o Final rule clarifying responsibilities for reporting
    
         pesticide incidents ("6(a)(2) Rule"). Section 6(a)(2) of the
    
         Federal Insecticide, Fungicide, and Rodenticide Act requires
    
         registrants to report incidents and other information
    
         indicating potential adverse effects of pesticides. This
    
         information is important in helping OPP decide if action
    
         should be taken to reduce the risks posed by a particular
    
         pesticide. In 1995, OPP completed a draft final rule to
    
         clarify the reporting obligations. OPP expects to publish
    
         the final rule in early 1996. (Chapter 6 provides further
    
         discussion of 6(a)(2) activities during 1995.)
    
    
    
       o Ground-water protection regulations. Complementing the
    
         ongoing field activities described in chapter 4, OPP also
    
         continued regulations development to protect ground water.
    
         Progress in 1995 included drafting a final rule defining
    
         criteria for identifying pesticides posing risks of ground-
    
         water contamination and a proposed rule to require state
    
         management plans for several specific pesticides that are
    
         frequently detected in ground water.
    
    
    
       o Standards for pesticide containers and containment.
    
         Approximately 200 comments, totalling 2900 pages, have been
    
         received in response to OPP's February 1994 proposed
    
         regulation establishing standards for pesticide containers
    
         and containment. In 1995, OPP reviewed, abstracted and
    
         summarized these extensive comments, in preparation for the
    
         development of a final rule. 
    
    
    
    Ecological Risk Assessment and Ground-Water Study Guidance
    
    
    
         In FY 1995, OPP launched an initiative to standardize and
    
    improve ecological risk assessments by creating a source of
    
    clear, easily accessible, up-to-date guidance documents for
    
    ecological reviews. The effort involved an extensive compilation
    
    and review of existing documents, updating established guidance,
    
    writing new guidance, and providing for internal peer review by
    
    senior scientists. The highest priority documents should be
    
    complete by December, 1995. 
    
    
    
         OPP scientists also developed draft guidance on a new design
    
    for small-scale, prospective ground-water monitoring studies.
    
    These studies are used to determine if residues may leach into
    
    ground water and often serve as the basis for restrictions on
    
    pesticide use to prevent ground-water contamination. The draft
    
    guidance drew hundreds of comments, most supporting OPP's
    
    proposed changes and many expressing appreciation for the
    
    opportunity to provide input at an early stage of policy
    
    development. OPP plans to issue final guidance in FY 1996.
    
    
    
    Community-Based Environmental Protection
    
    
    
         As part of the EPA-wide effort to promote community-based
    
    environmental protection initiatives, OPP participated in the
    
    development of a strategy for the Office of Prevention,
    
    Pesticides, and Toxic Substances that stressed providing
    
    information tools and creating partnerships for community-based
    
    ecosystem protection projects. In 1995, OPP launched its own
    
    Ecosystem Pilot Project, which included the following activities:
    
    
    
       o Participating in a joint federal-state assessment of
    
         environmental conditions in the Southern Appalachian Region.
    
         OPP provided information on pesticides in ground water and
    
         data from its Ecological Incident Information System.
    
    
    
       o Undertaking a survey to identify and catalogue the knowledge
    
         and expertise available from OPP to assist in ecosystem
    
         protection initiatives.
    
    
    
       o Working with EPA's Office of Water to train teachers in such
    
         areas of environmental concern as pollution prevention and
    
         preservation of streams. The program is intended to develop
    
         partnerships with minority colleges, beginning with a pilot
    
         in Petersburg, Virginia.
    
    
    
    Improving Methods, Modeling, And Information Systems for
    
    Environmental Assessments
    
    
    
         OPP scientists and statisticians continued to make progress
    
    in a number of areas aimed at improving methods and information
    
    systems that support pesticide decision-making. Accomplishments
    
    in 1995 included:
    
    
    
         Mapping, Monitoring, and Modeling Pesticides in the
    
         Environment
    
    
    
         Desktop Geographic Information System (GIS) mapping is now
    
    being used on a regular basis in OPP. New software integrates the
    
    visualization of geographic data with traditional tools like
    
    spreadsheets, databases, and business graphics. In FY 1995, OPP
    
    used desktop GIS to map pesticide use areas and pesticide
    
    detections in ground water. Integration of mapping with OPP's
    
    Ecological Incident Information System enables the system to
    
    combine visual displays showing location of pesticide
    
    contamination incidents with information on county and state
    
    boundaries, major roads, rivers, cities and land use patterns. 
    
    
    
         OPP also continued to participate in collaborative efforts
    
    to improve monitoring and modeling of pesticides in the
    
    environment. For example, OPP contributed to the work of the
    
    Intergovernmental Task Force on Monitoring Water Quality to
    
    improve coordination of monitoring efforts and make the data more
    
    useful and widely accessible nationwide. OPP also participated in
    
    the Exposure Modeling Workgroup, a partnership that includes the
    
    U.S. Department of Agriculture and private sector experts. The
    
    workgroup is developing improved computer models of how
    
    pesticides break down and are transported in the environment.
    
    1995 accomplishments included finalizing guidance on how to
    
    select the values, such as soil type and climate, to input to
    
    models and how industry should report results to OPP. The
    
    partnership also made substantial progress in standardizing the
    
    types of locations that should be modeled for each major crop and
    
    in determining the accuracy of modeling.
    
    
    
         Statistical and Computer Program Improvements
    
    
    
         OPP statisticians and scientists work continually to improve
    
    the efficiency and consistency of ecological effects data
    
    evaluations. The goal is to enhance confidence that conclusions
    
    are based on appropriate procedures, which enable OPP to better
    
    characterize the environmental risks of pesticides and evaluate
    
    reductions in risk resulting from regulatory decisions. To
    
    further these objectives in 1995, OPP conducted an in-house
    
    workshop and participated in conferences on ranking environmental
    
    risks and measuring uncertainty in ecological risk assessment.
    
    
    
         In 1995, OPP also worked to design an "environmental fate
    
    tool box," a series of computer programs that will help OPP
    
    understand how fast pesticides break down in the environment and
    
    the degree to which they can move through soil into ground water.
    
    
    
    Legislative Proposals
    
    
    
         EPA worked with the Department of Agriculture, the Food and
    
    Drug Administration, and others in the executive branch to
    
    develop Administration positions on proposed legislation relating
    
    to pesticides and food safety, prepare for Congressional hearings
    
    on these topics, and communicate the Administration's positions
    
    to members of Congress, their staffs, and the public. OPP
    
    provided analyses of antimicrobial reform legislation and a
    
    variety of funding options for reregistration and registration.
    
    In addition, OPP led a number of educational briefings for
    
    members and staff on key pesticide issues.
    
    
    
         The Administration is committed to working with Congress to
    
    enact sound reforms to both major pesticide statutes, the Federal
    
    Food, Drug, and Cosmetic Act (FFDCA) and the Federal Insecticide,
    
    Fungicide, and Rodenticide Act (FIFRA). In particular,
    
    Administration goals include adopting a single, health-based
    
    standard for pesticide residues in food; ensuring implementation
    
    of recommendations contained in the National Academy of Sciences
    
    report Pesticides in the Diets of Infants and Children; promoting
    
    the development of reduced risk pesticides; providing incentives
    
    for registering minor use pesticides; and providing OPP with the
    
    fee revenue required to complete on-going reregistration reviews,
    
    as mandated by Congress in 1988 amendments to FIFRA. 
    
    
    
         While no bills were introduced in 1995 that fully addressed
    
    all of EPA's concerns, OPP is continuing to work with Congress
    
    toward the goal of enacting legislation that will provide a
    
    strong, consistent framework for its efforts to better protect
    
    public health and the environment.
    
