Information provided for informational purposes only

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

United States Environmental Protection Agency Office of Pesticide Programs

Office of Pesticide Programs Annual Report for 1994

Publication Number: EPA 735-R-95-001
Date: January 1995

ABSTRACT:      This Annual Report describes many of the efforts

               and accomplishments of EPA's Office of Pesticide

               Programs (OPP) during fiscal year 1994 (October 1,

               1993 to September 30, 1994).  It also describes

               some of the opportunities and initiatives that OPP

               will pursue during 1995.



NOTE:          The following electronic version does not contain

               the full graphics of the original version. 

               Information on obtaining paper or electronic

               versions 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:  Paper copies including graphics (while supplies

               remain) are available free of charge from the

               National Center for Environmental Publications and

               Information (NCEPI), telephone 513-489-8190 or fax

               513-489-8695.  An electronic version containing

               full graphics is also being made available in

               Adobe Acrobat(tm) Portable Document File (PDF)

               format, version 1.0.  You may obtain this file

               from the Internet on EPA's gopher server,

               GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or

               using WWW (World Wide Web) on WWW.EPA.GOV.  It may

               also be downloaded from the Pesticide Special

               Review and Reregistration Information System at

               703-308-7224.



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 735-R-95-001

January 1995



       Office of Pesticide Programs Annual Report for 1994







                            Foreword



     EPA's Office of Pesticide Programs (OPP) has been entrusted

with an important responsibility: safeguarding the health of the

American public and the environment from risks that may be caused

by pesticides.  OPP also must make sure that pesticides are

regulated fairly and help ensure that effective measures for

controlling pests are available.  OPP has assembled a diverse and

talented team of employees to manage these responsibilities. 

This report is intended to explain how OPP is using its resources

to accomplish its mission.



     From this report, several themes emerge:



  o  Partnerships and Teamwork: OPP cannot oversee pesticides by

     itself.  EPA's regional offices and the state and tribal

     pesticide regulatory agencies have a fundamental role in

     implementing and enforcing pesticide policies and educating

     the public.  Other important partners include the pesticide

     industry and users, environmental and public interest

     groups, the news media, additional EPA programs, and other

     federal and international agencies.  And ultimately, all of

     us are partners because the personal choices that we make in

     using pesticides are important factors affecting pesticide

     risks.



  o  Customer Service, Streamlining, and Reinventing OPP: Many

     projects are underway to help OPP serve its partners and

     other "customers" more efficiently and effectively, and to

     better protect public health and the environment.  OPP

     strives to make decisions openly, with public involvement,

     and in a sensible, understandable manner.



  o  Sound Science and Data: Sound science and data provide the

     foundation for OPP's decisions.  OPP has required and

     reviewed thousands of studies on the potential effects of

     pesticides and their fate in the environment.  OPP also

     gathers much data on the use, effectiveness, and economics

     of pesticides.  OPP will continue to promote scientific

     excellence and ensure that scientific data are accessible

     and useful to EPA and the public.



  o  Pollution Prevention: OPP recognizes that it is neither

     economical nor effective to solve problems after they have

     been created.  As a result, OPP is increasingly focusing on

     preventing risks from pesticides in the environment. 

     Important elements of this approach include encouraging

     safer means of pest control, reducing pesticide use and

     exposure, and evaluating the effectiveness of protection

     efforts.



     I hope this report will help you understand what we

accomplished in 1994 and some of the many challenges that lie

ahead.



                                   Sincerely,



                                        /signed/



                                   Daniel M.  Barolo, Director

                                   Office of Pesticide Programs





     Dedication:  This first annual report is dedicated to the

employees of OPP.  They represent many disciplines, including

scientists, administrative staff, environmental protection

specialists, program analysts, and computer specialists. 

Although we have a few miles to go, everyone in OPP should feel

proud of our efforts and, more importantly, the positive impact

our actions have on our public health, environmental and worker

safety goals.





                          Introduction



     Pesticides differ from other classes of chemicals regulated

by EPA in several important ways.  They are often intentionally

applied in the environment, rather than occurring as a byproduct

of industry or other human activity.  They are used in a

remarkably diverse array of products, from insect repellents to

crop weed killers to household disinfectants to swimming pool

chemicals, to name a few.  In addition, they are likely to be

found or used in nearly every home and business in the United

States.  Although improper pesticide use may pose health risks,

many pesticides have public health benefits by killing potential

disease-causing organisms found in food, water, and other

settings.



     Given the unique attributes of pesticides, EPA has found

that protecting public health and the environment from the risks

that pesticides may pose is a complex endeavor.  To meet this

challenge, the Agency has developed an array of programs to

evaluate and reduce pesticide risks and promote safe pesticide

use.  These programs must be flexible enough to reflect the wide

variety of existing pesticide products and uses, and must take

into account the benefits that pesticides offer to society. 

State and tribal agencies and many other organizations, both

public and private, have been vital partners in this effort.



     This report describes many of the efforts and

accomplishments of the Office of Pesticide Programs (OPP) during

the 1994 fiscal year (October 1, 1993 to September 30, 1994).  It

also describes some of the opportunities and initiatives that OPP

will pursue in 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 budget process:



     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 their 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).





                            Contents

Foreword



Introduction



Chapter 1: Registration



     Overview Of Registration

     New Registrations In 1994

     Reduced-Risk Policy

     Other 1994 Registration Achievements

     Ensuring The Effectiveness Of Antimicrobial Pesticides

     Retaining Minor Uses

     Proposed Measures To Reduce Risks From Total Release Foggers

     Addressing Risks From Spraying Pesticides Aboard Aircraft

     Water Protection Measures For New 

          Pesticide Active Ingredients

     Efforts To Improve Pesticide Labels

     Pesticide Chemistry Laboratory Support For Registration

     Reducing Unnecessary Requirements For Pesticide Registration

     Agreement With California To Harmonize Pesticide Regulation

     Improvements To Regulatory File System



Chapter 2: Reregistration



     Steps In Reregistering Pesticides

     1994 Reregistration Progress

     Reducing Pesticide Spray Drift

     Reassessment Of Dioxin Risks

     Rejection Rate Analysis

     Pesticide Chemistry Laboratory Support For Reregistration

     Reducing Ecological Risks Under The "New Paradigm"

     The Label Use Information System (LUIS)



Chapter 3: Special Review



     1994 Formal Special Reviews And Follow-up Activities

     Cancellation Of Mevinphos

     Other Negotiated Risk Reduction Efforts

     Other Cancellation Activities

     Tolerance Revocations

     Initiative To Reduce Risks To Birds 

          (Avian Granular Initiative)



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

     Disposal Of Suspended And Cancelled Pesticides

     Promoting Integrated Pest Management

     Guidance For Posting Of Outdoor Pesticide Applications



   B. Communications, Public Response, and Coordination

     Outreach And Communications Strategies

     Responding To The Public

     Congressional And Federal Coordination

     Public Meetings

     Pesticide Information Network

     Agency Risk Management Communication Group

     Scientific Presentations And Publications

     International Coordination And Integration

     Regional, State, And Tribal Liaison

     Improving Internal Communication



   C. Support For Compliance Activities

     Support For The Lab Audit Program

     Analysis Of Product Chemistry

     Other Laboratory Support

     Additional Support For Compliance Activities



Chapter 5: Policy, Regulations, and Guidance



     Follow-Up To The National Academy Of Sciences (NAS) 

          Children's Study

     Reduced Use/Risk Initiative

     International Harmonization And Regulatory Coordination

     Technical Assistance: AID/EPA Central American Project

     Biological Pesticide Policy Highlights

     Activities Related To Implementation Of The "Delaney Clause"

     Standards For Pesticide Containers And Containment

     Other Regulations Under Development

     Legislative Proposals

     Maintaining And Improving OPP's Science Base



Chapter 6: Information and Program Management



     Operations, Maintenance And Integration 

          Of The Primary OPP Information Systems

     Ecological Incident Monitoring And Reporting

     Information And Records Management Activities

     Human Resources Management 

     Resource Allocation And Financial Management



Chapter 7: Opportunities and Initiatives For 1995



     Biological Pesticides And Promoting Risk Reduction

     Opening Up OPP

     Reinventing And Streamlining OPP's Organization



How To Obtain More Information



Pesticide Program Contacts





                     Chapter 1: Registration



     This chapter describes the registration program, which

provides the foundation for nearly all OPP activities related to

pesticides.  In addition to allowing the use of new pesticides,

this program includes many activities related to the ongoing

registration of existing pesticides, such as modifications to

where and how they may be used in order to reduce risks or in

response to requests by registrants.  OPP also carried out a

number of special registration programs in 1994, which are

described in more detail in this chapter.  These included

encouraging the registration of reduced-risk pesticides, ensuring

the effectiveness of antimicrobial pesticides, helping to retain

important minor use pesticides, proposing measures to reduce the

risks from total release foggers ("bug bombs") and from spraying

of pesticides aboard aircraft, improving pesticide labels,

reducing unnecessary registration requirements, and coordinating

registration activities with the State of California.



Overview Of Registration



     EPA is responsible under the Federal Insecticide, Fungicide,

and Rodenticide Act (FIFRA) for registering new pesticides and

ensuring that, when used according to label directions, they will

not cause unreasonable adverse effects to human health or the

environment.  Pesticide 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 kinds of specific 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 determine, among other things, whether a pesticide poses

a threat to groundwater or surface water (lakes, rivers, and

streams).



     Most of OPP's testing requirements focus on "active

ingredients" of pesticide products.  Active ingredients are those

substances that actually possess a pesticidal property -- that

is, they repel, destroy, or otherwise affect a pest.  Most

pesticide products also contain other ingredients that do not

have pesticidal properties, such as solvents, carriers, aerosol

propellants, and dyes.  Ingredients that are not active as

pesticides are called "inerts."



New Registrations In 1994



     OPP registered 31 new pesticide active ingredients in fiscal

year 1994, more than half of which are considered to be reduced

risk pesticides.  Reflecting the trend of recent years, a high

proportion of new ingredients -- 15, or nearly half -- were

biological pesticides.  Biological pesticides include "microbial

pesticides," which are bacteria, viruses, or other microorganisms

used to control pests, and "biochemical pesticides," which

include pheromones (insect sex attractants), insect or plant

growth regulators, and hormones used as pesticides.  Biological

pesticides generally pose less risk to health and the environment

than chemical pesticides, and as a result OPP imposes fewer

requirements on their registration.  The following table

describes the pesticide active ingredients registered for the

first time in fiscal year 1994.



            New Active Ingredients Registered in FY94



-----------------------------------------------------------------

  Pesticide      Registrant   Pesticide   Use(s)     Biological

    Name                        Type                  or Other

                                                    Reduced Risk

                                                     Pesticide?

--------------  -----------  ----------  ---------  -------------

Acetochlor      Monsanto     Herbicide   Corn

                Agric. Co.; 

                Zeneca Ag 

                Products



Ampelomyces     Ecogen       Fungicide   Grapes,        Yes 

quisqualis                               toma-      (biological)

                                         toes, 

                                         straw-

                                         berries, 

                                         apples



Bacillus        Gustafson    Fungicide   Cotton,        Yes 

subtilis (MBI                            grains     (biological)

600)



C-9211          Rohm and     Mildewcide  Paints

                Haas         



Castor Oil      Dinah        Repellent   Orna- 

                Pickett                  mental

                                         plants



Checkmate CM    Consep;      Pheromone   Fruits         Yes 

pheromone       Bedoukian                and nuts   (biological)

                Research



Corn Glutens    Gardens      Fungicide   Turf           Yes 

                Alive!                              (biological)



Cyproconazole   Sandoz Agro  Fungicide   Turf

                Inc.



Deltamethrin    Roussel      Insect-     Feed

                Uclaf;       icide

                AgrEvo 

                Environ

                -mental 

                Health



Difeno-         Ciba-Geigy   Fungicide   Wheat

conazole



DTEA            Dow          Anti-       Water 

                Chemical     microbial   Systems





Floral          Micro-Flo    Phero-      Corn           Yes 

Attractants                  mones                  (biological)

(seven                                             (7 pheromones)

different 

compounds)



Flumetsulam     DowElanco    Herbicide   Corn and 

                                         soybeans



Gusano          Crop         Insect-     Veget-         Yes 

(Alfalfa        Genetics     icidal      ables      (biological)

looper          Inter-       Virus

virus)          national



                             

Hexaflumuron    DowElanco    Insect-     Termit-        Yes

                             icide       icide



Hydrogen        SKW          Plant       Grapes

Cyanamide       Trostberg    Growth 

                AG           Regulator



Imidacloprid    Miles        Insect-     Turf

(NTN)                        icide



Irgarol 1051    Ciba-Geigy   Anti-       Anti-      

                             microbial   foulant 

                                         paints



Methyl          PMC          Bird        Turf           Yes

Anthranilate    Specialties  Repellent

                Group



Pseudomonas     Mauri Lab-   Fungicide   Mush-          Yes 

fluorescens     oratories                rooms      (biological)

Strain NCIB 

12089



Puccinia        Tifton       Herbicide   All            Yes 

canaliculate    Innovation               crops      (biological)

lagerheim       



RYH-86-A        Yoshitomi    Slimicide   Paper 

                Pharmaceut.              mills

                Industries



Tebuconazole    Miles        Fungicide   Peanuts



Tufted Apple    Bedoukian    Pheromone   Apples         Yes 

Bud Moth        Research                            (biological)

pheromone



Turpentine      DLT Lab-     Insect-     Non-Food   

                oratories    icide       Uses

----------------------------------------------------------------



     Summary Statistics



       o  31 new active ingredients registered

       o  2 chemical active ingredients registered as "reduced-

          risk pesticides"

       o  15 were biological/biochemical pesticides





Reduced-Risk Policy



     During fiscal year 1994, OPP implemented its voluntary

Reduced-Risk Pesticide Initiative.  Under this effort, OPP

invites applicants seeking to register new pesticide active

ingredients to provide information on how their pesticide

presents opportunities for risk reduction.  If OPP believes that

the pesticide demonstrates such potential, OPP accelerates the

registration process for the pesticide.



     In March 1994, OPP registered the first pesticide under this

initiative.  Hexaflumuron, developed by DowElanco, has the

potential to replace much larger amounts of the termiticide

chemicals traditionally used.  This product is used with a

monitoring system so that the chemical is applied only after a

termite problem has been identified.  In September 1994, OPP

registered the second reduced-risk pesticide, methyl

anthranilate.  This bird repellent, marketed by PMC Specialties

Group, is registered for use on turf.  Methyl anthranilate is

found in flower oils and in Concord and other grapes.  This

product solves bird pest problems where existing bird control

toxicants and repellents cannot be used.



