Foreword
EPA's Office of Pesticide Programs (OPP)"is making significant progress in carrying
out its important responsibilities safeguarding public health and the environment from
pesticide risks, and ensuring that pesticides are regulated fairly and efficiently. OPP's Fiscal
Year 1995 achievements are especially noteworthy as they were accomplished while the
program was engaged in extensive reinvention initiatives, planning for a major realignment,
and responding to pressures and concerns about impending budget actions.
.This was a banner year for both the registration and reregistration programs, with 40
new active ingredients registered and 40 Reregistration Eligibility Decisions (REDs) issued.
To put these numbers in perspective, consider that,historically, only about a dozen new
active ingredients were registered annually. Dramatic improvements began to show hi FY
1994, when 30 new active ingredients were registered. The upward trend continued in FY
1995, with a record-breaking 40 new registrations accomplished. Impressively, well over half
of the new registrations during the past two years are for "safer" or reduced risk products,
many with lower use rates than conventional pesticides, and 35 are biopesticides. .
During FY 95, the timeliness of EPA registration decisions improved substantially. ,
Historically, it has taken on average four to six years to register a new pesticide. During the
past year, average processing times were reduced as follows: reduced risk pesticides (8-16
months); biopesticides (3r16 months); and all other new active ingredients (3-52 months). :
i - ' ' , . . ' -^.
OPP also accelerated its reregistration program for older pesticides, reaching its
planned annual goal of 40 REDs in FY 95, for a grand total of 121 REDs. Combined with
last year's total of 34 REDs, this means an impressive 74 reregistration decisions two-
thirds of all REDs issued ^- were accomplished in the last two years. These decisions were
made following OPP's comprehensive review of literally mousands of scientific studies on
the potential effects of pesticides and their fate in the environment. Based on this review,
EPA took action to reduce pesticide risks by imposing many new requirements and
restrictions as conditions of reregistration. While much work-remains to be done, including
REDs for many major pesticides with food-related uses, less than half of the original
' universe of older pesticides remain in the pipeline for review.
Beyond the registration and reregistration programs, EPA implemented a number of
other .initiatives to protect public health and the environment. OPP worked to serve all of its
customers by responding to requests for information and managing the distribution of
hundreds of thousands of EPA-produced documents that help ensure safer pesticide practices
in the home, in schools, in agriculture, and in industrial settings. Notably, the Worker
Protection Standard became fully effective in 1995. This standard ensures that over three
million agricultural workers have the training and equipment they need to protect themselves
from pesticide risks on the job- At the same time, EPA continues to work to refine its rules
to ensure appropriate flexibility in unplementation, and to focus resources on true public
health and environmental problems, by streamlining and "deregulating" wherever possible
and establishing new alliances, such as the Pesticide Environmental Stewardship Program.
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A talented team of dedicated employees from across all OPP divisions made these
accomplishments possible. In addition, EPA's partners in the regional offices and state and
tribal pesticide regulatory agencies continue to play a key role in implementing and enforcing
pesticide programs and policies. This Foreword highlights only a few of OPP's positive
achievements over the past year. Others are described more fully in the following pages. The
goal of the Annual Report is to provide a public accounting of our work for all of our
constituencies. I hope that it will serve an important function in communicating .the depth and
breadth of OPP's responsibilities and accomplishments.
Daniel M. Barolo, Director
Office of Pesticide Programs
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Introduction
Protecting public health and the environment from the risks posed by pesticides is a
challenging and complex undertaking. JBy their very .nature, .pesticides create some risk of
harm to humans, animals or the environment because they are designed to be biologically
active and have a negative effect on living organisms. At the same time, pesticides are useful
to society because of their ability to kill potential disease-causing organisms and to control
insects, weeds, and other pests.
Over the past twenty years, EPA's Office of Pesticide Programs (OPP) has developed
a number of programs structured to meet the challenge of evaluating and reducing pesticide
risks .and promoting safe pesticide use. These programs govern a wide variety of pesticide
products and uses that are likely to be found in virtually every home and business in the ,
United States from insect repellents to weed killers to hospital disinfectants to swimming
pool chemicals .to name a few. The health and environmental issues raised.by pesticides in
these many settings are varied and complex. In carrying out its responsibilities, OPP must
consider both the need to minimize risks and the benefits that pesticides offer to society.
State and tribal agencies and many other organizations, both public and private, are vital
partners in this effort.
While it would take many more pages to fully depict the extensive efforts and
. achievements of this, program, mis report attempts to describe many of the accomplishments
of the Office of Pesticide Programs during the 1995 fiscal year (October 1, 1994 to .
September 30, 1995). . ,
Annual Report Structure
While OPP staff are formally organized into eight divisions and a policy staff, this
.report is organized around the six major activity areas used in the resource planning process.
In addition, the seventh chapter discusses some other special initiatives.
1 - Registration
Making decisions about the registration (licensing) of individual pesticide products,
and assuring that decisions are consistent and up-to-date.
2 - Reregistration
Bringing the scientific data base for older pesticide active ingredients up to current
standards, reassessing their regulatory status, mitigating risks, and documenting new
decisions. Assuring that products containing eligible active ingredients are supported by valid
data, are labeled correctly, and are reregistered.
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OPP Annual Report
3 - Special Review ,
Conducting in-depth assessments of pesticides suspected of posing unacceptable risks
to public health or the environment.
4 - Field Implementationand Communications
Working with EPA regional offices, states, and tribal organizations to implement
.pesticide programs, communicathig 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, arid budget planning).
7 - Biopesticide, Risk Reduction, and Reinvention Initiatives .
Though integrated into the other six areas for budget purposes, these initiatives are
given special attention hi this report. They involve encouraging the introduction of a new
generation of biological pesticides, reducing pesticide risks through environmental
stewardship, and reinventing OPP organizations.
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Contents
Foreword . . . . . ...'.;. ............ . ... . . ........ i
Introduction ........................... I ................... iii
Chapter 1: Registration . . . . .'. . ;-... ..,.' 1
Overview Of Registration ...... . .......... .'.._. . . . . . .'. . . . . . . . . .1
New Registrations In 1995 ........ ... .../.. ... . . . .... . ... .... . . 2
Other 1995 Registration Achievements . 1 5
Reinvention/Risk Reduction Activities ........................... . 6
Implementing Acetocbior Registration Conditions . . ..;. . . . . ......... ; . . . 7
Ensuring The Effectiveness Of Antimicrobial Pesticideis ..:.... ,.. ... . , . . . 8
Efforts To Improve Pesticide Labels . . . r . , . . . . .... . .... ... 9
Pesticide Chemistry Laboratory Support For Registration . .....: . . ... . . . 10
Chapter 2: Reregistration ......................... ., . . . . . . -t -. . . 12
Steps In Reregistering Pesticides ........ . . . ................. . . 12
1995 Reregistration Progress ... . . . . . .... ..... . . . . ....'......... . 12
Assessing E^)osure To Turf Pesticides . ... . » . . . . . . . . 22
^ Pesticide Chemistry Laboratory Support For Reregistration . ... 22
Reducing Pesticide Spray Drift .. ..f ....... .... 22
Chapter 3: Special Review . ... . . . . . . . ... ... . .'.'....: -....- . . 23
1995 Formal Special Reviews And Follow-up Activities . ............... 23
Limited Reintroduction Of Aldicarb Use On Potatoes ................. 25
Chapter 4: Field Implementation and Communications ................... 26
A. Field'Programs ....... . .'.'..' 26
Implementing The Worker Protection Standard ..... ...... ........ ... 26
Endangered Species Protection Program :.'. ....... . ..... . .... . . . ... 27
Protecting Ground Water 28
Certification And Training Of Pesticide Applicators . . .-, .... ..... ..... . 29
B. Communications, Public Response, and Coordination . . ,. . . . . ......... . . 30
Outreach And Communications Strategies .............:......... . 30
Responding To The Public . ... . .,, . . .... . . ... . . . . , . . . ... .... . 31
Congressional Relations And Coordination With Other Federal Agencies ...... 32
National Agricultural Pesticide Impact Assessment Program (NAPIAP) ...... 33
International Coordination And Integration . . . ... . . . . ........ . . ,., . . 33
- - Regional, State, And Tribal Liaison . ....... ... ............... . . 35
Laboratory Tools . . , . . . . . . ; . . . ...... 36
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OPP Annual Report
Chapter 5: Policy, Regulations, and Guidance .- 37
Improving Protection For Infants And Children . .' 37
Acute Dietary Risk Assessment Activities 38
Activities Related To Implementation Of The "Delaney Clause" 39
Revised Food And Livestock Feed Table 4°
"Reinvention" and Regulatory Reform: Ongoing Efforts to
Clarify and Update Regulatory Policies and Requirements . . . 40
Ecological Risk Assessment and .Ground-Water .Study Guidance 44
Community-Based Environmental Protection . . 44
Improving Methods, Modeling, And Information Systems
for Environmental Assessments ^5
Legislative Proposals .........: ....,: 46.
International Harmonization And Regulatory Coordination ...... 46
Technical Cooperation With Developing Countries 49
International Trade And Environment Policy ................ v 51
Chapter 6: Information and Program Management 52
Operations, Maintenance And Integration Of The Primary
OPP Information Systems . 52
Electronic Dissemination Of Information . . 53
Other Information Systems .,'.'. 54
Pesticide Adverse Effects Information Reporting/6(a)(2) Activities ......... 55
Ecological Incident Monitoring And Repprting 56
Information And Records Management Activities 56
Human Resources Management ................. *6
Resource Allocation And Financial Management . 57
Chapter 7: Biopesticide, Risk Reduction, and Reinvention Initiatives 60
Creation Of The New Division'-. . . . ..\ .....;... * 60
Promoting Integrated Pest Management (IPM) 62
Pesticide Environmental Stewardship Program (PESP) /. 62
Biological Pesticide Regulatory Relief 65
Reinventing And Streamlining OPP's Organization . . 66
How To Obtain More Information 67
Pesticide Program Contacts .-. . . . . 69
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Chapter 1: Registration
This chapter describes the pesticide registration program, which provides the
foundation for nearly all OPP activities. In addition .to allowing the use of new pesticides, the
registration program includes many activities related to the ongoing registration of existing
pesticides, such as label changes in.where and how they may be used in order to reduce risks
or in response to requests by registrants. This chapter also describes several reinvention
activities aimed at improving regulatory decisions, processes, and team structures. Also
contained in this chapter are summaries of,special programs ensuring the effectiveness of
antimicrobial pesticides, improving pesticide labels, and the role of OPP's laboratories in
pesticide registration. .
Overview Of Registration ,
r . ' "_ . , " ' -
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires that before
anyone, can sell or distribute any pesticide in the United States, they must obtain a
registration, or license, from EPA. The term pesticide means any substance or mixture of
substances intended for preventing, destroying, repelling, or mitigating any pest, and any
substance or mixture intended for use as a plant regulator, defoliant, or desiccant. When
making a pesticide registration decision, EPA must ensure that the pesticide, when used
according to label directions, ;wiil not cause unreasonable adverse effects to human health or
the environment.
Registration decisions are based primarily on EPA?s evaluation of the test data
provided by applicants. EPA has established a number of requirements, such as the Good
Laboratory Practice Standards, that apply to both registrants and testing facilities to ensure
the quality and integrity of pesticide data. .
Depending on the type of pesticide, OPP can require more than 100 different tests.
Testing is needed to determine whether a pesticide has.the potential to cause adverse effects
to humans.-wiidlife, fish, and plants, including endangered species. Potential human risks,
which are identified using laboratory tests in animals, include acute toxic reactions (such as
poisoning and skin and eye irritation) as well as possible long-term effects (such as cancer,
birth defects, and reproductive disorders). Data on the fate of pesticides in the environment
are also required so that OPP can assess threats to ground and surface water or other risks.
OPP processes a variety of registration applications., includhig: new pesticide active
ingredients, new uses (applications for new uses of an already registered pesticide), "me-
too's" (applications for registrations of pesticide products that are substantially similar or
identical in then: uses, and formulation to currently registered products), and experimental use
permits (which set specific terms under which prospective registrants may test pesticides
outside of the laboratory prior to registration).
Under section 18 of FIFRA, states may apply to EPA for an exemption or declare a
crisis exemption for emergency use of a pesticide not registered for that use. Four types of
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OPP Annual Report
emergency exemptions may be authorized. A specific exemption may be authorized in an
emergency situation to avert significant economic loss, of significant risks to endangered
species, beneficial organisms, or the environment A quarantine exemption may be
authorized1 in an emergency to control the spread of any pest new to or not known to be
widely prevalent within the United States or its territories. An emergency public health
exemption may be authorized to control a pest that will cause a significant risk to human
health. In an emergency where there is not time to allow for EPA authorization of the
applicable specific, quarantine^ or public health exemption, a state may invoke a crisis
exemption. . . . ,
Under section 24(c) .of FIFRA, states may issue registrations for additional uses of
currently registered pesticides to meet special local needs.
/
New Registrations In 1995
1995 was a banner year for OPP with the registration of 40 new pesticide active
ingredients, more than half of which are considered reduced risk pesticides, including
biopesticides. Biopesticides include "microbial pesticides" (bacteria, viruses, or other
microorganisms used to control pests) and "biochemical pesticides," such as pheromdnes
(insect mating attractahts), insect or plant growth regulators, and hormones used as
pesticides. Biopesticides generally pose less risk to human health and the environment than
conventional chemical pesticides. Many of these reduced risk pesticides were submitted under
the voluntary Reduced Risk Pesticides Initiative. The following table describes the pesticide
active ingredients registered for the first time in fiscal year 1995.
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. 1 Registration
PageS
New Pesticide Active Ingredients Registered in FY 1995*
Pesticide Name
AO-159
Bt Corn
Bt Potatoes
Bacillus thurinaiensis
subsp. kurstaki
Beauveria bassiana
- Strain GHA '
Beauveria bassiana
ATCC 74040
Candida oleophila
Celery Looper Virus
Chlorethoxyfbs
Cvdia Domonella ' .
(E)-5-Decenol
(E)-5-Deceoyl Acetate
Diethyl Sulfide
i
Difethialone
1 ,4 Dimethyl-naplhalene
Dioctyl Sodium
Sulfosuccinate
Fenbuconazole
Flumiclorac Pentyl Ester
(Resource) ,
. Halosulfuron
IHymexazol
Isobardac
.Registrant
DuPont
Ciba Seeds and
Mycogen
Monsanto
EcoGen Inc.
Mycotech Corp.
Troy Biosciences
EcoGen Inc.
BIOSYS
DuPont
Louis Falcon
: Consep Inc.
Consep Inc.
Bear Country
Products
LiphaTech, Inc.
D-l-1-4lnc.
Safe and Sure
Products
Rohm and Haas Co.
Valent
Monsanto
Sumitomo Chemical
Lonza, Inc.
Pesticide Type
Insecticide .
Plant-Pesticide
Plant-Pesticide
Microbial insecticide
Microbial Insecticide
Microbial Insecticide
Microbial fungicide.
Microbial insecticide
Insecticide .
Microbial Insecticide
Insect pheromone
Insect pheromone
Deterrent ; »
'Rodenticide
Plant Growth
Regulator
Insecticide
Fungicide
Herbicide
Herbicide -
Fungicide
Antimicrobial .
Use(s)
. >
Pets, livestock
Field corn . '
Potatoes
Potatoes, tomatoes,
eggplants
Various crops, rangeland,
pastures '
Ornamental plants, turf
Citrus and pome fruits
Vegetables
Corn
Fruits
Fruits, nuts -
Fruits, nuts
Bears
Residential use
Potatoes
Pets
Pecans
Corn
Corn, ornamental plants
Seed treatment
Water treatment
Biopesticide or
Other Reduced
Risk Pesticide?
No
Yes (biopesticide)
Yes (biopesticide)
Yes (biopesticide)
Yes (biopesticide)
Yes (biopesticide)
Yes (biopesticide)
Yes (biopesticide)
No
Yes (biopesticide)
Yes (biopesticide)
Yes (biopesticide)
'No
No
Yes
No
No
Yes. ,
No
Yes
No
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OPP Annual Report
Pesticide Name
Mattch Bt K
Maxim
Methyi Anthranilate
Neem Oil
Poly (N.N-dimethyl
diallyl ammonium
chloride)
Potassium Bicarbonate
(baking soda)
Prallethrin
Primisulfuron Methyl
! P, svrinqae ESC 1 0
P. svrinqae ESC 1 1
Pyridaben
Pyriproxyfen ,
Pyrithiobac-sodium
Rimsulfuron
Sodium Bicarbonate
(baking soda)
Sodium Carboxymethyl-
cellulose
Sodium 5-Nitro-
guaiacolate
Tebufenozide
Undecylenic Acid
-
=5S==^=5=
Registrant
==============
Mycogen
Ciba-Geigy
Dolphin Trust
W.R. Grace and Co.
Calgon
Church & Dwight
Co.
Sumitomo
Ciba-Geigy
EcoScience Corp. .
EcoScience Corp.
Nissan Chemical
Mclaughlin Gormley
King Company
OuPont
DuPont
Church & Dwight
Co.
Creative Services
Inc.
Asahi Chemical
Manufacturing
Rohm and Haas Co.
Safe and Sure
Products
3======
==5==
Pesticide Type
=====
Microbial insecticide
Fungicide
Bird Repellent
Fungicide
Antimicrobial
Fungicide
Insecticide
Herbicide
Microbial fungicide
Microbial fungicide
Insecticide
Insecticide
Herbicide
Herbicide
Fungicide
'Insecticide
Plant Growth
Regulator
Insecticide
Insecticide
Use(s)
================
Fruits
Seed treatment
Small fruits, ornamental
plants
Ornamental plants
Water systems
(Retail pesticide products
not yet approved)
Pets, residential uses
Corn
Fruits (post-harvest)
Fruits (post-harvest)
Ornamental plants
Pets
Cotton
Com
(Retail pesticide products
not yet approved)
Ornamental plants
Cotton,
rice, soybeans
Walnuts
Pets
=====^=1
Biopesticide or
Other Reduced
Risk Pesticide?
============
Yes (biopesticide)
Yes
Yes
Yes (biopesticide)
No
Yes
No
No
Yes (biopesticide)
Yes (biopesticide)
No
No
No
No
'Yes
Yes .