    
    
    International Harmonization And Regulatory Coordination
    
    
    
         OPP's international harmonization projects aim to develop
    
    common or compatible international approaches to pesticide
    
    review, registration and standard-setting. Common approaches to
    
    regulation will allow work sharing and reduce regulatory burdens
    
    on national governments, improve the science supporting pesticide
    
    regulatory decisions worldwide, provide greater assurance that
    
    imported food is safe, and reduce trade problems and costs for
    
    registrants.
    
    
    
         OECD Pesticide Forum
    
    
    
         The Pesticide Forum of the Organization for Economic
    
    Cooperation and Development (OECD) brings pesticide regulators
    
    together to address common problems, promote harmonization of
    
    policies and procedures, and enable work sharing. The U.S.
    
    participates in a number of ongoing Forum projects, including:
    
    (1) providing feedback to the European Commission on Europe's new
    
    registration/reregistration procedures; (2) working with
    
    Australia and Canada on guidance for interpreting studies and
    
    documenting data reviews for subchronic oral toxicity (90-day
    
    rodent) tests; (3) developing common test guidelines; (4)
    
    exchanging data reviews; and (5) participating in a survey and a
    
    workshop on pesticide risk reduction activities. As a result of
    
    Forum activities, countries are developing much closer working
    
    relationships and are beginning to share information on a more
    
    routine basis. Specific examples in 1995 include:
    
    
    
         o    Cooperation among the U.S., Germany, and Canada to use
    
              Canadian reviews and new registrant data to facilitate
    
              review and establishment of a U.S. tolerance for
    
              amitraz on hops.
    
    
    
         o    Cooperation between the U.S. and Australia to resolve
    
              problems of chlorfluazuron residues in imported beef.
    
    
    
         Intergovernmental Forum on Chemical Safety
    
    
    
         In response to the Agenda 21 Report prepared at the 1992
    
    United Nations Conference on Environment and Development, U.N.
    
    member countries established the Intergovernmental Forum on
    
    Chemical Safety (IFCS). The IFCS coordinates national and
    
    international chemical safety activities in a number of areas:
    
    (1) risk assessment; (2) harmonization of classification and
    
    labeling systems; (3) information exchange, including prior
    
    informed consent (PIC); (4) risk reduction; and (5) strengthening
    
    national capabilities. The IFCS is improving global coordination
    
    of chemical safety activities, including high visibility
    
    initiatives such as PIC and Persistent Organic Pollutants, which
    
    are described separately in this report.
    
    
    
         In support of the goals of Agenda 21, OPP contributed to the
    
    design of a model risk assessment document and prototype
    
    production process. The resulting documents, known as Concise
    
    International Chemical Assessment Documents (CICADs), will
    
    provide internationally peer reviewed risk assessments for
    
    priority chemicals. OPP also drafted a CICAD for the pesticide
    
    amitraz.
    
    
    
         During FY 1995, OPP helped plan and participated in a
    
    meeting of 14 American countries that are members of the IFCS to
    
    establish regional priorities for chemical safety. This expanded
    
    Americas meeting, chaired by Mexico, established good working
    
    relationships among the countries represented and provided a
    
    foundation for greater chemical safety in the Americas.
    
    
    
         Canada/U.S. Technical Working Group on Pesticides
    
    
    
         The Canada-U.S. Trade Agreement (CUSTA) directed the two
    
    countries to work toward equivalence of pesticide standards. The
    
    more recent adoption of the North American Free Trade Agreement
    
    (NAFTA) by Canada, Mexico, and the United States emphasized the
    
    goals of harmonization, without lowering the level of public
    
    health and environmental protection in any country, and
    
    cooperation to enhance conditions throughout the hemisphere.
    
    
    
         To further these objectives, CUSTA established a Technical
    
    Working Group (TWG) on Pesticides. This group is currently co-
    
    chaired by OPP and the Pest Management Regulatory Agency of
    
    Canada. In light of NAFTA, Mexican regulatory authorities have
    
    also been invited to participate, and attended the first
    
    trilateral meeting in 1995.
    
    
    
         After initiating various pilot projects to become
    
    knowledgeable about and confident in each country's regulatory
    
    processes, in 1995 the TWG began moving toward more active
    
    harmonization and actual work-sharing. For example, OPP utilized
    
    Canadian reviews of acute toxicity data in registering a product,
    
    thereby saving significant review time. OPP will also use
    
    Canadian reviews in the reregistration process for creosote, an
    
    important wood preservative.
    
    
    
         In addition, the TWG has made significant progress in
    
    cooperation with agricultural producers and industry to reduce
    
    trade disruptions caused by differences in residue limits between
    
    the U.S. and Canada. In 1995, equivalent import tolerances were
    
    established for six pesticide/crop combinations (permethrin on
    
    spinach; acephate on beans, peppers, and cranberries; clethodim
    
    on potatoes; and dimethoate on blueberries), eliminating trade
    
    barriers for affected commodities. Moreover, the U.S. registered
    
    the new, reduced-risk pesticide tebufenozide after conducting a
    
    collaborative review with Canada. The two countries also began to
    
    share information in the areas of occupational exposure,
    
    toxicology, and environmental effects and initiated scientific
    
    staff exchanges. A more complete description of the TWG's
    
    achievements can be found in its first formal Accomplishments
    
    Report, issued in June 1995.
    
    
    
         Persistent Organic Pollutants (POPs)
    
    
    
         A number of chemicals, known as persistent organic
    
    pollutants (POPs), present health and environmental risks due to
    
    their persistence in the environment, toxicity, tendency to
    
    bioaccumulate, and potential for long range transport. POPs have
    
    become an issue of global concern as they have been detected
    
    throughout the world, including remote Antarctic and Arctic
    
    regions. Although EPA has banned most pesticides considered to be
    
    POPs, such as aldrin, DDT, and dieldrin, they continue to be used
    
    in other countries, and residues persist in the United States.
    
    
    
         OPP is currently working with other EPA offices and U.S.
    
    agencies to develop mechanisms to address POPs at the global
    
    level. In FY 1995, OPP contributed information on the health and
    
    environmental effects of POPs and provided guidance on criteria
    
    for identifying POPs of greatest concern to such international
    
    agencies as the U.N. Environment Programme and the U.N. Economic
    
    Commission for Europe/Convention on Long Range Transboundary Air
    
    Pollution. OPP is also assisting in the development of strategies
    
    for reducing the use of POPs in this hemisphere through the North
    
    American Commission for Environmental Cooperation.
    
    
    
    Technical Cooperation With Developing Countries
    
    
    
         As a world leader in pesticide regulation and environmental
    
    protection, EPA is often called upon to work with developing
    
    countries to improve pesticide safety. Requests range from
    
    responses to specific inquiries to longer term projects aimed at
    
    building institutional capacity. Following are highlights of
    
    several initiatives managed by OPP in FY 1995.
    
    
    
         AID/EPA Central American Project
    
    
    
         According to the World Health Organization, Central America
    
    has the highest per capita pesticide use in the world. The impact
    
    on human health and the environment is significant. Since 1992,
    
    the U.S. Agency for International Development (AID) and EPA have
    
    been implementing a model collaborative program designed to
    
    enhance Central American efforts aimed at improving appropriate
    
    pesticide regulation and use, and achieving food safety, public
    
    health, and environmental protection goals.
    
    
    
         In 1995, one of the project's major accomplishments was the
    
    effort to upgrade regional pesticide laboratories in Central
    
    America. OPP and FDA jointly surveyed pesticide laboratory needs
    
    and capabilities, developed regional workshops for laboratory
    
    personnel, and produced the first-ever comprehensive laboratory
    
    training course and manual. Participants from five Central
    
    American countries attended a comprehensive training course
    
    sponsored in cooperation with FDA in June 1995. This "train the
    
    trainers" technical cooperation should enhance pesticide
    
    regulation and control throughout the region.
    
