United States
Environmental Protection
Agency
Prevention, Pesticides,
and Toxic Substances
(7506C)
EPA 735-R-95-001
January 1995
vvEPA
Office of Pesticide Programs
Annual Report for 1994
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Foreword
EPA's Office of Pesticide Programs (OPP) has been entrusted with an important responsibility: safe-
guarding the health of the American public and the environment from risks thai: may be caused by pesticides.
OPP also must make sure that pesticides are regulated fairly and help ensure that effective measures for
controlling pests are available. OPP has assembled a diverse and talented team of employees to manage these
responsibilities. This report is intended to explain how OPP is using its resourcps to accomplish its mission.
From this report, several themes emerge:
Q Partnerships and Teamwork: OPP cannot oversee pesticides by itself. EPA's regional offices and the
state and tribal pesticide regulatory agencies have a fundamental role in implementing and enforcing
pesticide policies and educating the public. Other important partners include the pesticide industry and
users, environmental and public interest groups, the news media, additional EPA programs, and other
federal and international agencies. And ultimately, all of us are partners because the personal choices
that we make in using pesticides are important factors affecting pesticide risks.
Q Customer Service, Streamlining, and Reinventing OPP: Many projects are underway to help OPP
serve its partners and other "customers" more efficiently and effectively, and to better protect public
health and the environment. OPP strives to make decisions openly, with public involvement, and in a
sensible, understandable manner. i
Q Sound Science and Data: Sound science and data provide the foundation for OPP's decisions. OPP has
required and reviewed thousands of studies on the potential effects of pesticides and their fate in the
environment. OPP also gathers much data on the use, effectiveness, and economics of pesticides. OPP
will continue to promote scientific excellence and ensure that scientific data are accessible and useful
to EPA and the public.
Q Pollution Prevention: OPP recognizes that it is neither economical nor effective to solve problems
after they have been created. As a result, OPP is increasingly focusing on preventing risks from
pesticides in the environment. Important elements of this approach include encouraging safer means of
pest control, reducing pesticide use and exposure, and evaluating the effectiveness of protection
efforts.
I
j
I hope this report will help you understand what we accomplished in 1994 and some of the many
challenges that lie ahead.
Daniel M. Barolo, Director
Office of Pesticide Programs
Dedication: This first annual report is dedicated to the employees of OPP. They represent many
disciplines, including scientists, administrative staff, environmental protection specialists, program analysts,
and computer specialists. Although we have a few miles to go, everyone in OPP should feel proud of our
efforts and, more importantly, the positive impact our actions have on our public health, environmental and
worker safety goals.
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Introduction
Pesticides differ from other classes of
chemicals regulated by EPA in several important
ways. They are often intentionally applied in the
environment, rather than occurring as a
byproduct of industry or other human activity.
They are used in a remarkably diverse array of
products, from insect repellents to crop weed
killers to household disinfectants to swimming
pool chemicals, to name a few. In addition, they
are likely to be found or used in nearly every
home and business in the United States. Although
improper pesticide use may pose health risks,
many pesticides have public health benefits by
killing potential disease-causing organisms found
in food, water, and other settings.
Given the unique attributes of pesticides,
EPA has found that protecting public health and
the environment from the risks that pesticides
may pose is a complex endeavor. To meet this
challenge, the Agency has developed an array of
programs to evaluate and reduce pesticide risks
and promote safe pesticide use. These programs
must be flexible enough to reflect the wide
variety of existing pesticide products and uses,
and must take into account the benefits that
pesticides offer to society. State and tribal
agencies and many other organizations, both
public and private, have been vital partners in
this effort.
This report describes many of the efforts
and accomplishments of the Office of Pesticide
Programs (OPP) during the 1994 fiscal year
(October 1, 1993 to September 30, 1994). It also
describes some of the opportunities and initia-
tives that OPP will pursue in 1995.
Annual Report Structure
While OPP staff are formally organized
into eight divisions and a policy staff, this report
is organized around the six major activity areas
used in the budget process:
1 - Registration
Making decisions about the registration
(licensing) of individual pesticide products, and
assuring that decisions are consistent and up-to-
date.