Yes
Yes I
No 1
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1 Registration
Page 5
Other 1995 Registration Achievements
Registering new pesticides for the first time is only one of an enormous number of
pesticide registration actions that OPP carries out each year. Decisions made in 1995 are
summarized hi the following table. Both approvals and denials of the requests received by
OPP are included in the number of decisions.
1995 Registration Activities
Registration-Activity
Registrations of, new
pesticides ' ' _
Additional registrations
for previously registered
pesticides
Amendments to existing
registrations
New uses for previously
registered pesticides
Emergency exemptions
("Section 18s")
Experimental Use
Permits (EUPs)
Tolerances ' ,
Temporary Tolerances
Special Local Need
Registrations ("Section,
24(c)s") '
Description of Activity
First approval for use of pesticides not currently
registered in the United States,
Registrations for new products containing
pesticide ingredients already approved for
proposed uses.
Amendments, for example, to reflect revised
labels and changed formulations for. products,
already registered, " . - .
Approvals for uses of a pesticide (such as on
particular food crops) for which it has never been
registered.. - , ; :
Decisions on granting emergency exemptions to
states or other federal agencies to allow use for a
limited period, of pesticides not registered for
those particular uses.
Decisions on permits that allow pesticide
producers to test new pesticide uses outside of
the laboratory; generally required if more than 10 '
acres are involved in the proposed study.
Decisions on approving tolerances, or maximum
allowable levels of pesticide residues in food or
animal feed. Tolerances (or exemptions from
tolerances) are required whenever a pesticide is
registered for use on a food or feed crop.
.Decisions on tolerances for experimental purposes
for an unregistered pesticide. ; -
Registrations of pesticide products by state
agencies for, specific uses not federally registered.
(The pesticides must be federally registered for
other uses.)
Number of
Decisions
40
832
f* . ' '
3,614
124
400 ,
100
122
34 ,
475
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Reinvention/Risk Reduction Activities
OPP Annual Report
Over the past several years, OPP has undertaken a major effort to overhaul its
registration program, which in 1995 began to pay substantial dividends. The reinvention
effort aims to accelerate the pace of decision-making and redirect staff activities to those
most important in protecting health and me environment. This section describes the highlights
of these1 initiatives.
A]?reement with California to Harmonize Pesticide Regulation
OPP and the Department of Pesticide Regulation (DPR) of the California
Environmental Protection Agency began an initiative in 1994 to harmonize and simplify
pesticide registration, and to exchange work products to reduce duplication of effort and
expense. The -first major milestone of this initiative was the signing of a Memorandum of
Understanding (MOU) in May 1994. During, 1995, significant progress was made in
achieving the objectives of the MOU. For example, OPP and DPR began sharing the
workload of reviewing acute toxicology studies, thereby reducing review cost and time. This
should help OPP continue to reduce its current backlog of pending acute toxicity
submissions. OPP also identified products intended for registration under FEFRA as well as
in California. Other ongoing cooperative activities include harmonization of risk assessment
. methods, international standards, and registration of new active ingredients.
' '
Voluntary Reduced Risk Pesticide Initiative
Since the inception of this initiative hi. 1993, OPP has received 20 reduced risk
pesticide applications. OPP has accepted nine candidates (registering six so far), denied seven
candidates, and is considering four. OPP is committed to expedited review of reduced risk
applications and to making a registration decision within one year after a candidate has been
granted reduced risk status. OPP issued a draft Pesticide Regulation (PR) Notice expanding
the initiative to include new uses of pesticides that have been granted reduced risk status, and
expects to finalize the notice by December 1995.
Faster Approval of Minor Registration Changes
In May 1995, OPP took a major step in reducing its workload in reviewing minor
registration changes by issuing PR Notice 95-2. The notice significantly expands the
categories of minor changes, such as changes to labeling and packaging, that registrants can
make without waiting for OPP approval. Under this program, OPP expects that as many as
500 amendments each year, or 10% of the total, will be made by notifying OPP rather than
requesting approval. For certain cases of minor changes not expected to change the potential
risks of the products, registrants are not even required to notify OPP of the changes. In
addition, the notice creates an accelerated process for reviewing minor formulation changes
ii, ~5 days instead of 90 days. Besides reducing OPP's workload, this action will allow
re .ustrants to make changes much more quickly:
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1 Registration '_ " , .
Exemption of Effluent Discharge Statements for Small Container Products
Page?
On May 1, 1995, OPP issued PR Notice 95-1 exempting small containers (less than
five gallons liquid or 50 pounds dry weight) from previously-required effluent discharge
labeling. This reduces the burden on small container products with labels that lack space for
these statements. Effluent discharge statements continue to be required for larger containers
used in the industrial/commercial sector.
Encouraging Water Soluble Packaging (WSP)
Water soluble packaging allows a pesticide product to be transferred from its original
container to the tank from which it will be applied with a minimal risk of spills or splashes.
It also eliminates the need for rinsing the original container. Because of these benefits to
pesticide handlers and the environment, OPP began to implement a streamlined process for
registering WSP products in 1995. Registrants who wish to market a registered product in
water soluble packaging can do so using the same registration number and by notifying OPP
rather than waiting for OPP approval.
Other Reinvention Initiatives in Progress
Other efforts to improve the registration process in 1995 included:
> Exploring the possibility of allowing registrants to self-certify the results of product-
specific .acute toxicity tests ramer man requiring OPP review. \
'. + Working to finalize a rule proposed in 1994 under section 25(b) of FIFRA that would
exempt a number of pesticides from regulation because they do not pose risks
warranting regulation. . . '
> Developing guidance to standardize and simplify procedures for certain registration
applications. .
'*'-, '""-'.. ' . '
> Preparing a proposal to streamline the registration of different sizes of rodent control
pesticide products.,
>, Developing a proposal to allow self-certification by registrants of certain "me-too"
products.
Implementing Acetochlor Registration Conditions
: In registering the pesticide acetochlor in 1994, OPP embarked on a new approach by
setting strong standards to protect ground arid surface water. The approach establishes clear
criteria that trigger voluntary suspension or cancellation of the registration if water quality is
.adversely affected. In particular, the Acetochlor Registration Partnership (ARP) is required to
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OPP Annual Report
conduct extensive monitoring programs to ensure that use of this herbicide will not adversely
affect ground or surface water.
During the past year, OPP worked with the partnership and State Lead Pesticide .
Agencies to implement-the registration agreement. The ARP established 175 monitoring
wells, 25 in each of the seven major use states (Illinois, Indiana, Iowa, Kansas, Minnesota,
Nebraska, and Wisconsin). The ARP also established 175 surface water monitoring sites at
drinking water supply facilities in 12 states, and began biweekly monitoring in March.
Detections of acetochlor in ground water were reported in eight wells, which the ARP is
investigating. Acetochlor was found in approximately 20% of the surface-water samples
collected, generally well below the 2 ppb annual trigger. Also, the ARP began work on a
second monitoring program, initiating two of eight prospective ground-water studies hi
Wisconsin and in Ohio. Four additional studies will begin hi 1996, and the last two in 1997.
The Agreement between the ARP and OPP has already produced results. In the first
year of use, the ARP has restricted the use of acetochlor on sandy soils to reduce the risk of
ground-water contamination. OPP has validated the ARP's multi-residue method for detecting
acetochlor and is reviewing the ARP's acetochlor-specific detection method. Finally, an ARP
evaluation found that commercially available, low-cost methods may be useful hi screening
for the presence of acetochlor and similar compounds in water.
Recently, OPP made available to the public a map indicating areas throughout the
country where acetochlor has been sold between March 1994 and January 1995. This county
level usage information will be made available to the public annually by QPP and can be
used to target monitoring by states and others.
- Ensuring The Effectiveness Of Antimicrobial Pesticides
Antimicrobial products are used to control "germs" such as bacteria and fungi (molds
and mildews) that can cause odors, food spoilage, or infections. They are used in homes,
hospitals, cafeterias, restaurants, and many other institutions. Over the past several years,
OPP has implemented a comprehensive strategy to ensure the efficacy of antimicrobial
pesticides, placing highest priority on those mat have significant public health uses. During
1995, OPP accomplished many of its research goals under a comprehensive Antimicrobial
Program Strategy. Highlights include: - .
Test Methodology Research Cooperative Agreements
Substantial progress was made in each of the five research cooperatives. Three
cooperatives finalized most of the research to improve the existing test methods used to
determine antimicrobial product efficacy. New sporicidal, virucidal and tuberculocidal test
methods have been developed arid are -in the process of being validated through collaborative
Studies. Another agreement focused on bacterial cell injury and proposed a protocol for
determining the level of injury sustained during typical efficacy test conditions.
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1 Registration
Antimicrobial Complaint System Cooperative Agreement
Page 9
Through the National Pesticide Telecommunications Network (NPTN), the
Antimicrobial Complaint System (ACS) handles phone inquiries and complaints regarding
EPA-registered antimicrobials. The ACS responded to over a thousand calls in 1995. ,
Antimicrobial Product Testing Program -
In 1995, the Antimicrobial Product Testing Program was converted from a contract to
an OPP-managed program. Product efficacy testing of! tuberculocides and hospital
disinfectants is now being conducted at OPP's new Microbiology Laboratory in Cincinnati.
The laboratory will continue to evaluate selected hospital disinfectant and tuberculocidal
product claims in support of OPP's Testing Program to ensure the efficacy of antimicrobial
pesticides. The laboratory will also assjst-in enforcement actions where efficacy claims
cannot be confirmed. ,
Efforts To Improve Pesticide Labels
."* ~ v J ' '
Labeling is one of OPP's most important tools for achieving its mission of protecting
human health and the environment. No other pesticide document or publication has a more
direct impact on risk reduction or the potential to prevent pollution. Over time, however,
some labels have become cluttered and confusing. OPP has taken several steps to address
labeling concerns and has accomplished the following: , :
Computer Software to Standardize Precautionary Labeling.
Precautionary statements are those portions of a pesticide label that summarize a product's
hazards, provide first aid instructions, and list storage and disposal instructions. In 1995,
OPP began developing a computer program which displays the correct precautionary labeling
statements for a product based on acute toxicity studies. This systern could be used by both
OPP. and registrants to assure accurate and appropriate precautionary 'labeling. This could
help reduce review time and rejection of applications with incorrect labeling. OPP expects to
distribute the software in early 1996. . , -
Label Review Manual. In December 1994, OPP completed and made available its
first comprehensive Label Review Manual, a document to be used by OPP staff in reviewing
and determining the acceptability of pesticide labeling. The manual is available to the public.
Label Policy Directory. In October 1994, OPP launched an electronic "on-line"
Labeling Policy Directory that allows OPP staff to quickly search and access labeling policy
information via computer. Portions of the directory will soon be made available to the.
public. .
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Page 10
OPP Annual Report
Labeling Coordination. OPP issued a draft PR Notice establishing an annual
compliance date for implementing most EPA-mandated labeling changes, and describing
current approaches to coordinating labeling issues and related streamlining efforts. After
review of public comments, OPP plans to issue a final notice in 1996.
Total Release Fogger Labels. OPP continued to work to improve the labels of total
release foggers, sometimes called "bug bombs." The aerosol propellants found hi these
indoor fumigants can cause fires or explosions if the products are not used properly. OPP
expects to issue finallabeling requirements in 1996. .
Pesticide Chemistry Laboratory Support For Registration
OPP's pesticide registration program is supported by two pesticide chemistry labs: the
Analytical Chemistry Laboratory (ACL) in Beltsville, Maryland, and the Environmental
Chemistry Laboratory.(ECL) in Bay St. Louis, Mississippi. The labs support registration
through the food tolerance and environmental chemistry methods validation programs, which
ensure that pesticide residues can be accurately measured hi food and the environment.
The ACL has the lead responsibility for the food tolerance methods validation
program In fiscal year 95, ACL validated a record 65 food tolerance methods out of a total
of 102 submitted or carried-over from 1994 (see figure on next page). In addition, the ACL
developed a new method for detecting residues of multiple sulfonylurea pesticides in water
using capillary zone electrophoresis. Scientists are enthusiastic about the method and
additional work is underway at both EPA and industry labs to determine the suitability of the
method for monitoring pesticide residues. '
The ECL has lead responsibility for the environmental chemistry methods validation
program The demand for environmental chemistry methods testing increased dramatically in
1995 '(see second figure on next page). The primary emphasis of this program is to evaluate
those methods associated with studies .for environmental fate, exposure, and ecological
effects The ECL completed 35 validations in 1995, including three expedited methods for
acetochlor. ECL continued to evaluate new, low-cost technology for detecting pesticide
residues' using immunoassay tests, completing review of eight tests hi 1995.
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; 1 Registration .: '' , '
100
11
Tolerance Method Validations
FY91 FV92 FY93 FY94
RscalYear
FY95
FY96
Carryover || New
Completed.
100
Environmental Chemistry Method Evaluations
FYS1
PfSS.
FY93
Rscal Year
FY94
FY95
Carryover f>| New 0 .Total Q Completed
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* Chapter 2: Reregistration
Pesticide reregistration is one of OPP's most vital programs. OPP is required by 1988
amendments to federal pesticide law to review and, as warranted, reregister all existing
pesticide products that contain active ingredients initially registered before November 1,
1984. The goal is to update labeling and use requirements and reduce potential risks
associated with older pesticide active ingredients those first registered when the standards
for government approval were less stringent than they arejtoday. This comprehensive
reeyaluation of pesticide safety in light of current standards is critical to protecting human
health and the environment. '
This chapter discusses OPP's progress in reregistering pesticides, as well as some
related initiatives. These include efforts to develop additional information on pesticide
exposure to people who enter treated lawn and turf areas and to reduce the risks posed by
pesticide spray drift,
Steps In Reregistering Pesticides
Through the pesticide reregistration program, now in its final phase, OPP is
reviewing studies submitted to support each reregistration case (or group of related pesticide
active ingredients). After examining the health and environmental effects, OPP employs
measures to mitigate risks most effectively. This evaluation and risk mitigation process is
complete when OPP is satisfied that the pesticide, used in accordance with approved labeling,
will not pose unreasonable risks to human health or the environment. , ,
OPP's regulatory conclusions about each case are presented in a Reregistration
Eligibility Decision document, .or RED. Later, once product-specific data and revised
libeling are submitted and approved, OPP reregisters products containing the eligible
pesticide(s).1 A product is not reregistered, however, until all of its active ingredients are
eligible, for reregistration.
1995 Reregistration Progress
OPP is making significant progress in reregistering pesticides. During fiscal year
1995, OPP completed 40 Reregistration Eligibility .Decisions, or REDs, a record hi terms of
both the number and magnitude of the decisions. Working with the Special Review program
(described in chapter 3), the reregistration program is employing a variety of measures to
reduce the most serious pesticide risks. These include use phaseouts, voluntary cancellations,
restricted use classifications, ground-water label advisories, and strengthened requirements to,
better protect pesticide handlers and other workers. New label guidance for aerial
applications, requirements for vegetative buffer strips bordering areas treated with pesticides,
and reduced application rates are reducing risks to wildlife.
For example, the Picloram RED Team worked with state representatives and the ,
registrant to reduce use rates in order to decrease risks to npntarget plants. The Ethaliluralin
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2 'Reregistration
Page 13
RED Team strengthened personal protective, equipment and restricted entry intervals to
reducerisks of cancer and developmental effects to workers, and required buffer strips to
mitigate threats to aquatic wildlife.
With this year's accomplishments, OPP has completed a total of 121 REDs covering
30 percent of the cases to be reregistered, including glyphosate, metolachlor, picloram, and
-.other major pesticides. About 1,000 tolerances (maximum legally permissible levels of
pesticide residues in foods) have been reassessed, and many are being revised to better ,
ensure food safety. About 750 products have completed the process and have, been
reregistered. r . '
Looking to thefuture, more pesticides with food uses and other significant human
exposures are scheduled for reregistratibn eligibility decisions during fiscal year 1996,. For
the first time, OPP expects that the number of candidates ready for decisions in FY 1996 will
exceed the resources available to complete those decisions.
Some of the principal accomplishments of the reregistration program during fiscal
year 1995 and cumulatively are summarized below.. .
"'.'" i " . f '*.-'
Annual and Cumulative Completion of REDs ,
~ ," i \ -. , ' ,'..<
The number of REDs completed per fiscal year has been increasing steadily since the
.accelerated reregistration program began. This number reached 40 in fiscal year 1995 for a
cumulative total of 121 completed REDs. A target of 40 more REDs has been set for 1996.
Number of REDs Completed
200
FY91 FY 92.. '-'FY 93 FY94 FY95FY96G6al
Per Fiscal Year n Cumulative
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Page 14
OPP Annual Report
Status of Rerefristration Cases
OPP has completed a total of 121 REDs, representing nearly one third of the 382
chemical cases currently supported for reregistratipn. Meanwhile, 230 of the original.612
cases are unsupported (meaning that the registrants have decided riot to complete and submit
the studies required for reregistration). Cases that remain unsupported have been or will be
cancelled. OPP therefore has 261 more REDs to complete, less than half of the original cases
from 1988.
Status of Reregistration Cases
261 More to go
121 REDs
completed
230 Unsupported
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.2 Reregistration
Page 15
Anatomy of the 121 REDs Completed '
,..Or, What
Completed" Means...
The 121 REDs completed coyer 170 pesticide active ingredients, 4,633 products, and
957 tolerances. They represent about 30% of all supported reregistration cases (a case
consists of one or more related pesticide active ingredients); 30% of all food use pesticides
(supported List A cases); and 17% of original List A tolerances reassessed.
As described in the table below, the completed REDs represent about two-thirds of
the total quantity of pesticides used (by volume) in the United States. They include over two-
thirds of all homeowner-applied pesticides, about one third of all pesticides used in
agriculture, and two-thirds of all pesticides used commercially, by industry and government.
Amount of Pesticide Usage (by Volume)
: Covered By REDs Completed*
Fungicides
Homeowner
Applied
50% to 55%
Agriculture
60% to 65%
Commercial/
Industrial and
Government
4% to 7%
TOTAL
40 to 48%
Herbicides
20% to 25%
30% to 35%
16% to 30%
28 to 32%
Insecticides
10% to 15%
1%to2%
3% to 5%
8 to 10%
Antimicrobials
99% +
99% +
99%
99%
TOTAL
68%
32%
65%
65%
* Please note that the REDs completed for two antimicrobial cases bleach
(sodium and calcium hypochlorite) and chlorine account for a large
proportion of the usage of antimicrobials and the overall usage of pesticides
covered by the REDs completed so far. Note, too, that the pounds used may
not indicate the relative percent of market share or number of applications.