    
    
         In 1995, the EPA-AID Central American project also completed
    
    the Spanish translation of two important reference documents: 1)
    
    Regulatory Guide for Exporters of Nontraditional Crops from Latin
    
    American and the Caribbean Countries, an overview of the roles
    
    and regulations of U.S. federal agencies affecting the import of
    
    fresh fruits and vegetables; and 2) Recognition and Management of
    
    Pesticide Poisonings, a valuable tool for the early diagnosis and
    
    treatment of acute poisonings.
    
    
    
         Overall, the EPA-AID Central American project has formed an
    
    "essential alliance" that facilitates free information flow and
    
    appropriate technical assistance, helps ensure the safe
    
    importation of agricultural products into the United States, and
    
    allows Central Americans to make informed decisions as they
    
    strive to improve their economies, sustain their natural resource
    
    base, and understand the importance of environmental protection.
    
    One measure of the success of the pilot project, which was to
    
    conclude at the end of FY 1995, is that it has instead been
    
    expanded to cover broader environmental issues.
    
    
    
         Indonesia
    
    
    
         In FY 1995, EPA launched a two-year cooperative project to
    
    assist Indonesia's Ministry of Agriculture in improving pesticide
    
    regulation. EPA's involvement is a part of two larger projects, a
    
    pesticide management project funded by a five-year World Bank
    
    loan and an agribusiness project funded by AID. OPP will furnish
    
    data on pesticides that the Indonesian Ministry will access via
    
    Internet. OPP and other EPA staff are also working with
    
    Agriculture Ministry staff to evaluate information needs and
    
    develop solutions to specific issues including regulation of
    
    pesticides of particular concern, enforcement, legislative
    
    reform, and pesticide storage and disposal.
    
    
    
    Accomplishments in 1995 include:
    
    
    
       o Preparing an assessment of acute risks to workers for 10 of
    
         the 16 pesticides identified as posing particular concerns
    
         under conditions of use in Indonesia.
    
    
    
       o Providing pesticide-specific information to assist in
    
         Indonesia's evaluation of certain pesticide risks.
    
    
    
       o Summarizing non-EPA sources of pesticide information on the
    
         Internet to assist Indonesia's use of this resource and to
    
         avoid duplicating information that is already available.
    
    
    
         Pesticide Disposal
    
    
    
         OPP worked closely in FY 1995 with the U.N. Food and
    
    Agricultural Organization (FAO), the U.N. Environment Programme,
    
    and the World Health Organization to issue two new technical
    
    guidance documents to assist developing countries in disposing of
    
    both large and small quantities of pesticides. In addition, OPP
    
    is working with FAO and other organizations to resolve the
    
    growing problem of massive quantities of obsolete pesticides
    
    requiring disposal.
    
    
    
         International Fund For Agricultural Development
    
    
    
         An OPP staff member is on assignment to the International
    
    Fund for Agricultural Development (IFAD) in Rome to address
    
    social and environmental impacts which may result from use of
    
    agricultural inputs, including pesticides, in the Fund's
    
    projects. IFAD is a specialized United Nations agency devoted to
    
    alleviating rural poverty. In 1995, OPP helped prepare an
    
    Operational Statement on Pesticides to assist IFAD project design
    
    and helped prepare for a 1996 international workshop entitled
    
    Pest Management Approaches Suitable for Small-Scale Farmers.
    
    These efforts are aimed at reducing hunger and poverty, while
    
    providing farmers with sustainable and cost-effective crop
    
    protection capabilities. Besides helping local farmers, such
    
    efforts should benefit U.S. citizens through safer imported
    
    foods, a healthier environment, and stronger and more stable
    
    economies in developing countries.
    
    
    
    International Trade and Environment Policy
    
    
    
         With the approval of the NAFTA and the new World Trade
    
    Organization (WTO) agreements, OPP has been called upon
    
    increasingly in recent years to support trade policy initiatives
    
    and implement efforts promoting international environmental goals
    
    and regulatory coordination. 
    
    
    
         Notably, in 1995 OPP served on delegations to the NAFTA and
    
    WTO Sanitary and Phytosanitary Committees, as well as a new
    
    working group for a Free Trade Agreement for the Americas. OPP
    
    also participated in preparatory discussions for the accession of
    
    Chile to NAFTA. OPP's goal in these deliberations is to promote
    
    international harmonization while safeguarding the integrity of
    
    the U.S. public health and environmental regulatory system. 
    
    
    
         In 1995, OPP continued to participate in the international
    
    food safety standard-setting activities of the Codex Alimentarius
    
    Commission. In collaboration with USDA and FDA, EPA took steps to
    
    enhance the scientific basis of Codex actions and increase public
    
    input into U.S. positions at Commission meetings. OPP also
    
    studied the steps needed to ensure compliance with U.S.
    
    obligations under international trade treaties to notify other
    
    countries of U.S. actions and consider international standards in
    
    making regulatory decisions.
    
    
    
         Finally, as discussed in more detail earlier in this
    
    chapter, OPP supported EPA's Office of Air and Radiation and USDA
    
    in efforts to foster the development of alternatives to the
    
    ozone-depleting pesticide methyl bromide.  In addition to U.S.
    
    laws, methyl bromide is subject to international controls under
    
    the Montreal Protocol, an international agreement governing
    
    ozone-depleting chemicals.
    
    
    
              Chapter 6: Information and Program Management
    
    
    
         OPP's information and program management activities are not
    
    as publicly visible as some of its other programs. However, these
    
    support activities keep the OPP engine running. The buildings OPP
    
    occupies; the supplies and equipment used; the careful planning,
    
    budgeting and administration of resources; the systems developed
    
    and maintained to process and store vast amounts of pesticide
    
    information -- these are but a few examples of the critical
    
    program support efforts managed under this program area. Major
    
    achievements during 1995 are described below.
    
    
    
    Operations, Maintenance And Integration Of The Primary OPP
    
    Information Systems
    
    
    
         OPP has embarked on an effort to integrate virtually all of
    
    its many information systems under a single umbrella. These
    
    systems are used to track the hundreds of pesticides registered
    
    by OPP and the tens of thousands of studies associated with these
    
    pesticides. The systems include information about approved uses,
    
    reregistration status, product ingredients, and many other facts.
    
    Under the new Automated Information Management Master
    
    Implementation Plan, OPP is analyzing needs, linkages, and
    
    problems among the various systems. The analyses conducted in
    
    1995 are expected to help achieve the goal of a unified system
    
    that provides consistent, comprehensive, and accurate information
    
    to all OPP users and that avoids multiple entries of the same
    
    data into different databases.
    
    
    
         As work proceeded in planning for an umbrella data system,
    
    OPP made a series of improvements to existing information
    
    management systems. For example, the Pesticide Regulatory Action
    
    Tracking Systems (PRATS), which is used for tracking registration
    
    and reregistration actions, was enhanced to provide statistics on
    
    work accomplished every month by various OPP organizational
    
    units. The Chemical Review Management System (CRMS), which tracks
    
    reregistration information, was modified to track information for
    
    new pesticides. An innovative decision support system was
    
    developed to accept a wide range of toxicological (and other)
    
    data and generate a facsimile pesticide label containing the
    
    appropriate health and environmental warning language.
    
    
    
         Finally, the OPP Local Area Network (LAN) Group upgraded the
    
    LAN infrastructure with new network technology resulting in an
    
    increase in network reliability. Remote access to OPP's LAN
    
    increased dramatically during 1995, with access extended to many
    
    EPA regional and headquarters employees. The group also
    
    established "One-Stop" Shopping to reduce the time it takes to
    
    create various network accounts, and increased the use of
    
    software employed in developing and executing surveys.
    