     OPP will continue the voluntary initiative in its current

form for at least one additional year.  During this time, OPP

will explore other types of incentives that could encourage the

development, registration, and use of lower-risk pesticide

alternatives.  In addition, OPP will consider approaches for

expanding the current pilot program to other types of

registration applications.



Other 1994 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.  The decisions made in 1994 are summarized

in the following table.  Both approvals and denials of the

requests received by OPP are included in the number of decisions.



                  1994 Registration Activities



---------------------------------------------------------------

Registration        Description of Activity           Number of 

Activity                                              Decisions

------------------  --------------------------------  ---------

Registrations of    First approval for use of               31

new pesticides      pesticides not currently 

                    registered in the United States.



Additional          Registrations for new products         782

registrations       containing pesticide ingredients 

for previously      already approved for proposed 

registered          uses.

pesticides



Amendments to       Amendments, for example, to          3,233

existing            reflect revised labels and 

registrations       changed formulations for 

                    products already registered.





New uses for        Approvals for uses of a                 56

previously          pesticide (such as on particular 

registered          food crops) for which it has 

pesticides          never been registered.





Emergency           Decisions on granting emergency        265

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        104

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                  70

                    tolerances, or maximum allowable 

                    levels of a pesticide 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 approving                   26

tolerances          tolerances for experimental 

                    purposes for an unregistered 

                    pesticide.



Special Local       Registrations of pesticide             411

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.)

---------------------------------------------------------------





Ensuring The Effectiveness Of Antimicrobial Pesticides



     While all pesticide products are required to work as claimed

by the manufacturer, EPA is particularly concerned about the

effectiveness, or efficacy, 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.  Not only are they used in homes, but

also in hospitals, cafeterias, restaurants, and many other

institutions.  Over the past several years, EPA has implemented a

comprehensive strategy to ensure the efficacy of antimicrobial

pesticides, placing highest priority on those that have

significant public health uses.  Among these efforts, EPA has:



  o  Funded six cooperative agreements to develop new or revise

     existing test methods for determining the efficacy of

     antimicrobial public health products.



  o  Implemented a pre- and post-registration testing program. 

     Six new sterilants were subjected to pre-registration

     testing this past fiscal year, of which one has been

     registered and the others are pending.  Testing of hospital

     disinfectants and products with tuberculocidal claims is in

     progress.



  o  Administered the Antimicrobial Complaint System to receive

     inquiries and complaints from users and the public.  The

     system received more than 4,000 calls from medical

     professionals and infection control personnel in 1994.  This

     system also provides valuable information for assessing

     needed regulatory changes.



  o  Implemented comprehensive label improvement programs to

     upgrade the label claims and directions for products used

     against the AIDS virus (HIV-1) and for tuberculocidal,

     sanitizing, and pine oil products (household disinfectants).



Retaining Minor Uses



     Minor use pesticides are those that generate relatively

little income for their manufacturers because they are used on

limited acreages.  Increased costs of pesticide registrations,

especially the costs associated with reregistering pesticides,

often result in registrants choosing to cancel minor use

registrations and not pursue approval for new uses.  However,

minor use pesticides are of major importance to growers in

producing many fruits, vegetables, and ornamental plants.  In

1994, OPP continued to participate in several activities to help

preserve important minor uses:



  o  IR-4 Efforts.  OPP supports the efforts of the Interregional

     Research Project Number 4, or IR-4 program, which is jointly

     funded by the U.S. Department of Agriculture and the states. 

     IR-4 has generated data for many minor use pesticides

     undergoing reregistration and has committed to providing

     residue data to support reregistration of an additional 250

     high priority pesticide food uses.  OPP supports increased

     IR-4 funding as the best way to protect minor uses without

     sacrificing health and safety data development and reviews.

     

  o  Data deferrals/waivers.  OPP tries to be flexible on the

     data required for registration and reregistration of minor

     use pesticides, but must also ensure that pesticides do not

     pose unacceptable risks to people or the environment.



  o  Crop grouping.  OPP has supported the establishment of

     tolerances (maximum approved levels in food) for multiple

     related crops based on residue data from a representative

     set of crops.  This cuts the costs of registering minor

     uses.



  o  Legislation.  In 1994, the Administration proposed

     legislative changes to help retain important minor uses, and

     encourage registration of new minor uses, as part of its

     Food Safety Initiative.  This proposal embodies many

     elements from a proposal by the Minor Crop Farmers Alliance

     (MCFA).



Proposed Measures To Reduce Risks From Total Release Foggers



     Total release foggers -- sometimes called "bug bombs" -- are

pesticide products containing aerosol propellants that release

all of their contents at once to fumigate an area.  They are used

in homes to kill cockroaches, fleas, and other pests.  On April

15, 1994, OPP proposed new labeling requirements for total

release foggers based on information that demonstrated that total

release foggers, as currently labeled, represent an unreasonable

risk to users from fires and explosions.  The proposed rule would

require additional flammability label warnings and a standard

graphic symbol, representing fire and explosion, to alert

consumers to these potential dangers.  In addition, pesticide

labels for these products would include more detailed directions

for proper use.  The proposed rule encourages registrants to use

other hazard communication mechanisms to reinforce the required

precautionary language.  OPP is reviewing comments on the

proposal and expects to issue a final rule in 1995.



Addressing Risks From Spraying Pesticides Aboard Aircraft



     In late 1993, EPA became aware of several incidents in which

airline personnel and passengers experienced adverse health

effects after being exposed to an insecticide treatment aboard

foreign-bound aircraft.  Although the United States has not

required spraying since 1979, several foreign countries do

require the spraying of incoming aircraft, with passengers and

crew present, prior to landing.  Traditionally, passengers are

not told that this treatment will occur until the spraying

actually begins.  The pesticide used in these treatments is known

as sumithrin.  Although EPA has data indicating that sumithrin is

generally low in toxicity to humans, the Agency does not know how

the chemical may affect susceptible sub-populations.  EPA is

particularly concerned that individuals who are chemically

sensitive, or who suffer from respiratory problems or allergies,

may have adverse reactions.



     In March 1994, OPP issued a Data Call-In Notice to the two

registrants that still held U.S. registrations for in-flight

insecticide treatments requiring them to either develop new

toxicity data or amend the pesticide label to delete the aircraft

use.  Since then, both registrants have removed the aircraft use

from the label.  Many countries, however, continue to require in-

flight spray treatments.  Recently, the U.S. Department of

Transportation (DOT) issued a proposed rule to require

notification to passengers at the time they purchase their

tickets.  EPA continues to work with the State Department and DOT

to encourage foreign countries to rescind the airline spraying

requirement.  OPP is also preparing a notice to registrants to

ensure that pesticide labels do not allow the use of other

insecticides on board aircraft with passengers and crew present.



Water Protection Measures For New Pesticide Active Ingredients



     In 1994, OPP initiated a new approach for registering

pesticide active ingredients that sets strong standards for

ground and surface water protection.  The approach establishes

clear criteria that trigger voluntary suspension or cancellation

of the registration if water quality is adversely affected. 

These criteria are based on an assessment of the chemical and

physical properties of the pesticide and other factors indicating

its potential to contaminate water resources.  Acetochlor was the

first pesticide registered using this approach.  Highlights of

the water protection approach include:



  o  Requirements for analytical methods to detect the presence

     of the pesticide in water, including a low-cost immunoassay.



  o  Early warning systems to prevent ground water emergencies,

     including monitoring of wells and surface water in several

     states.



  o  Product stewardship programs to foster proper use by

     customers and to prevent problems from occurring.



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. 

In response to needs expressed by OPP's customers and an internal

evaluation process, OPP formed a Labeling Unit in July 1994.  The

goal of the unit is to ensure that product labels are clear,

technically accurate, and consistent.  In 1994 the unit

accomplished the following:



  o  Introduced a process for tracking and resolving short-term

     labeling problems and issued responses to more than 50

     requests for guidance.



  o  Established an electronic labeling policy directory which

     contains over 300 easily accessible documents.



  o  Established a Labeling Bulletin Board system for sharing

     information about labeling projects with internal and

     external customers.



  o  Helped finalize and release a comprehensive Label Review

     Manual for use by internal and external customers.



  o  Initiated projects to improve consumer labeling, test the

     electronic submission/review/storage of labels, and revise

     OPP regulations to allow certain information on labels that

     consumers need to make more informed choices.



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 properly measured in food and the

environment.



     The ACL has the lead responsibility for the food tolerance

methods validation program.  In fiscal year 1994, ACL validated a

record 49 food tolerance methods for registration.  The ACL's

achievements also included the development of a method for

detecting residues of multiple sulfonylurea pesticides in food

using a new technology called capillary zone electrophoresis,

which generated much interest among the scientific community. 

The ECL has the lead responsibility for the environmental

chemistry methods validation (ECMV) program.  The demand for

environmental chemistry support for new pesticides grew

substantially in 1994, with the primary emphasis being in the

areas of environmental fate and exposure and ecological effects. 

The ECL completed seven ECMV requests for new pesticides in 1994,

including a ten-fold lowering of the detection limit for the

pesticide acetochlor, allowing it to be more readily detected in

the environment.  The ECL also continued to provide support to

the new, low-cost technology for detecting pesticide residues

known as immunoassay tests.



Reducing Unnecessary Requirements For Pesticide Registration



     In 1994, OPP continued to identify areas where pesticide

regulations could be reduced, allowing OPP to better focus on

high risk areas and preventing undue burdens on the regulated

community.  One area identified was the potential exemption of

certain low-risk pesticides from registration requirements.  In

January 1994, OPP established an exemption from registration

requirements under section 25(b) of FIFRA for natural cedar

pesticides labeled to repel arthropods (other than ticks) or to

retard mildew growth.  OPP concluded that use of these pesticides

poses negligible risks to human health and the environment and

that, as a result, the burden imposed by regulation is not

justified.



     Subsequently, the Agency proposed a second rule (also under

section 25(b)) to exempt 31 additional low-risk substances from

regulation.  Most of these were food items (such as cinnamon,

garlic, and mints) or substances otherwise derived from natural

sources.  Under the proposal, to be eligible for exemption these

substances could not be sold in formulations with other

pesticides or chemicals of concern, and could not be labeled to

control organisms posing a risk to public health.  The labels

would be required to list all ingredients.  OPP will review

comments received and determine how to proceed in 1995.



Agreement With California To Harmonize Pesticide Regulation



     OPP and the Department of Pesticide Regulation of the

California Environmental Protection Agency began an initiative in

1994 to harmonize and simplify federal and California 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.  Under this MOU, the agencies agreed to share

reviews of acute toxicology studies submitted by pesticide

registrants.  The agreement sets out a plan to reduce duplicative

review of identical data, improve coordination, and reduce the

workload of both agencies by allowing each agency to use acute

toxicity data reviews generated by the other.  Through this

effort, products posing fewer risks will be registered much

faster and at less cost, and older pesticides lacking adequate

health data will be more quickly removed from the market.



Improvements To The Regulatory File System



     Among OPP's most important files are the regulatory

"jackets" for each pesticide product that has been federally

registered.  During fiscal year 1994, the Regulatory File Area

implemented several changes to improve service.  In particular, a

computerized system that provides OPP users with the ability to

request jackets from their workstations was activated.  The new

system has been integrated with other OPP computer systems, and

provides status information on each registration (such as

cancelled, withdrawn, or suspended).  Under this system, files

can be more efficiently managed; for example, quick

identification of cancelled files facilitates their removal to

make room for new incoming files.  95% of file room users have

been trained to use the new system and training will continue in

1995.





                    Chapter 2: Reregistration



     The reregistration program is one of OPP's largest and most

visible programs.  OPP is required by law to reregister existing

pesticides originally 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.  In 1988, Congress amended the federal pesticide law

to strengthen and accelerate OPP's reregistration program.  The

"FIFRA '88" amendments apply to each product containing any

active ingredient registered before November 1, 1984.



     This chapter discusses the progress OPP is making in

reregistering pesticides, as well as some related initiatives. 

These include efforts to reduce the number of studies rejected by

OPP, reduce the risks posed by pesticide spray drift, more

effectively assess and decrease ecological effects, help

understand and control dioxin risks, and expand a database of

label directions for pesticides undergoing reregistration.



Steps In Reregistering Pesticides



     OPP identified the pesticides to be reregistered and issued

comprehensive data requests to registrants of those pesticides

during Phases 1 through 4 of the accelerated reregistration

process.  Reregistration is now in its final phase, Phase 5, as

OPP reviews the studies that are being submitted, examines the

health and environmental effects of each reregistration case

(group of related pesticide active ingredients), and attempts to

mitigate effects of concern.  This evaluation and risk management

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 conclusion about whether a pesticide's uses are

eligible for reregistration is presented in a Reregistration

Eligibility Decision, or RED.  About 14 months later, once

certain product-specific data and revised labeling are submitted

and approved, OPP begins reregistering products containing the

eligible pesticide(s).  A product will not be reregistered until

OPP has determined that all of its active ingredients are

eligible for reregistration.



1994 Reregistration Progress



     During fiscal year 1994, OPP made significant progress in

administering the reregistration program.  Many decisions were

made resulting in significant risk reductions.  The program's

investment in people, computer systems and data gap

identification is paying off with steady production of the

decisions needed to complete the reregistration process.  



     Several different stages of reregistration offer

opportunities to contribute to safer use of older pesticides. 

New risks identified during the reregistration process may be

addressed by imposing interim risk reduction measures before the

scheduled REDs.  The next important stage for reducing risks

occurs with the issuance of REDs.  Many types of risk reductions

are required through REDs, and OPP completed an unprecedented

number of REDs this fiscal year, as detailed later in this

chapter.  Finally, perhaps the most comprehensive risk reduction

impacts occur during the product reregistration stage.  During

fiscal year 1994, program emphasis began shifting toward product

reregistration, as many more products became eligible.  Product

reregistration will become even more important during the next

several years.  Some of the principal accomplishments of the

reregistration program during fiscal year 1994 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 34 in fiscal year 1994 for a

cumulative total of 81 completed REDs.  A target of 40 more REDs

has been set for fiscal year 1995.