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Page 16
OPP Annual Report
REDS Co'mpleted in 1995
The following table summarizes the 40 REDs completed in FY 1995:
i r
Pesticide Case
Aarobacterium radiobacter
Aliphatic Alcohols (ethanol
and isopropanol)
Alkyl Imidazolines
Amitraz
Ancymidol
Asulam
Banzocaina
O-Benzyl-Chlorophenol
Bis(trichtoromethyl)sulfone
Bromohydroxyacetophenone
(BHAP)
Bronopol
Chlorhexidine Diacetate
Chtorpropham
4-Chlorophenoxyacetic Acid
(4-CPA)
Cyanazine
Cytokinin
DCPA * '
Dimethoxane
' T
Pesticide Type
=====
Fungicide
Insecticide
Antimicrobial
Fungicide
Insecticide
Plant Growth Regulator
Antimicrobial
Insecticide
Plant Growth Regulator.
Herbicide
No longer considered a
Antimicrobial
Antimicrobial
Antimicrobial
Antimicrobial
Antimicrobial
Herbicide
Plant Growth Regulator
Plant Growth Regulator
Herbicide
Plant Growth Regulator
Herbicide
Antimicrobial
Use(s)
Fruit, nut, and ornamental trees (nursery
stock)
Indoors (including homes),
agriculture
Fuel oil
Cotton, pears, livestock, dogs ,
Ornamental plants
Sugarcane, ornamental plants, turf,
other non-cropland uses
Medicine (regulated by Food and Drug
Administration, not EPA)
Various indoor uses, including
agricultural, food, and medical facilities
Water systems, industrial uses, chemical
products '
Paints, adhesiyes, and other chemicals
Water systems, industrial uses, chemical
products
Livestock facilities
Potatoes, spinach, ornamental plants
Food industry (bean sprouts)
Com, cotton, sorghum
Various crops, ornamental plants, .
forestry
Various crops, ornamental plants, lawns
Industrial uses, chemical products ,
Eligible for ||
Reregistration?
=====
All uses
All uses
All uses
All uses
All uses
Some uses
(Not applicable)
All uses
Some uses; one use
awaiting additional
information ||
All uses II
All uses 1
All uses I
Some uses; others 1
awaiting additional 1
information 1
All uses 1
No: uses are being 1
phased out |
.Some uses; others
awaiting additional
information |
All uses |
All uses ' 1
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2 Reregistration ,
Page 17
Pesticide Case
; Diquat Dibromide
Dowicil 100 -
Ethalfluralin
Ethephori
Fenitrothion*.
Fpsamine Ammonium
Linuron . ' __"/.
Methyl Nonyl Ketone ,
Metolachlor '
Nabam
Nuranone
Picloram,
Polybutene
Prometryn ,
Propamocarb
. . ,'
Sodium . Fluoroacetate ( 1 080)
Sodium Omadine
Starlicide
Terbuthylazine
Tetrachlorvinphos
Trichlorfon
Trifluralin .
Pesticide Type
Herbicide
Antimicrobial
Herbicide
Plant Growth Regulator
Insecticide
Herbicide
Herbicide
Animal and Insect
Repellent ,
Herbicide '
Antimicrobial
Insect (Japanese
beetle) Pheromone
Herbicide
Bird and Squirrel
Repellent
Herbicide
Fungicide
Predator (coyote)
Poison
Antimicrobial
Bird Poison
Algicide
. Antimicrobial
Insecticide '
Insecticide
Herbicide
Use(s)
Potatoes, seed crops, non-crop areas
Industrial uses, paint, textiles
.Various of vegetable and grain crops
Cotton, various other crops, ornamental
plants
Ornamental plants, greenhouses, indoors
(including homes)
Rights-of-way, industrial sites,
fencerows-
Soybeans, other crops, ornamental
plants
Residences, ornamental plants
Various crops, lawns, ornamental plants,
rights-of-way, forestry
Water systems, other industrial uses
Agricultural and ornamental plants
Rights-of-way, forestry, rangelands,
pastures, small grain crops
Roosting sites, other indoor and outdoor
locations
Celery, cotton, dill .
Ornamental plants, lawns, turf,. golf
courses .
Sheep, goats ...
Industrial uses, chemical products
Bird feeding and roosting areas
Water systems, fountains, aquaria
Livestock, pets, various other sites
Various crops, other indoor and outdoor
sites
Various crops, ornamental plants
Eligible for
Reregistration?
All uses ;
All uses
Some uses; others
awaiting additional
information
Air uses
Some uses
Some uses.
Some uses
All uses
Some uses
All uses '
All uses
All uses
AH uses
All uses
Some uses
All uses
All uses . ,
'All uses
All uses ' ' \ ;
Some uses
Some uses
Some uses
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Page 18
OPP Annual Report
Risk Reductions Achieved Through FY 1995 REDs
The 1995 REDs include many changes intended to reduce risks to people and the .
environment. Some of the risk reduction measures achieved in the 40 REDs completed this
fiscal year are summarized in the following table:
Number of REDs
2
14
5
27
21
19 -
40
»
25
10
18
12
.Risk Reduction Measures Required By RED
Voluntary cancellation I of all or many uses. (Cyanazine voluntary
cancellation of all production for domestic use effective 12/31/99; use
of existing stocks will be phased out in stages, and entirely by 1/1/03.
Fenitrothion voluntary cancellation qf all uses except ant & roach bait .
treatments.) ' ,
Some uses deleted or not currently eligible for reregistration.
Restricted Use Pesticide classification added or maintained, so that the
pesticide may be used only by 'or under the direct supervision of a
certified applicator.
Personal Protective Equipment (PPE) requirements for pesticide
applicators strengthened or confirmed.
Restrictions that limit entry of workers into treated areas (including
Restricted Entry .Intervals/REIs) strengthened or confirmed.
Amount, frequency, or rate of application is reduced, limited, or
specified.
Use Directions on labeling strengthened or made more specific,, or
Application Restrictions imposed. .
User .safety measures required.
Label Advisory or other measures to protect ground or surface water
required. . .
Environmental Hazard statements to reduce ecological risks
strengthened.
Tolerances revised (reduced, revoked, or newly approved).
Tolerances Reassessed .
As part of reregistration, OPP is reassessing pesticide tolerances, or maximum residue
limits in food and feed. A pesticide must have a tolerance (or be granted an exemption from
the tolerance requirement) for each different type of food or-animal feed on which it may be
used. The number of tolerances for the List A pesticides (which represent the most
significant food use pesticides) was about 5,600 hi November 1988, when the accelerated
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ReTegistralion
Page 19
reregistration program began. Since then, almost 1,000 (or 18 %) of the List A pesticide
tolerances have been reassessed as part of me reregistration process.
Several hundred more tolerances are associated with List A active ingredients no
longer supported for reregistration. These active ingredients ultimately will be cancelled and ,
their tolerances revoked. Meanwhile, OPP is actively revoking tolerances as warranted by the
tolerance reassessment decisions reflected hi the REDs.
: Status Of Studies Received
' '' ' ;..'''. - t . . ' '*.''.
Registrants have responded to Data Call-Ins and other requirenients by submitting .
over 20,000 studies in support of reregistration. Reviews of these studies provide the basis
for OPP's reregistration decisions. By end of fiscal year 1995, OPP. had reviewed almost.
13,000 of these studies, including over 7,000 of the 9,500 studies received for List A
pesticides. Thie cumulative numbers of studies received, reviewed, and awaiting review by
scientific discipline are shown in the foUowing figures for the List A pesticides and.for all
pesticides undergoing reregistration. ;-'
Review Status of List A Pesticides
4,000
Received
Reviewed Q
Await. RevieU]
Residue Chemist^
2,962
2,309
653
Envfronmental Fa^
2,242
1,440
802
Ro-entry - Non-Die
214
59
155
Tox Non-COhl
1,580 ,
1,278
302
Tox CORT
766
684 ,
82
Ecological Effects
1,822
1,483 ,
339
All Disciplines
9,586
7,253
2,333
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Page 20
OPP Annual Report
0)
14,000
12,000
8 10,000 -
. = 8,000
10 6,000
o-
4,000
2,000
0
Review Status of Pesticides
* * ' \- '. ~ '
Lists A-D
Received
Reviewed [^
Await Revigi
4,760
3.102
1,658 -
3.916
: 2,194
1.722
283
67
216
5,292
3.061
2.231
1,913.
1,238
675
4,529
. 3,249
1,280
20,693
12,911
7,782
Product Reregistration .:
While REDs are OPP's major reregistration output,- much of the real world impact of,
eligibility decisions and risk reduction measures occurs after the RED is issued,-once
products are reregistered. As of October 1995, about 2,200 products have completed this
concluding phase. OPP has reregistered about 750 of these products, granted 1,175 voluntary
cancellations, amended 20 existing registrations, and suspended 300. An additional 600
products have just entered this phase, and decisions are pending on another 1,750. Activity in
this important area is increasing rapidly and will accelerate during the next several years.
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\ I
2 Reregistration
Page 21
Product Reregistration Status
300 Suspended
20 Amend
2,392 Pending
1,175 Cancelled
747 Reregistered
Process Improvement ' . - . . .
. Some innovations that have helped improve OPP's reregistration and Special Review
processes and products during FY 1995 include the following:
SRRD Peer Review Committee The Special Review and Reregistration Division
(SRRD) Peer Review Committee, comprised of both staff and managers, is reviewing draft
RED documents and Special Review Position Documents (PDs) to ensure clarity and
consistency in addressing risk and regulatory issues. . , -,-
Policy Capture Workgroup This workgroup is developing a means of capturing
electronically the issues addressed, policies established, and risk mitigation measures required
by key .regulatory decisions, primarily REDs and Special Review Position Documents.
RED Process Improvement Committee This committee developed "A 'How to'
Guide for REDs" providing guidance on RED schedules, team responsibilities, and meetings.
RED Document Improvement Workgroup This workgroup is considering new, more
comprehensible ways to present and disseminate the large body of information currently
contained in a complete RED document package.
Pesticide Use and Usage Data Outputs OPP is improving the compilation of
pesticide use and usage information by consolidating information into a single^ database.
While still in the developmental stage, it has already provided efficiencies by allowing quick
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Page 22
.OPP Annual Report
access to a preliminary overview of pesticide use parameters. In a related effort, OPP is
piloting a-new matrix format to provide key pesticide usage parameters to be used in the
development of REDs. These efforts will continue to be refined.
Assessing Exposure to Turf Pesticides
OPP began a cooperative effort in 1995 with 35 pesticide manufacturers (the Outdoor
Residential Exposure Task Force), California EPA, and Health Canada to obtain information
on exposure to applicators and residents from pesticides used on home lawns. In March, OPP
issued a Data Call-In for data which will be used to evaluate exposure to pesticides
undergoing reregistration, as well as new pesticides being registered for the first tune. The
goal of the effort is to develop generic exposure data for different types of pesticide . .
formulations so that exposure to lawn-care pesticides can be predicted without requiring data
on specific compounds. This effort will save industry and OPP time and resources. Since the
project is a joint effort with California and Canada, the findings from the required studies
will be used to support pesticide registrations by their respective regulatory agencies as well.
OPP expects the task force to begin submitting its initial findings in 1997 and to complete the
effort in 1999.
Pesticide Chemistry Laboratory Support For Reregistration
In addition to supporting the pesticide registration program, as described in chapter 1,
OPP's pesticide chemistry labs provide reregistration support. The labs work to confirm that
the methods described by registrants for detecting pesticide residues'in food and in the
environment are effective. The Analytical Chemistry Laboratory (ACL) received 23 requests
to validate food tolerance methods for reregistration in 1995, a marked increase from the
seven requested in 1994, and validated nine methods. The Environmental Chemistry
Laboratory (ECL) completed 20 analytical method validations for pesticides in soil and water
under the reregistration program in 1995. . ,
Reducing Pesticide Spray Drift
Aerial or ground application of pesticides may lead to off-target drift and result in
exposure to workers, nearby residents, nontarget plants, and other ecological resources.
During 1995 OPP continued its work with the Spray Drift Task Force (SDTF), an industry
consortium conducting research into the factors which contribute to and can control spray
drift. During 1995* the task force submitted its research Jesuits to OPP. OPP began a
comprehensive scientific review of the data in 1995 and the review will continue during
1996. . ,
In 1995, OPP continued its work with EPA's Office of Research and Development to
develop computer models which will estimate the potential for off-target pesticide drift and
. suggest methods for reducing drift. Also, in conjunction with the SDTF and following input
from some state and pesticide applicator groups, OPP developed a set of Best .Management
Practices (BMPs) for aerial pesticide application. During 1995, the BMPs were added to
REDs, new chemical registrations, and other OPP actions involving aerial pesticide
applications. ' .
-------
Chapter 3: Special Review
.,..'.."'- . - . i , : - ' " "
Special Review is EPA's formal process for determining whether the use of a
pesticide poses unreasonable risks to people or the environment. In making this
determination, EPA must consider the pesticide's risks and benefits. Special Review is
designed to allow formal public input to the decision-making process. A Special Review can
result in a decision to cancel, restrict, or continue the pesticide uses in question.
The Special Review process is set in motion when EPA .has reason to believe that the
use of a registered pesticide poses significant risks to people or the environment. Over 100
pesticides or groups of closely related pesticides have been evaluated through Special
Review. While reregistration applies to all older pesticides, Special Reviews apply to those
pesticides of particularly serious concern.
1995 Formal Special Reviews And Follow-up Activities
Triazines and
sine Phaseout
OPP initiated a Special Review for these related herbicides hi November 1994. Up to
121 million pounds of atrazine, cyanazine, and simazine are used yearly on food crops
including corn, and on cotton and turf. Atrazine currently is one of the two most widely used
agricultural pesticides in the U.S. (based on pounds of active ingredient applied per year) and
cyanazine ranks among the top five agricultural pesticides. In initiating the Special Review,
the Agency determined that the triazines may pose significant risks of cancer due to exposure
to residues in food and drinking water and through exposure when mixing, loading, and
applying these pesticides. Growers, professional agricultural and lawn care applicators, and
some homeowners appear to be at risk from using one or more of these products. OPP is
also concerned about the risks to the environment from the large amount of triazines used.
Because each of the three pesticides appear to have similar potential to cause adverse
effects, and because they can be used to some degree interchangeably, OPP decided to
address their risks simultaneously. The announcement of the Special Review prompted over
87,000 public comments, all of which have been screened/The substantive comments are
now being evaluated. The Agency's risk and benefit analyses, .including responses to the
comments, should be publishedrby the end of 1996.
In August 1995, the primary registrant, DuPont, agreed to completely phase out
production of cyanazine for domestic use and to voluntarily cancel its registration effective
December 31, 1999. (The other fdrmulator of cyanazine is now compelled to follow suit).
Use of remaining stocks will be allowed through 2002, but maximum use rates will drop
incrementally in 1997, 1998, and 1999. OPP believes that a significant reduction in potential
risks from exposure to cyanazine will result from these reductions in cyanazine production
and use. Additionally, beginning in 1998, all applications must be made from within a closed
cab (meaning that the driver of the vehicle applying the pesticide is enclosed in a cab
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Page 24
OPP Annual Report
designed-to significantly reduce the exposure to pesticides being applied). The Agency
expects to terminate the Special Review of cyanazine in 1996.
v > , "''', '- '
. Lindane
In March 1994; the Agency proposed not to initiate a Special Review of lindane. The
proposal was prompted by a review of studies in which laboratory animals were exposed to
this organochlorine insecticide. Initially, OPP was concerned about risks to humans based on
an effect on kidney function in male rats; the kidney effect is a serious and uncommon one
that is usually associated with exposure to petroleum products. Further research showed that
the lindane effect was particular to male rats, not female rats or any other species tested, and
.unlikely to occur in humans. OPP formally closed the Special Review for kidney effects hi
July 1995. Comments on the 1994 proposal, however, identified lindane as a potential
disrupter of the endocrine system, so the Agency is now developing a strategy for evaluating
that e.ffect in lindane and three other organochlorine pesticides that are candidates for
reregistration.
s '
Propoxur ;
In January, the Agency proposed not to initiate a Special Review of propoxur, an
insecticide once suspected of posing 'an unreasonable cancer risk to residents and pest control
professionals. Propoxur is u£ed to control indoor pests such as ants and cockroaches and also
to control fleas on pets. In its proposal, OPP reported that the cancer risk has diminished
since the Special Review was first suggested in 1988 because the registrants voluntarily
dropped the uses" which caused the greatest concern^ OPP also reported that a revaluation of
exposure data and the cancer potency of propoxur indicated that the remaining uses are likely
to present only negligible risks. OPP expects to complete its review of comments and issue a
final decision in FY 1996. ^ '_:'..
, , . - > i . .
Carbofuran , . "
The uses of granular carbofuran on corn, sorghum, and rice were marked for
phaseout by 1994 because of risks to wildlife, which were substantiated by large and
widespread bird kills in and around treated fields. Birds of prey (such as eagles), waterfowl,
game birds, and songbirds were all affected. The registrant appealed the decision, and in
March 1995, the Agency rejected the reinstatement of uses on corn and sorghum while
extending the use on rice for two years. The rice decision, was based on a continued lack of
alternatives to control the rice water weevil, a serious rice pest, and on the vigorous
identify and avoid times and sites where carbofuran application poses the greatest risk to
threat-sired species, such as the bald eagle and the giant garter snake. The rice growers
orgac.nation also supported a user education program and the development of publications for
the program! The Agency is currently negotiating with the registrants of liquid carbofuran
formulatio'ns to mitigate wildlife risks. .
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3 Special Review -
Dichlorvos
Page 25
OPP issued a proposal to minimize the cancer and neurological risks of the insecticide
dichlorvos (DDVP) in September 1995. Dichlorvos is used to control pests in the home, on
livestock and manure, and in warehouses. The Agency is proposing to cancel some uses of.
dichlorvos, including all residential uses and use on stored food. Additional uses could be
cancelled unless certain changes, such as restrictions on reentry into treated areas and
prohibition of use except by licensed applicators wearing protective clothing, -are incorporated
into product labels. Public comment on the proposal will be accepted for 90 days.