    
    
    Electronic Dissemination Of Information
    
    
    
         OPP continues to experiment with innovative ways of making
    
    information available to affected organizations and the general
    
    public. In 1995, OPP completed the process of enabling all OPP
    
    personnel to easily communicate with anyone on the worldwide
    
    Internet. OPP has also begun to make many of its publications and
    
    databases available on the Internet, and is developing plans to
    
    significantly expand the amount of OPP pesticide information that
    
    the public can access electronically. In 1996, OPP will request
    
    public comments on its plans to make additional information
    
    available electronically.
    
    
    
         OPP currently uses three systems for delivering electronic
    
    access to its information: the EPA Internet servers, and two
    
    bulletin board systems, the Pesticide Information Network (PIN)
    
    and the Pesticide Special Review and Reregistration Information
    
    System (PSRRIS). OPP plans to consolidate its electronic
    
    information into a single system during the next fiscal year, so
    
    that users will find OPP's information at a single site. OPP will
    
    still offer both Internet and dial-up access. (For details on how
    
    to access the Internet site and bulletin boards, see the section
    
    entitled "How to Obtain More Information.")
    
    
    
         Information Currently Available from OPP through the
    
         Internet
    
    
    
         Almost all of OPP's electronically-available documents are
    
    available through the Internet, including all Federal Register
    
    notices and press announcements, and many Reregistration
    
    Eligibility Decisions (REDs). This information may be accessed
    
    using any of several methods in widespread use: through EPA's
    
    World Wide Web, Gopher, or FTP (file transfer protocol) servers.
    
    Interactive databases maintained on the PIN cannot now be
    
    accessed via Internet, but hardware and software changes planned
    
    for the coming year will provide single-point Internet access to
    
    all of OPP's electronically available information.
    
    
    
         Pesticide Information Network (PIN)
    
    
    
         The Pesticide Information Network (PIN) is a computerized,
    
    on-line collection of files containing current and historic
    
    pesticide information. This system is designed to enhance OPP's
    
    data gathering efforts; aid state agencies and others in
    
    obtaining needed information on a timely basis, thereby improving
    
    their ability to respond to local pesticide situations and
    
    federal requirements; save OPP resources through automated
    
    dissemination and updating of public information; and enhance
    
    cooperative efforts between EPA and other federal agencies
    
    through a convenient method of information sharing.
    
    
    
         The PIN contains several different types of information.
    
    These consist of the Pesticide Monitoring Inventory (PMI)
    
    (including the Pesticides in Ground Water Database), the
    
    Ecological Incident Information System (EIIS) (described in more
    
    detail elsewhere in this chapter), a Regulatory Status database,
    
    the Certification and Training Bibliography, and a Biological
    
    Pesticides data set.
    
    
    
         Pesticide Special Review and Reregistration Information
    
         System (PSRRIS)
    
    
    
         This bulletin board system, or BBS, contains recent
    
    Reregistration Eligibility Decision (RED) documents and all the
    
    RED fact sheets. Other files available for downloading include
    
    basic information explaining reregistration and Special Review,
    
    lists of pesticides under review and the appropriate Chemical
    
    Review Managers' names and telephone numbers, the Status of
    
    Pesticides in Reregistration and Special Review (or Rainbow
    
    Report), OPP Selected Terms and Acronyms, OPP's Annual Reports,
    
    the Rejection Rate Analysis chapters, and the periodic Pesticide
    
    Reregistration Progress Reports.
    
    
    
         Outside Sources of Electronic Pesticide Information
    
    
    
         OPP plans to make use of, rather than duplicate, other
    
    sources of electronic information on pesticides. Internet users
    
    who access OPP's site will find reference and in some cases
    
    electronic links to other key pesticide databases around the
    
    world. For example, considerable information that is useful to
    
    the general public will soon be available through an Internet
    
    site being established by the National Pesticide
    
    Telecommunications Network (NPTN). NPTN currently offers a toll-
    
    free pesticide information hotline by telephone (1-800-585-PEST),
    
    a service operated by Oregon State University and partially
    
    funded by OPP. Another pesticide information resource with which
    
    EPA and OPP will link is the Global Information Network on
    
    Chemicals (GINC), an Internet-based project that has its roots in
    
    the June, 1992 U.N. Conference on Environment and Development
    
    (UNCED). This fledgling network intends to "promote intensified
    
    exchange of information on chemical safety, use and emissions"
    
    among all nations.
    
    
    
    Other Information Systems
    
    
    
         The Label Use Information System (LUIS). LUIS is a database
    
    of label directions that appear on pesticide products. It
    
    contains detailed information on approved use sites, application
    
    methods, application rates, and limitations on the use of
    
    pesticides (e.g., preharvest intervals, reentry intervals). LUIS
    
    can produce reports by active ingredient to support chemical
    
    regulatory decisions; it can also produce reports by product to
    
    monitor product compliance with regulatory decisions. In
    
    addition, the database can be used to help locate labels which
    
    match a specified parameter. In 1995, LUIS was used to support
    
    completion of Reregistration Eligibility Decisions (REDs), and
    
    the updating of records in LUIS focused on pesticides scheduled
    
    for reregistration. Work is also progressing to integrate LUIS
    
    with related databases and to make this data available
    
    electronically to all OPP staff.
    
    
    
         Ecological Effects Pesticide Toxicity Database. OPP
    
    continues efforts to develop a database that will provide more
    
    comprehensive ecotoxicity data for registered pesticides used in
    
    the U.S. Over 410 active ingredients are presently covered by the
    
    database, which contains entries for over 9,100 studies on
    
    pesticide effects on terrestrial and aquatic plants, aquatic
    
    invertebrates, insects, amphibians, fish, birds, reptiles, and
    
    mammals. OPP receives approximately 20 database information
    
    requests per month from agricultural associations, private
    
    consulting firms, and international, federal and state agencies. 
    
    
    
         Pesticide Handler Exposure DataBase (PHED). In March 1995,
    
    OPP released a revised version of the PHED database. This
    
    database is used to estimate the degree to which workers are
    
    exposed to pesticides they handle, and ultimately to ensure that
    
    pesticides do not pose unreasonable risks to workers. The revised
    
    version allows the user to analyze a greater variety of exposure
    
    scenarios. In addition, OPP began a massive reprogramming of the
    
    database to make it more "user-friendly" and statistically
    
    powerful, as well as to incorporate much of the exposure analysis
    
    work being conducted in Europe via EUROPOEM, a European database.
    
    
    
         OPP List of Chemicals Evaluated for Carcinogenic Potential.
    
    OPP has revised and made available electronically the List of
    
    Chemicals Evaluated for Carcinogenic Potential. This semiannual
    
    list provides an overview of compounds evaluated for
    
    carcinogenicity by OPP's peer review teams and various other
    
    national and international review groups, such as the World
    
    Health Organization.
    
    
    
    Pesticide Adverse Effects Information Reporting/6(a)(2)
    
    Activities
    
    
    
         Section 6(a)(2) of the Federal Insecticide, Fungicide, and
    
    Rodenticide Act (FIFRA) 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.
    
    
    
         Studies. OPP's 6(a)(2) Team screened nearly 600 adverse
    
    effects information submissions consisting of studies and
    
    preliminary reports of possible adverse effects. As a result of
    
    this screening, 15% of the submissions were determined to warrant
    
    expedited review. Of the 15%, one-third required no further
    
    action; 20% showed a new adverse effect which will be addressed
    
    by Special Review, an imminent reregistration decision, or risk
    
    mitigation negotiations; 17% are still in review; 14% resulted in
    
    label changes to reduce risks, mostly in cases of new findings in
    
    acute toxicity studies; 15% required more information; and 3%
    
    resulted in other actions such as new tolerances and voluntary
    
    cancellations.
    
    
    
         Incidents. In 1995, OPP stepped up efforts to communicate
    
    with registrants on 6(a)(2) reporting requirements, which
    
    contributed to the substantial increase in pesticide incidents
    
    reported this year. OPP received approximately 1,435 6(a)(2)
    
    submissions containing more than 7,500 incident reports in 1995.
    