                    Number of REDs Completed:



                              FY91:   13

                              FY92:   15

                              FY93:   19

                              FY94:   34

                                      --

           Cumulative through FY94:   81



                         FY95 Goal:   40

              FY95 Cumulative Goal:  121





     Status of Reregistration Cases 



     OPP has completed a total of 81 REDs, representing one fifth

of the 405 chemical cases currently supported for reregistration. 

Meanwhile, 207 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.



     Anatomy of the 81 REDs Completed

          ...Or, What "81 REDs Completed" Means...



     The 81 REDs completed cover 120 active ingredients, 3,521

products, and 500 tolerances.  They represent 20% of all

supported reregistration cases (a case consists of one or more

related pesticide active ingredients); 17.5% of all currently

registered pesticide products; 19% of food use pesticides

(supported List A cases); and 9% of original List A tolerances

reassessed.  As described in the table below, the completed REDs

represent about two-thirds of the quantity of pesticides used (by

volume) in the United States, including about two-thirds of all

homeowner-applied pesticides and 9 to 14% of all pesticides used

in agriculture.



              Amount of Pesticide Usage (by volume)

                   Covered By REDs Completed*



---------------------------------------------------------------

               Homeowner    Agriculture  Commercial/    TOTAL

               Applied                   Industrial 

                                         and 

                                         Government     

-------------  -----------  -----------  -----------  ---------

Fungicides     50% to 55%   55% to 60%    4% to 7%    40 to 48%



Herbicides          4%       4% to 7%    16% to 30%   6% to 10%



Insecticides   10% to 15%    1% to 2%     1% to 3%    4% to 10%



Anti-             99% +        99% +        99% +        99%

microbials



TOTAL              65%       9% to 14%     65%           65%

---------------------------------------------------------------



     * Please note that the REDs completed for the 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.  





     Risk Reductions Achieved



     Each Reregistration Eligibility Decision (RED) document

issued in 1994 involved changes to reduce the potential risks of

the pesticide being evaluated.  Risks can be reduced by

cancelling products, declaring uses ineligible for

reregistration, strengthening the requirements on product

labeling, or limiting the amount of pesticide residues that may

remain in food by establishing, reducing or revoking "tolerances"

(enforceable maximum residue limits).  Some of the risk reduction

measures achieved in the 34 REDs completed this fiscal year are

described in the following table:



----------------------------------------------------------------

 Number of REDs   Risk Reduction Measures Required By RED

----------------  ----------------------------------------------

        1         All products and uses voluntary cancelled

                  (mevinphos).



        6         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.



       19         Personal Protective Equipment requirements for

                  pesticide applicators strengthened or

                  confirmed.



       10         Restrictions that limit entry of workers into

                  treated areas (including Restricted Entry

                  Intervals) strengthened or confirmed.



        8         Limits/reductions/specifications regarding the

                  amount, frequency, or rate of application

                  required.



        3         Use Directions on labeling strengthened or 

                  made more specific.



        6         Other user safety measures required.



        5         Label Advisory or other measures to protect

                  ground or surface water required.



       14         Environmental Hazard statements to reduce

                  ecological risks strengthened.



        8         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

a tolerance) 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, about 500

(or 9%) List A pesticide tolerances have been reassessed as part

of the reregistration process.  About 600 more List A tolerances

are associated with active ingredients no longer supported for

reregistration; these active ingredients ultimately will be

cancelled and their tolerances revoked.  During the past several

years, some new tolerances have been added for the List A

chemicals, while others have been revoked.  OPP estimates that

approximately 4,500 tolerances for List A pesticides still need

to be reassessed during reregistration.



     Data Call-In (DCI) Notices



     OPP has issued 453 comprehensive Data Call-In (DCI) notices

under the reregistration program to obtain studies needed to

assess potential health and environmental risks.  As Phase 4 of

reregistration has been completed, which involved issuing DCIs to

complete pesticide databases, the number of DCIs issued per year

has decreased.  OPP issued 77 DCIs in 1994.



     Status Of Studies Received



     Registrants have responded to DCIs and other requirements by

submitting more than 19,000 studies in support of reregistration. 

Review of these studies is essential for making reregistration

decisions.  By end of fiscal 1994, OPP had reviewed more than

11,500 of the studies, including nearly 7,000 of the

approximately 9,000 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                2,632       2,118       514

Environmental Fate               2,140       1,349       791

Reentry Non-Dietary                209          51       158

Toxicology, Non-CORT**           1,515       1,238       277

Toxicology, CORT*                  738         658        80

Ecological Effects               1,742       1,365       377

--------------------------------------------------------------





             Status Review Status For All Pesticides

        Undergoing Reregistration (Lists A, B, C, and D)



--------------------------------------------------------------

Study Type                     Received    Reviewed   Awaiting

                                                       Review

-----------------------------  ----------  ---------  --------



Residue Chemistry                4,250       2,709      1,541

Environmental Fate               3,741       1,960      1,781

Reentry Non-Dietary                268          55        213

Toxicology, Non-CORT**           5,045       2,721      2,324

Toxicology, CORT*                1,777       1,127        650

Ecological Effects               4,304       2,930      1,374

--------------------------------------------------------------



* 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.





     Suspensions



     When pesticide registrants fail to submit studies required

for reregistration in a timely way, EPA's Office of Enforcement

and Compliance Assurance (OECA) can issue Notices of Intent to

Suspend (NOITS) product registrations.  NOITS serve as an

effective mechanism for bringing about compliance with EPA's data

requirements for reregistration; in most instances companies

comply with the NOITS by submitting the missing studies.  If

companies fail to comply by either submitting the required

studies, voluntarily withdrawing their product registrations, or

requesting a hearing, EPA can issue suspensions.



     During fiscal year 1994, EPA issued NOITS to 179 companies. 

The Agency eventually withdrew 128 of these NOITS because the

companies achieved compliance.  However, EPA also issued 47

suspensions, and in four other cases is responding to requests

for hearings to resolve questions about the Agency's data

requirements.  These fiscal year 1994 actions bring the total

number of NOITS issued since 1989 to 779, and the number of

suspensions to 301.  In most of the remaining 478 cases,

compliance has been achieved, while hearings continue to resolve

remaining issues in some of the cases.



     Voluntary Cancellations



     In some instances, registrants have responded to

reregistration requirements by withdrawing support for pesticide

active ingredients and products.  Reregistration cases have

dropped overall from 612 cases in 1988 to 405 today.  Registered

products declined during the early 1990s from approximately

45,000 to about 20,000 subject to reregistration.  This initial

decline represented pesticides with little or no use; more than

19,000 of these pesticides had not been produced in the three

years prior to their cancellation.  As product reregistration

proceeds (please see below), a significant number of additional

products are being voluntarily cancelled by their registrants.  



     Product Reregistration



     While REDs are OPP's major reregistration output, much of

the real world impact of eligibility decisions and risk reduction

requirements does not occur until products are reregistered. 

This occurs at least 14 months after a RED is issued because of

the time required for registrants to submit product-specific data

and labels and for OPP to review them.  As of October 1994, OPP

had reregistered over 600 products, granted a greater number of

voluntary cancellations (925), amended 11 existing registrations,

and suspended 449 products.  Reregistration decisions are pending

on a total of 980 products.  Activity in this important area will

increase dramatically during the next several years.



Rejection Rate Analysis



     In 1991, OPP discovered that the submission of unacceptable

studies was the most significant factor delaying reregistration. 

Repeating studies can add years to the reregistration process,

significantly increase OPP's administrative and science review

costs, and cost registrants millions of dollars.  To address the

high rate of rejection of studies submitted during

reregistration, OPP developed the Rejection Rate Analysis.



     OPP's analysis, which involves the active cooperation of the

pesticide industry and the IR-4 program, is an intensive effort

to identify and resolve the underlying problems that most

frequently cause studies to be rejected.  The resulting reports

for each discipline -- including Residue Chemistry, Worker

Exposure, Toxicology, and Environmental Fate -- are designed to

make sure that future studies will be acceptable to the Agency.



     By 1994, two years after the first Rejection Rate Analysis

chapter was published by OPP, the quality of studies submitted to

OPP was improving.  For example, processing studies, which

initially had the highest rejection rate among residue chemistry

studies, improved from a 29% rejection rate before the analysis

to a 16% rate afterwards.  The second most often rejected study,

plant metabolism, improved dramatically from a 27% rejection rate

before the analysis to only 8% after.  Improvements such as these

will assist OPP in making reregistration decisions in a more

timely way.



     The next milestone in the Rejection Rate Analysis will be

publication of the final chapter on Ecological Effects in 1995. 

EPA and industry scientists first met in April 1994 to improve

understanding of factors leading to ecological effects study

rejection.  This effort became a forum for expressing divergent

perspectives on the way risk to birds is assessed.  The analysis

discovered that rejection rates for some testing requirements

have decreased over time, but that rates for others have not.  On

average, the rate at which OPP rejects ecological effects studies

has declined from 36% prior to 1986 to the current rate of 20%.  



     While some testing issues have been resolved through the

Rejection Rate Analysis, others remain to be addressed by future

workgroups that OPP hopes will involve continued public

participation.  



Pesticide Chemistry Laboratory Support For Reregistration



     In addition to supporting pesticide registration (as

described in chapter 1), OPP's two pesticide chemistry labs

provide support for the reregistration program.  The Analytical

Chemistry Laboratory validated one food tolerance method for

reregistration in 1994.  Approximately five to ten methods are

expected in 1995.  The Environmental Chemistry Laboratory (ECL)

completed four analytical method validations for pesticides in

soil and water under the reregistration program in fiscal year

1994.  In addition, the ECL developed a multianalyte method for

detecting nine sulfonylurea pesticides in water.  The ECL also

prepared a draft of the new environmental chemistry methods

manual, which will contain all of the EPA validated and non-

validated soil and water methods.



Reducing Pesticide Spray Drift



     Aerial or ground application of pesticides may lead to drift

off the site of intended application and result in exposure to

workers, nearby residents, nontarget plants, and other ecological

resources.  To better understand the factors which affect spray

drift, OPP worked closely in 1994 with the Spray Drift Task Force

(SDTF), a coalition of 32 pesticide registrants.  The SDTF is

conducting extensive research into the factors that contribute to

and can control spray drift.  The information generated by the

task force will greatly enhance OPP's ability to assess exposure

resulting from spray drift, prevent excessive spray drift, and

reduce risks caused by drift.  These data will help fulfill

requirements of pesticide registration.  1994 highlights include:



  o  EPA's Office of Research and Development (ORD), the U.S.

     Department of Agriculture (USDA), and the SDTF signed a

     Cooperative Research and Development Agreement in March

     1994.



  o  OPP is providing input to spray drift modeling efforts under

     the cooperative research agreement.  The models developed

     will enable optimal use of spray drift data and provide

     options for reducing drift and managing risk.



  o  A conference was held in June 1994 to discuss the SDTF's

     preliminary data on drift from airblast applications to tree

     crops and to identify additional research priorities. 

     Orchard crop specialists from the United States and Europe

     attended.



  o  OPP reviewed the first official data submission of the SDTF.



Reassessment Of Dioxin Risks



     Dioxins comprise a group of chemically-similar, highly toxic

compounds that are of concern to EPA.  Because some pesticides

have been found to be contaminated with low levels of dioxins,

OPP has contributed to EPA's exhaustive reassessment of dioxin

risks conducted since 1991.  OPP's Environmental Chemistry

Laboratory performed a number of analyses of animal tissue in

1994 as part of the reassessment, and helped review dioxin

sampling and analysis methods.  In September 1994, the Agency

publicly released a draft version of the reassessment of dioxin

risks and issued a voluntary call for additional information. 

The report highlighted not only cancer concerns but also possible

reproductive, developmental, and immunological effects detected

in animals.



     OPP has taken several steps to ensure that pesticides do not

contain dioxins at levels that pose unreasonable risks to public

health or the environment.  In 1987, OPP issued two data call-ins

that applied to 161 active ingredients.  Of those, 92 have been

cancelled or are no longer being supported for reregistration. 

To date, OPP has reviewed submissions regarding the manufacturing

processes of 43 of the supported active ingredients and

determined that dioxins are unlikely to be formed.  Through

analysis of production samples, nine other active ingredients

were found not to contain dioxin impurities.  Thus, of the 161

originally subject to review, 144 are no longer of concern.



     As of 1994, four of the remaining 17 active ingredients have

been found to have manufacturing processes which produced levels

of dioxins slightly above what is known as the Level of

Quantification.  Based on assessments using the "Toxicity

Equivalent Factor" approach, OPP believes that the levels of

dioxins in these four active ingredients pose a negligible risk

to human health.  OPP expects to complete review of the

manufacturing processes of the remaining 13 chemicals by the end

of 1995.



Reducing Ecological Risks Under The "New Paradigm"



     In March 1992, EPA established an internal task force to

review and assess the role of ecological and environmental fate

data in OPP's regulatory process.  One of the task force's

accomplishments was the development of an approach known as the

"New Paradigm."  This approach is intended to strengthen the

Agency's efforts to prevent adverse effects to the environment

from pesticides, while simultaneously accelerating pesticide

reregistration.  The strategy of this program is to reduce risks

more quickly when the Agency receives information that pesticides

may be causing adverse environmental effects, rather than

requesting and waiting for additional studies to be submitted.  



     This emphasis led OPP to develop a paper providing

preliminary guidance on risk reduction strategies and monitoring

programs, including a format for registrants to follow when

submitting mitigation and monitoring proposals.  OPP then

initiated a number of outreach activities related to risk

mitigation and monitoring, such as presentations at workshops and

scientific conferences and wide distribution of the document to

pesticide registrants during the registration and reregistration

processes.  As a result of this effort, the regulated community

has submitted improved mitigation proposals.  Many are now

following OPP's proposed format, which has led to the submission

of more clearly defined and justified mitigation measures.  In

addition, OPP has incorporated environmental risk mitigation in

almost half of the documents issued through the reregistration

process.  This approach of requiring risk mitigation and

monitoring applies during the registration of new pesticides as

well.



The Label Use Information System (LUIS)



     The Label Use Information System (LUIS) is a product-level

database of pesticide label directions.  It contains detailed

information on registered sites, application methods, application

rates, and limitations on the use of pesticides (e.g., preharvest

intervals, reentry intervals).  LUIS information can be reported

by active ingredient to support chemical regulatory decisions; it

can also be reported 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

1994, OPP completed initial entry of information for most

pesticides undergoing reregistration.  During 1995, OPP will

complete initial data entry and begin expanding LUIS capabilities

so it can support registration and Special Review as well

reregistration.  Eventually, it will be linked to other pesticide

data systems and made available electronically to all OPP staff.