2 - Reregistration
Bringing the scientific data base for older
pesticide active ingredients up to current stan-
dards, reassessing their regulatory status, mitigat-
ing their risks, and documenting new decisions.
Assuring that products containing eligible active
ingredients are supported by valid data, Eire
labeled correctly, and are reregistered.
3 - Special Review
Conducting in-depth assessments of
pesticides suspected of posing unacceptable risks
to public health or the environment.
4 - Field Implementation
and Communications
Working with EPA regional offices, states,
and tribal organizations to implement pesticide
programs, communicating with the public about
pesticide issues, and supporting compliance
efforts.
5 - Policy, Regulations, and Guidance
Developing pesticide policies and regula-
tions, 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 (includ-
ing human resources, facilities, finances, and
budget planning).
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OPPANNUAL REPORT
Contents
Foreword , . i
Introduction . 1
Chapter 1: Registration 5
Overview Of Registration 5
New Registrations in 1994 6
Reduced-Risk Policy 7
Other 1994 Registration Achievements 8
Ensuring The Effectiveness Of Antimicrobial Pesticides ; .9
Retaining Minor Uses .....9
Proposed Measures To Reduce Risks From Total Release Foggers 10
Addressing Risks From Spraying Pesticides Aboard Aircraft 10
Water Protection Measures For New Pesticide Active Ingredients 10
Efforts To Improve Pesticide Labels 11
Pesticide Chemistry Laboratory Support For Registration... 11
Reducing Unnecessary Requirements For Pesticide Registration 12
Agreement With California To Harmonize Pesticide Regulation,.; , 12
Improvements to the Regulatory File System 12
Chapter 2: Reregistration 13
Steps In Reregistering Pesticides 13
1994 Reregistration Progress ; 14
Rejection Rate Analysis . .: , 20
Pesticide Chemistry Laboratory Support For Reregistration 20
Reducing Pesticide Spray Drift , ; ...21
Reassessment Of Dioxin Risks 21
Reducing Ecological Risks Under The "New Paradigm" , 22
The Label Use Information System (LUIS) 22
Chapter 3: Special Review 23
1994 Formal Special Reviews And Follow-up Activities 23
Cancellation Of Mevinphos 24
Other Negotiated Risk Reduction Efforts 24
Other Cancellation Activities : 24
Tolerance Revocations 25
Initiative To Reduce Risks To Birds (Avian Granular Initiative) 25
Chapter 4: Field Implementation and Communication 27
A. Field Programs 27
Implementing The Worker Protection Standard ...;... ...: 28
Endangered Species Protection Program 29
Protecting Ground Water -...:.. .....29
Certification And Training Of Pesticide Applicators 30
Disposal Of Suspended And Cancelled Pesticides 30
Promoting Integrated Pest Management 31
Guidance For Posting Of Outdoor Pesticide Applications 31
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INTRODUCTION
PageS
B. Communications, Public Response, and Coordination 31
Outreach And Communications Strategies 32
Responding To The Public...... ...:.. ^ ' 32
Congressional And Federal Coordination 33
Public Meetings . '' 33
Pesticide Information Network j 33
Agency Risk Management Communication Group 34
Scientific Presentations And Publications ! 34
International Coordination And Integration 34
Regional, State, And Tribal Liaison .."^'.IZ.."..Z'"r 35
Improving Internal Communications..... 1 36
C. Support For Compliance Activities 3g
Support For The Lab Audit Program 37
Analysis Of Product Chemistry 37
Other Laboratory Support ".':' 37
Additional Support For Compliance Activities ! 37
Chapters: Policy, Regulations, and Guidelines 39
Follow-up To The National Academy Of Sciences (NAS) Children's Study ! 40
Reduced Use/Risk Initiative _ ] 4Q
International Harmonization And Regulatory Coordination 41
Technical Assistance: AID/EPA Central American Project.., .'.'."."""I.".'.'.'41
Biological Pesticide Policy Highlights , 42
Activities Related To Implementation Of The "Delaney Clause" I!.'.'" 43
Standards For Pesticide Containers And Containment '.'."!'."" 43
Other Regulations Under Development 44
Legislative Proposals 44
Maintaining And Improving OPP's Science Base [[ r 45
Chapter 6: Information and Program Management „ 47
- i
Operations, Maintenance And Integration Of The Primary OPP Information Systems 1 47