Limited Reproduction Of Aldicarb Use On Potatoes ,
When excessive residues of aldicarb appeared on potatoes in 1990, the Agency halted
its sale and use in potato production. In September 1995, the Agency reapproved this use for
fanners using positive displacement equipment a new technology designed to control
application rates more precisely and prevent spills and leaks. Use on potatoes is permitted
only in Oregon, Idaho, Washington, Montana, northern Florida, and parts of Utah and
Nevada, where the risk of ground-water contamination is believed to be low. Several other
measures to reduce risks have also been imposed: furrow irrigation is .prohibited; use after
planting is prohibited; and the minimum interval between aldicarb application and pptato
harvest has been extended from 90 days to 100 days in Florida and 150 days elsewhere.
Additionally, anyone wishing to apply aldicarb must receive special training hi product
stewardship. The reinstatement of use on potatoes is supported by data from the registrant
showing that residue levels under the new application technology are within safe limijs.
Federal agencies will continue to monitor potatoes for aldicarb residues. The Special Review
of aldicarb on the issue of ground-water contamination is still proceeding.
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Chapter 4: Field Implementation and Communication
The first three chapters of this report have focused largely on OPP's work to ensure
that individual pesticides are appropriately licensed, .that decisions are made in a timely
manner, and that the conditions of registration reflect up-to-date scientific standards. This
chapter'turns to the important area of field implementation and communication: OPP's work
with pesticide users and others to ensure safe pesticide use practices are implemented in the
field and to provide organizations and individual citizens with the information they need to
make environmentally sound pesticide decisions: These efforts complement die pesticide
regulatory programs described hi the first three chapters and are critical to achieving our
nation's health and environmental protection goals.
A. Field Programs
OPP managed four major field programs in FY 1995. These programs are aimed at
protecting agricultural workers, endangered species and ground water from pesticide risks,
and ensuring that applicators of potentially more hazardous pesticides are appropriately
trained and certified in their use^ In all of these programs, OPP relies heavily on cooperative
relationships with regional offices, state and tribal pesticide regulatory agencies, other public
and private organizations, and individuals. Only through the combined efforts of all of these
groups can EPA's field programs be- successfully implemented.
Implementing The Worker Protection Standard
OPP's Worker Protection Standard (WPS) for agricultural pesticides became fully
effective on January 1, 1995. The Standard represents a major strengthening of national
efforts to safeguard agricultural Workers. It requires agricultural employers to ensure that
employees receive basic training in pesticide safety and to notify workers when pesticides are
applied. Employers also must provide washing facilities and supplies if workers are likely to
. come into contact with pesticides, and provide and maintain protective equipment to reduce
potential health risks due to pesticide exposure in agriculture. OPP believes that effective
implementation of the WPS will substantially reduce the risk of pesticide poisonings _among
agricultural workers and pesticide handlers. . ,
In 1995, OPP carried out a numb'er of WPS activities in collaboration with EPA's ten
regional offices. In addition, OPP continued to refine requirements to .maximize effective
protection for workers in a wide variety of agricultural settings, while ensuring appropriate
flexibility in implementation. Highlights of OPP's 1995 efforts include:
* Ongoing work with pesticide registrants to ensure that the labeling of all agricultural
pesticides was revised to convey stronger worker protection requirements, such as
restrictions on entry into treated areas and use of personal protective equipment. The
goal of ensuring that all end-users received the required WPS labeling by October
1995 was achieved, without creating undue burdens on.the pesticide industry.
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4 Field Implementation and Communication
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' >' Work with the states, USDA's Cooperative Extension Service, and the agricultural
community to help employers obtain the information and assistance they-need. opp
created or funded 1,100,000 grower compliance manuals, 2,700,000 safety training
manuals, 685,000 safety posters, 11,500 safety training videos, and 6,000 grower
compliance video/slide sets that were made available free or at low cost to farmers
.and farmworkers.
>'' Implementation of a voluntary program to issue training verification cards to
agricultural workers and pesticide handlers upon completion of WPS training. This
will promote safety training and help agricultural employers fulfill their
responsibilities by making it easier for them to verify that their workers have been
trained. To date, 2,500,000 training verification cards have been distributed to the 42
': states, Puerto Rico, and two tribes participating hi the program.
> Workshops, periodic meetings, and ongoing discussions with agricultural groups and
farmworker organizations affected by the. WPS. These discussions enabled OPP to
identify key concerns, resolve problems and improve implementation:
> Implementation of a process for considering requests for exceptions to WPS
requirements. Under the WPS, OPP may approve exceptions if the benefits outweigh
the costs (including any health risks attributable to the exception). In 1995, OPP
denied an exception to the WPS early entry restrictions for uses of chlorothalonil in
certain states, because the information supplied to OPP did not justify the exception.
» Issuing several final rules that strengthened WPS safety training requirements, but
reduced certain requirements in situations where the restrictions were not necessary to
achieve WPS objectives. For example, OPP reduced requirements for crop advisors
who have already been through comprehensive training, for irrigation activities and
other work that results in only limited contact with pesticides, and for situations
.involving use of relatively low risk pesticides.
Endangered Species Protection Program
The primary goal of OPP's Endangered Species Protection Program (ESPP) is to
protect federally listed threatened and endangered species from the direct and indirect
impacts of pesticide use, while minimizing regulatory burdens on pesticide users. OPP's
current ESPP is an interim non-regulatory program. A final program will be established that
reflects any necessary changes once Congress enacts legislation 'reauthorizing the Endangered
Species Act. . .. "^'.
During this interim period, the ESPP relies primarily on the development and
dissemination of county-specific pamphlets that describe voluntary measures pesticide users
can take to avoid affecting endangered species. In 1995, OPP began developing the
pamphlets internally, ending dependence on contractors. A total of 277 pamphlets have been
completed and are being distributed with state assistance hi 25 states and Puerto Rico. OPP
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OPP Annual Report
also developed additional fact sheets on endangered species in FY 1995, bringing the total to
59, and continued to operate a toll-free endangered species hotline.
In implementing the ESPP, OPP works closely with EPA regions, states, and other
federal agencies. The ESPP allows states to develop plans to protect species in their states in
a manner suited to local conditions. At present, 20 states have developed plans, which may
include detailed assessments and site-specific protection measures as well as provisions for
agreements with landowners to protect species on their property: During 1995, OPP
completed a status review of the plans, and (working with the U.S. Fish and Wildlife
Service) approved the first two, prepared by North Dakota and Kansas. Several other states
are close to approval.
Other FY 1995 highlights include:
* Continuing cooperative efforts with the Wyoming Department of Agriculture, U.S.
Fish and Wildlife Service (FWS), and EPA's Region 8 to locate and protect the
Wyoming toad. Local landowners .again agreed to delay pesticide applications until
their lands were searched for the presence of toads. Although reintroductions of this
endangered species are being made in wildlife refuges, it appears that the toad no
' longer exists'elsewhere in the wild, and ail of the searched lands were cleared for
pesticide use.
+ Initiation of efforts to clarify the roles of OPP-.and federal land management agencies
to protect species! Procedures have been worked out with the National Park Service
and are being developed with the Department of Defense and the U.S. Forest Service.
* Cooperation with pesticide manufacturers, who have formed a task force to provide
extensive and valuable information about where endangered species are located,
relative to pesticide use sites on private lands. .
> Verification with the FWS of the accuracy of OPP's comprehensive national database
of the county-by-county location of endangered species. This database is available to
other EPA offices and federal agencies, and to the public upon request.
Protecting Ground Water -
Protection of ground water from pesticide contamination is the focus of OPP's third
major field program. Ground water is a priority concern for both human health and
environmental protection reaspns. It is the source of drinking water for about half of the
U.S. population, and because it flows into lakes and rivers it helps supports; fish and wildlife
habitats and commercial activity. i /
The centerpiece of OPP's ground-water strategy is a cooperative effort with the states
.and EPA regions to develop State Management Plans (SMPs) to prevent ground-water
pollution from pesticides. Forty-eight states have submitted draft "generic" SMPs, designed
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4 Field Implementation and Communication
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to create capacity for protecting ground water regardless of the particular pesticides used.
The other two states are developing pesticide-specific plans in lieu of a generic plan. In
1995, EPA regions concurred (with comments) on three of the state plans, and are expected
to concur on the remaining plans by the end of 1996. In 1995, OPP completed much of the
work on the next major step, a proposed rule requiring SMPs for five widely-used herbicides
frequently detected in ground water. OPP consulted extensively with state officials during
1995, so the proposed rule is expected to have broad support among the states when
published for comment in 1996.
S " ' ' , ' " ',', ',. ,'
Another important feature of OPP's strategy has been to evaluate a pesticide's
potential to contaminate ground water whenever OPP makes registration and reregistration
decisions, with an emphasis on early mitigation of ground-water risks, as first implemented
in 1994. The Agency is also continuing to track evidence of ground-water contamination
through its Pesticides hi Ground Water Database, In 1992, the Agency proposed a rule to
establish specific criteria for classifying a pesticide as "restricted use" if any of its
ingredients has the potential for contaminating ground water on a widespread basis.
Restricted use pesticide products may be purchased and used only by certified pesticide
applicators or individuals under their supervision. OPP believes that these specialized
requirements will reduce the potential for ground-water contamination. In 1995, OPP
completed much of the work on the final rule, which will be published in 1996.
Certification And Training Of Pesticide Applicators
When OPP designates some or all uses of a pesticide as "restricted use," then the
pesticide may only be used by or under the direct supervision of specially trained and - N
certified applicators. Certification programs are conducted by states, territories, and tribes in
accordance with national standards set by OPP. All states require commercial applicators to
be recertified, generally every three to five years, to maintain their certification. States also
sometimes require recertification or other training forprivate applicators.
Over one million applicators are currently certified nationwide, including over .
900,000 private applicators and about 350,000 commercial applicators. In 1994, the most
recent year for which figures are available, more than 80,000 private and 60,000 commercial
applicators were certified. More than 120,000 private and 120,000 commercial applicators
were recertified in the same year. In addition, several hundred thousand applicators attended
training sessions to learn or review appropriate methods for applying pesticides, in some
cases as part of receiving or maintaining certifications. .
In FY 1995, OPP continued work to revise national standards to better ensure
continued competency of certified applicators. To assist state, territorial and tribal
governments in conducting certification programs, OPP also funded 64 cooperative
agreements and provided support to state extension coordinators through the U.S.
Department of Agriculture. Other activities included support for train-the-trainer and
pesticide applicator workshops; development of training materials on improving pesticide
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OPP Annual Report
drift management and application technology; and methods for evaluating behavioral and
attitudinal changes in applicators as a result of certification and training programs.
B. Communications, Public Response, and Coordination
Few organizations serve a wider "public" than OPP. Communications efforts must be
tailored'to the needs of a broad spectrum of constituents who are affected by or interested in
OPP actions and policies: other EPA offices and regions, state and tribal agencies, individual
citizens, environmental and public interest groups, industry and trade associations, pesticide
users, health professionals, academia, foreign governments and international organizations,
Congress and other federal agencies, and the media.
Appropriate outreach activities are vital to OPP's efforts to ensure that groups arid
individuals have the information they need to make responsible decisions about pesticides and
promote public health and environmental protection goals. The challenge is to make
information widely available, easily accessible, and suited to the needs of OPP's many
"publics." To accomplish this, OPP issues announcements and publications for both general
and scientific audiences, provides information by telephone and electronic network, responds
to written requests for information, maintains a public docket for walk-in visitors, holds
public meetings, and presents speeches and Congressional testimony. This section describes
some of the ways OPP provides information and obtains valuable public input. Additional
information on electronic information dissemination isi found in chapter 6.
**
Outreach And Communications Strategies .
In 1995, OPP issued^ approximately 65 announcements informing the public of major
regulatory and .policy decisions, continuing an upward trend from 1994. Each announcement
is planned using a communications strategy, which often entails a press notice and additional
outreach materials, such as fact sheets or questions and answers. In addition, OPP issued
background materials to respond to inquiries arising out of media reports on pesticide-related
issues.
Public demand for pesticides information increased dramatically hi FY 1995. Directly
and through the National Center for Environmental Publications and Information, OPP
managed distribution of over 700,000 copies of publications, a four-fold increase over FY
1994.
OPP is working with others inside and outside EPA to increase public awareness of
available information resources on pesticides and ensure the most cost-effective, timely
distribution of educational materials. One key accomplishment hi FY 1995 was the
production of an updated catalogue of pesticide publications. The catalogue was distributed hi
"hard copy" in 1995; it will be posted electronically and updated annually hi the future.
Significant new publications developed hi FY 1995 include joint publication with the
Occupational Safety and Health Administration of a Guide to Heat Stress for Agricultural
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4 Field Implementation and Communication
Page 31
Workers and a major update and expansion of OPP's core consumer publication, Citizen's
Guide to Pest Control and Pesticide Safety, to be printed and distributed in FY 1996.
Protecting children from pesticide poisoning continues to be an important focus of
outreach efforts. In collaboration with the Poison Prevention Council and the Consumer
Product Safety Commission, OPP participated in Poison Prevention Week and other
activities, distributing thousands of copies of fact sheets to medical establishments and the
general public. Fact sheet topics included child safety and using insect repellents safely (both
in English and Spanish). :
Responding To The Public
Freedom of information Act (POIAV Requests
' '. ... . , *!. . ' ' ... ' '
OPP responds to technical or complicated requests for information from the public '
under the Freedom of Information Act (FOIA). OPP continues to receive the highest number
of FOIA requests of any program within EPA, and in fiscal year 1995 received 1,537
requests and completed 1,235 responses. The majority of requestors receive all of the records
requested, with the most common requests being for science reviews of registration data,
administrative files for pesticide products, and reregistration information.
OPP Public Docket '."'.'
OPP has established four dockets to house the regulatory notices, background
documents, and public comments on OPP activities. These consist of the Federal Register,
Special Review, Registration Standard, and Special Program Dockets. The docket now has
the capability to accept the electronic submission of public comments. The most active docket
action was the Triazines Special Review, which received over 87,000 public comments. Over
2,000 requests for docket information received by letter, telephone, and in person were filled
in fiscal year 1995. l
National Pesticides Telecommunications Network (NPTN)
NPTN is a national service accessible by a toll-free telephone number that provides
objective information about pesticides upon request to anyone in the tjnited States, Puerto
Rico, and the Virgin Islands. The service operates Monday through Friday from 6:30 a.m. to
4:30 p.m. (Pacific Tune). NPTN provided services to more than 17,000 callers during fiscal
year 1995, including approximately 1,700 calls concerning pesticide incidents. The remaining
calls were requests for general information on pesticide products and issues concerning
health, safety, and use.
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OPP Annual Report
National Pesticide Medical Monitoring Program
The NPMMP, located at Oregon State University, provides information and referrals
on clinical toxicology questions and analytical services for biological and environmental
samples. Health care professionals and possible victims of pesticide poisonings are major
users of the service. NPMMP handled 452 incidents in FY 1995.
Other Letters and Inquiries
Rising public interest in pesticides and their effects on people and the environment is
reflected hi the hundreds of letters and telephone inquiries that OPP receives annually. In
1995, OPP prepared responses for senior EPA officials to over 1,600 letters, ranging from
highly complex Congressional inquiries to postcard write-in campaigns. In addition to the
docket letters described above, OPP* received over 30,000 cards and letters supporting
alternatives to animal testing and nearly 1,000 letters on biotechnology issues. The triazines
Special-Review (involving ground-water issues) was the next most popular topic, with over
70 letters. Other frequent subjects included the Worker Protection Standard, pesticides and
children, the Delaney clause and other food safety issues. Over the past year, OPP laid the
groundwork to be one of the first EPA offices to adopt a new automated correspondence
control and information storage and retrieval system. This will enhance efficiency and allow
improved responsiveness to OPP's many customers. ,
Congressional Relations And Coordination With Other Federal Agencies
Congressional interest and oversight of pesticide and food safety issues continues at a
high level. Over 450 of the letters described above were responses to Congressional
inquiries. In addition, OPP prepared testimony and briefing materials for four Congressional
hearings on pesticide issues and activities, including implementation of the Worker Protection
Standard and proposals for major changes in legislation governing pesticide regulation and
food safety. - . .
OPP continued to assist the General Accounting Office and EPA's Inspector General
with several ongoing evaluations of pesticide program activities, including implementation of
the Worker Protection Standard, activities to address alternatives to the pesticide methyl
bromide (scheduled for phaseout under the Clean Air Act), management of the fees paid by
pesticide registrants', incident monitoring and follow-up, the progress of reregistration of
older pesticides, and a review of the effect of environmental laws and regulations on U.S.
agriculture and other industry/
Pesticide and pest control issues often involve the jurisdiction of several federal
agencies. To promote efficiency and consistency of federal effort, OPP coordinates many of
its activities with those agencies -through Memoranda of Under standing and less formal
working groups. Some of the areas of common activity are: FDA food safety and
antimicrobial pesticides (such as hospital disinfectants); USDA food safety and farm-
'related regulations (such as worker protection and pesticide storage and disposal); Consumer
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4 Field Implementation and Communication
Page 33
Product Safety Commission labeling issues; Department of Interior endangered species;
Occupational Safety and Health Administration worker protection; Customs and Coast
Guard import and export issues; Department of Defense pest control on military
installations; and Department of Transportation harmonization of safety standards for
hazardous chemicals. .
One example of OPP federal coordination in 1995 was its interagency agreement with
the U.S. Geological Survey (USGS). This agreement will allow OPP to access USGS
monitoring data and information on water quality trends, thereby enhancing OPP's ability to
assess ground and surface water vulnerability to pesticide contamination and to make sound
regulatory decisions to protect water resources.
National Agricultural Pesticide impact Assessment Program (NAPIAP)
OPP played a significant role in the independent panel review of NAPIAP, a USDA
program. Recognizing significant changes hi the demands for information and in regulatory
priorities, tight budgets, and government reinvention, the panel1 was charged with evaluating
NAPIAP in the context of USDA's overall pesticide and pest management information
function. The panel's report highlighted 13 key findings and recommendations. The report
reaffirmed NAPIAP's primary mission to provide science-based benefits mformation that
.contributes to EPA?s pesticide .regulatory decisions; The report recommended improving
benefits information by establishing formal procedures and assessment-specific protocols, and
continuing to improve communications and cooperation betweeii USDA and EPA. OPP is
continuing to work with USDA to address these recommendations.