                    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 the Special Review process.  While

reregistration applies to all older pesticides, Special Review is

applied to those pesticides of particularly serious concern.



1994 Formal Special Reviews And Follow-up Activities



     Inorganic arsenicals.  OPP concluded the Special Review for

     inorganic arsenicals by publishing a Notice of Final

     Determination.  All affected uses (uses other than as wood

     preservatives and sealed ant baits) were voluntarily

     cancelled as a result of the Special Review.  This action

     culminated a Special Review initiated in 1978 because of

     concerns about risks of cancer, reproductive and fetal

     effects, and mutagenicity (genetic effects).



     EBDCs.  OPP completed a Special Review for a group of

     fungicides known as the EBDCs in 1992 by cancelling a number

     of uses and placing restrictions on the remaining uses. 

     Subsequently, a registrant requested a change in certain of

     the restrictions.  In 1994, OPP helped support the hearing

     that responded to the request, which resulted in an

     amendment allowing the use of more than one EBDC on a crop

     during the course of the growing season, as long as the

     total amount of pesticide applied does not exceed the

     maximum amount allowable from any one EBDC application.



     Carbofuran.  OPP also revisited the Special Review for the

     granular formulation of the insecticide carbofuran when

     registrants requested an extension of uses for rice, corn,

     and sorghum.  OPP published a proposal in the Federal

     Register which would allow for a maximum of two more years

     of use on rice but no more use on corn and sorghum.  OPP

     began phasing out most uses of carbofuran in 1991 because of

     risks of bird poisonings.



Cancellation Of Mevinphos



     OPP continues to reduce risks by means other than the

traditional Special Review process, particularly through

negotiated settlements.  The agreement to cancel all uses of the

agricultural insecticide mevinphos -- one of the most acutely

toxic pesticides produced in the United States -- exemplifies how

such actions can achieve substantial protection of human health

and the environment.



     In response to planned actions by OPP and the State of

California to remove mevinphos from the market, the registrant

requested that its registrations be cancelled.  The registrant

also agreed to a voluntary recall of all product still in the

channels of trade after sale and distribution of product was no

longer allowed.  The cancellation was based on OPP's

determination that the risks to agricultural workers were

unacceptable.  Poisoning data from California and other states

showed that even when workers followed stringent label

restrictions, an alarming number of poisoning incidents occurred. 

From 1982 through 1992, California (where about half of U.S. use

of mevinphos occurred) recorded 594 poisonings associated with

the use of mevinphos alone and in combination with other

pesticides.  Mevinphos alternatives are significantly less risky

to workers than mevinphos.



Other Negotiated Risk Reduction Efforts



     During fiscal year 1994, OPP successfully negotiated for the

reduction of health risks associated with several pesticides in

addition to mevinphos:



     PCNB.  Registrants agreed to lower levels of two

     carcinogenic contaminants, HCB and PCB, in their products,

     bringing dietary risk down to the negligible level.



     Metrex.  OPP negotiated a settlement with the registrant

     because of concerns about the risk posed by failure of this

     hospital sterilant to work properly.  The settlement imposed

     label requirements for longer contact times with treated

     surfaces and higher treatment temperatures to ensure that

     treated medical instruments were adequately sterilized.



     Simazine.  Twenty-two registrations of simazine used as an

     algicide in swimming pools were voluntarily cancelled after

     OPP approached registrants about unacceptable cancer risk to

     swimmers.  OPP subsequently cancelled the remaining swimming

     pool simazine products when their registrants declined to

     join the voluntary cancellation.



Other Cancellation Activities



     In addition to the negotiated settlements described

previously, OPP handled several cancellation actions in 1994. 

Two (for TBT fluoride and mercury compounds used on turf) were

voluntary actions prompted by the registrants' decision not to

develop required data.  OPP also amended the earlier cancellation

notices for the herbicide methazole (to extend the existing

stocks period) and for Wipeout, a medical sterilant containing

glutaraldehyde (to add new risks of concern).



Tolerance Revocations



     OPP continued to propose or finalize revocations of

tolerances (maximum residues allowed in food) for pesticides

cancelled through Special Review or for other reasons.  OPP

generally revokes tolerances some time after the uses are

cancelled to allow legally treated foods to move through the

marketplace and to account for possible foreign use on imported

food.  OPP proposed or finalized tolerance revocations and

revisions for eight active ingredients in 1994: arsenic acid,

carbophenothion, DDVP, diallate, dicofol, PCNB, perthane, and

ronnel.



Initiative To Reduce Risks To Birds (Avian Granular Initiative)



     OPP continued to track the progress of the voluntary risk

reduction initiative begun in 1992 for granular pesticide

formulations posing risks to birds.  OPP prepared a progress

report that describes the voluntary risk reduction proposals

received from seven registrants.  The proposals include lower

application rates, reduced number of applications, and use of

application methods designed to reduce the number of exposed

granules in end rows.  Granular pesticides can be eaten by birds

feeding in agricultural areas.





        Chapter 4: Field Implementation and Communication



     The major regulatory areas discussed by the first three

chapters -- registration, reregistration, and Special Review --

primarily involve interaction with pesticide registrants, though

many other organizations are also affected by and involved with

OPP's decisions in these areas.  In this chapter, the emphasis

shifts to regulatory programs directed at pesticide users and

implemented in the field.  This chapter also discusses how OPP

shares information with pesticide users and the myriad of other

organizations and citizens interested in pesticides.  Finally,

this chapter discusses OPP's support for efforts to ensure

compliance with pesticide requirements.  All of these efforts

complement the pesticide regulatory programs described in the

first three chapters by improving the safety with which

pesticides are used, and by making the public aware of the risks

and benefits of pesticides and the availability of alternatives.



                       A.  Field Programs



     The major field programs that OPP implements, as described

in more detail in this chapter, are the Worker Protection

Standard, the Endangered Species Protection Program, ground water

protection programs, certification and training of pesticide

applicators, and disposal of suspended and cancelled pesticides

(completed in 1994).  Voluntary field efforts in 1994 included

promoting integrated pest management (IPM) and drafting guidance

for states for posting of residential and commercial pesticide

applications.



Implementing The Worker Protection Standard



     OPP revised the Worker Protection Standard (WPS) for

agricultural pesticides in 1992 and it became fully effective on

January 1, 1995.  The Standard represents a major strengthening

of national efforts to safeguard agricultural workers. 

Agricultural employers are required to follow new measures to

protect their employees, including safety training, notifications

about pesticide applications, provisions for washing facilities,

and maintenance of protective equipment.  OPP believes that the

WPS will substantially reduce the risk of pesticide poisonings

and injuries among agricultural workers and pesticide handlers.



     In 1994, OPP carried out a number of Worker Protection

activities in preparation for full implementation in 1995, many

of which included the participation of EPA's ten regional

offices.  OPP:



  o  Worked 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 to treated areas and use of personal

     protective equipment.



  o  Continued to work with the states, USDA's Cooperative

     Extension Service, and the agricultural community to help

     employers obtain the information and assistance they need. 

     Over 1.7 million copies of OPP's "Agricultural Worker

     Training Handbook" have been distributed, as well as

     thousands of the "How To Comply Manual" and the "Pesticide

     Handler Training Handbook." A number of other publications,

     videos, and training materials are available.



  o  Developed a voluntary program to issue training verification

     cards to workers and handlers to promote safety training for

     agricultural workers and to make it easier for agricultural

     employers to ensure that their workers have been trained. 

     To date, 40 states, Puerto Rico, and two tribes have agreed

     to participate in the program, with more expected to join.



  o  Met directly with more than 25 organizations affected by the

     WPS to resolve problems and improve implementation of the

     standard.  EPA held workshops on the WPS and conducted

     periodic meetings and discussions with agricultural groups.



  o  Approved the first exception to the WPS.  For a two-year

     period and under specified conditions, the exception allows

     early entry into pesticide-treated areas in greenhouses to

     harvest cut roses.  The WPS establishes a process for OPP to

     approve requests for exceptions if the benefits of the

     exception outweigh the costs (including any health risks)

     attributable to the exception.



  o  Evaluated certain WPS provisions where change or flexibility

     may be needed to make sure that workers are protected and

     that the requirements are fair and achievable.  OPP has

     proposed changes to the WPS in the following areas and,

     based on public comments, expects to finalize them in the

     spring of 1995:



      --  Strengthened safety training requirements.

      --  Reduced requirements for crop advisors.

      --  Reduced restrictions for lower risk pesticides.

      --  Reduced requirements for irrigation activities.

      --  Reduced requirements for other activities that result

          in limited contact to 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.  As mandated by the 1988 amendments to the

Endangered Species Act, this goal is to be accomplished while

minimizing the burden on pesticide users.  Currently, OPP is

carrying out an interim, non-regulatory program to protect

endangered species while finalizing an endangered species

protection regulation.  



     The ESPP was very productive in 1994.  OPP produced and

widely distributed many materials supporting and promoting the

voluntary program, and is currently distributing 240 county-

specific pamphlets in 22 states and Puerto Rico that describe

voluntary measures pesticide users can take to avoid affecting

threatened and endangered species with pesticides.  OPP also

completed fact sheets about eight additional endangered species,

such as the Bald Eagle and Whooping Crane, bringing the total

number of species fact sheets to 45.  OPP also continued the

operation of a toll-free endangered species hotline to provide

more information about the program.



     In implementing the endangered species program in 1994, OPP

worked closely with EPA regions, states, and other federal

agencies, such as the U.S. Fish and Wildlife Service (FWS).  This

cooperation was exemplified by efforts to protect the Wyoming

Toad, an endangered species known to occur in the wild only in

Albany County, Wyoming.  The Wyoming Department of Agriculture,

FWS, EPA's Region 8 Office, and OPP forged an agreement with

local landowners and officials to postpone pesticide use on land

within the toad's range until the land could be surveyed for

potential habitat.  No new toad populations were found on private

lands, and pesticide applications resumed in areas where the toad

was not found.  The case serves as a model for the cooperation of

landowners and federal, state, and local governments to implement

the Endangered Species Act.



     OPP also provided extensive comments on the Fish and

Wildlife Service's draft Biological Opinion, which addresses the

potential impacts of all uses of 15 major agricultural

pesticides.  In addition, OPP has begun requesting endangered

species data from registrants on particular registration

requests.  Registrants may form a task force to supply the

necessary data to cover all pesticide use sites.  The next major

step is to announce the final regulation and program by

publishing a Notice in the Federal Register.  OPP spent much of

1994 working with FWS and the U.S. Department of Agriculture to

develop the final plans for the ESPP.



Protecting Ground Water



     Ground water provides about one-fourth of all water used in

the United States and is the source of drinking water for about

half the U.S. population.  It also is a vital component of the

ecosystem.  For example, ground water often flows into surface

water systems that are habitats for fish, sustain wetlands, and

support commerce.  OPP has several programs in place to protect

this critical natural resource from pesticide contamination.



     The centerpiece of OPP's strategy is a cooperative effort to

develop State Management Plans (SMPs) to prevent ground-water

pollution from pesticides.  An important step in this approach

has been the development of "Generic" SMPs, which aim to create

the capacity for protecting ground water regardless of the

pesticide.  Forty-six states have submitted draft Generic plans

to the EPA regions, and the regions have provided comments on

most of these plans.  Final regional concurrence on all Generic

plans is expected January 1996.  The next major step will be the

requirement that states develop pesticide-specific SMPs for those

pesticides found to leach into ground water.  OPP has received

comments on a draft rule for pesticide-specific SMPs from all ten

EPA regions and expects to issue a Notice of Proposed Rulemaking

(NPRM) during 1995.  OPP also works closely with EPA's Office of

Water to ensure that the pesticide SMP program will complement

the Agency's Comprehensive State Ground Water Protection Program.



     Another important feature of OPP's strategy has been to

establish procedures during registration and reregistration to

evaluate a pesticide's potential to contaminate ground water.  In

1994, OPP began to implement a new approach that achieves early

mitigation of ground-water risks.  In cases such as the

registration of acetochlor, OPP required that registrants better

target the use of pesticides and conduct follow-up monitoring to

protect ground water quality.  OPP continues to track evidence of

ground water contamination through its Pesticides and Ground

Water Data Base.



     Furthermore, OPP expects to issue a final rule in 1995 that

would add criteria for classifying a pesticide for restricted use

if any of its ingredients has the potential for contaminating

ground water on a widespread basis.  Pesticide products

classified for restricted use may be purchased and used only by

certified pesticide applicators or individuals under their

supervision.  OPP believes that a pesticide is less likely to

contaminate ground water if it is used only by trained

applicators.



Certification And Training Of Pesticide Applicators



     When OPP designates some or all uses of a pesticide as

"Restricted," then the pesticide may be used only by or under the

direct supervision of certified users.  Certification Programs

are conducted by states, territories, and tribes and are designed

to ensure that users of the most risky pesticides are

knowledgeable about their risks and uses.  OPP sets national

standards for the programs, which certify over one million

applicators nationwide.



     In 1994, OPP continued to work to revise its national

standards to better ensure continued competency of certified

applicators.  To assist the state, territory and tribal

governments in conducting certification programs, OPP also

continued cooperative agreements and provided funding to 64

governments.  OPP also provided funding to state extension

coordinators through the U.S. Department of Agriculture to

conduct certification training programs.  Training covers general

areas of pesticide use as well as specific uses for which a

person wishes to become certified.  For example, training to

become certified to apply pesticides to structures (such as

schools, houses, and office buildings) includes information about

ventilating structures prior to re-occupation.



Disposal Of Suspended And Cancelled Pesticides



     In 1994, OPP completed its disposal program for suspended

and cancelled pesticides, thus removing the risks posed by unused

stocks of these pesticides.  Prior to the 1988 revisions of the

Federal Insecticide, Fungicide, and Rodenticide Act, OPP was

required to accept suspended and cancelled pesticide products for

disposal if requested by holders.  2,4,5-T and silvex pesticides

were suspended and cancelled prior to 1988 because of concerns

about dioxin contamination.  OPP accepted about 300 tons of

granular 2,4,5-T/silvex materials and 30,000 gallons of liquid

materials from several hundred holders at a hazardous waste

storage facility.  On May 27, 1994, OPP disposed of the last of

these 2,4,5-T/silvex stocks at a hazardous waste incinerator.