    To manage this data more efficiently, OPP is negotiating with
    
    several registrants on formats for aggregate, statistical
    
    reporting of less serious incidents. Analysis of incident data
    
    resulted in several risk reduction actions. For example, OPP used
    
    California worker poisoning data in requiring more stringent
    
    protective clothing requirements for products containing
    
    paraquat. Further, in the area of 6(a)(2) enforcement, EPA issued
    
    and settled a civil administrative complaint against DowElanco
    
    for failure to submit hundreds of reports of incidents associated
    
    with their registered products. The settlement included an
    
    agreement to submit additional adverse effects information and
    
    payment of a penalty of $876,000.
    
    
    
    Ecological Incident Monitoring And Reporting
    
    
    
         OPP continued to broaden the scope of ecological incidents
    
    collected and reviewed in 1995. Since September 1994, 27% of the
    
    state agencies have reported incidents to OPP, up from 7%
    
    previously. Ecological incident data are useful in determining
    
    trends of effects that ultimately will provide information needed
    
    to reduce risk to nontarget species. The impacts on fish,
    
    wildlife and plants observed are valuable for confirming known or
    
    identifying unknown ecological risks associated with pesticides.
    
    
    
         In 1995, OPP performed an analysis of the 700 ecological
    
    incidents evaluated to date. This analysis will be useful in
    
    designing future risk mitigation measures as pesticides are
    
    evaluated through reregistration and Special Review. Of the 78
    
    types of uses with reported incidents, 48 were associated with
    
    agriculture, of which 20 were observed to have more than one
    
    incident. The highest number of incidents reported involved fish
    
    kills (34%), followed by bird kills (30%) and plant effects
    
    (18%). OPP has received reports of adverse effects to 270 species
    
    of birds due to pesticide exposure. The carbamates, a group of
    
    insecticides, appear to cause significantly more incidents of
    
    adverse effects to birds of prey and songbirds than other classes
    
    of pesticides. Ducks, geese, and other waterfowl appeared to be
    
    most affected by organophosphates, another class of insecticides.
    
    Some of the incidents appear to be caused by pesticide misuse,
    
    such as using a pesticide as an illegal bait to control coyotes
    
    that results in the death of birds of prey.
    
    
    
    Information And Records Management Activities
    
    
    
         When an applicant seeks to register a pesticide, all data
    
    related to that request must be logged, reviewed, indexed, and,
    
    if acceptable, microfilmed. Approximately 12,000 studies were
    
    subjected to this process in 1995. In addition, OPP received
    
    approximately 1,300 information requests for 4,600 files per
    
    month from its central collection of active pesticide regulatory
    
    case files. OPP also worked to properly manage the records
    
    reflecting decisions made on particular pesticide applications
    
    for future reference.
    
    
    
    Human Resources Management
    
    
    
         OPP's human resources efforts focused not only on the
    
    administrative aspects of personnel processing (including
    
    recruitment; processing of actions; providing guidance to OPP
    
    managers on policy, procedures, and regulations) but also on the
    
    development of OPP's employees. Key 1995 activities included
    
    leadership training for supervisors; ethics training for middle
    
    and upper level management staff; formal training for
    
    knowledge/skills enhancement and career development; and piloting
    
    a divisional information sharing program called "LINKs." LINKs
    
    provided a method for OPP divisions to share information on their
    
    functions and linkages to other divisions. In so doing, OPP
    
    divisions increased the understanding of how their activities fit
    
    within the overall OPP mission.
    
    
    
         OPP also continued to participate in the Howard University
    
    Environmental Specialty Program (HUES). This program provides an
    
    opportunity for OPP support staff, primarily composed of
    
    minorities and women, to prepare for a new career in the
    
    Environmental Protection Specialist series. Twenty-two students
    
    successfully completed the first year course work of the three
    
    year HUES Program. Twenty-five additional staff have are expected
    
    to participate during the 1995-1996 school year. In addition, OPP
    
    participated in the Howard University Academic Relations Program,
    
    which aims to develop talented minority candidates during a
    
    summer internship program and to enhance the relationships
    
    between the Agency and Historically Black Colleges and
    
    Universities.
    
    
    
    Resource Allocation And Financial Management
    
    
    
         OPP resources are allocated in three distinct phases: budget
    
    formulation, planning, and execution. During any given year, OPP
    
    is formulating a budget two years in advance, planning a budget
    
    for the upcoming year, and executing a budget for the current
    
    year.
    
    
    
         Budget Formulation
    
    
    
         Budget formulation is the process by which, on an annual
    
    basis, OPP develops what becomes the President's Budget that is
    
    submitted to Congress. In Fiscal Year (FY) 1995, OPP prepared the
    
    submission of the FY 1997 budget. In so doing, OPP worked with
    
    the Administrator's office to develop a budget that reflects
    
    Agency goals, objectives, and priorities. After approval by the
    
    Administrator, the FY 1997 budget was reviewed by OMB and
    
    ultimately will become the President's Budget. The budget is then
    
    subject to Congressional review. Ideally, the final budget is
    
    approved with the signing of the Appropriations Bill by the
    
    President prior to October 1 (the beginning of the new fiscal
    
    year).
    
    
    
         Budget Planning
    
    
    
         Each year senior OPP officials, Program Area Workgroups
    
    (made up of a cross section of OPP staff), and the resource
    
    management staff work together to develop the OPP Resource
    
    Management Plan. This plan identifies OPP's goals, objectives,
    
    and outputs for the upcoming year and the resources needed to
    
    accomplish them. In FY 1995, the resource planning process was
    
    streamlined, resulting in significantly less time and staff
    
    effort to develop the FY 1996 Plan.
    
    
    
         For the FY 1996 plan, the OPP planning process tentatively
    
    allocated $17.4 million for headquarters contracts and grants,
    
    $3.5 million in headquarters administered regional grants, $4.0
    
    million in expenses, and $55 million in salaries for
    
    approximately 760 employees. Nondiscretionary state grants and
    
    assistance, which are allocated outside of the OPP planning
    
    process, totalled approximately $13 million. 
    
    
    
         Budget Execution
    
    
    
         After the Appropriations Bill is signed by the President,
    
    the EPA Comptroller issues a new Operating Plan, which is
    
    executed by each Agency office. In executing the budget, OPP must
    
    carefully monitor expenditure of all funds, track compliance with
    
    budget plans, and coordinate appropriate Agency financial
    
    reports. During 1995, OPP obligated (spent) $87 million dollars.
    
    These funds consisted of $54 million in salaries and travel
    
    expenses for approximately 760 employees; $19 million for
    
    contracts, interagency agreements, grants, and expenses; and $13
    
    million for grants and support to regions and states.
    
    
    
         In 1995, OPP continued to collect several types of fees from
    
    pesticide registrants, which supplement Congressional
    
    appropriations. The collected funds consisted of $2.5 million in
    
    tolerance fees, used to help support OPP's effort in establishing
    
    tolerances, and $14.3 million in annual registration maintenance
    
    fees, used to help support the reregistration program.
    
    
    
    
    
                   1995 Staff Effort Per Program Area
    
    
    
    ----------------------------------------------------------
    
    Program Area                                         FTEs
    
    ---------------------------------------------------  -----
    
    Registration                                          185
    
    Reregistration                                        227
    
    Special Review                                         66
    
    Field Implementation and Communications                80
    
    Policy, Regulations, and Guidance                      73
    
    Information and Program Management                    119
    
    
    
    TOTAL                                                 750
    
    ----------------------------------------------------------
    
    
    
         This table indicates the approximate distribution of OPP
    
    staff effort to the six program areas.  The table is presented in
    
    terms of "Full-Time Equivalents" (FTEs).  One FTE represents the
    
    number of hours spent by one employee working full-time for one
    
    year.  Because some employees work part-time, or are hired or
    
    leave part-way through the year, the actual number of employees
    
    in any given year exceeds the number of FTEs.  Many employees
    
    divide their time among different program areas.
    