" - - ' " * l
International Coordination And Integration
This section describes OPP's efforts to inform foreign governments about changes in
the status of pesticides hi the U.S. and major:OPP programs. The purpose of these efforts is
to help foreign governments, especially those that have not yet developed extensive pesticide
regulatory and information-gathering programs, make informed choices about the use of
pesticides hi 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. .
A ...
Export Notification for Unregistered Pesticides .
For all exports of pesticides not registered hi the United States, section 17(a) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FEFRA) requires the U.S. exporter to
obtain a statement from the buyer acknowledging that the product is not registered. The
exporter must submit this statement to OPP, and OPP forwards a copy to the importing
government. In 1995, OPP transmitted approximately 2,000 export notifications for about
260 pesticide active ingredients to the governments of more than 125 importing countries.
Since 1992, reporting has increased by more than 150% for exports containing active .
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OPP Annual Report
ingredients approved in other U.S. products, but where the particular export formulation is ;
not registered by OPP. In 1994, such pesticides comprised more than half of the unregistered
pesticide exports.
Reinventing EPA's Pesticide Export Notification Program
In September 1995, as part of the effort to reinvent government, OPP made options
for revising its pesticide export notification policies available for public comment. The key
option would take a risk-based approach hi determining when export notices would be
required, significantly reducing the number of exports, subject to notification. After
consideration of comments, OPP will revise its current requirements. In addition, the
European Union (EU) has recently announced plans to revise its pesticide export regulations.
This announcement presents an opportunity for the United States to work with the EU in
developing complementary export notification programs.
Information
with Foreign Countries
'Another provision of FEFRA, section 17(b), requires OPP to share information with
liealth and environmental agencies in other countries. Under this requirement, OPP sends
notices to other governments on important regulatory decisions made hi the United States
related to pesticides, food safety, and pest management. In 1995, OPP transmitted 31 notices
covering a range of regulatory actions, such as initiation of the triazine Special Review and
the new agricultural Worker Protection Standard. Notifications are distributed directly to
pesticide regulatory authorities; hi approximately 140 countries.
Prior Informed Consent (PIO . . '.'
OPP continues to actively .participate in this joint program developed by the United
Nations Environment Programme (UNEP) and the U.N. Food and Agriculture Organization
(FAO) to promote the safe management of chemicals in international trade. PIC establishes a
mechanism whereby importing countries can receive information about pesticides and
industrial chemicals and then make informed decisions on whether to allow, restrict, or
prohibit future imports. In 1995, OPP prepared a discussion paper for FAO/UNEP on
determining which pesticides pose particular concerns under conditions of use in developing
countries, reviewed draft FAO/UNEP Decision Guidance Documents prepared to assist
importing countries, and responded to requests from other countries for additional
information. .
Work progressed internationally toward making PIC a legally binding instrument.
Formal negotiations toward an international treaty are expected hi FY 1996.
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4 ->- Field Implementation and Communication
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International Visitors
OPP arranges briefings with key U.S. officials for foreign visitors interested in U.S.
pesticide policies and scientific evaluation procedures. During the past fiscal year, OPP
hosted 85 visitors, including representatives from Australia, Brazil, Canada,. Chile, Denmark,
France, Hong Kong, Indonesia, Japan, Latvia, Malaysia, South Korea, Moldova, New ,
Zealand, Russia, Taiwan, the United Kingdom, and Venezuela. .
Regional, State, And Tribal Liaison .
Regional Coordination
O i mi -.,.,- , ij _ * . ^
. EPA's 10 regional offices are OPP's primary connection to state, territorial, and
tribal governments. They negotiate cooperative agreements for OPP's field programs, assist
in developing and implementing programs, and oversee accomplishments and commitments ,
made by the states, territories and tribes. Regional staff communicate OPP's programs and
policies to the public and in turn provide OPP with public input.
'State and Territorial Programs , '
States and territories are true partners with EPA in protecting human health and the
environment from pesticide risks. They assist in developing and implementing field
programs, and they enforce OPP's regulations and pesticide labeling and use requirements.
To further these common goals, OPP supports a-cooperative agreement with the Association
of American Pesticide Control Officials for the State FIFRA Issues Research and Evaluation
Group (SFDREG). In 1995, SFIREG continued to meet periodically with OPP to develop
pesticide programs and discuss implementation and enforcement issues of concern to the
states and territories.
Tribes "' i '. ." ' .' " '' ...- .' ,. "' .-/. . - ." ,'
Native American tribal governments have sovereign rights and certain specific
assurances from the federal government under treaties. The capacity of tribal governments to
carry out environmental regulatory programs varies significantly from tribe to tribe, and the
challenge for OPP is to accommodate tribal differences while ensuring that basic health and
environmental protections are achieved for all Native Americans.
~* ' . *
. .. . * . ' ,.-, '.'. \ .', ' ,
OPP is working with tribes to assist them in building capacity to conduct regulatory
and field programs for pesticides. In 1995, OPP helped fund an environmental scholarship
program to assist college students studying environmental sciences and interested hi
addressing Native American issues. OPP also sponsored a Native American intern to work
on these issues and learn more about how EPA works, supported efforts by the Native
American Higher Education Consortium to develop college-level courses related to pesticide
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OPP Annual Report
safety, aid developed and piloted a seminar on Native American culture and history for OPP
staff. N . ' . .
OPP is also addressing specific issues uniquely affecting Native Americans. In 1995,
OPP continued work with other state and federal authorities to address potential pesticide
exposure by members of the California Indian Basketweavers Association (CEBA). CEBA
members are concerned about potential exposure to pesticides from contact with-native plant
materials used in traditional basketweaving.
Laboratory Tools . .
Pesticide Chemistry Laboratories (PCLs) in Beltsville, Maryland, and Bay St. Louis,
Mississippi, support EPA regions and states with technical reference standards, technical
assistance, and laboratory services. (Technical reference standards are pesticide samples .of
known concentration that can be used, for example, in verifying the formulations of
pesticides being offered for sale.) In FY 1995, OPP distributed 735 technical reference
standards to the regions and states, and PCLs responded to 76 requests for assistance. Most
of'the requests came from chemists in other federal, state or private labs. OPP's PCLs are
the primary repository for all food tolerance, product, and environmental chemistry methods,
as described in chapters 1 and 2.
In 1995, OPP also drafted an Environmental Chemistry Methods Manual describing
how to detect pesticides in soil and water. When finalized, it will include introductory
chapters, formatted methods developed by EPA or pesticide registrants, and technical
appendices. OPP is planning wide distribution and will make the manual available to public
and private labs for a fee. - . .
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Chapter 5: Policy, Regulations, and Guidelines
OPP makes many individual decisions in its registration, reregistration, and special
review programs. To guide these decisions and inform its many stakeholders, OPP develops
regulations, policy documents, guidelines and analyses covering scientific, legal, and
international matters. Active public participation and feedback is critical to the development
of practical pesticide policies. Regulations are-published for notice and comment in the
Federal Register. When final, they are incorporated in the Code of Federal Regulations. OPP
makes other policy and guidance documents available through a variety of mechanisms, such
as the Government Printing Office, .direct mailings, and increasingly, through electronic ,
dissemination. This chapter highlights some key areas of progress over the last fiscal year. ,
Improving Protection For Infants And ChUdren
OPP has made substantial progress implementing recommendations in the 1993 report
of the National Academy of Sciences (NAS), Pesticides in the Diets of Infants and Children.
The report made recommendations to improve protection of infants arid children in four
areas: iojticology, risk assessment, residue chemistry, and food consumption.
Toxicology , .
* To better assess newborn and pre-radolescent toxicity, EPA's Scientific Advisory Panel
(SAP) peer reviewed hi 1995 a number of data requirements developed by OPP. The
requirements are for assessing the potential effects of pesticides on immune function,
the nervous system, reproduction and development, and the visual system. The
^ requirements will be proposed in 1996 as part of comprehensive revisions to OPP's
data requirement regulations (40 CFR Part 158).
> test guidelines for each of these areas have been developed (neurodevelopmental,
neurotoxicity) or will be completed in 1996 (reproductive/developmental, visual \
system). . /
> The National Toxicology Program at the Department of Health and Human Services
(HHS) completed a pilot study on.the use of an additional thyroid test which is now
being evaluated by OPP. _ ;
Risk Assessment
> EPA is revising its guidelines for assessing the cancer risks posed by chemicals to
take into account all available biologically-based information.
+ OPP is phasing hi the evaluation of multiple routes of pesticide exposure (such as
from food, drinking water, and household use) and combined exposures to multiple
pesticides which have the same mechanism of action (that is, they cause the same
f toxic effect in the same way). For example, in the Special Review of the triazine
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family of pesticides, the potential combined risks from consumption of these
chemicals in food and drinking water is being considered along with application .
exposure via agricultural and residential'use. In addition, OPP now routinely
addresses the potential for additive risks from drinking water and food in making.
reregistration decisions. Evaluation of exposure to children and other potentially
sensitive subpopulations is a routine aspect of dietary risk assessments in both the
registration and reregistration programs.
Food Consumption '
i
> To provide more reliable information regarding exposure to pesticides in foods, OPP
will be using USDA's Food Grouping System in standardizing the "recipes" used to
convert foods "as eaten" (for example, pizza) to raw agricultural commodities (for
example, wheat, and tomatoes). In addition, OPP is revising its commodity list which,
upon completion, will be transmitted to USDA so all recipes can be standardized
based on the new commodity list by the end of 1996. .
* USDA requested additional funds to carry out a supplemental food consumption
survey, but monies were not appropriated. OPP is working with USDA and HHS, as
part of the Food Consumption Working Group, to design future surveys.
Residue Chemistry ' . . >
> A design for a National Pesticide Residue Monitoring Database is complete and could
be implemented in FY 1997, if funds were available.
> OPP completed a market basket feasibility study for monitoring pesticides in the top
20 foods eaten by children. .
* OPP routinely uses actual field trial data to estimate potential residues in treated food.
Guidance specifying number of field trials per crop was peer reviewed by the SAP
and completed in 1995.
Acute Dietary Risk Assessment Policies
Acutely toxic pesticides are those which could cause illness or injury based on short
term exposure to excessive residues. For example, high residues of such a pesticide hi food
could cause illness to some people after a single serving of the food. Unlike potential chronic
effects, which-are evaluated based on likely consumption of foods containing varied residue
levels over many years, acute effects must be evaluated based on the possibility of excessive
exposure to "high residue" foods within a relatively short period. Using average residue
values in evaluating health risks would not provide an adequate margin of safety for
consumers in the case of acutely toxic pesticides.
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5 Policy, Regulations, and Guidelines
Page 39
In FY 1995, OPP developed new, refined guidance for determining potential risks
posed by acutely toxic, pesticide residues in food. The policy optimizes the use of available
residue data and takes a tiered approach, proceeding from worst case assumptions to more
realistic assumptions. The new approach incorporates recommendations from the National
Academy of Sciences report oh Pesticides in the Diets of Infants and Children and was
presented to the OPP's Science Advisory Panel for expert peer review in October 1994. The
new policy standardizes OPP risk assessment for acutely toxic pesticides, enabling the agency
to compare risks more directly and to make sound, protective tolerance decisions.
Activities Related To Implementation Of The "Delaney Clause"
Following a 1992 decision by the Ninth Circuit Court of Appeals, OPP has made
progress implementing the Delaney clause of the Federal Food, Drug and Cosmetic Act
(FFDCA). The Delaney clause prohibits the establishment of food additive regulations or
maximum residue limits for processed foods for any pesticide that induces cancer in humans
or test animals. In FY 1995, EPA:
V Proposed in January to revoke six food additive regulations involving four pesticides
found to induce cancer, continuing the orderly process of making decisions on
existing food additive regulations potentially subject to the Delaney clause initiated in
July, 1994.
* ' ' . *.*"*-"' " *
* Obtained a court approval in February of a settlement with the Natural Resources
Defense Council and others (NRDC settlement) to take a number of actions within
certain time frames to comply with the Delaney clause as interpreted in the Ninth
Circuit decision. ;
.'-,'." , ,r " - ^ "" '-* f ' -
> Articulated commonsense, science-based policies for defining when pesticide residues
concentrate in processed food and when processed food is considered "ready to eat,"
These new policies, published in June, responded to certain issues raised by the.
National Food Processors Association, and others. Although established as a result of
Delaney actions, the policies apply to the tolerance setting process in general. A
significant consequence of these policies is that fewer food/feed additive tolerances
will be needed for processed foods, due to more realistic assumptions of the
likelihood of residues in processed foods. .
* Began applying these new policies hi a number of specific tolerance decisions. For
example, in August, EPA proposed to revoke tolerances for trifluralin in mint oils
since mint oils are not "ready to eat," and residues in ready-to-eat foods made with
mint oilswould not be higher,than the raw agricultural commodity tolerances. In
September, the Agency proposed the revocation of 36 livestock feed additive
regulations involving 16 pesticides. Of these, 34 proposed revocations were based on
a determination that they were no longer needed (e.g., the residues were found not to
concentrate hi ready-to-eat processed feed), while two revocations were proposed
because the tolerances violate the Delaney clause. With' this action, EPA completed
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Page 40 . ' . OPP Annual Report
initial proposals on all existing food additive regulations that had been identified as
potentially subject to Delaney. Final decisions will be made on these proposals
between December 1995 and March 1997. -
Revised Food And Livestock Feed Table
>'"" :
OPP has issued a revised version of its Food and Livestock Feed Table (Table 2 of
Subdivision O of the Pesticide Assessment Guidelines, entitled "Raw Agricultural and
Processed Commodities and Feedstuffs Derived from Field Crops"). This table lists raw and
processed human foods and livestock feeds (derived from field crops) for which tolerances
are established and residue data are required.
Changes to the table were needed to reflect significant changes in livestock feeding
practices in recent years. Some commodities formerly listed (such as barley bran and tomato
paste) are no longer considered to be significant feed items and have been dropped from the
table. Residue data and tolerances are no longer required for these commodities. This new
information on feeding practices improves the accuracy of exposure assessments for residues
in livestock-derived foods. OPP has already begun using the new table in making tolerance
decisions.
t ' ' '" i " '
"Reinvention" and Regulatory Reform: Ongoing Efforts to Clarify and Update
Regulatory Policies and Requirements
FY 1995 was a year of significant progress hi a number of ongoing efforts to update
and reform core OPP policies in order to improve the quality of pesticide regulatory
decision-making and make OPP's requirements clearer and more consistent.
-*./. ' ,' ' ''
Comprehensive Review of Existing Regulatory Burdens
In the spring of 1995, President Clinton directed all federal agencies to reduce
regulatory burdens and signed into law a new Paperwork Reduction Act. In response to the
President's call, OPP mounted a concentrated effort to review every regulation on the books,
with the goals of eliminating outdated or unnecessary rules and reducing reporting and
recordkeeping requirements where appropriate. All interested stakeholders had the
opportunity to become involved hi this effort, ihrough public meetings and solicitation of
written comments. . ;
OPP reported back to the President hi June, 1995» and announced a number of new
initiatives designed to streamline and reduce burdens posed by pesticide regulation.
Highlights included steps to exempt low-risk pesticides from regulation, eliminate regulatory
overlap between EPA and the Food and Drug Administration for certain products, and permit
minor changes hi the conditions of .pesticide product registrations without prior OPP
approval. OPP is also exploring other approaches to reducing regulatory burdens, including
implementation of self-certification programs for certain registration requirements. Finally, as
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Policy, Regulations, and Guidelines
Page 41
described in more detail in chapter 4, OPP is reviewing current policies with a view toward
"reinventing" its export notification programs; .
Tolerances and Food Safety
In FY 1995, OPP continued to work on proposals for reinventing its processes for
establishing tolerances and estimating risks to consumers (including children) from exposure
to pesticide residues in food.
A major component of this effort was the opening up of OPP's current procedures for
wider public review and comment. Based on the comments received, OPP has already taken
steps to incorporate improved statistical techniques into dietary exposure analyses and to
consider average field trial residues in determining the need for separate tolerances for
processed foods. .
OPP is continuing to assess the comments received and expects to announce a number
of additional changes in FY 1996; Some of the changes under consideration are designed to ;
take into account factors known to reduce pesticide residues in foods between the time crops
are harvested and eaten (e.g., washing and peeling) when setting tolerances. Other proposals
involve gathering more data on pesticide usage and actual residues on crops in order to make
more accurate estimates of dietary exposure, harmonizing terminology with current
international practices, improving OPP.'s ability to track total dietary exposure for food use ;
pesticides, and developing materials to improve public understanding of the tolerance-setting
process. The goal is to establish tolerances that more closely reflect real exposure to residues
in food and to make the tolerance-setting process more open and accessible to the public.
Revised Pesticide Registration Data Requirements (40 CFR Part 158)
As part of the Administration's regulatory reform initiative, OPP has undertaken a
comprehensive review and updating of its pesticide data requirements, found in Title 40 Part
158 of the Code of Federal Regulations.
In 1995, OPP submitted a draft proposal to the Scientific Advisory Panel (SAP) for
peer review. Among other provisions, the proposal includes significant regulatory relief for
biological pesticides, sets forth data requirements for clearance of inert ingredients of
pesticides, and provides more explicit criteria for when specific types of studies are required
for agricultural uses of pesticide chemicals. For the most part, the SAP endorsed the
proposed changes, except for a provision to require comparative performance testing. Based
oh the SAP response, OPP plans to issue a proposed rule for full public comment in 1996.
In addition, OPP made significant advances in laying the groundwork for revising
data requirements for biocides and other non-agricultural pesticides and tailoring them to
reflect specific use and exposure conditions. Collaboration with Canada and .the European
Union to promote international harmonization of data requirements and-testing strategies for
non-agricultural pesticides also began during this fiscal year. , ;
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OPP Annual Report
Draft Guideline for Independent Laboratory Validation of Environmental Chemistry
Methods '
OPP published a draft data reporting guideline that requires registrants to obtain
independent laboratory validation of methods used to detect pesticide residues in soil and
water. The guideline applies to nine environmental fate, exposure and ecological effects
studies that OPP requires of pesticide .registrants. The guideline is based on OPP's findings
that a large number of existing detection methods were incomplete, inadequately documented
and insufficiently effective, while other methods used outdated technology no longer available
in EPA laboratories. These new guidelines will save OPP resources and reduce delays hi
reviewing methods. A revised draft is planned to be published in the Federal Register w.
early 1996. .