Promoting Integrated Pest Management



     Integrated Pest Management, or IPM, 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's IPM accomplishments extended to both the urban and

agricultural sectors.  In the urban arena, OPP published "Pest

Control in the School Environment: Adopting Integrated Pest

Management." This creatively illustrated booklet, already in wide

circulation, will be provided to every school district in the

United States by the end of 1995.  Companion training videos,

produced in cooperation with Texas A&M University, should be

finished during the spring of 1995.  OPP also edited and

published, through Lewis Publishing Company, "Integrated Pest

Management for Turf Grass and Ornamentals." This book is the most

up-to-date and comprehensive publication on the subject and has

already been widely accepted within the professional landscape

community.



     In the agricultural sector, OPP has hosted a series of

commodity-specific workshops to inform growers about existing IPM

techniques and help identify impediments to IPM adoption.  The

proceedings from this year's peanut, stored commodity, and potato

workshops, along with those developed during 1993, are being used

to help frame the Agency's position on agricultural legislation

(such as the Farm Bill).



Guidance For Posting Of Outdoor Pesticide Applications



     During 1994, OPP began the development of draft guidance for

states and local jurisdictions regarding "posting" of outdoor

residential and commercial pesticide applications.  Posting

refers to the placement of signs at visible entry areas to inform

bystanders that a pesticide has been recently applied.  This

guidance is being developed to help harmonize such state and

local programs.  OPP hopes that such guidance will help lead to

better consumer awareness and understanding of posting, increased

compliance with posting requirements, and reduced burdens upon

lawn care professionals who sometimes must deal with a confusing

array of differing requirements.  OPP intends to publish a draft

in the Federal Register for public comment in 1995.



      B.  Communications, Public Response, and Coordination



     Outreach to the public is vital to the mission of OPP.  By

the term "public," OPP means all constituents affected by or

interested in pesticide issues -- not only states, tribes, and

EPA regions, but also citizens, environmental and public interest

groups, industry and trade associations, pesticide users,

Congressional staff, medical and health representatives,

academia, international organizations, other federal agencies,

and the media.  This section describes several of the ways that

OPP provides information to the public, responds to inquiries,

and in turn obtains valuable public input.



     OPP's approach to communications is to make information

widely available, easily accessible, and suited to different

public preferences.  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.



Outreach And Communications Strategies



     In 1994, OPP issued more than 50 announcements inform the

public about OPP's major regulatory and policy decisions  Each

announcement is planned using a communications strategy, and

often entails a press notice and additional outreach materials,

such as fact sheets or questions and answers.  OPP also made

special efforts during the past year to make the public aware of

available information resources and to provide general pesticide

information.  In June, OPP issued a Pesticide Regulation Notice

(PR 94-3) that summarizes the many avenues one can take to obtain

information from OPP.  Another accomplishment this year was the

preparation of OPP's first catalog of pesticide publications. 

OPP distributed both documents extensively, and they continue to

be widely requested.  OPP also continued to distribute other

documents to the public with the help of the National Center for

Environmental Publications and Information; for example, OPP

distributed over 45,000 copies of the booklet "Healthy Lawn,

Healthy Environment: Caring for Your Lawn in an Environmentally

Friendly Way" and over 15,000 copies of the booklet "Citizen's

Guide to Pesticides."



     Protecting children from pesticide poisoning continues to be

an important focus of OPP's outreach efforts.  Working with the

Poison Prevention Council and the Consumer Product Safety

Commission, OPP has participated over the past three years in the

activities leading to Poison Prevention Week.  Through this

mechanism, each year OPP distributes thousands of copies of fact

sheets on pesticides and child safety and on using insect

repellents safely (both in English and Spanish) to medical

establishments and the general public.



Responding To The Public



     Freedom of Information Act (FOIA) Requests



     OPP responds to specific technical or complicated

information requests from the public under the Freedom of

Information Act.  OPP continues to receive the highest number of

FOIA requests of any program within EPA, and in fiscal year 1994

received 1,578 requests.  Despite this heavy workload, OPP was

able to reduce its backlog of FOIA requests by more than half. 

The majority of requestors receive all of the records they

request, with the most common requests being for science reviews

of registration data, administrative files for pesticide

products, and product labels.



     OPP Public Docket



     OPP has established four dockets, operated by a contractor,

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.  Thousands of requests were received in 1994 for

docket information -- by letter (over 1,000 requests), telephone

(over 2,000 requests), and in person.  Citizens account for the

largest number of requests for docket information.



     National Pesticides Telecommunications Network (NPTN)



     NPTN is a toll-free telephone service available to provide a

variety of impartial information about pesticides to anyone in

the United States, Puerto Rico, and the Virgin Islands.  The

service operates Monday through Friday from 8:00 a.m.  to 6:00

p.m.  (Central Standard Time).  NPTN provided services to more

than 25,000 callers during fiscal year 1994, including

approximately 1,300 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 the clinical toxicology of

pesticides and analytical services for both biological and

environmental samples.  Consultations are given to both possible

victims and health care professionals.  NPMMP handles 200 to 300

cases per year.



     Letters



     OPP also responded to a substantial number of letters to the

Agency on pesticide-related issues, including letter campaigns on

subjects such as food safety, pesticides and children, the

Delaney clause, livestock predator pesticides, and worker

protection.



Congressional And Federal Coordination



     Congressional interest and oversight in pesticide and food

safety issues continues at a high level as OPP responded to

almost 400 inquiries over the past year.  OPP also prepared

testimony and briefing materials for eight Congressional hearings

concerning pesticide issues (such as pesticide exports/food

safety and worker protection standards).  During the past year,

OPP assisted the General Accounting Office (GAO) and EPA's

Inspector General (IG) office with seven ongoing evaluations of

the pesticide program's activities:  EPA's decision on

carbofuran; a survey of EPA actions related to EBDC uses; EPA's

process for reinventing tolerances for cancelled pesticides;

EPA's collection of user fees; the Chief Financial Officer's

audit of the fiscal year 1994 financial statement; environmental

laws and regulations pertaining to agriculture; and the federal

government's compliance with the Endangered Species Act.



Public Meetings



     OPP continues to seek ways to provide meaningful

opportunities for the public to meet with the Agency and discuss

pesticide issues of concern.  OPP held several meetings during

1994, some on a quarterly basis, with a variety of constituent

groups.  OPP hosted regular meetings with environmental and

public interest groups during the year, and set up several on

topics of special interest, such as international issues and the

farmworker protection program.  OPP also held quarterly meetings

with the American Crop Protection Association (formerly NACA). 

Additionally, OPP conducted two large-scale workshops in 1994 for

a broad spectrum of participants, with one workshop focusing on

general pesticide issues and the other on reducing pesticide use

and risk.  Looking ahead, OPP will seek opportunities for more

in-depth discussions of critical program policies and issues with

a cross-section of constituent groups.



Pesticide Information Network



     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.



     In 1994, OPP worked to upgrade the system, and the revised

PIN is expected to open in early 1995.  The PIN will contain

several different types of information.  These will consist of

the Pesticide Monitoring Inventory (PMI) (including the

Pesticides in Ground Water Database), the Ecological Incident

Information System (EIIS) (described in more detail in chapter

6), an Environmental Fate and Ecological Effects compilation, a

Regulatory Status database, the Certification and Training

Bibliography, and a Biological Pesticides data set.



Agency Risk Management Communication Group



     OPP actively participated during 1994 in the Agency

Ecological Risk Management Communication Group, which was formed

to address EPA's difficulties in using the assessments of

ecological risks to properly manage those risks.  The first major

project of the Group, completed in 1994, was to write a document

that would help risk managers throughout the Agency make

decisions that include a consideration of ecological risk.  The

document is introductory in nature and contains a great deal of

basic information about the value of ecological resources,

determining what resources should be protected, understanding the

involvement of a risk manager in the risk assessment process, and

using a risk assessment for risk decision-making.  The Group also

hopes that experienced risk managers will benefit from the

document.



Scientific Presentations And Publications



     OPP believes that sound scientific information is the

cornerstone for assessing and managing risks, as will be

described in chapter 5.  OPP scientists continue to contribute to

the development and application of their varied scientific

disciplines, including hydrology, biology, agronomy, chemistry,

toxicology, and many others.  In 1994, OPP scientists presented

several dozen papers and posters at a number of professional

meetings of organizations such as:



  o  American Chemical Society

  o  American Society of Agronomy

  o  American Phytopathological Association

  o  International Union of Pure and Applied Chemistry

  o  Society of Environmental Toxicology and Chemistry

  o  Society of Quality Assurance

  o  Soil Science Society of America



     OPP scientists served as editors for a book titled

"Agrichemical Environmental Fate State of the Art," which is

scheduled to be released in May 1995.  They also published a

number of professional papers, including several that appeared in

conference proceedings and symposiums of associations listed

above and in journals like the "Journal of Invertebrate

Pathology" and "Environmental Toxicology and Chemistry." In

addition, OPP scientists lectured at Clemson University, the

University of Maryland, and other universities and organizations.



International Coordination And Integration



     This section describes OPP's efforts to inform foreign

governments about the status of U.S. pesticides and 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, federal pesticide law (FIFRA section 17(a)) requires the

U.S. exporter to obtain a statement from the buyer acknowledging

that the product is unregistered in the U.S.  The exporter must

then submit this statement to OPP, and OPP forwards a copy to the

importing government.  In 1994, OPP transmitted approximately

1,600 export notifications to the governments of importing

countries.  



     Information Exchange with Foreign Countries



     Another provision of federal pesticide law, FIFRA section

17(b), requires OPP to operate an information-sharing program

with health and environmental agencies in other countries. 

Through this program, OPP sends information notices to other

governments on important regulatory decisions made in the United

States related to pesticides, food safety, and pest management. 

In 1994, OPP transmitted several notices of major regulatory

actions on specific pesticides, such as the voluntary

cancellation of mevinphos, and other pesticide documents. 

Section 17(b) notifications are distributed directly to the

pesticide regulatory authorities in approximately 140 countries. 





     Prior Informed Consent (PIC)



     EPA is a participant in this 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.  PIC establishes a mechanism whereby importing

countries can receive information about pesticides and industrial

chemicals and then determine whether to allow, restrict, or

prohibit future imports of the chemicals.  In 1994, EPA formally

nominated mevinphos for inclusion on the UN list of banned

pesticides because it was voluntary cancelled in 1994 (see the

Special Review chapter for more information).  In addition, work

progressed internationally toward making PIC a legally binding

instrument.  Formal negotiations toward an international treaty

are expected to occur during 1995 and 1996.



     International Visitors



     OPP has an ongoing program to arrange meetings for foreign

visitors to discuss U.S. pesticide policies and scientific

evaluation procedures.  During the past year, OPP received 95

visitors from 23 nations.  The majority of visitors came from

Japan, South Korea, and the People's Republic of China.



Regional, State, And Tribal Liaison



     Regional Coordination



     Staff in each of 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

the governments in developing and implementing programs, and

oversee accomplishments and commitments made by the states,

territories and tribes.  Additionally, regional staff communicate

OPP's programs and policies to the public and in turn provide OPP

with information from the public.  Clearly, OPP's regional

counterparts are critical to the success of developing,

implementing and communicating OPP programs and actions. 

Therefore, OPP works to ensure that the regional offices are

involved in or informed of all OPP activities.



     State and Territorial Programs



     States and territories are true partners with OPP in

carrying out the functions of protecting human health and the

environment.  They assist in developing and implementing many of

OPP's field programs, and they enforce OPP's regulations and

pesticide labeling and use requirements.  To ensure that programs

are successful, direct communication among these governments is

often necessary.  To accomplish this, OPP in 1994 continued a

cooperative agreement with the Association of American Pesticide

Control Officials (AAPCO) to maintain the State FIFRA Issues

Research and Evaluation Group (SFIREG).  SFIREG meets

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.  A considerable diversity exists among the tribes. 

Some have land areas and populations comparable to many of the

smaller states, whereas others have fewer than 50 tribal members

and 100 acres of land.  The capacity of the tribal governments to

carry out environmental regulatory programs also varies

significantly from tribe to tribe.



     OPP's major effort with tribes has been to assist them in

building the capacity to conduct regulatory and field programs

for pesticides.  In 1994, OPP participated in the Native American

Environmental Conference to demonstrate different ways in which

tribes can implement OPP programs.  OPP also funded an

environmental scholarship program to assist college students

studying environmental sciences and interested in addressing

Native Americans issues.  OPP also addressed Native American

issues by assigning one employee to work at the Administration

for Native Americans and another to work with EPA's Office of

Civil Rights.



     In addition, OPP attempts to address specific issues

uniquely affecting Native Americans.  In 1994, OPP began a

project involving other state and federal authorities to address

potential pesticide exposure by members of the California Indian

Basketweavers Association (CIBA).  CIBA members expressed concern

to the Agency about their potential exposure to pesticides from

contact with native plant materials used in traditional

basketweaving.



Improving Internal Communications



     The OPP Committee on Networking, Education, Communication,

and Training Strategy (OPP CONECTS) made a significant effort in

1994 to improve internal communications.  Based on

recommendations of the committee to OPP management in June, two

new initiatives are underway.  "OPP PULSE," a publication 'by OPP

staff, for OPP staff,' began publication in September.  The OPP

LINKS series, in which each OPP division educates the others

about its roles and responsibilities, often in innovative and

creative ways, began in October.  Both initiatives are helping

OPP staff better understand the work of other divisions and gain

a sense of how they fit into the larger picture.  The two

initiatives also give staff members the opportunity to share what

they do and what they know with the rest of the program, making

OPP a less impersonal workplace.



              C.  Support For Compliance Activities



     Compliance activities -- such as helping regulated entities

understand and meet applicable requirements, verifying that

requirements are met, and taking enforcement action when they are

not -- are indispensable parts of EPA programs to protect public

health and the environment.  OPP provides support to Agency

pesticide compliance activities, which are directed by the Office

of Enforcement and Compliance Assurance (OECA).  (Pesticide

compliance activities formerly were coordinated by the Office of

Compliance Monitoring, which was integrated into the newly-

created OECA in 1994.)



Support For The Lab Audit Program



     OPP relies on data submitted by registrants to make

regulatory decisions involving product registrations, tolerances,

use restrictions and requirements, and other areas.  EPA conducts

a program to inspect and audit the laboratories that produce

these data.  Important components of the lab audit program are

the Good Laboratory Practice Standards (GLPS), which are designed

to ensure the quality and integrity of pesticide data.  In 1994,

43 GLPS inspections were conducted for OPP, and OPP scientists

assisted in three of the inspections.  Targeted areas included

product chemistry, residue chemistry, environmental fate,

toxicology, and antimicrobial testing.  As a result of the

inspections, EPA developed four GLPS enforcement cases involving

four laboratories and thirteen registrants or sponsors, and

revoked the registrations of two products.