    
    
    
    
    
    
             Funds Expended in 1995 By the Six Program Areas
    
    
    
    ----------------------------------------------------------
    
    Program Area                                         Funds 
    
    ---------------------------------------------------  -----
    
    Registration                                          14 %
    
    Reregistration                                        30 %
    
    Special Review                                         3 %
    
    Field Implementation and Communications               12 %
    
    Policy, Regulations, and Guidance                     21 %
    
    Information and Program Management                    20 %
    
    
    
    TOTAL                                                100 %
    
    ----------------------------------------------------------
    
    
    
         In 1995, OPP expended approximately $13.2 million allocated
    
    through the program area budget process. These "discretionary"
    
    funds were used for external contracts. This table shows how
    
    these funds were distributed among the different program areas.
    
    (Other major pesticide expenditures not reflected in this figure
    
    are travel expenses; salaries; and grants and other assistance to
    
    states, regions, and other organizations).
    
    
    
              Chapter 7: Biopesticide, Risk Reduction, and
    
                         Reinvention Initiatives
    
    
    
         For much of its history, the primary function of OPP has
    
    been to register and regulate pesticides, particularly chemical
    
    pesticides. In recent years, however, OPP has begun to shift from
    
    simply regulating pesticides to promoting systems of pest
    
    management that better protect health and the environment and
    
    enhance the quality of our lives. This approach recognizes that
    
    pesticides are only one element in controlling pests, and that in
    
    some cases non-chemical alternatives can be as effective as
    
    chemical pesticides with fewer health or environmental risks.
    
    Related to this shift in approach have been efforts to "reinvent"
    
    OPP's ways of conducting its work. This chapter summarizes OPP's
    
    accomplishments in 1995 in encouraging the introduction of a new
    
    generation of biological pesticides, reducing pesticide risks
    
    through environmental stewardship, and reinventing OPP
    
    organizations.
    
    
    
    Creation Of The New Division
    
    
    
         One of OPP's most important steps in adopting a new approach
    
    to pesticides and pest management has been the creation of a new
    
    division, the Biopesticides and Pollution Prevention Division
    
    (BPPD). Organized as a pilot in November 1994, the unit was
    
    established as a permanent division within OPP in September 1995.
    
    The division has assumed the registration and reregistration
    
    activities for biological pesticides, and also has the lead
    
    responsibility for the Pesticide Environmental Stewardship
    
    Program, which will be discussed later in this chapter.
    
    
    
         Biopesticide Accomplishments
    
    
    
         As with chemical pesticides, OPP is responsible for
    
    registering biologically-based pesticides, or "biopesticides,"
    
    used in the United States. The three major types of biopesticides
    
    that OPP registers are microbial pesticides, biochemical
    
    pesticides, and plant-pesticides. (Other biological pest control
    
    agents, such as insects that prey on crop pests, are exempt from
    
    OPP's pesticide regulations.) Microbial pesticides are bacteria,
    
    fungi, protozoans, and viruses used to control pests. Biochemical
    
    pesticides are naturally-occurring compounds that have a nontoxic
    
    mode of action to the target pest, such as insect hormones and
    
    pheromones (mating attractants) and plant growth regulators. As
    
    defined by EPA, plant-pesticides are pesticidal substances newly
    
    introduced into plants, along with the genetic material necessary
    
    for the production of the substances within plant tissues.
    
    
    
         Because EPA believes that in general biopesticides are less
    
    hazardous than traditional chemical methods of pest control, the
    
    Agency has taken a number of steps to encourage their development
    
    and use. OPP's data requirements -- that is, the types of studies
    
    that applicants must submit to register their new pesticides --
    
    and other regulations are tailored to the characteristics of
    
    biopesticides and, generally, significantly reduced compared to
    
    chemical pesticides. As a result, applicants can fulfill testing
    
    requirements and achieve registration more quickly and at
    
    substantially less cost.
    
    
    
         In 1995, OPP registered a record 20 new biopesticides (see
    
    chapter 1 for a detailed listing), with processing times for new
    
    biopesticides ranging from three to 16 months. This registration
    
    time represents a substantial savings compared to traditional
    
    chemical pesticides. Some of the newly-registered biopesticides
    
    include:
    
    
    
       o A strain of the fungus Beauveria bassiana. This fungus was
    
         registered to control the silverleaf whitefly, which has
    
         caused millions of dollars of damage to vegetable crops and
    
         cotton over the past five years. The fungal strain was also
    
         registered to control grasshoppers and related pests on
    
         rangeland, pastures, and various crops.
    
    
    
       o A peach twig borer pheromone. This pheromone was registered
    
         to disrupt the mating of an insect known as the peach twig
    
         borer, a pest of a number of fruit and nut trees.
    
    
    
       o Two strains of the bacterium Pseudomonas syringae. These
    
         bacterial strains were registered to control rot caused by
    
         several kinds of fungi during the storage of citrus and
    
         other fruits.
    
    
    
       o Three plant-pesticides derived from the bacterium Bacillus
    
         thuringiensis, or Bt. In March 1995, OPP approved limited
    
         registrations for insecticidal substances produced by Bt and
    
         genetically transferred into corn, cotton, and potato
    
         plants. The products will help control a number of insect
    
         pests, such as the European corn borer, cotton bollworm, and
    
         Colorado potato beetle. OPP approved full commercial use of
    
         the Bt-potato pesticide in May and the Bt-field corn
    
         pesticide in August.
    
    
    
         Piloting New Organizational Approaches
    
    
    
         In addition to advancing new methods of pest control, the
    
    new division is serving as a pilot for testing new approaches to
    
    organizational structure and execution of work, such as those
    
    recommended in the Vice-President's report on reinventing
    
    government. The division is made up of multidisciplinary teams
    
    that manage all phases of registration and reregistration,
    
    including both risk assessment (scientific assessment of
    
    potential health and environmental risks) and risk management
    
    (policy decisions based on risks and benefits). The division is
    
    also testing a streamlined management structure that exceeds
    
    EPA's goal of an 11:1 staff to manager ratio. While adjustments
    
    continue to be made, many of the approaches have proved
    
    successful and will provide valuable lessons as EPA moves toward
    
    overall reorganization of OPP in 1996.
    
    
    
    Promoting Integrated Pest Management (IPM)
    
    
    
         Integrated Pest Management involves the carefully managed
    
    use of an array of pest control tactics -- including biological,
    
    cultural, and chemical methods -- to achieve the best results
    
    with the least disruption of the environment. IPM relies upon an
    
    understanding of life cycles of pests and their interactions with
    
    the environment. Biological control refers to using natural
    
    enemies of the pest, such as employing ladybugs to control
    
    aphids. Cultural control involves practices of cultivation, crop
    
    rotation, and other methods that prevent or control pests. IPM
    
    also involves the judicious use of chemical pesticides, if
    
    necessary.
    
    
    
         OPP is involved in both urban and agricultural IPM. In the
    
    urban arena, OPP is providing the booklet, Pest Control in the
    
    School Environment: Adopting Integrated Pest Management and a
    
    companion training video to interested organizations. This year
    
    OPP worked with a consortium of outside groups to send this
    
    booklet and other materials on IPM to every school superintendent
    
    in the country. Projects related to IPM in the agricultural
    
    sector are described in the following section on environmental
    
    stewardship.
    
    
    
    Pesticide Environmental Stewardship Program (PESP)
    
    
    
         The Pesticide Environmental Stewardship Program (PESP) is a
    
    broad effort by EPA, USDA and FDA to work with pesticide users to
    
    reduce pesticide risk and use in both agricultural and non-
    
    agricultural settings. This program stems from a commitment in
    
    made in September 1993 by the three agencies to:
    
    
    
       o Promote the adoption of integrated pest management programs
    
         on 75 percent of U.S. agricultural acreage by the year 2000.
    