Guideline Harmonization and Updating
In another regulatory reform initiative, OPP is nearing completion of a multi-year
project to harmonize its pesticide chemical test guidelines with those of the EPA's Office of
Pollution Prevention and Toxics, California, and the Organization for Economic Cooperation
and Development (OECD), an international organization that includes most major
industrialized countries among its members.
OPP's test guidelines outline how studies should be designed and conducted hi order
to satisfy OPP's regulatory requirements and support pesticide registration. Greater clarity
and consistency in test requirements will eliminate duplicative or redundant, testing and
provide greater assurance that pesticide studies reflect the best, most current science. As
harmonization and updating efforts are completed, the test guidelines are being consolidated
into a single, cataloguing system and will be made available through the Government Printing
Office beginning in 1996.
EPA currently has 340 guidelines, organized into 10 categories based on scientific
discipline. Once the Agency has reviewed a guideline and developed an updated/harmonized
version, the revised guideline is subject to peer review and international notification where
appropriate, prior to publication.
Accomplishments in'FY 1995 included:
> Guidelines harmonized and/or updated
Toxicology (57)
Nontarget Organisms (45)
Residue Chemistry (18)
Physical Chemistry (25)
. * Guidelines Peer Reviewed
Residue Chemistry (18)
Physical Chemistry (25)
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5 Policy, Regulations, and Guidelines Page 43
' .. ' - i' ,
.* . Guidelines Ready for Republication
Applicator Exposure (7)
Post Application Exposure (9) ,
Microbial Pest Control Agents (44)
Biochemical Pest Control Agents (7) ...'..,;-
OPP plans to publish all remaining test guidelines after appropriate peer review and public
comment during 1996.
Methyl Bromide Alternatives .. ,
Methyl bromide is a broad spectrum pesticide which is effective in controlling insects,
fungi, nematodes, and weeds when used to fumigate soil, structures, and commodities.
However, it has also been found to contribute to depletion of the ozone layer. Consequently,
under the Clean Air Act, EPA has prohibited the production and importation of methyl
bromide after January 1, 2001. In light of this phaseout, EPA is cooperating with the U.S.
Department of Agriculture, commodity groups, and others to give priority to the
development, registration, and adoption of alternatives to methyl bromide, including both
chemical and non-chemical pest control strategies.
In 1995, OPP issued two formal policy statements: a commitment to giving priority
review to methyl bromide alternatives, and a requirement that applications for "emergency
exemptions" involving methyl bromide use demonstrate efforts to develop alternative means
of pest control. In keeping with its overall policy of reducing pesticide use and risk, OPP
also supported the Port of San Diego's efforts to develop an innovative technology to capture
and reuse methyl bromide in its quarantine fumigation operation. This method has the
potential to decrease use and emissions of methyl bromide.
Other Ongoing Regulatory Improvement Initiatives
OPP made significant progress on a number of additional regulatory improvement initiatives
during 1995, including work toward publication of several key proposed and final rules:
> Final rule clarifying responsibilities for reporting pesticide incidents ("6(a)(2)
Rule"). Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act
requires registrants to report incidents and other information indicating potential
adverse effects of pesticides. This information is important in helping OPP decide if
action should be taken to reduce the risks posed by a particular pesticide. In 1995,
OPP completed a draft final rule to clarify the reporting obligations. OPP expects to
publish the final rule in early 1996. (Chapter 6 provides further discussion of 6(a)(2)
activities during 1995.) '.''' :
* Ground-water protection regulations. Complementing the ongoing field activities
described in chapter 4, OPP also continued regulations development to protect ground
water. Progress in 1995 included drafting a final rule defining criteria for identifying
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Page 44 ' ' OPP Annual Report
pesticides'posing risks of ground-water contamination and a proposed rule to require
state management plans for several specific pesticides that are frequently detected in
ground water.
+ Standards for pesticide containers and containment. Approximately 200 comments,
totalling 2900 pages, have been received in response to OPP's February 1994
proposed regulation establishing standards for pesticide containers and containment. In
1995, OPP reviewed, abstracted and summarized these extensive comments, in
preparation for the development of a final rule.
Ecological Risk Assessment and Ground-Water Study Guidance
In FY 1995, OPP launched an initiative to standardize and improve ecological risk
assessments by creating a source of clear, easily accessible, up-to-date guidance documents
for ecological reviews. The effort involved an extensive compilation and review of existing
documents, updating established guidance, writing new guidance, and providing for internal
peer review by senior scientists. The highest priority documents should be complete by
December, 1995.
OPP scientists also developed draft guidance on a new design for small-scale,
prospective ground-water monitoring studies. These studies are used to determine if residues
may leach into ground water and often serve as the basis for restrictions on pesticide use to
prevent ground-water contamination. The draft guidance drew hundreds of comments, most
supporting OPP's proposed changes and many expressing appreciation for the opportunity to
provide input at an early stage of policy development. OPP plans to issue final guidance in
FY 1996.
Community-Based Environmental Protection
As part of the EPA-wide effort to promote community-based environmental protection
initiatives, OPP participated in the development of a strategy for the Office of Prevention,
Pesticides, and Toxic Substances that stressed providing information tools and creating
partnerships for communiry-rbased ecosystem protection projects. In 1995, OPP launched its
own Ecosystem Pilot Project, which included the following activities:
> Participating in a joint federal-state assessment of environmental conditions in the
Southern Appalachian Region. OPP provided information on pesticides in ground
water and data from its Ecological Incident Information System.
* Undertaking a survey to identify and catalogue the knowledge and expertise available
from OPP to assist in ecosystem protection initiatives.
> Working with EPA's Office of Water to train teachers'in such areas of environmental
concern'as pollution prevention and preservation of streams. The program is intended
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5 Policy, Regulations, and Guidelines
Page 45
to develop partnerships with minority colleges, beginning with a pilot in Petersburg,
Virginia.
Improving Methods, Modeling, And Information Systems for Environmental
Assessments
OPP scientists and statisticians continued to make progress in a number of areas
aimed at improving methods and information systems that support pesticide decision-making.
Accomplishments in 1995 included:
Mapping. Monitoring, and Modeling Pesticides in the Environment
Desktop Geographic Information System (GIS) mapping is now being used on a
regular basis in OPP New software integrates the visualization of geographic data with
traditional tools like spreadsheets, databases, and business graphics. In\FY 1995, OPP used
desktop GIS to map pesticide use areas and pesticide detections in ground water. Integration
of mapping with OPP's Ecological Incident Information System enables the system to
combine visual displays showing location of pesticide contamination incidents with
information on county and state boundaries, major roads, rivers, cities and land use patterns.
' OPP^also continued to participate hi collaborative efforts to improve monitoring and
modeling of pesticides in" the environment. For example, OPP contributed to the work of the
Intergovernmental Task Force on Monitoring Water' Quality to improve coordination of
monitoring efforts and make tne data more useful and widely accessible nationwide. OPP
also participated in the Exposure Modeling Workgroup, a partnership that includes the U.S.
Department of Agriculture and private sector experts. The workgroup is developing improved
computer models of how pesticides break down and are transported in the environment. 1995
accomplishments included finalizing guidance on how to select the values, such as soil type
and climate, to input to models and how industry should report results to OPP. The
partnership also made substantial progress in standardizing the types of locations that should
be modeled for each major crop and in determining the accuracy of modeling'.
Statistical and.Computer Program Improvements
" ' ' .r ' " '. . '.... ' . ' ' ,
* " ' '''',
OPP statisticians and scientists work contmuaUy to improve the efficiency and
consistency of ecological effects data evaluations. The goal is to enhance confidence that
conclusions are based on appropriate procedures, which enable OPP to better characterize the
environmental risks of pesticides and evaluate reductions in risk resulting from regulatory
decisions. To further these objectives in 1995, OPP conducted an in-house workshop and
participated in conferences on ranking environmental risks and measuring uncertainty in
ecological risk assessment.
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OPP Annual Report
In 1995, OPP also worked to design an "environmental fate tool box," a series of
computer programs that will help OPP understand how fast pesticides break down in the
environment and the degree to which they can move through soil into ground water.
Legislative Proposals
EPA worked with the Department of Agriculture, the Food and Drug Admmistration,
and others hi the executive branch to develop Administration positions on proposed
legislation relating to pesticides and food safety, prepare for Congressional hearings on these
topics, and communicate the Administration's positions to members of Congress, their staffs,
and the public. OPP provided analyses of antimicrobial reform legislation and a variety of
funding options for reregistration and registration. In addition, OPP led a number of
educational briefings for members and staff on key pesticide issues.
' \
The Administration is committed to working with Congress to enact sound reforms to
both major pesticide statutes, the Federal Food, Drug, and Cosmetic Act (FFDGA) and the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In particular, Administration
goals include adopting a single, health-based standard for pesticide residues in food; ensuring
implementation of recommendations contained in the National Academy of Sciences report
' Pesticides in the Diets of Infants and Children; promoting the development of reduced risk
pesticides; providing incentives for registering minor use pesticides; and providing OPP with
the fee revenue required to complete on-going reregistration reviews, as mandated by
Congress in 1988 amendments to FIFRA.
While no bills were introduced in 1995 that fully addressed all of EPA's concerns,
OPP is continuing to work with Congress toward the goal of enacting legislation that will
provide a strong, consistent framework for its efforts to better protect public health and the
environment.
' i ' -
International Harmonization And Regulatory Coordination .
OPP's international harmonization projects aim to develop common or compatible
international approaches to pesticide review, registration and standard-setting. Common
approaches to regulation will .allow work sharing and reduce regulatory burdens on national
governments, improve the science supporting pesticide regulatory decisions, worldwide,
provide greater assurance that imported food is safe, and reduce trade problems and costs for
registrants. . .: '
OECD Pesticide Forum
The Pesticide Forum of the Organization for Economic Cooperation and Development
(OECD) brings pesticide regulators together to address common problems, promote
harmonization of policies and procedures, and enable work sharing. The U.S. participates in
a number of ongoing Forum projects, including: (1) providing feedback to the European
Commission on Europe's new registration/reregistration procedures; (2) working with
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5 Policy, Regulations, and Guidelines
Page 47
Australia and Canada on guidance for interpreting studies and documenting data reviews for
subchronic oral toxicity (90-day rodent) tests; (3) developing common test guidelines; (4)
exchanging data reviews; and (5) participating in a survey and a workshop on pesticide risk
reduction activities. As a result of Forum activities, countries are developing much closer
working relationships and are beginning to share information on a more routine basis.
Specific examples in 1995 include:
o Cooperation among the U.S., Germany, and Canada to use Canadian reviews
and new registrant data to facilitate review and establishment of a U.S.
tolerance for amitraz on hops. .
o .Cooperation between the U.S. and Australia to resolve problems of
cblprfluazuron residues in imported beef.
Intergovernmental Forum on Chemical Safety ,
In response to the Agenda 21 Report prepared at the 1992 United Nations Conference
on Environment and Development, U.N. member countries established the Intergovernmental
Forum on Chemical Safety (IFCS). The IFCS coordinates national and international chemical
safety activities in a number of areas: (1) risk assessment; (2) harmonization of classification
and labeling systems; (3) information exchange, including prior informed consent (PIC); (4)
risk reduction; and (5) strengthening national capabilities. The. IFCS is improving global
coordination of chemical safety activities, including high visibility initiatives such as PIC and
Persistent Organic Pollutants, which are described separately in mis report.
In support of the goals of Agenda 21, OPP contributed to the design of a model risk
assessment document and prototype production process. The resulting documents, known as
Concise' International Chemical Assessment Documents (CfCADs), will provide
internationally peer reviewed risk assessments for priority chemicals. OPP also drafted a
CICAD for .the pesticide amitraz.
1 During FY 1995, OPP helped plan and participated in a meeting of 14 American
countries mat are members of the IFCS to establish regional priorities for chemical safety.
This expanded Americas meeting, chaired by Mexico, established good working relationships
among the countries represented and provided a foundation for greater chemical safety in the
Americas. ,
ratiada/TT-S. Technical Working Group on Pesticides
The Canada-U.S. Trade Agreement (CUSTA) directed the two countries to work
toward equivalence of pesticide standards. The more recent adoption of the North American
Free Trade Agreement (NAFTA) by Canada, Mexico, and the United States emphasized the
goals of harmonization, without lowering the level of public health and environmental
protection in any country, and cooperation to enhance conditions throughout the hemisphere..
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OPP Annual Report
To farther these objectives, CUSTA established a Technical Working Group (TWO)
on Pesticides. This group is currently co-chaired by OPP and the Pest Management
Regulatory Agency of Canada. In light of NAFTA, Mexican regulatory authorities have also
been invited to participate, and attended the first trilateral meeting in 1995.
. After initiating various pilot projects to become knowledgeable about and confident in
each country's regulatory processes, in 1995 the TWO began moving toward more active
harmonization and actual work-sharing. For example, OPP utilized Canadian reviews of
acute toxicity data in registering a product, thereby saving significant review time. OPP will
alsq use Canadian reviews in the reregistration process for creosote, an important wood
preservative.
In addition, :the TWO has made significant progress hi cooperation with agricultural
producers and industry to reduce trade disruptions caused by differences hi residue limits
between the U.S. and Canada. In 1995, equivalent import tolerances were established for six
pesticide/crop combinations (permethrin on spinach; acephate on beans, peppers, and
cranberries; clethodim on potatoes; and dimethoate on blueberries), eliminating trade barriers
'for affected commodities. Moreover, the U.S. registered the new, reduced-risk pesticide
tebufenozide after conducting a collaborative review with Canada. The two countries also
began to share information in the areas of occupational exposure, toxicology, and
environmental effects and initiated scientific staff exchanges. A more complete description of
the TWG's achievements can be found hi its first formal Accomplishments Report, issued in
June 1995.
Persistent
(POPs)
A number of chemicals, known as persistent organic pollutants (POPs), present health
and environmental risks due to their persistence in the environment, toxicity, tendency to
bioaccumulate, and potential for long range transport. POPs have become an issue of global
concern as they have been detected throughout the world, including remote Antarctic and
Arctic regions. Although EPA has banned most pesticides considered to be POPs, such as
aldrin, DDT,' and dieldrin, they continue to be used in other countries, and residues persist hi
the United States. . . . . , ' .
OPP is currently working with other EPA offices and U.S. agencies to develop
mechanisms to address POPs at the global level. In FY 1995, OPP contributed information
on the health and environmental effects of POPs and provided guidance on criteria for
identifying POPs of greatest concern to.such international agencies as the U.N. Environment .
Programme and the U.N. Economic Commission for Europe/Convention on Long Range
Transboundary Ah* Pollution. OPP is also assisting in the development of strategies for
reducing the use of POPs hi this hemisphere through the North American Commission for
Environmental Cooperation.
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5 Policy, Regulations, and Guidelines
Technical Cooperation With Developing Countries
Page 49
As. a world leader in pesticide regulation and environmental protection, EPA is often
called upon to work with developing countries to improve pesticide safety. Requests range
from responses to specific inquiries to longer term projects aimed at building institutional
capacity. Following are highlights of several initiatives managed by OPP in FY 1995.
AID/EPA Central American Project
According to the World Health Organization, Central America has the highest per
capita pesticide use in the world. The impact on human health and the environment is
significant. Since 1992, the U.S. Agency for International Development (AID) and EPA have
been implementing a model collaborative program designed to enhance Central American
efforts aimed at improving, appropriate pesticide regulation and use, and achieving food
safety, public health, and environmental protection goals.
In 1995, one of the project's major accomplishments was the effort to upgrade
regional pesticide laboratories in Central America. OPP and FDA jointly surveyed pesticide
laboratory.needs and capabilities, developed regional workshops for laboratory personnel,
and produced the first-ever comprehensive laboratory training course and manual.
Participants from five Central American countries attended a comprehensive training" course
sponsored hi cooperation with FDA hi June 1995. This "train the trainers" technical
cooperation should enhance pesticide regulation and control throughout the region.
In 1995, the EPA-ADD Central American project also completed the Spanish
translation of two important reference documents: 1)" Regulatory Guide for Exporters of
Nontraditional Crops from Latin American and the Caribbean Countries, an overview of the
roles and regulations of ILS. federal agencies affecting the import of fresh fruits and
vegetables; and 2) Recognition and Management of Pesticide Poisonings, & valuable tool for
me early diagnosis and treatment of acute poisonings.
Overall, the ERA-AID Central American project has formed an "essential alliance"
that facilitates free information flow, and appropriate technical assistance, helps ensure the
safe importation of agricultural products into.the United States, and allows Central
Americans to make" informed decisions as they strive to improve their economies, sustain
then: natural resource base, and understand the importance of environmental protection. One
measure of the success of the pilot project, which was to conclude at the end of FY 1995, is
thatit has instead been expanded to cover broader environmental issues.
- Indonesia . ; -
In FY 1995, EPA launched a two-year cooperative project to assist Indonesia's
Ministry of Agriculture hi improving pesticide regulation. EPA's involvement is a part of
two larger projects, a pesticide management project funded by a five-year World Bank loan
and an agribusiness project funded by AID. OPP will furnish data on pesticides mat the
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Page 50
;OPP Annual Report
Indonesia^ Ministry will access via Internet. OPP and other EPA staff are also working with
Agriculture Ministry staff to evaluate information needs and develop solutions to specific
issues including regulation of pesticides of particular concern, enforcement, legislative
reform, and pesticide storage and disposal.
Accomplishments in 1995 include:
> Preparing an assessment of acute risks to workers for 10 of the 16 pesticides
identified as posing particular concerns under conditions of use in Indonesia.
> Providing pesticide-specific.information to assist in Indonesia's evaluation of certain .
pesticide risks.
> Summarizing non-EPA sources of pesticide information on the Internet to assist
Indonesia's use of this resource and to avoid duplicating information that is already
, available.
Pesticide Disposal . . ,
OPP worked closely in FY 1995 with the U.N. Food and Agricultural Organization
(FAO), the U.N. Environment Programme, and the World Health Organization to issue two
new technical guidance documents to assist developing countries in disposing of both large
and small quantities of pesticides. In addition, OPP is working with FAO and other
organizations to resolve the growing problem of massive quantities of obsolete pestici
organizations to resolve the growing probl
requiring disposal. .