Analysis Of Product Chemistry



     OPP's pesticide chemistry laboratories are essential for

verifying the description and amount of active ingredients

provided by registrants on pesticide product labels.  During

1994, OPP analyzed a large number of new pesticide product

samples, both for technical and end-use formulations, to verify

registrant label claims.  The methods used to perform the

analyses are published in an EPA manual of methods by the

Association of Official Analytical Chemists (AOAC) International

and used by state agencies and other organizations.



Other Laboratory Support



     OPP's two pesticide chemistry labs often provide high

priority support for other enforcement efforts.  In 1994, OPP

supported seven external EPA region/state projects: Craven

Laboratories investigation with the Department of Justice; State

of New York investigation of DCPA contamination of the Suffolk

County drinking water supply; State of Florida's investigation of

alleged benomyl damage in greenhouses; State of Oklahoma's

analysis of dioxin/furan samples; EPA Region 5 and Region 7

investigation of the WTI incinerator in Ohio; Louisiana Board of

Regents request to review technical proposals; and EPA Region 3's

request to analyze samples for diatomaceous earth.  The pesticide

chemistry labs supported several other external projects,

including the Central American Lab Project; Gulf of Mexico

Project; U.S. State Department Project in Russia; two EPA Office

of Research and Development Dioxin Projects; U.S. Army air

samples from the Mideast (dioxins); and air samples from Croatia

(dioxins).



Additional Support For Compliance Activities



     In addition to laboratory support, OPP often contributes

expertise and records for compliance activities.  One example of

this in 1994 was OPP's work on the Raid Max Roach Bait

enforcement case.  In this case, EPA alleged that S.C.  Johnson &

Son, Inc., the manufacturer, began illegally marketing this

product in new design packaging without first receiving EPA

approval.  This information contributed to EPA Region 5 issuing a

Stop Sale, Use, or Removal Order to S.C.  Johnson to immediately

halt the sale and distribution of the product.  EPA also

requested that the company voluntarily recall all unapproved Raid

Max Roach Bait products in the hands of consumers and in the

channels of trade.  Another example was OPP's work on the recall

by the registrant of Natrapel Insect Repellent products because

of potential bacterial contamination.





         Chapter 5: Policy, Regulations, and Guidelines



     OPP's fifth major program area involves developing

regulations and other policies for pesticides.  These efforts are

intended to help develop and implement national legislation

passed by Congress, to improve the quality of pesticide

regulation (which can include both formulating new policies and

streamlining existing ones), and to augment the quality of OPP's

scientific information.  In some cases, OPP finds that policies

are needed to address newly-discovered concerns, or to keep up

with technological advances in pest control, such as in the area

of genetically-engineered biological pesticides.  Wherever

possible, OPP encourages public participation in the development

of policies.



     Federal policies can be regulatory (promulgated by

regulation) or non-regulatory.  Regulations are published in the

Federal Register for formal public notice and comment and

incorporated into the Code of Federal Regulations.  Regulations

proposed or finalized in 1994 and discussed in this chapter

include those related to biological pesticides and pesticide

containers.  Non-regulatory programs, in general, are not

directly mandated by law and do not impose legally enforceable

requirements.  A prime example, discussed in more detail below,

is OPP's voluntary pesticide environmental stewardship

partnership.  Policies often include both regulatory and

nonregulatory components, such as OPP's international

coordination efforts and OPP's response to the National Academy

of Sciences report on children and pesticides.



Follow-up To The National Academy Of Sciences (NAS) Children's

Study



     EPA, the Food and Drug Administration (FDA), and the U.S.

Department of Agriculture (USDA) are working together to address

the concerns identified by the June 1993 National Academy of

Sciences report, "Pesticides in the Diets of Infants and

Children." The Academy concluded that exposure of children to

pesticides is substantially different from that of adults and

that the federal government should do more to address the unique

risks posed to children.  To provide additional measures of

protection for children, the Academy recommended numerous changes

to the way the federal government safeguards the nation's food

supply.



     OPP is moving ahead to implement many of the NAS

recommendations.  Additional toxicological studies will be

included in the standard battery of testing requirements (known

as the part 158 requirements) that are under revision.  OPP plans

to collect data on immune functions, nervous system development

and toxicity, and visual systems.  In addition, OPP has completed

an analysis of the utility of including in utero exposure in

long-term toxicology studies.  EPA and FDA have completed plans

to standardize the reporting of pesticide levels in food and to

store these data in a centralized National Pesticide Residue

Monitoring Database, though additional funding is needed to

proceed.  OPP is working closely with USDA on the design of

future USDA national food consumption surveys to ensure that the

eating habits of infants and children are adequately represented. 

OPP is also exploring ways to combine the risks from multiple

sources of exposure.  These include combining the risks posed

from chemicals with similar mechanisms of action as well as

several routes of exposure, including both nondietary and dietary

routes.



Reduced Use/Risk Initiative



     The Pesticide Use/Risk Reduction Initiative announced in

June 1993 is a joint effort with EPA, USDA, and FDA to reduce the

use and risks of pesticides.  As part of the initiative, a

voluntary program called "Pesticide Environmental Stewardship

Partnership - PEST SMART" has been created to form partnerships

with all affected interests (including commodity organizations

and public interest groups) and develop plans which will reduce

the risks posed by pesticides while maintaining cost-effective

pest control methods.



     In December 1994, the Administration announced the initial

partners (grower groups and utility companies) in the program. 

In forming this partnership, the federal agencies and the

participating groups and companies agree that environmental

stewardship is an integral part of pest management practices. 

Specifically, the partners have agreed to a number of guiding

principles that will shape pest management.  In summary, the

principles state that (1) pesticide users will continue to work

towards pest management practices that reduce risks and to

minimize the pesticide use where desirable and practicable; (2)

users will continue to develop and implement regional pesticide

environmental stewardship plans; (3) the federal government will

seek to foster effective alternative pest management technologies

and practices; (4) and the federal government will integrate the

environmental stewardship plans into its agricultural and

environmental policies and programs.

     

     The partnerships represent a major step in the overall

federal efforts to encourage environmental stewardship.  OPP is

actively seeking additional pesticide user groups, from both

agricultural and non-agricultural sectors, to participate.  The

voluntary measures will help prevent pollution and reduce

potential risks to both people and the environment from

pesticides.



International Harmonization And Regulatory Coordination



     OPP's international harmonization projects aim to develop

common or compatible international approaches to pesticide

review, registration and standards-setting.  The benefits of

making pesticide regulatory programs more consistent

internationally include improved safety of food imported into the

United States, reduced regulatory burden on national governments,

upgrading of supporting science, fewer trade problems, and

reduced costs for registrants.  



     OECD Pesticide Program



     OPP worked closely with other member countries of the

Organization for Economic Cooperation and Development (OECD) to

establish a Pesticide Forum and pesticide work program.  For the

first time, the Forum brings government pesticide regulators

together to address common problems and achieve greater

harmonization of policies and procedures.  The Pesticide Forum is

working in five areas:  reregistration, data requirements, risk

reduction, test guidelines, and hazard assessment.  Under

reregistration, for example, the United States served as the lead

country for the Pilot Project to Compare Pesticide Data Reviews. 

The pilot project has led to a number of follow-up activities to

expand the exchange and use of national data reviews.  As a

result of Forum efforts, countries are gaining a much better

understanding of each other's practices.



     Intergovernmental Forum on Chemical Safety



     The United States participated in the June 1992 United

Nations Conference on Environment and Development (UNCED) held in

Rio de Janeiro, Brazil.  The conference report "UNCED Agenda 21"

made comprehensive recommendations for better coordination and

management of environmental risks.  Chapter 19 of Agenda 21

covers the environmentally sound management of toxic chemicals.  



     In May 1994, governments and international organizations

meeting in Stockholm, Sweden agreed to continue the

Intergovernmental Forum on Chemical Safety (IFCS) to improve the

management of international chemical safety activities.  The

United States is working to implement the many Agenda 21 and IFCS

recommendations, including the assessment of several hundred

priority chemicals by the year 2000.  These new assessments are

intended primarily to meet the needs of developing countries. 

The IFCS is also moving to implement Agenda 21 recommendations

for improvements in harmonization of classification and labeling,

information exchange and prior informed consent, risk reduction,

and strengthening national capabilities.



     Canada/U.S. Technical Working Group on Pesticides



     The Canada-U.S. Trade Agreement (CUSTA) directs the

countries to work toward equivalence of pesticide standards.  To

assist in this effort, CUSTA established a Technical Working

Group on Pesticides, currently co-chaired by OPP and the Chemical

Evaluation Division of Health Canada's Food Directorate.  Pilot

projects in progress in 1994 included:  1) parallel registration

review of tebufenozide, an insect growth regulator, in Canada and

the United States; 2) harmonization of maximum residue limits

(tolerances) for four chemical/crop combinations; and 3)

cooperative reevaluation of heavy-duty wood preservatives. 

Subgroups of the Technical Working Group have also been formed to

address specific environmental, toxicological, and occupational

exposure issues.



Technical Assistance: AID/EPA Central American Project



     The AID/EPA Central American Project is a pilot technical

project involving EPA, the U.S. Agency for International

Development (AID), FDA, and USDA.  It is designed to enhance

Central American efforts to improve pesticide safety and pest

management practices.  During 1994, EPA participated in regional

technical workshops in Central America to provide information

about integrated pest management, safe pesticide use practices,

and U.S. pesticide/food safety import requirements.  EPA

implemented a short-term assistance program in El Salvador to

identify and manage old pesticide storage sites.  EPA also

provided technical assistance to the Government of Ecuador to

assist them in dealing with the "Taura Syndrome," a condition

causing high shrimp mortality in shrimp farms in the Gulf of

Guayaquil.



Biological Pesticide Policy Highlights



     EPA believes that many biological pesticides are less

hazardous than traditional chemical methods of pest control, and

in 1994 the Agency continued to take steps to encourage their

development and use.  This section summarizes those efforts.  EPA

expects that as biological and other safer pesticides are brought

to market, they will displace an older generation of more toxic

chemical pesticides.



     Pheromone Regulatory Relief Policy



     Insect pheromones are a class of biochemical pesticides and

are considered to be reduced risk pesticides.  They are used to

disrupt the mating of insect pests that infest agricultural

crops.  As part of its efforts to provide regulatory relief for

pheromones, OPP published a final rule expanding the allowable

acreage from 10 acres to 250 acres for testing without obtaining

an Experimental Use Permit (EUP) from OPP.  OPP also published an

exemption from the requirement of a tolerance for certain

formulations of pheromones and their inert ingredients based on

low risks to people.  These rules applied to solid matrix

dispensers (such as those made of plastic) that can be retrieved

from fields.  OPP is considering further expanding the exemption

for testing of certain groups of pheromones to include all

broadcast formulations for experimental testing on up to 250

acres.



     Final Rule on the Testing of Microbial Pesticides



     EPA published a final rule on September 1, 1994, that amends

the Agency's experimental use permit regulations and modifies

prior policy regarding small scale testing of microbial

pesticides.  Microbial pesticides consist of microorganisms such

as bacteria, fungi, viruses, or protozoans used to control pests. 

The rule will codify existing policy that requires notification

to OPP prior to initiating small-scale field tests with certain

genetically modified microbial pesticides.  This rule reduces the

regulatory burden of testing microbial pesticides compared to

existing policy, while preserving sufficient federal oversight to

prevent unreasonable adverse effects from testing of microbial

pesticides.



     Proposed Regulation of Plant-Pesticides



     The Agency has proposed a number of actions to regulate

certain novel pesticidal substances genetically introduced into

plants for the purpose of protecting them against pests and

disease.  These substances have been designated plant-pesticides. 

The proposed regulations, issued in November 1994, address plant-

pesticides and not the plants themselves.



     EPA is proposing to exempt three types of low risk plant-

pesticides from registration requirements:



(1)  Plant-pesticides derived from a closely related plant (e.g.,

     those taken from one corn plant and engineered into another

     corn plant).



(2)  Plant-pesticides that act primarily by affecting the plant

     (e.g., plants that have been engineered to produce a

     thicker, more protective outer layer of wax) rather than by

     having a direct toxic effect.



(3)  Plant-pesticides consisting of certain components of viruses

     called "viral coat proteins," and the genetic material

     needed to create the coat proteins.  Scientists are now able

     to transfer genes from a virus into the plant so that the

     plant can produce viral coat proteins.  These proteins

     provide the plant with resistance to infection by disease-

     causing plant-viruses.



     EPA is proposing to exempt three categories of low risk

plant-pesticides (including associated genetic material) from the

requirement to obtain a tolerance:



(1)  Plant-pesticides derived from closely related plants.



(2)  Plant-pesticides not derived from closely related plants, as

     long as the plant-pesticide would not result in

     substantially different exposure through food (e.g., those

     taken from a highly consumed crop such as corn and

     engineered into another crop such as eggplant).



(3)  Coat proteins from plant viruses.



Activities Related To Implementation Of The "Delaney Clause"



     In 1992, the Ninth Circuit Court of Appeals issued a

decision in the Les v Reilly case mandating a strict

interpretation of the Delaney clause of the Federal Food, Drug

and Cosmetic Act (FFDCA).  According to the court, the Delaney

clause forbids EPA approval of food additive regulations if the

pesticide has been found to induce cancer, regardless of the

degree of risk to the public.  (Food additive regulations are

maximum residue limits, or tolerances, for processed food and are

required if a pesticide is used or becomes concentrated in

processed food.)  The Delaney clause does not apply to tolerances

for raw agricultural commodities.  EPA has taken a number of

actions to achieve full and continuing compliance with the

Delaney clause, and in fiscal year 1994:



  o  Proposed to revoke food additive regulations for a number of

     pesticides found to cause cancer.  OPP proposed the

     revocation of 26 tolerances of 7 pesticides on July 1, 1994. 

     OPP expects to propose the revocation a number of other

     tolerances in 1995.



  o  Revoked tolerances for dichlorvos (DDVP) on bagged

     commodities, for dicofol on tea, and mancozeb on washed

     raisins.  A temporary stay of the revocation is in effect

     for DDVP and dicofol.



  o  Issued a notice to registrants (PR Notice 93-12) explaining

     the revised policy that dried hops are a raw agricultural

     commodity (RAC), and therefore no longer subject to the

     Delaney clause.  Two tolerances were subsequently

     established for dried hops as a RAC.



  o  Published in the Federal Register an updated list of

     pesticides potentially affected by the Delaney clause.



  o  Issued a Federal Register Notice explaining OPP's policy to

     delay action on pending petitions and registration actions

     subject to the Delaney clause until Delaney policy issues

     are resolved.