    
    
       o Develop specific risk and use reduction strategies that
    
         include reliance on biological pesticides and other
    
         approaches to pest control that are considered safer than
    
         traditional chemical methods.
    
    
    
         USDA assumed lead responsibility for the first goal, and EPA
    
    assumed the lead for the second, naming it the Pesticide
    
    Environmental Stewardship Program. PESP takes a four-pronged
    
    approach of public-private partnership, regulatory relief,
    
    research and demonstration, and education to achieve the goal of
    
    reducing the risk and use of pesticides.
    
    
    
         The Partnership
    
    
    
         The cornerstone of PESP is a public-private partnership
    
    approach, with pesticide user organizations working cooperatively
    
    with OPP. The partnerships are completely voluntary and entered
    
    into with the recognition by the federal government of the need
    
    for efficient, cost-effective pest control. Both the private
    
    sector Partners and the federal government make commitments under
    
    the program. Each Partner agrees to develop and implement an
    
    environmental stewardship strategy to reduce pesticide risk and
    
    use tailored to its own circumstances. The strategies should
    
    contain specific pest management goals and emphasize reduction in
    
    the use of pesticides and a shift to less toxic methods.
    
    
    
         When EPA, USDA and FDA announced PESP in December 1994, the
    
    following private organizations agreed to become charter
    
    Partners:
    
    
    
      Agricultural organizations:
    
    
    
    American Corn Growers Association
    
    California Citrus Research Board
    
    California Pear Advisory Board
    
    California Pear Growers
    
    International Apple Institute
    
    National Potato Council
    
    Pear Pest Management Research Fund
    
    
    
      Utility companies:
    
    
    
    Appalachian Power             New York State Electric & Gas
    
    Atlantic Electric             Ohio Power
    
    Carolina Power & Light        Pennsylvania Electric
    
    Columbus Southern Power       Pennsylvania Power and Light
    
    Delmarva Power                Pennsylvania Rural Electric Assn
    
    Duke Power                    Virginia, Maryland, Delaware Assn
    
    Indiana Michigan Power             of Electric Cooperatives
    
    Kentucky Power                Wheeling Power
    
    Kingsport Power               Wisconsin Public Service
    
    Corporation
    
    
    
    
    
      The following organizations also subsequently joined as
    
    Partners in 1995:
    
    
    
    California Cling Peach Advisory Board
    
    California Tomato Board
    
    Cranberry Institute
    
    Edison Electric Institute
    
    Golf Course Superintendents Association of America
    
    Mint Industry Research Council
    
    New England Vegetable and Berry Growers Association
    
    Northwest Alfalfa Seed Growers Association
    
    Pebble Beach Company
    
    Processed Tomato Foundation
    
    Professional Lawn Care Association of America
    
    Tennessee Valley Authority
    
    Texas Pest Management Association
    
    
    
         PESP Partner organizations now represent more than 31,000
    
    growers and 15,000 non-agricultural pesticide users. Many
    
    organizations that are not pesticide users have also expressed
    
    interest in supporting PESP; therefore, OPP created another
    
    membership category, Supporter, and plans to announce a group of
    
    Charter Supporters in early fiscal year 1996.
    
    
    
         Partnership Commitments
    
    
    
         Under PESP, the federal government commits to seek to
    
    promote and fund the adoption of alternative techniques and
    
    practices that enhance pest management and reduce pesticide risk
    
    and use. The federal government will also integrate the
    
    environmental stewardship strategies developed by Partners into
    
    its policies and programs for agriculture and the environment.
    
    Finally, the federal government will lead by example with its own
    
    use practices. Among OPP's activities in 1995 to fulfill this
    
    commitment were the streamlined registrations of biological
    
    pesticides described earlier in this chapter, as well as
    
    registrations of other reduced risk pesticides described in
    
    chapter 1. Also, the Department of Defense (DOD) signed a
    
    memorandum of understanding with OPP committing to reduce its
    
    pesticide use by 50 percent. DOD is a significant pesticide user
    
    on golf courses, runways, and in homes and schools located on
    
    military property in the U.S. and throughout the world.
    
    
    
         Partners began making specific commitments in 1995. For
    
    example, the American Corn Growers agreed to promote and expand
    
    its "bottom-line" corn growing contest, which seeks to maximize a
    
    grower's profit while reducing production inputs such as
    
    pesticides. Utility companies committed to train their pesticide
    
    users in techniques to lower risks from pesticide application.
    
    
    
         Grants and Demonstration Projects
    
    
    
         Merely putting less-risky products on the market does not
    
    guarantee that they will be used. To encourage their use, the
    
    demonstration portion of PESP offers funding to investigate and
    
    demonstrate reduced-risk methods of controlling pests. These
    
    methods may include pesticides, cultural practices, management
    
    techniques, or mechanical controls.
    
    
    
         In 1995, demonstration grants went to growers, regional EPA
    
    offices and PESP Partners. OPP and USDA matched funds to make
    
    available $800,000 in a special call for proposals targeted to
    
    risk/use reduction of pesticides in 25 key commodities. Twenty
    
    awards were made to demonstrate reduced risk technologies on the
    
    following crops and sites: apples, citrus, cranberries, field
    
    corn, sweet corn, potatoes, tomatoes, alfalfa, and cotton; and in
    
    greenhouses, nurseries, highway rights-of-way, and landscaping.
    
    
    
         Three EPA regional offices, Regions 5, 9, and 10, also
    
    received OPP funding. One project from Region 5 (which covers six
    
    Midwest states) addressed ultra-Low-Volume (ULV) herbicide
    
    application technology, a promising method for reducing
    
    application to one-half or less of label rates while still
    
    achieving comparable weed control. Region 5 also received funding
    
    to provide on-farm comparisons of the new generation lower risk
    
    pesticides with the heavily used triazine herbicides. EPA's
    
    Region 9 office (representing the states of Arizona, California,
    
    Hawaii, and Nevada) is part of a broad pollution prevention
    
    partnership known as the Biologically Integrated Orchard Systems
    
    Project (BIOS). The State of California, almond organizations,
    
    and USDA are among the other participants in BIOS, which is
    
    reducing pesticide and nutrient applications on the $600 million
    
    almond crop. This model information and technology transfer
    
    program is well suited to replication on other crops. Region 10,
    
    representing the Pacific Northwest, received funding for urban
    
    IPM programs for schools and public housing and to support
    
    alternatives to chemical pesticides for grasshopper control.
    
    
    
         OPP also awarded seven grants, totalling $260,000, to PESP
    
    Partners to assist in implementing portions of their stewardship
    
    strategies. These projects include education in expert systems,
    
    training and demonstration of IPM techniques, and development of
    
    new computer information systems.
    
    
    
         To obtain a free brochure published in 1995 or other
    
    information on PESP, contact the toll-free INFOLINE at
    
    1-800-972-7717.
    
    
    
    Biological Pesticide Regulatory Relief
    
    
    
         Over the past few years, OPP has provided regulatory relief
    
    to encourage the development and registration of insect
    
    pheromones, which can replace the use of certain chemical
    
    insecticides. OPP's 1995 efforts included expanding the allowable
    
    acreage from 10 acres to 250 acres for testing of certain
    
    pheromones without obtaining an Experimental Use Permit (EUP)
    
    from OPP. This rule applied to most types of lepidopteran
    
    pheromones (those designed to control butterfly and moth pests),
    
    including those tested for food crops, applied by any method at a
    
    low application rate. OPP also published a rule exempting these
    
    pheromones from tolerance requirements, meaning that crops grown
    
    during pheromone tests need not be destroyed, as is usually the
    
    case in pesticide testing. These regulatory decisions were
    
    expedited by comprehensive scientific submissions filed by the
    
    American Semiochemical Association, which represents the
    
    pheromone industry.
    