Pesticide Incident Reporting/6(a)(2) Activities '" j 48
Ecological Incident Monitoring And Reporting ; '.'.'.'".""] 48
Information And Records Management Activities , 49
Human Resources Management 40
Resource Allocation And Financial Management I 50
Chapter 7: Opportunities and Initiatives For 1995 !.. 53
Biological Pesticides And Promoting Risk Reduction I 53
Opening Up OPP !.""!!""""ZZ!!!Z!"! 54
Reinventing And Streamlining OPP's Organization '.".".'.".'""'" 56
How To Obtain More Information 58
Pesticide Program Contacts 59
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OPPANNUAL REPORT
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1
Registration
This chapter describes the registration
program, which provides the foundation for
nearly all OPP activities related to pesticides. In
addition to allowing the use of new pesticides,
this program includes many activities related to
the ongoing registration of existing pesticides,
such as modifications to where and how they may
be used in order to reduce risks or in response to
requests by registrants. OPP also carried out a
number of special registration programs in 1994,
which are described in more detail in this chapter.
EPA is responsible under the Federal
Insecticide, Fungicide, and Rodenticide Act
(FIFRA) for registering new pesticides and
ensuring that, when used according to label
directions, they will not cause unreasonable
adverse effects to human health or the environ-
ment. Pesticide registration decisions are based
primarily on EPA's evaluation of the test data
provided by applicants. EPA has established a
number of requirements, such as the Good
Laboratory Practice Standards, that apply to both
registrants and testing facilities to ensure the
quality and integrity of pesticide data. Depending
on the type of pesticide, OPP can require more
than 100 different kinds of specific tests.
Testing is needed to determine whether a
pesticide has the potential to cause adverse
effects to humans, wildlife, fish, and plants,
including endangered species. Potential human
risks, which are identified using laboratory tests
These included encouraging the registration of
reduced-risk pesticides, ensuring the effective-
ness of antimicrobial pesticides, helping to retain
important minor use pesticides, proposing
measures to reduce the risks from total release
foggers ("bug bombs") and from spraying of
pesticides above aircraft, improving pesticide
labels, reducing unnecessary registration require-
ments, and coordinating registration activities
with the State of California.
Overview Of Reg stration
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). Date on the
fate of pesticides in the environment are also
required so that OPP can determine, among other
things, whether a pesticide poses a threat to
groundwater or surface water (lakes, rivers, and
streams).
Most of OPP's testing requirements focus
on "active ingredients" of pesticide products.
Active ingredients are those substances that
actually possess a pesticidal property — that is,
they repel, destroy, or otherwise affect a pest.
Most pesticide products also contain other
ingredients that do not have pesticidal properties,
such as solvents, carriers, aerosol propellants,
and dyes. Ingredients that are not active as
pesticides are called "inerts."
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OPP ANNUAL REPORT
New Registrations in 1994
OPP registered 31 new pesticide active
ingredients in fiscal year 1994, more than half of
which are considered to be reduced risk pesti-
cides. Reflecting the trend of recent years, a high
proportion of new ingredients — 15, or nearly
half — were biological pesticides. Biological
pesticides include "microbial pesticides," which
are bacteria, viruses, or other microorganisms
used to control pests, and "biochemical pesti-
cides," which include pheromones (insect sex
attractants), insect or plant growth regulators, and
hormones used as pesticides. Biological pesti-
cides generally pose less risk to health and the
environment than chemical pesticides, and as a
result OPP imposes fewer requirements on their
registration. The following table describes the
pesticide active ingredients registered for the first
time in fiscal year 1994.