Standards For Pesticide Containers And Containment



     In February 1994, OPP proposed the "Standards for Pesticide

Containers and Containment."  These measures are intended to

protect human health and the environment by reducing exposure to

pesticides and reducing production of wastes when pesticide

containers are stored, handled, and refilled.  The standards are

a result of Congressional amendments to FIFRA in 1988, which

authorized EPA to issue regulations in two areas of concern:

pesticide container design standards and residue removal

standards.  The proposed rule would establish standards for the

removal of pesticides from the containers and the rinsing of the

containers and would facilitate safe use, refill, and disposal of

containers.  The rule also would establish requirements for the

containment of stationary bulk containers and pesticide

dispensing areas.



     OPP reviewed and summarized approximately 200 public

comments and entered them into an issue-oriented data base.  A

workgroup is being re-established to finalize the rule, which is

expected to take 18 months.



Other Regulations Under Development



     In 1994, OPP continued to develop a number of regulations

designed to increase protection of human health and the

environment.



     Tolerances and Food Safety



     OPP is reinventing its processes for establishing tolerances

and estimating risks to consumers (including children) from

exposure to pesticide residues in food.  Thus far, eight

potential procedural changes have been identified.  OPP is

considering taking into account factors such as those known to

reduce pesticide residues in foods between the time crops are

harvested and eaten (e.g., storage, processing, washing, peeling,

and cooking) when setting tolerances.  The resulting tolerances

would more closely reflect real exposure to pesticide residues in

food.  OPP expects to issue an Advance Notice of Proposed

Rulemaking (ANPRM) in the spring of 1995.



     Revised Pesticide Registration Data Requirements (Part 158)



     In 1994, OPP provided draft comprehensive revisions to data

requirements for registering pesticides (Part 158 of the Code of

Federal Regulations) to the EPA Scientific Advisory Panel (SAP)

for review in preparation for proposed rulemaking in early 1995. 

Much of this proposed rule would implement changes already

adopted in OPP in the course of registration and reregistration. 

The revisions would ensure that comprehensive data packages are

supplied to OPP so that each pesticide can be evaluated using

current health and environmental standards.



     Reporting of Pesticide Incidents (6(a)(2) Rule)



     Section 6(a)(2) of federal pesticide law requires

registrants to report to OPP incidents related to pesticide use

or other information related to 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 1994, OPP worked to finalize the

proposed 6(a)(2) rule, which would clarify the incident reporting

obligations of registrants.  OPP expects to publish the final

rule in mid-1995.  (Chapter 6 provides further discussion of

6(a)(2) activities during 1994.)



     Protecting Endangered Species and Ground Water



     As described in more detail in chapter 4, OPP continued to

work on a final regulation to protect federally listed threatened

and endangered species from the impacts of pesticide use and to

draft several regulations to further protect ground water

resources.



Legislative Proposals



     OPP played a lead role in working with USDA, FDA and the

White House domestic policy staff to draft comprehensive

pesticide and food safety legislative reforms advanced by the

Administration, preparing for Congressional hearings on the

proposals, and conducting numerous communications and outreach

activities.  OPP also performed a preliminary cost analysis and

analyzed other bills advanced in the 103rd Congress.  The

Administration proposals aim to provide authorities under both

the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal

Insecticide, Fungicide, and Rodenticide Act (FIFRA) to enable

regulatory agencies to take prompt action to reduce risks to

health and the environment, and to promote development of safer

methods of pest control.  



     Notably, the Administration's legislation would replace the

"Delaney clause" of the FFDCA with a consistent, health-based

standard for setting tolerances for pesticide residues in all

types of food.  Other FFDCA proposals respond to the

recommendations of the National Academy of Sciences report

"Pesticides in the Diets of Infants and Children"; call for a

review of all existing tolerances against the new, health-based

standard; and enhance FDA's enforcement powers.  FIFRA proposals

include registration "sunset" provisions; incentives for

development and registration of reduced risk and minor use

pesticides; support for risk and use reduction and IPM

activities; streamlined cancellation and suspension procedures;

export restrictions; record-keeping for all agricultural

pesticide use; additional fees to support FIFRA '88

reregistration; enhanced enforcement for FIFRA violations; and a

number of other regulatory tools.  



     The Administration's proposals were introduced into the

103rd Congress, but no final action was taken before the close of

the session.  OPP expects a number of these issues to resurface

in the next Congress, either as independent legislation or in the

context of the 1995 Farm Bill.



Maintaining And Improving OPP's Science Base



     OPP's critical decisions rely upon the scientific

information and judgment about those pesticides.  OPP invests

considerable effort in obtaining the best scientific information

available and working with other experts within and outside of

government to make sure its standards reflect the latest

scientific thinking.  This section describes some of OPP's

efforts in 1994 to build upon its scientific base.



     Ecological Effects Pesticide Toxicity Database



     Over the past two years, OPP has developed a database to

provide a rapidly accessible source of ecotoxicity data for all

pesticides in use nationwide.  Ecotoxicity data consist of

information about the toxicity of pesticides to birds, mammals,

fish, plants, and other organisms.  The database will track,

record, and summarize OPP's vast library of toxicological data,

which until now has been available only in paper format, and

should prove to be an extremely valuable tool for assessing the

risks associated with various alternative pesticide uses.  OPP

has already provided database information to EPA regions and

other offices, USDA, the U.S. Fish and Wildlife Service, a number

of state agencies, and others.  The database will also allow OPP

to more efficiently complete registration and reregistration

actions.  The database currently contains over 7,000 toxicity

records for 300 major use pesticides and is about halfway

completed.  OPP plans to incorporate this database into the

Pesticide Information Network (described in chapter 4) and other

publicly available data sources.



     National Water-Quality Assessment Program



     OPP scientists have worked closely with the U.S. Geological

Survey's National Water-Quality Assessment (NAWQA) Program over

the past several years.  NAWQA is describing the status and

trends in a representative part of the nation's ground and

surface waters.  One product from the joint efforts is the

publication entitled "Summary of National Standards and

Guidelines For Pesticides in Water, Bed Sediment and Aquatic

Organisms and Their Application to Water-Quality Assessments."

This publication summarizes current national standards and

guidelines, and provides definitions, originating agencies,

statutory authorities, regulatory status, applicable sampling

media, beneficial use and resource protected, and full citations

of published documentation.  An entire issue of Reviews of

Environmental Contamination and Toxicology has been dedicated to

the publication.



     EPA's Contaminated Sediment Management Strategy



     OPP has actively participated in the Agency's Contaminated

Sediment Management Strategy, published August 1994.  OPP

scientists have served on various Agency committees covering a

wide range of topics from toxicity testing to use of sediment

water quality criteria.  They have also worked closely with EPA's

Office of Pollution Prevention and Toxics to provide a

Prevention, Pesticides and Toxic Substances policy, as well as a

scientific position on the Strategy.  



     Health Effects Research and Guidelines



     OPP participated in a number of projects in 1994 to advance

scientific knowledge and understanding of the health effects of

pesticides.  Some of these projects included:



  o  Drafting and sharing publicly the test guidelines for

     reproduction and developmental toxicity studies.  OPP is

     finalizing the guidelines based on public comment.  OPP has

     also developed Standard Evaluation Procedures (SEPs) for

     reproduction and developmental toxicity studies and is

     gathering public comment.  These procedures should

     standardize how the studies are evaluated both by industry

     and EPA.



  o  Holding an Ocular Toxicity Workshop to explore testing

     options for the adverse eye effects associated with

     organophosphate pesticides.  OPP and pesticide registrants

     discussed the protocols and feasibility of several proposed

     tests.



  o  Convening a workshop with leading researchers to obtain

     comment on draft revisions to the guidelines (known as the

     Subdivision K guidelines) for assessing pesticide exposure

     to people in both work and residential settings.



  o  Working with the International Life Sciences Institute

     (ILSI) to explore a number of contentious scientific issues. 

     Among the most important ones are the significance of

     mammary and bladder tumors in laboratory animals and how to

     interpret certain effects in laboratory animals found at

     extremely high doses of pesticides (the Maximum Tolerated

     Dose, or MTD, issue).



  o  Drafting and distributing for preliminary comment revised

     guidelines for performing toxicology metabolism studies. 

     The new guidelines will have a tiered system of testing. 

     OPP plans to hold a workshop on the guidelines in May 1995.





          Chapter 6: Information and Program Management



     OPP's information and program management efforts are not as

publicly visible as some of its other programs, but without them

none of the other programs could operate.  The buildings that OPP

occupies, the supplies and equipment it uses, the funds it

administers, the systems for processing and storing the vast

amounts of information that OPP uses, and the staff itself -- all

of these critical program components are managed under this

program area.  This section describes some of the information and

program management achievements during 1994.



Operations, Maintenance And Integration Of The Primary OPP

Information Systems



     In 1994, OPP finished major parts of its automated

information management infrastructure.  All OPP employees are now

equipped with personal computers linked via a high-speed local

area network (LAN).  Detailed and summary information about

pesticide chemicals, products and their uses, registrants,

registration action requests, tolerances, reregistration status,

and other information is available through the LAN.  Electronic

mail (email), scheduling, word processing, spreadsheet, and other

software packages are also available.  This infrastructure is

reliable and has greatly improved internal communication and

data-sharing in OPP.



     Additionally, OPP completed the integration of several

computer systems used to manage the pesticide reregistration

process into an improved system called the Chemical Review

Management System (CRMS).  OPP used CRMS in preparing the

Reregistration Report Cards sent to each registrant involved in

reregistering a pesticide.  Major improvements were also added to

the Pesticide Regulatory Action Tracking System (PRATS), which

OPP uses to help manage the flow of registration actions through

the program.  The improvements added capabilities for priority

planning, scheduling, and performance analysis.



     Other major improvements to the automated information

management infrastructure in 1994 included upgrading the staff

personal computers, completing the major preparatory steps for

integrating all the OPP-wide computer systems into one umbrella

system, aggressively pursuing electronic submission of detailed

data critical to science studies, and adding more software to the

network.



Pesticide Incident Reporting/6(a)(2) Activities



     Section 6(a)(2) of federal pesticide law requires

registrants to report to EPA incidents, studies, or other

information indicating new potential adverse effects of

registered pesticides.  This information is important in helping

EPA decide if action should be taken to reduce the risks posed by

a particular pesticide.



     The number of 6(a)(2) submissions to OPP increased in 1994

to approximately 700 covering 4,500 individual incident reports. 

OPP's 6(a)(2) Team screened 755 adverse effects submissions,

which were primarily studies and preliminary reports of possible

adverse effects from studies not yet completed.  As a result of

screening, 20% of the submissions were determined to warrant

expedited review.  Of those, about 20% resulted in label changes

to reduce risks, mostly in cases of new findings of acute

toxicology studies, and 8% showed a new adverse effect that is

being addressed by Special Review, an imminent reregistration

decision, or risk mitigation measures.  The remainder are in

various stages of review or required no further action.



Ecological Incident Monitoring And Reporting

     

     In 1994, OPP completed the development of the Ecological

Incident Information System (EIIS).  OPP expects that this system

will play an essential role in understanding how poisoning

incidents involving nontarget species (unintentionally affected

animals and plants) occur and will help OPP to reduce

environmental risks.  This database is a compilation of the

information currently used for completing risk assessments.  A

total of 630 incidents have been entered into the database,

including the most recently reviewed pesticide, carbofuran. 

Based on the data entered to date, over 101 active ingredients

have caused adverse effects to 1,300 species of nontarget

organisms.



     In response to substantial interest in the EIIS, OPP has

distributed the software to 175 state and federal agencies as

well as to private industry.  OPP contacted over 75% of the state

agencies who are responsible for collecting the data.  OPP has

presented its efforts at professional meetings and to other

federal agencies such as the National Biological Survey (NBS). 

OPP has also initiated cooperative agreement efforts between EPA,

NBS, and the Fish and Wildlife Service and is developing a

standardized protocol for ecological incident monitoring and

reporting.



Information And Records Management Activities



     OPP receives and generates an enormous number of documents

each year, such as studies submitted regarding the effects of

pesticides and OPP's review of these studies.  These records must

be properly managed to ensure timely, appropriate decisions and

for future reference.  Significant accomplishments were made in

OPP's records management program in 1994.  OPP conducted regular

training for its network of records management liaison offices

and drafted major changes to the records retention schedule for

review by the National Archives.



Human Resources Management



     OPP's human resources efforts included hiring, training, and

promoting staff.  More than half of OPP employees received some

form of technical, career, or management development training in

1994.  Another human resource effort was that of the Cultural

Diversity Task Force.  The Task Force is committed to valuing OPP

employees regardless of physical attributes, ethnicity, or sexual

orientation.  Three subcommittees have been formed:

Communications, Planning, and Outreach.  In 1994, the

Communications Committee educated OPP staff on the mission of the

task force.  The Planning Committee determined that the task

force should focus on recruiting and retaining minorities,

developing careers for minorities, and ensuring unbiased reviews

for minorities eligible for promotion.  In 1994, the committee

participated in drafting a Diversity Plan that should be

finalized in early 1995.  The Outreach Committee developed a

database of potential applicants that will be made accessible to

all managers to help them find qualified applicants.



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 of developing the budget

submitted by the President to Congress each year.  During fiscal

year (FY) 1994, OPP prepared the submission of the FY 1996

budget.  OPP worked with the Administrator's office to develop

the budget, investing in some areas and disinvesting from others,

based on Agency priorities and objectives.  OPP's major proposed

areas of investment are ecological protection (including reducing

pesticide use/risk and building tribal capacity), food safety,

and implementation of the Worker Protection Standard.  These

investments are to be accompanied by disinvestments from

registration and reregistration, by completion of some efforts,

and by streamlining efficiencies.  The budget will then be

reviewed by OMB and ultimately become part of the President's

Budget.  After Congressional review and ratification, it becomes

the Congressional Budget.  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



     The planning process starts about nine to 12 months before

funds are actually appropriated by Congress; OPP began FY 1995

planning in January 1994.  The participants include a Senior

Management Board, a Steering Committee, six Program Area

Workgroups (PAWs), and coordinators from each of OPP's divisions. 