    
    
         In May 1995, OPP issued a rule which, among other things,
    
    allowed agricultural workers to reenter areas treated with many
    
    biological pesticide products more quickly (after four hours)
    
    than previously allowed under the Worker Protection Standard.
    
    This rule will further encourage biological pesticides while
    
    still protecting agricultural workers.
    
    
    
    Reinventing And Streamlining OPP's Organization
    
    
    
         As part of the efforts to "reinvent" the federal government
    
    structure and to increase responsiveness, OPP has undertaken a
    
    number of streamlining projects. In addition to registration
    
    reinvention efforts and piloting the Biopesticides and Pollution
    
    Prevention Division, described elsewhere in this report, the most
    
    significant reinvention projects during 1995 were:
    
    
    
       o Exploring new approaches to environmental risk assessment,
    
         including the creation of a multidisciplinary pilot branch
    
         on environmental risk characterization and interdisciplinary
    
         teams charged with developing options for reducing ground-
    
         water risks.
    
    
    
       o Forming the OPP Streamlining Council, a forum in which OPP's
    
         managers and representatives of its staff can work together
    
         to address the issues and opportunities presented by the
    
         drive to reinvent and streamline OPP's organization and
    
         operations.
    
    
    
       o Developing the OPP Reinvention Implementation Plan of March
    
         1995 by the Streamlining Council, including the general
    
         design for a new divisional alignment. The plan was
    
         presented in draft to the full staff of OPP, and discussed
    
         in a series of open meetings. Hundreds of staff comments
    
         were received and reflected in the final version of the
    
         plan. The proposal was discussed extensively with industry
    
         groups, environmental groups, and other stakeholders, and
    
         refined to reflect some of their suggestions.
    
    
    
       o Developing the full Reorganization Proposal of July 1995 by
    
         the Division Design Teams. These self-directed teams were
    
         formed to propose functional statements, work flows, and
    
         staffing patterns for each of the proposed divisions in the
    
         new alignment of OPP. Nearly 25% of the staff of OPP
    
         participated in the teams. 
    
    
    
         OPP's reorganization is scheduled to begin in 1996 but is
    
    contingent upon the status of EPA's budget. A number of other
    
    reinvention activities continued in 1995, such as completing a
    
    survey of customer satisfaction; performing an outside management
    
    review; piloting a continually updated, automated pesticide
    
    position file; and piloting non-supervisory, quality review teams
    
    for science issues. Comprehensive changes to the registration
    
    process are described in chapter 1.
    
    
    
                     How To Obtain More Information
    
    
    
         The Office of Pesticide Programs (OPP) wishes to provide
    
    timely and consistent information to the public. If you would
    
    like additional information on subjects discussed in this report
    
    or other topics, here are some sources available to you:
    
    
    
    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 subway station), telephone 703 305-5805.
    
    
    
    Catalog of OPP Publications and Other Information Media -- This
    
    catalog provides a listing of hundreds of pesticide publications,
    
    including science chapters, fact sheets, etc., and 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 513 891-6561
    
    or Fax 513 891-6685).
    
    
    
    Pesticide Regulation (PR) Notice 94-3 -- This document 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. PR 94-3 can be obtained from:
    
    
    
         Communications Branch, FOD (7506C)
    
         Office of Pesticide Programs, U.S. EPA 
    
         401 M Street, S.W.
    
         Washington, DC 20460
    
         (703 305-5017)
    
    
    
    Communications Branch -- Recent announcements and copies of non-
    
    technical brochures and fact sheets on pesticide issues can be
    
    obtained from the Communications Branch, as listed above.
    
    
    
    National Pesticides Telecommunications Network (NPTN) -- NPTN,
    
    accessible by a toll-free telephone number, provides general
    
    information about pesticides and is available to anyone in the
    
    United States, Puerto Rico and the Virgin Islands (Monday-Friday,
    
    6:30 a.m. to 4:30 p.m. Pacific Time) at 1 800 858-7378.
    
    
    
    Electronic Availability of Pesticide Documents -- Many EPA
    
    pesticide documents are available electronically from a variety
    
    of sources. Most of OPP's electronically-available documents,
    
    including Federal Register notices, press announcements, and
    
    Reregistration Eligibility Decisions (REDs), are available
    
    through the Internet. They can be accessed via EPA's World Wide
    
    Web server (http://www.epa.gov), EPA's Gopher server
    
    (gopher.epa.gov), or EPA's FTP server (ftp.epa.gov). Some
    
    documents can also be accessed through Fedworld (fedworld.gov).
    
    Reregistration and Special Review documents can be downloaded
    
    from an electronic bulletin board system, which can be reached
    
    via modem at 1 703 308-7224. A fact sheet describing these
    
    services can be obtained from the Public Docket, NCEPI, or the
    
    Communications Branch.
    
    
    
    Pesticide Information Network (PIN) -- The PIN is an interactive
    
    database system containing current and historic pesticide
    
    information. It is free and operational 24 hours per day, seven
    
    days per week. It can be reached via modem and communications
    
    software at 703 305-5919.
    
    
    
    
    
                       Pesticide Program Contacts
    
    
    
    The following is a listing of OPP's senior managers as of October
    
    1995, as well as the managers of OPP's parent office, the Office
    
    of Prevention, Pesticides and Toxic Substances (OPPTS). All OPP
    
    telephone area codes are 703.
    
    
    
          Office of Prevention, Pesticides and Toxic Substances
    
    
    
    Lynn R. Goldman, M.D., Assistant Administrator     (202) 260-2902
    
    Susan H. Wayland, Deputy Assistant Administrator   (202) 260-2910
    
    James V. Aidala, Associate Assistant Administrator (202) 260-2897
    
    Arnold E. Layne, Pesticide Program Advisor to      (202) 260-2896
    
         the Assistant Administrator
    
    
    
                      Office of Pesticide Programs
    
    
    
         Daniel M. Barolo, Director                        305-7090
    
         Penny Fenner-Crisp, Deputy Director               305-7092
    
         Marjorie Fehrenbach, Executive Assistant          308-4775
    
    
    
                    Policy and Special Projects Staff
    
    
    
         Anne Lindsay, Director                            305-7102
    
         Paul F. Schuda, Deputy Director                   305-7102
    
    
    
                Biological and Economic Analysis Division
    
    
    
         Allen L. Jennings, Director                       305-8200
    
         Susan M. Lawrence, Acting Deputy Director         305-8200
    
    
    
             Biopesticides and Pollution Prevention Division
    
    
    
         Janet L. Andersen, Acting Director                308-8712
    
         Flora Chow, Acting Deputy Director                308-8712
    
    
    
                 Environmental Fate and Effects Division
    
    
    
         Denise M. Keehner, Acting Director                305-7695
    
         Evert K. Byington, Acting Deputy Director         305-7695
    
    
    
                        Field Operations Division
    
    
    
         William Jordan, Acting Director                   305-7410
    
    
    
                         Health Effects Division
    
    
    
         Stephanie R. Irene, Acting Director               305-7351
    
         Debra F. Edwards, Acting Deputy Director          305-7351
    
    
    
                 Program Management and Support Division
    
    
    
         Frank T. Sanders, Director                        305-5440
    
         Norman W. Chlosta, Deputy Director                305-5440
    
    
    
                          Registration Division
    
    
    
         Stephen L. Johnson, Director                      305-5447
    
         Peter P. Caulkins, Deputy Director                305-5447
    
    
    
               Special Review and Reregistration Division
    
    
    
         Lois A. Rossi, Director                           308-8000
    
         Richard D. Schmitt, Deputy Director               308-8000
    
    
    
    

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