' International Fund For Agricultural Development
pesticides
An OPP staff member is on assignment to the International Fund for Agricultural
Development (IFAD) 'm Rome to address social and environmental impacts which may result
from use of agricultural inputs, including pesticides, in the Fund's projects. IFAD is a
specialized United Nations agency devoted to alleviating rural poverty. In 1995, OPP helped
prepare an Operational Statement on Pesticides to assist IFAD project design and helped
prepare for a 1996 international workshopi entitled Pest Management Approaches Suitable for
Small-Scale Farmers. These efforts are aimed at reducing hunger and poverty, while
providing farmers with sustainable and cost-effective crop protection capabilities. Besides
helping local farmers, such efforts should benefit U.S. citizens through safer imported foods,
a healthier environment, and stronger and more stable economies in developing countries.
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Policy, Regulations, and Guidelines
Page 51
International Trade and Environment Policy.
With the approval of the NAFTA and the new World Trade Organization (WTO)
agreements, OPP has been called upon increasingly in recent years.to support trade policy
initiatives and implement efforts promoting international environmental goals and regulatory
coordination.
Notably, in 1995 OPP served on delegations to the NAFTA and WTO Sanitary and
Phytosanitary Committees, as well as a new working group for a Free Trade Agreement for
the Americas, OPP also participated in preparatory discussions for the accession of Chile to
NAFTA. OPP's goal in these deliberations is to promote international harmonization while
safeguarding the integrity of the U.S. public health and environmental regulatory system.
In 1995, OPP continued to participate hi the international food safety standard-setting
activities of the Codex Alimentarius Commission. In collaboration with USDA and FDA,
FJ?A took steps to enhance the scientific basis of Codex actions and increase public input into
U.S. positions at Commission meetings. OPP also studied the steps needed to ensure
compliance with U.S. obligations under international trade treaties to notify other countries
of U.S. actions and consider international standards in making regulatory decisions.
Finally, as discussed in more detail earlier hi this chapter, OPP supported EPA's
Office of Ak and Radiation and USDA in efforts to foster the development of alternatives to
the ozone-depleting pesticide methyl bromide. In addition to U.S. laws, methyl bromide is
subject to international controls under the Montreal Protocol, an international agreement
governing ozone-depleting chemicals. .
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Chapter 6: Information and Program Management
, QPP's information and program management activities are not as publicly visible as
some of its other programs. However, these support.activities keep the OPP engine running.
The buildings OPP occupies; the supplies and equipment used; the careful planning,.
budgeting and administration of resources; the systems developed and maintained to process
and store vast amounts of pesticide information these are but a few examples of the
critical program support efforts managed under this program area. Major achievements
during 1995 are described below.
Operations, Maintenance And Integration Of The Primary OPP Information Systems
OPP has embarked on an effort to integrate virtually all of its many information
systems under a single umbrella. These systems are used to track the hundreds of pesticides
registered by OPP and the tens of thousands of studies associated with these pesticides. The
systems include information about approved uses, reregistration status, product ingredients,
and many other facts. Under the new Automated Information Management Master
Implementation Plan, OPP is analyzing needs, linkages, and problems among the various
systems. The analyses conducted in 1995 are expected to help achieve the goal of a unified
system that provides consistent, comprehensive, and accurate information to all OPP users
and that avoids multiple entries of the same data into different databases.
- i ."'"'' -- ' , ' . " ' " -
As work proceeded in planning for an umbrella data system, OPP made a series of
improvements to existing information management systems. For example, the Pesticide
Regulatory Action Tracking Systems (PRATS), which is used for tracking registration and
reregistration actions, was enhanced to provide statistics on work accomplished every month
by various OPP organizational units. The Chemical Review Management System (CRMS),
which tracks reregistration information, was.modified to track Mormatidn for new
pesticides. An innovative decision support system was developed to accept a wide range of
lexicological (and other) data and generate a facsimile pesticide label containing the
appropriate health and environmental warning language.
, ' / ,-. . .,"' ' - . .'.- ' ' '
Finally, the OPP Local Area Network (LAN) Group upgraded the LAN infrastructure
with new network technology resulting in an increase hi network reliability. Remote access to
OPP's LAN increased dramatically during 1995, with access extended to many FJPA regional
and headquarters employees. The group also established "One-Stop" Shopping to reduce the
time it takes to create various network accounts, and increased the use of software employed
in developing and executing surveys.
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6 Information And Program Management .
Electronic Dissemination Of. Information
Page 53
OPP continues to experiment with innovative ways of making information available to
affected organizations and the general public. In 1995, OPP completed the process of
enabling all OPP personnel to easily communicate with anyone on the worldwide Internet.
OPP has also begun to make many of its publications and databases available on the Internet,
and is developing plans to significantly expand the amount of OPP pesticide information that
the public can access electronically. In 1996, OPP will request public comments on its plans
to make additional information available electronically.
, ' «
OPP currently uses three systems for delivering electronic access to its information:
the EPA Internet servers, and two bulletin board systems, the Pesticide Information Network
(PIN) and the Pesticide Special Review and Reregistration Information System (PSRRIS).
OPP plans to consolidate its electronic information into a single system during the next fiscal
year, so that users will find OPP's information at a single site. OPP will still offer both
Internet and dial-up access. (For details on how to access the Internet site and bulletin
boards, see the section entitled "How to Obtain More Information.'')
Information Currently Available from OPP through the Internet
Almost all of OPP's electronically-available documents are available through the
Internet, including all Federal Register notices and press announcements, and many
Reregistration Eligibility Decisions (REDs); This information may be accessed using any of
several methods in widespread use: through EPA's World Wide Web, Gopher, or FTP (file
transfer protocol) servers. Interactive databases maintained on the PIN cannot now be
accessed via Internet, but hardware and software changes planned for the- coming year will
provide single-point Internet access to all of OPP's electronically available information.
Pesticide Information Network (PIN)
,' ' * . ,;'.;'.''' - ' .- i . , " ,
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 hi obtaining needed information
on a timely basis, thereby mproving their ability to respond to local pesticide situations and
federal requirements; save OPP resources through automated dissemination and updating of
public information; and enhance cooperative efforts between EPA and other federal agencies
through a convenient method of information sharing.
The PIN contains several different types of information. These consist of the Pesticide
Monitoring Inventory (PMI) (including the Pesticides in Ground Water Database), the
Ecological Incident Information System (EIIS) (described in more detail elsewhere in this
chapter), a Regulatory Status database, the Certification and Training Bibliography, and a
Biological Pesticides data set. .
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OPP Annual Report
Pesticide Special Review and Rerepistration Information System (PSKRIS")
This bulletin board system, or BBS, contains recent Reregistration Eligibility Decision
(RED) documents and all the RED fact sheets. Other files available for downloading include
basic information explaining registration and. Special Review, lists of pesticides under
review and the appropriate Chemical Review Managers' names and telephone numbers, the
Status of Pesticides in Reregistration and Special Review (or Rainbow Report), OPP Selected
Terms and Acronyms, OPP's Annual Reports, the Rejection Rate Analysis chapters, and the
periodic Pesticide Reregistration Progress Reports.
Outside Sources of Electronic Pesticide Information
OPP plans to make use of, rather than duplicate, other sources of electronic
information on pesticides. Internet users who access OPP's site will find reference and in
some cases electronic links to other key pesticide databases around the world. For example,
considerable information that is useful to the general public will soon be available through an
' Internet site being established by-the National Pesticide Telecommunications Network
(NPTN) NPTN currently offers a toll-free pesticide information hotline by telephone (1-8UU-
585-PEST) a service operated by Oregon State University and partially funded by OPP.
Another pesticide information resource with which EPA and OPP will link is the Global ,
Information Network on Chemicals (GINC), an Internet-based project that has its roots in the
June 1992 -U N Conference on Environment and Development (UNCED). This fledgling
network intends to "promote intensified exchange.of information on chemical safety, use and
emissions" among all nations.
Other Information Systems
The Label Use Information System (LUIS). LUIS is a database of label directions
that appear on pesticide products. It contains detailed information on approved use sites,
application methods, application rates, and limitations on the use of pesticides (e.g.,
preharvest intervals,.reentry intervals). LUIS can produce reports by active ingredient to
support chemical regulatory decisions; it can also produce reports by product to monitor
product compliance .with regulatory decisions. In addition, the database can be used to help
locate labels which match a specified parameter. In 1995, LUIS was used to support^
completion of Reregistration Eligibility Decisions (REDs), and the updating of records in
LUIS focused on pesticides scheduled for reregistration. Work is also progressing to integrate
LUIS with related databases and to make this data available electronically to all OPP start.
Ecological Effects Pesticide Toxkity Database. OPP continues efforts to develop a
database that will provide more comprehensive ecotoxicity data for registered pesticides used
in the U.S. Over 410 active ingredients are presently covered by the database, which
contains entries for over 9,100 studies on pesticide effects on terrestrial and aquatic plants,
aquatic invertebrates, insects, amphibians, fish, birds, reptiles, and mammals. OPP receives
approximately 20 database information requests per month from agricultural associations,
nrivate consulting firms, and international, federal and state agencies.
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6 Information And Program Management
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Pesticide Handler Exposure DataBase (PHED). In March 1995, OPP released a
revised version of the PHED database. This database is used to estimate the degree to which
workers are exposed to pesticides they handle, and ultimately to ensure that pesticides do not
pose unreasonable risks to workers. The revised version allows the user to analyze a greater
variety of exposure scenarios. In addition, OPP began a massive reprogramming of the
database to make it more "userrfriendly" and statistically powerful, as well as to incorporate
much of the exposure analysis work being conducted in Europe via EUROPOEM, a
European database. . , :
OPP List of Chemicals Evaluated for Carcinogenic Potential. QPP has revised and
made available electronically the List of Chemicals Evaluated for. Carcinogenic Potential.
This semiannual list provides an overview of compounds evaluated for carcinogenicity by
OPP's peer review teams and various other national and international review groups, such as
the World Health Organization.
Pesticide Adverse Effects Information Reporting/6(a)(2) Activities '
, Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
requires registrants to report to OPP any studies, incidents^ or other information indicating
new adverse effects of registered pesticides. This information helps OPP decide what action,
if any, is necessary to reduce the risks posed by a particular pesticide.
Studies. OPP's 6(a)(2) Team screened nearly 600 adverse effects information
submissions consisting of studies and preliminary reports of possible adverse effects. As a
result of this screening, 15% of the submissions were determined to warrant expedited
'reviewi Of the 15%, one-third required no further action; 20% showed a new adverse effect
which will be addressed by Special Review, an imminent reregistration decision, or risk
mitigation negotiations; 17% are still in review; 14% resulted in label changes to reduce
risks, mostly in cases of new findings in acute toxicity studies; 15% required more
information; and 3% resulted in other actions such as new tolerances and voluntary
cancellations. ,
Incidents, In 1995, OPP stepped up efforts to communicate with registrants on
6(a)(2) reporting requirements, which contributed to the substantial increase in pesticide
incidents reported this year. OPP received approximately 1,435 6(a)(2) submissions
containing more than 7,500 incident reports in 1995. To manage this data more efficiently,
OPP is negotiating with several registrants on formats for.aggregate, statistical reporting of
less serious incidents. Analysis of incident data resulted in several risk reduction actions. For
example, OPP used California worker poisoning data in requiring more stringent protective
clothing requirements for products containing paraquat. Further, in the area of 6(a)(2)
enforcement, EPA issued and settled a civil administrative complaint against DowElancp for
failure to submit hundreds of reports of incidents associated with their registered products.
The settlement included an agreement to submit additional adverse effects information and
payment of a penalty of $876,000.
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OPP Annual Report
Ecological Incident Monitoring And Reporting
OPP continued to broaden the scope of ecological incidents collected and reviewed in
1995. Since September 1994, 27% of the state agencies have reported incidents to OPP, up
from 7% previously. Ecological incident data are useful in determining trends of,efforts> that
ultimately will provide information needed to reduce risk to nontarget species. The mpacts
on fish; wildlife and plants observed are valuable for confinning known or identifying
unknown ecological risks associated with pesticides.
In 1995 OPP performed an analysis of the 700 ecological incidents evaluated to date
This analysis w'ill be useful in designing future risk mitigation measures as pesticides; are
equated through reregistration and Special Review. Of the 78 types of uses with reported
Sdents, 48 wire associated with-agriculture, of which 20 *?**°f
one incident. The highest number of incidents reported involved fish kills (34%)
bird kills (30%) and plant effects (18%). OPP has received reports of adverse effects to^
species of birds due to pesticide exposure. The carbamates, a group of msectlcKld^s'f Pe
caSsignificantly moreP incidents, of adverse effects to birds of prey and songbirds^thanBother
classes of pesticides. Ducks, geese, and other waterfowl appeared to be most affected by
organophosphates, another class of insecticides. Some of the incidents appear to be caused by
pSde nSuse, such as using a pesticide as an illegal bait to control coyotes that results in
. the death of birds of prey. . .
1 ' ' v
Information And Records Management Activities
When an applicant seeks to register a pesticide, all data related to that requesi^must be
logged,Reviewed, mdexed, and, if acceptable, microfilmed. Approximately 12 000 studies
were subjected to this process in 1995. In addition, OPP received approximately 1,300
SS requests for 4,600 files per month from its central collection of ^***£
regulatory cas7files. OPP also worked to properly manage the records reflecting decisions
made on particular pesticide applications for future reference.
Human Resources Management , '. . -
OPP's human resources efforts focused not only on the administrative aspects of
personnel processing (including recruitment; processing of actions; providing guidance to_
OPP managers on policy,- procedures, .and regulations) but also on ** Al°Vi<*° S
employees Key 1995 activities included leadership training for supervisors; ethics training
for middle and upper level management staff; formal training for knowledge/skills
enhancement and career development; and piloting a divisional information sharing program
S "LINKs - LINKs provided a method for OPP divisions to share information on their
functions and linkages to other divisions. In so doing, OPP divisions increased the
understanding of how their activitiesi fit within the overall OPP mission.
OPP also continued to participate in the Howard University Envkonmental Specialty
Program (HUES). Tbis program provides an opportunity for OPP support staff, primarily
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6 Information And Program Management
Page 57
composed of minorities and women, to prepare for a new career in the Environmental
Protection Specialist series. Twenty-two students successfully completed the first year course
work of the three year HUES Program. Twenty-five additional staff have are expected to
participate during the 1995-1996 school year. In addition, OPP participated in the Howard
University Academic Relations Program, which aims to develop talented minority candidates
during a summer internship program and to enhance the relationships between the Agency
and Historically Black Colleges and Universities.
Resource Allocation And Financial Management
OPP resources are allocated in three distinct phases: budget formulation, planning,
and execution. During any given year, OPP is formulating a budget two years hi advance,
planning a budget for the upcoming year, and executing a budget for the current year.
Budget Formulation
Budget formulation is the process by which, on an annual basis, OPP develops what
becomes the President's Budget that is submitted to Congress. In Fiscal Year (FY) 1995,
OPP prepared the submission of the FY 1997 budget. In so doing, OPP worked with the
Administrator's office to develop a budget that reflects Agency goals, objectives, and
.priorities. After, approval by the Administrator, the FY 1997 budget was reviewed by OMB
and ultimately will become the President's Budget. The budget is then subject to
Congressional review. Ideally, the final budget is approved with the signing of the
Appropriations Bill by the President prior to October 1 (the beginning of the new fiscal
year).
Budget Planning . .
Each year senior OPP officials, Program Area Workgroups (made up of a cross,
section of OPP staff), and the resource management staff work together to develop the OPP
Resource Management Plan. This plan identifies OPP's goals, objectives, and outputs for the
upcoming year and the resources needed to accomplish them. In FY 1995, the resource
planning process was streamlined, resulting in significantly less time and staff effort to
develop the FY 1996 Plan.
For the FY 1996 plan, the OPP planning process tentatively allocated $17.4 million
for headquarters contracts and grants, $3.5 million in headquarters administered regional
grants, $4.0 million in expenses, and $55 million in salaries for approximately 760
employees. Nondiscretionary state grants and assistance, which are allocated outside of the
OPP planning process, totalled approximately $13 million.
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OPP Annual Report
: Budget Execution ,." . . /.,-:'
* ' ' . ' " ' '*.''
After the Appropriations Bill is signed by the President, the EPA Comptroller issues a
new Operating Plan, which is executed .by each Agency office. In executing the budget, OPP
must carefully monitor expenditure of all funds, track compliance with budget plans, and
coordinate appropriate Agency financial reports. During 1995, OPP obligated (spent) $87
million dollars. These funds consisted of $54 million in salaries and travel expenses for
approximately 760 employees; $19 million for contracts, interagency* agreements, grants, and
expenses; and $13 million for grants and support to regions and states. ,
In 1995, OPP continued to collect several types of fees from pesticide registrants,
which supplement Congressional appropriations.- The collected funds consisted of $2.5
million in tolerance fees, used to help support OPP's effort hi establishing tolerances, and
$14.3 million in annual registration.maintenance fees, used to help support the reregistration
program. " , - . '.
The figure below indicates the approximate distribution of OPP staff effort to the six
program areas. The figure 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.
* ' ' > ' ' . ' .
1995 STAFF EFFORT PER PROGRAM AREA
. (TOTAL = 750)
227
185
119
| Registration
I Field Implementation!
and Communication
I Reregistration
D Special Review
I Policy, Regulations, H Information and Prograj
and Guidance Management
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6 Information And Program Management
Page 59
In 1995, OPP expended approximately $13:2 million allocated through the program
area budget process. These "discretionary" funds were used for external contracts. The
figure below shows how these funds were distributed among the different program areas.
(Other major pesticide expenditures not reflected in this,figure are travel expenses; .salaries;
and grants and other assistance to states, regions, and other organizations)..'.-"<
FUNDS EXPENDED IN 19 95
BY THE SIX PROGRAM AREAS
30:0%
3.0%
12.0%
14.0%
i '
20.0%
21.0%
Registration [flj] Reregistration
I Field Implementation^ Policy, Regulations,
and Communication and Guidance
[Jj Special Review
U Information and Program
Management
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Chapter 7: Biopesticide, Risk Reduction, and
Reinvention Initiatives
For much of its history, the primary function of OPP has been to register and regulate
pesticides, particularly chemical pesticides. In recent years, however, OPP has begun to shift
from simply regulating pesticides to promoting systems of pest management that better
protect health and the environment and enhance the quality of our lives. This approach
recognizes that pesticides are only one element in controlling pests, and that in some cases
non-chemical alternatives can be as effective as chemical pesticides with fewer health or
environmental risks. Related to this shift in approach have been efforts to "reinvent" OPP's
ways of conducting its work. This chapter summarizes OPP's accomplishments in 1995 in
encouraging the introduction of a new generation of biological pesticides, reducing pesticide
risks through environmental stewardship, and reinventing OPP organizations.