The PAWs identify resources needed to fund Program Area

activities and prioritize those activities.  The Steering

Committee then makes recommendations based on the PAW efforts to

the Senior Management Board, which integrates the area plans into

the OPP Resource Management Plan.  This plan describes the

projects to be performed and their level of funding for the

upcoming fiscal year.



     For FY 1995, the OPP planning process allocated $18.2

million for headquarters contracts and grants, $3.3 million in

expenses, and $52 million in salaries for approximately 785

employees.  The planning process incorporated reductions

requested by Congress, the conversion of some contractor

functions to OPP staff, "buy-outs" to facilitate staff

reductions, and implementation of the new pilot division. 

Nondiscretionary state grants and assistance, which are allocated

outside of the OPP planning process, totalled $15 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 1994, OPP obligated (spent) $93 million dollars. 

These funds consisted of $52 million in travel expenses and

salaries for approximately 785 employees; $26 million for

contracts, interagency agreements, grants, and expenses; and $15

million for grants and support to regions and states.  In 1994,

OPP continued to collect several types of funds from pesticide

registrants, which supplement Congressional appropriations.  The

collected funds consisted of $2.1 million in tolerance fees,

$14.1 million in annual registration maintenance fees, and

$800,000 in reregistration fees.  The collected fees are placed

in revolving funds that may be used over multiple years, whereas

most Congressional appropriations must be used within two years.



     In 1994, OPP improved its systems for using the revolving

funds and helped carry out financial management responsibilities,

such as those under the Chief Financial Officer's Act and the

Government Performance and Results Act.  OPP also continued to

fully use available resources to meet mission goals.





               1994 Staff Effort Per Program Area



----------------------------------------------------------

Program Area                                         FTEs

---------------------------------------------------  -----

Registration                                          189

Reregistration                                        241

Special Review                                         70

Field Implementation and Communications                78

Policy, Regulations, and Guidance                      69

Information and Program Management                    120



TOTAL                                                 767

----------------------------------------------------------



     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 1994 By the Six Program Areas



----------------------------------------------------------

Program Area                                         Funds 

---------------------------------------------------  -----

Registration                                          11 %

Reregistration                                        33 %

Special Review                                         3 %

Field Implementation and Communications               13 %

Policy, Regulations, and Guidance                     16 %

Information and Program Management                    24 %



TOTAL                                                100 %

----------------------------------------------------------



     In 1994, OPP expended approximately $14.2 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 table

are travel expenses; salaries; grants and other assistance to

states, regions, and other organizations; and set-asides for

special projects, such as pesticide disposal.)





        Chapter 7: Opportunities and Initiatives For 1995



     In addition to continuing the work previously described

throughout this report, OPP expects to pursue several important

opportunities and initiatives during 1995.  This section

highlights some of those opportunities.



Biological Pesticides And Promoting Risk Reduction



     OPP is taking several measures to promote biological and

other potentially safer pesticides, such as waiving data

requirements, where possible, and placing a high priority on

completing needed scientific reviews.  OPP is also encouraging

alternatives to pesticides and other ways of reducing pesticide

use and risks.  Two important new opportunities for continuing

progress in these areas are the creation of a pilot division and

the Memorandum of Understanding between EPA and the U.S.

Department of Agriculture.



     Creation of the Pilot Division



     EPA has established a pilot, multi-disciplinary division of

33 employees within OPP to promote reduced pesticide use,

encourage development and use of safer pesticides, and accelerate

registration of new biological pesticides.  The Biopesticides and

Pollution Prevention Division (BPPD) is responsible for: (1) all

registration and reregistration actions for biological

pesticides; (2) Integrated Pest Management (IPM) programs and

strategies; and (3) continued development of pesticide pollution

prevention activities, including the Pesticide Environmental

Stewardship Partnership.  



     In accordance with the Administration's National Performance

Review (highlighted in the Vice-President's report on reinventing

government), the pilot division will have a streamlined structure

which exceeds the goal of 11:1 staff to management ratio.  Small,

self-directed and empowered teams are being formed as an

alternative management structure.  The approach is designed to

promote staff development and OPP productivity for all science

reviews and administrative processes for registration and

reregistration actions, providing team leadership opportunities

and allowing OPP to test and evaluate new methods of operation to

assist with the overall streamlining of OPP scheduled for 1996.



     EPA/USDA Memorandum of Understanding (MOU)



     Under this MOU, signed in August 1994 by EPA Administrator

Carol Browner and Department of Agriculture Secretary Mike Espy,

the two agencies agree to work in collaboration to provide the

agricultural community with pest management practices to reduce

the risks associated with pesticides.  The agreement will

increase USDA research for alternative methods for pest control

and establish practical means for transferring these tools to the

farmer.  Each year, USDA will identify those crop/pest/control

combinations which are potentially vulnerable for the producer

(i.e., situations where growers have few effective alternatives

or where pest resistance limits effective pest management). 

Similarly, EPA will identify agricultural pesticides for which it

is considering regulatory action that would affect their

availability or use.  Together, USDA and EPA will expedite

research, development, education and registration, if necessary,

to meet these priority needs.



Opening Up OPP



     OPP has several projects underway to "open up OPP" -- that

is, to allow everyone to obtain information from OPP more easily,

and to participate in and understand OPP's decision-making

process.  OPP strongly believes that a well-informed public will

make wiser choices involving pesticides and will help improve the

quality of federal pesticide actions.



     Electronic Dissemination of Information



     OPP continues to experiment with innovative ways of making

information available to affected organizations and the general

public.  The Agency's Email (electronic mail) Integration Pilot

this year extended OPP's realm of communications to include EPA

regional offices and made possible the exchange of Internet

messages.  Internet is a telecommunications system that connects

thousands of computer networks and literally millions of computer

users.  Early in calendar year 1995, OPP expects to complete the

process enabling all OPP personnel to easily communicate with

anyone on the worldwide Internet.  OPP has also begun to make

some of its publications available on the Internet.



     During fiscal year 1994, OPP also piloted the new Pesticide

Special Review and Reregistration Information System, an

electronic bulletin board system (BBS) available free of charge

to any member of the public who has access to a PC with a modem. 

This 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 Rainbow Report (or "Status of Pesticides

in Reregistration and Special Review"), and "OPP Selected Terms

and Acronyms." Additional documents to be added soon include this

Annual Report, the Rejection Rate Analysis chapters, and the

quarterly "Pesticide Reregistration Progress Report." To reach

this BBS from a PC with modem, dial 1-703-308-7224.  The BBS also

can be reached on the Internet via FEDWORLD.GOV.  EPA's "gopher

server," EARTH1.EPA.GOV, is another source of these electronic

files.  The Sysop, or system operator, welcomes comments,

questions and feedback.



     Public Involvement in Risk Decisions



     Achieving risk reduction through negotiations with pesticide

registrants can lead to quicker action than formal Special Review

procedures; however, it has been criticized for not always

providing an adequate opportunity for public involvement.  OPP

published a notice in the Federal Register in 1994 that described

a number of ways OPP would be making the process more open,

including a process for public comment on proposed agreements

with registrants.  OPP will continue this process in the coming

year.  OPP is also exploring avenues for expanding its efforts to

include the public in pesticide registration decision-making.



     The Aquatic Risk Assessment and Mitigation Dialogue Group



     To help implement the "New Paradigm" for pesticide

regulatory decisions (described in chapter 2), OPP organized a

workgroup known as the Aquatic Risk Assessment and Mitigation

Dialogue Group with the joint sponsorship of the American Crop

Protection Association (formerly NACA).  The group consisted of

representatives from the pesticide industry, academia,

environmental groups, OPP, and EPA's Office of Research and

Development (ORD).  The group met seven times in 1993 and 1994 to

promote an open scientific dialogue about the assessment and

mitigation of risks to aquatic organisms posed by pesticides. 

The primary topics discussed by the Dialogue Group were

ecological effects and exposure characterization, integrated risk

characterization, and mitigation practices to reduce the risk of

pesticides to aquatic resources.  Subgroups researched a variety

of topics, such as how to better employ existing data in risk

assessments, how to improve pesticide risk assessment

methodology, and cataloguing pragmatic short-term mitigation

practices.  Long-term needs for mitigation and monitoring were

also discussed.  The Group reached a number of conclusions and

recommendations in a final report issued in November 1994.



Reinventing And Streamlining OPP's Organization



     As part of the efforts to "reinvent" and flatten the federal

government structure and to increase responsiveness, OPP has

undertaken twenty major streamlining projects in four main areas. 

Progress through fiscal year 1994 is summarized for each project

in the table below.  This broad range of activities is overseen

by an OPP Streamlining Council, composed of the senior program

managers, and an Employee Advisory Group, representing the staff.





                    OPP Streamlining Projects



===============================================================

    Streamlining Project               Current Status

==========================  ===================================

                 Review and Evaluate OPP Program

---------------------------------------------------------------

    Survey Customer         Preliminary test complete. Full 

    Satisfaction            surveys of regulated community and

                            general public to begin in FY 95.

                            Surveys of states/regions completed

                            in FY 94.



    Perform Outside         Pre-test complete. Interviews of 160 

    Management Review       OPP staff began mid-October 1994.

                            Final report submitted in January

                            1995.



    Upgrade Monitoring of   Performance to be measured against 

    Performance vs. Plan    fiscal year 1995 resource allocation

                            plans.

---------------------------------------------------------------

             Revise Core Production Processes in OPP

---------------------------------------------------------------

    Drop Activities         Identification of candidate 

    Contributing Little     processes complete. Winnowing 

    to Risk Reduction       process underway. 



    Increase Delegations    Many redelegations completed; others 

    and Empowerment         in progress. Allows quicker decision-

                            making and fewer layers of review.



    Streamline Correspond-  Project getting underway.

    ence Management in OPP



    Pilot a "Living RED"    Test effort to maintain a continually

                            updated, automated OPP regulatory and

                            scientific position about a specific

                            pesticide. Pilot pesticide selected,

                            and prototype system under

                            development. 



    Standardize Science     Pilot efforts completed in 1994. Two 

    Review Documentation    subgroups now focusing on review

                            content and on technology for

                            storing,indexing,and retrieving

                            reviews.



    Automate Product        Electronic letterhead and 

    Manager Team            concurrence copies now used to 

    Operations              simplify correspondence. Work to

                            further automate correspondence

                            underway.



    Use Quality Circles     Pilot under development for non- 

    in Health Effects       supervisory quality management in 

    Division                science review division.

---------------------------------------------------------------

              Implement Human Resources Initiatives

---------------------------------------------------------------

    Implement Diversity     Draft OPP Diversity Plan completed 

    Initiatives             and circulated for comment throughout

                            OPP. Revisions in response to

                            comments underway. Final plan

                            implementation in 1995.



    Develop New Perfor-     OPP working jointly with Office of 

    mance Appraisal         Pollution Prevention and Toxics. 

    System                  Staff survey planned for early 1995;

                            full pilot to be in place for 1996

                            standards.



    Appraise Supervisory    Full OPP-wide implementation began

    Performance by Staff    in September 1994.



    Establish Multiple      OPP effort, which depends upon 

    Career Tracks           Agency-wide progress, is in beginning

                            stages.



    Implement Administra-   System approved and implementation 

    tive Support Career     underway.

    Management System



    Redefine Leadership     OPP effort is in beginning stages.

    Needs in Streamlined 

    Organization



    Develop Staff           OPP effort is in beginning stages.

    Rotation Program



    Develop Comprehensive   OPP-wide survey of training needs 

    Training Strategy       has begun.

---------------------------------------------------------------

                   Streamline OPP Organization

---------------------------------------------------------------

    Establish               Pilot operations began in October 

    Biopesticides and       1994.

    Pollution Prevention 

    Division



    Realign Organization    Divisional reorganization plans 

    to Meet Streamlining    completed 3/94. Overall OPP 

    Mandates                streamlining plan to be developed by

                            2/95 by Streamlining Council.

===============================================================





     Registration Streamlining



     In September 1994, OPP released its plan for streamlining

several aspects of the registration process.  Two major areas for

improvement identified are amendments to pesticide product

registrations and other process changes.  In the first area, OPP

is proposing to expand the types of amendments which may be

accomplished by notification.  Under a notification system, a

pesticide registrant may modify its pesticide label without prior

approval so long as it notifies OPP of its action and fulfills

OPP label requirements.  This notification process will be

limited to minor changes that do not increase risks.  OPP is also

proposing to simplify the notification process.  Other potential

areas for improving the registration process include streamlining

the review of acute toxicity studies, self-certification by

registrants for products with low acute toxicity, strengthening

precautionary labeling statements, and expediting the review of

products similar to products already registered ("me-too"

registrations).





                 How To Obtain More Information



     The Office of Pesticide Programs (OPP) wishes to provide

timely and consistent information to the public and offers a

variety of ways to do so.  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, D.C. 20460 (Telephone 202 260-2080); or the National

Center for Environmental Publications and Information (NCEPI),

P.O.  Box 42419, Cincinnati, Ohio  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, D.C. 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 is a

toll-free telephone service which provides general information

about pesticides and is available to anyone in the United States,

Puerto Rico and the Virgin Islands (Monday-Friday, 8:00 a.m. to

6:00 p.m. CST) at 1 800 858-7378.



Electronic Availability of Pesticide Reregistration Documents -

Many reregistration and Special Review documents are available

through an electronic bulletin board system, which can be reached

via modem at 1-703-308-7224.  They are also available through the

Internet via FEDWORLD.GOV and via EPA's gopher server,

EARTH1.EPA.GOV.  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 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 January

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



                  Office of Pesticide Programs



     Daniel M. Barolo, Director                   305-7090

     Penny Fenner-Crisp, Acting Deputy Director   305-7092



                Policy and Special Projects Staff



     Anne Lindsay, Director                       305-7102



            Biological and Economic Analysis Division



     Allen L. Jennings, 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



     Anne L. Barton, Director                     305-7695

     Paul F. Schuda, Deputy Director              305-7695



                    Field Operations Division



     William Jordan, Acting Director              305-7410



                     Health Effects Division



     Stephanie R. Irene, Acting Director          305-7351

     Richard D. Schmitt, Acting Deputy Director   305-7351



             Program Management and Support Division



     Frank T. Sanders, Acting Director            305-5440

     Norman W. Chlosta, Deputy Director           305-5440



                      Registration Division



     Stephen L. Johnson, Director                 305-5447

     Lois A. Rossi, Acting Deputy Director        305-5447



           Special Review and Reregistration Division



     Peter P. Caulkins, Acting Director           305-8000




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