Creation Of The New Division
One of OPP's most important steps in adopting a new, approach to pesticides and pest
management has been the creation of a new division, the Biopesticides and Pollution
Prevention Division (BPPD). Organized as a pilot hi November 1994, the unit was
established as a permanent division within OPP hi September 1995. The division has
assumed the registration and reregistration activities for biological pesticides, and also has the
lead responsibility for the Pesticide Environmental Stewardship Program, which will be
discussed later in this chapter.
Biopesticide Accomplishments '..'"
As with chemical pesticides, OPP is responsible for registering biologically-based
pesticides, or "biopesticides," used in the United States. The three .major types of
biopesticides that OPP registers are microbial pesticides, biochemical pesticides, and plant-
pesticides. (Other biological pest control agents, such as insects that prey on crop pests, are
exempt from OPP's pesticide regulations.) Microbial pesticides are bacteria, fungi,
.protozoans, and viruses used to control pests. Biochemical pesticides are natufally-occurririg
compounds that have a nontoxic mode of action to the target pest, such as insect hormones
and pheromones (mating attractants) and plant growth regulators. As defined by EPA; plant- -
pesticides are pesticidal substances newly introduced into plants, along with the genetic
material necessary for me production of the substances within plant tissues.
Because EPA believes that in general biopesticides are less hazardous than traditional
chemical methods of pest control, the Agency has taken a number of steps to encourage then:,
development and use. OPP's data requirements that is, the types of studies that applicants
must submit to register their new pesticides and other regulations are tailored to the
characteristics of biopesticides and, generally, significantly reduced compared to chemical
pesticides. As a result, applicants can fulfill testing requirements and achieve registration
more quickly and at substantially less cost.
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7 Biopesticides, Risk Reduction, and Reinvention Initiatives
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In 1995, OPP registered a record 20 new biopesticides (see chapter 1 for a detailed '
listing), with processing times for new biopesticides ranging from three to 16 months. This
registration time represents a substantial savings compared to traditional chemical pesticides.
Some of the newly-registered biopesticides include:
* A strain of the fungus Beauveria bassiana. this fungus was registered to, control the
silverleaf whitefly, which has caused millions of doUars of damage to vegetable crops
and cotton over the past five years. The fungal strain was also registered to control
grasshoppers and related pests on rangeland, pastures, and various crops.
* A peach twig borer pheromone. This pneromone was registered to disrupt the mating
, of an insect known as the peach twig borer, a pest of a number of fruit and nut trees.
i - i " .' , ,.-'.,',
> ' Two strains of the bacterium Pseudoinonas svringae. These bacterial strains were
registered to control rot caused by several kinds of fungi during the storage of citrus
and other fruits.
> Three plant-pesticides derived from the bacterium Bacillus thuringiensis. or Bt. In
March 1995, OPP approved limited registrations for insecticidal substances produced
by Bt and genetically transferred into corn, cotton, and potato plants. The products
will help control a number of insect pests, such as the European corn borer, cotton
bollworm, and Colorado potato beetle. OPP approved full commercial use of the Bt-
potato pesticide in May and the fit-field corn pesticide in August.
Piloting New Organizational Ai
In addition to advancing hew methods of pest control, the new division is serving as-a
pilot-for testing new approaches to organizational structure and execution of work, such as
those recommended hi the Vice-President's report on reinventing government. The division is
made up of multidisciplinary teams that manage all phases of registration and reregistration,
including both risk assessment (scientific assessment of potential health and environmental
risks) and risk management (policy decisions based on risks and benefits). The division is
also testing a streamlined management structure that exceeds EPA's goal of an 11:1 staff to
manager ratio. While adjustments continue to be made,.many of the approaches have proved
successful and will provide valuable lessons as EPA moves toward overall reorganization of
OPP in 1996.
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OPP Annual Report
Promoting Integrated Pest Management (IPM)
Integrated Pest Management involves the carefully managed use of an array of pest
control tactics - including biological, cultural, and-chemical methods -.tt> achieve the best
results with the least disruption of the environment. IPM relies upon an understanding of life
cycles of pests and their interactions with the environment. Biological control refers to using
natural.enemies of the pest, such.as employing ladybugs to control aphids, Cultural control
involves practices of cultivation, crop rotation, and other methods that prevent or control
pests. IPM also involves the judicious use of chemical pesticides, if necessary.
OPP is involved in both urban and agricultural'IPM. In the urban arena, OPP is
providing the booklet, Pest Control in the School Environment: Adopting Integrated Pest
Management and a companion training video to interested organizations This year OPP _
worked with a consortium of outside groups to send this booklet and other materials on IPM
to every school superintendent in the country. Projects related to IPM in the agricultural
; sector are described in the following section on environmental stewardship.
Pesticide Environmental Stewardship Program (PESP)
The Pesticide Environmental Stewardship Program (PESP) is a broad effort by EPA,
USDA and FDA to work with pesticide users to reduce pesticide risk and use in both
agricultural-and non-agricultural settings. This program stems from a commitment in made in
September 1993 by the, three agencies to: > - -. .
; > Promote the adoption of integrated pest management programs on ?5 percent of U.S.
agricultural acreage by the year 2000.
' * Develop specific risk and use reduction strategies that include reliance on biological
pesticides and other approaches to pest control that are considered safer than
traditional chemical methods I
USDA assumed lead responsibility for the first goal, and EPA assumed the lead for
the:second, naming it the Pesticide Environmental Stewardship Program. PESP takes a four-
pronged approach of public-private partnership, regulatory relief, research and _
demonstration, and education to achieve the goal of reducing the risk and use of pesticides.
The Partnership
The cornerstone of PESP is a public-private partnership approach, with pesticide user
organizations working cooperatively with OPP. The partnerships are completely v^untary
and entered into with the recognition by the federal government of the need for efficient,
^Svr^sTcontrol. Bourne private sector Partners and the federal government make
commitments under the program. Each Partner agrees to develop ^^"^"V
environmental stewardship strategy to reduce pesticide nsk and use tailored to its own
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7 Biopesticides, Risk Reduction, and Reinvention Initiatives
Page 63
circumstances. The strategies should contain specific pest management goals and emphasize
reduction in the use of pesticides and a shift topless toxic methods.
When EPA, USDA and FDA announced PESP in December 1994, the following :
private organizations agreed to become charter Partners:
Agricultural organi/ations:
American Corn Growers Association
California Citrus Research Board
California Pear Advisory Board
California Pear Growers
, s
Utility companies:
International Apple Institute
National Potato Council
Pear Pest Management Research Fund
Appalachian Power
Atlantic Electric
Carolina Power & Light
Columbus Southern Power
Delmarva Power
Duke Power
Indiana Michigan Power
Kentucky Power
Kingspbrt Power
New York State Electric & Gas
Ohio Power
Pennsylvania Electric
Pennsylvania Power and Light
Pennsylvania Rural Electric Association
Virginia, Maryland, Delaware Association
of Electric Cooperatives
Wheeling Power
Wisconsin Public Service Corporation
The following organizations also subsequently joined as Partners in 1995:
-/''' -i . " '
California Cling Peach Advisory Board
California Tomato Board ,
Cranberry Institute .
Edison Electric Institute
Golf Course Superintendents Association of America
Mint Industry Research Council
New England Vegetable and Berry Growers Association
Northwest Alfalfa Seed Growers Association
Pebble Beach Company
'Processed Tomato Foundation
Professional Lawn Care Association of America
Tennessee Valley Authority
Texas Pest Management Association
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OPP Annual Report
PESP Partner organizations now represent more than 31,000 growers and 15,000 non-
agricultural pesticide users. Many organizations that are not pesticide users have also ^
e^sseTmLest in supporting PESP; therefore, OPP created another membership.category,
Supporter, and plans to announce a group of CharterSupporters in early fiscal year 1996.
i ; ,
Partnership Commitments
: . « ,'
Under PESP the federal government commits to seek to promote and fund the
adoption of alternatiVe techniques and practices that enhance pest management and reduce
kand use. The federal government will also integrate the environmental
sStegTes developed by Partners into its policies and programs for agriculture
fnt Finally^ federal government will lead by example with its own use
OPP's activities in 1995 to fulfill this commitment were the streamlined
togW ~^"JS£^
of other reduced risk pesticides described in chapter 1. Also, the Department of Defense
SoD) sS^d a memorandum of understanding with OPP committing to reduce i*; pesUcide
use by Solercent. DOD is a significant pesticide user on golf courses, runways, and in
homes andSols located on notary property in the U.S. and throughout the world.
' Partners began making specific commitments in 1995. For example, the American
Corn <£S£d to promoTand expand its "bottom-line" corn growmg contest^which
seeks to maximize a grower's profit while reducing production inputs such as pesticides.
UtiUty companies committed to train their pesticide users in techniques to lower risks from
pesticide application. . . .
Grants and "Demonstration Projects
Merely putting less-risky products on the market does not guarantee that they will be
used To encourage their use, the demonstration portion of PESP offersjunding to
n^stigatTand demonstrate reduced-risk methods of controlling pests.These methods may
includef pesticides, cultural practices,; management techniques, or mechanical controls.
In 1995, demonstration grants went to growers, regional EPA offices and PESP
Partners OPP and USDA matched funds to make available $800,000 in a special call for
p±sSsSgeS to ris^use reduction of pesticides in 25 key commodities. Twenty awards
ITnSde^Sonstrate reduced risk technologies on the following crops ^ sites: apples,
citais cranberries, field corn, sweet corn, potatoes, tomatoes, alfalfa, and cotton, and in
greenhouses, nurseries, highway rights-of-way, and landscaping.
ThreeEPAregional offices, Regions 5, 9, and 10, also received OPP fimding. One
nTRtgfonJ (which covers six Midwest states) addressed ultra-Low-Volume (ULV)
e appUcftion technology, a promising method for ^££f£?££* °f
of label rates while still achieving" comparable weed control. Region 5 also received
ofVnew generation lower risk pesticides with the
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7 Biopesticides, Risk Reduction, and Reinvention Initiatives Page 65
*
heavily used triazine herbicides. EPA's Region 9 office (representing the states of Arizona,
California, Hawaii, and Nevada) is part o'f a broad pollution prevention partnership known'as
the Biologically Integrated Orchard Systems Project (BIOS). The State of California, almond
organizations, and USDA are among the other participants in BIOS, which is reducing .
pesticide and nutrient applications on the $600 million almond crop. This model information
and technology transfer program is well suited to replication on other crops. Region 10,
representing the Pacific Northwest, received funding for urban IPM programs for schools
and public housing and to support alternatives to chemical pesticides for grasshopper control.
OPP also awarded seven grants, totalling $260,000, to PESP Partners to assist in
implementing portions of their stewardship strategies. These projects include education in
expert systems, training and demonstration of IPM techniques, and development of new
computer information systems.
To obtain a free brochure published in 1995 or other information on PESP contact
the toll-free INFOLINE at 1-800-972-7717. '
Biological Pesticide Regulatory Relief
Over the past few years, QPP has provided regulatory relief to encourage the
development and registration of insect pheromones, which can replace the use of certain
chemical insecticides. OPP's 1995 efforts included expanding the allowable acreage from 10
acres to 250 acres for testing of certain pheromones without obtaining an Experimental Use
Permit (EUP) from OPP. This rule applied to most types of lepidopteran pheromones (those
designed to control butterfly and moth pests), including those tested for food crops, applied
by any method at a low application rate. OPP also published a rule exempting these
pheromones from tolerance requirements, meaning that crops grown during pheromone tests
need not be destroyed, as is usually the case in pesticide testing. These regulatory decisions
were expedited by comprehensive scientific submissions filed by the American
Semiochemical Association, which represents the pheromone industry. '
In May 1995, OPP issued a rule which, among other things, allowed agricultural
workers to reenter areas treated with many biological pesticide products more quickly (after
four hours) than previously allowed under the Worker Protection Standard. This rule will
further encourage biological pesticides while still protecting agricultural workers. >
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OPP Annual Report
Reinventing And Streamlining OPP's Organization
As part of the efforts to "reinvent" the federal government structure and to increase
responsiveness, OPP has undertaken a number of streamlining projects In addition to
registration reinvention efforts and piloting Ihe Biopesticides and Pollution Prevention
Division, described elsewhere in this report, the most significant reinvention projects during
1995 were: ,
> Exploring new approaches to environmental risk assessment, including the creation of
a multidisciplinary pilot branch on environmental risk characterization and
interdisciplinary teams charged with developing options for reducing ground-water
risks. .
»> Forming the OPP SteeamUning Council, a forum in which OPP's managers and
representatives of its staff can work together to address the issues and opportunities
presented by the drive to reinvent and streamline OPP's organization and operations.
> Developing the OPP Reinvention Implementation Plan of March 1995 by the
Streamlining Council, including the general design for a new divisional alignment.
The plan was presented in draft to the full staff of OPP, and discussed in a series of
open meetings. Hundreds of staff comments were received and reflected in the final
" version of the plan. The proposal was discussed extensively with industry groups,
environmental groups, and other stakeholders, and refined to reflect some of their
suggestions. , '
* Developing the full Reorganization Proposal of July 1995 by the Division Design
Teams These self-directed teams were formed to propose functional statements, work
flows, and staffing patterns for each of the proposed divisions in the new alignment of
OPP. Nearly 25 % of the staff of OPP participated in the teams.
OPP's reorganization is scheduled to begin in 1996 but is contingent upon the status
of EPA's budget. A number of other reinvention activities continued hi 1995, such as
completing a slirvey of customer satisfaction; performing an outside management review;
piloting a continually updated, automated pesticide position file; and piloting non-
supervisory, quality review teams for science issues. Comprehensive changes to the
registration process are described hi chapter 1.
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OPP Annual Report
Page 67
How To Obtain More Information
,..,". .'''. .' . '. /
The Office of Pesticide Programs (OPP) wishes to provide timely and consistent
information to the public. If you would like additional information on subjects discussed in
this report or other topics, here are some sources available to you:
' '-".' .' " '). ,'
OPP Public Docket OPP's docket houses the regulatory notices, background documents
and public comments on OPP activities. The Docket is open to the public from 8:00 a.m. to
4:30 p.m., Monday through Friday, and is located hi Room 1132 of Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, Virginia (near the Crystal City subway station)
'telephone 703 305-5805. '
Catalog of OPP Publications and Other Information Media This catalog provides a
listing of hundreds of pesticide publications, including science chapters, fact sheets, etc., and
is available from EPA's Public Information Center, 401 M Street, S.W., Washington, DC
20460 (Telephone 202 260-2080); or the National Center for Environmental Publications and
Information (NCEPI), P.O. Box 42419, Cinpinnati, OH 45242-2419 (Telephone 513 891-
6561 or Fax 513 891-6685).
Pesticide Regulation (PR) Notice 94-3 This document provides general guidance for
obtaining a variety of OPP records and publications. It provides key information and contacts
for many resources available to the public (including Pesticide Dockets^ Freedom of
Information Act, the pesticide hotline, and on-line databases). Lists of OPP program contacts
are included to help direct public requests regarding specific chemicals or policy issues. PR
94-3 can be obtained from:
Communications Branch, POD (7506C)
Office of Pesticide Programs, U.S. EPA
401 M Street, S.W. ' ' .
Washington, DC 20460
(703305-5017) . .
Communications Branch Recent announcements and copies of non-technical brochures
and fact sheets on pesticide issues can be obtained from the Communications Branch, as
listed above.
National Pesticides Telecommunications Network (NPTN) NPTN, accessible by a toll-
free telephone number, provides general information about pesticides and is available to
anyone in the United States, Puerto Rico and the Virgin Islands (Monday-Friday, 6:30 a.mt
to 4:30 p.m. Pacific Time) at 1 800 858-7378.
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OPP Annual Report
Electronic Availability of Pesticide Documents - Many EPA pesticide documents are
avatrele^TnicaUyfrom a variety of sources. Most of OPP's e ectromcaUy-a^k
dements- including Federal Register notices, press announcements, and Reregistratoon -
S^iSons (REDs), are available through the Internet. .They can be accessed via
^AVWorldWide Web server (http://www.epa.gov), EPA's Gopher server
NCEPI or the Communications Branch.
305-5919.
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OPP Annual Report
Page 69
Pesticide Program Contacts
-.. " ' - -' - 'i . ' - - -
The following is a listing of OPP's senior managers as of October 1995, as well as the
managers of OPP's parent office, the Office of Prevention, Pesticides and Toxic Substances
(OPPTS). All OPP telephone area codes are 703.
Office of Prevention, Pesticides and Toxic Substances
Lynn R. Goldman, M.D., Assistant Administrator ,' '
Susan H. Wayland, Deputy Assistant Administrator
James V. Aidala, Associate Assistant Administrator
Arnold E. Layne, Pesticide Program Advisor to
the Assistant Administrator
Office of Pesticide Programs
Daniel M. Barolo, Director
Penny Fenner-Crisp, Deputy Director
Marjorie Fehrenbach, Executive Assistant
Policy and Special Projects Staff
Anne Lindsay, Director
Paul F. Schuda, Deputy Director
Biological and'Economic Analysis Division
Allen L. Jennings, Director
Susan M. Lawrence, Acting Deputy Director
Biopesticides and Pollution Prevention Division
Janet L. Andersen, Acting Director
Flora ChoWi Acting Deputy Director
Environmental Fate and Effects Division
Denise M. Keehner, Acting Director
Evert K. Byington, Acting Deputy Director
Field Operations Division
(202) 260-2902
(202) 260-2910
(202) 260-2897
(202)260-2896
305-7090
305-7092
308-4775
305-7102
305-7102
305-8200
305-8200
308-8712
308-8712
305-7695
305-7695
William Jordan, Acting Director
305-7410
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OPP Annual .Report
Health Effects Division
Stephanie R. Irene, Acting Director
Debra F. Edwards, Acting Deputy Director
Program Management and Support Division
Frank T. Sanders, Director
Norman W. Chlosta, Deputy Director
Registration Division
Stephen L. Johnson, Director
Peter P. Caulkins, Deputy Director
Special Review and Rerepistration Division
Lois A. Rossi, Director -
Richard D. Schmitt, Deputy Director
305-7351
305-7351
305-5440
305-5440,
305-5447
305-5447
308-8000
308-8000
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