New Active Ingredients Registered in Fiscal Year 1994
I Pesticide Name
Acetochlor
Ampelomyces
quisqualis
Bacillus subtilis
(MBI 600)
C-9211
Castor Oil
Checkmate CM
pheromone
Corn Glutens
Cyproconazole
Deltamethrin
Difenoconazole
DTEA
Floral Attractants
(seven different
compounds)
Flumetsulam
Gusano (Alfalfa
looper virus)
Registrant
Monsanto Agric. Co,;
Zeneca Ag Products
Ecogen
Gustafson
Rohm and Haas
Dinah Pickett
Consep;
Bedoukian Research
Gardens Alive!
Sandoz Agra Inc.
Roussel Uclaf; AgrEvo
Environmental Health
Ciba-Geigy
Dow Chemical
Micro-Flo
DowElanco
Crop Genetics
International
Pesticide
Type
'
Herbicide
Fungicide
Fungicide
Mildewcide
Repellent
Pheromone
Fungicide
Fungicide
Insecticide
Fungicide
Antimcrobial
Pheromones
Herbicide
Insecticidal
Virus
Use(s)
Corn
Grapes, tomatoes,
strawberries, apples
Cotton, grains
Paints
Ornamental plants
Fruits and nuts
Turf
Turf
Feed
Wheat
Water systems
Corn
Corn and soybeans
Vegetables
Biological or Other
Reduced Risk
Pesticide? :
Yes (biological)
Yes (biological)
Yes (biological)
Yes (biological)
Yes (biological)
(7 pheromones)
Yes (biological)
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1 - REGISTRATION
Page?
New Active Ingredients Registered in Fiscal Year 1994 (cont.)
Pesticide Name
Hexaflumuron
Hydrogen Cyanamide
Imidacloprid (NTN)
Igarol 1051
Methyl Anthranilate
Pseudomonas
fluorescens Strain
NCIB 12089
Puccinia canaliculate
lagerheim
RYH-86-A
Tebuconazole
Tufted Apple Bud
Moth Pheromone
Turpentine
Registrant
-- • *?
DowElanco
SKW Trostperg AG
Miles
Ciba-Geigy
PMC Specialties Group
Mauri Laboratories
Tifton Innovation
Yoshitomi Pharmaceut.
Industries
Miles
Bedoukian Research
DLT Laboratories
Pesticide
Type
Insecticide
Plant Growth
Regulator
Insecticide
Antimicrobial
Bird Repellent
Fungicide
Herbicide
Slimicide
Fungicide
Pheromone
Insecticide
Use(s) , Biological or Other I
, Reducec Risk
'-• , ' Pesticife?
Termite control Yes
Grapes
Turf
Anti-foulant paints
Turf Yes
Mushrooms Yes (biological)
All crops Yes (biological)
Paper mills
Peanuts
Apples Yes (biological)
Non-food uses
Summary Statistics:
Q 31 new active ingredients registered
Q 2 chemical active ingredients registered as "reduced-risk pesticides"
Q 15 were biological/biochemical pesticides
Reduced-Risk Policy
During fiscal year 1994, OPP implemented
its voluntary Reduced-Risk Pesticide Initiative.
Under this effort, OPP invites applicants seeking
to register new pesticide active ingredients to
provide information on how their pesticide
presents opportunities for risk reduction. If OPP
believes that the pesticide demonstrates such
potential, OPP accelerates the registration
process for the pesticide.
In March 1994, OPP registered the first
pesticide under this initiative. Hexaflumuron,
developed by DowElanco, has the potential to
replace much larger amounts of the terrniticide
chemicals traditionally used. This product is used
with a monitoring system so that the chemical is
applied only after a termite problem has been
identified. In September 1994, OPP registered
the second reduced-risk pesticide, methyl
anthranilate. This bird repellent, marketed by
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Pages
Other 1994 Registration Achievements
PMC Specialties Group, is registered for use on
turf; Methyl anthranilate is found in flower oils-
and in Concord and other grapes. This product
solves bird pest problems where existing bird
control toxicants and repellents cannot be used.
OPP will continue the voluntary initiative
in its current form for at least one additional year.
During this time, OPP will explore other types of
incentives that could encourage the development,
registration, and use of lower-risk pesticide
alternatives. In addition, OPP will consider
approaches for expanding the current pilot
program to other types of registration applica-
tions.
Registering new pesticides for the first time
is only one of an enormous number of pesticide
registration actions that OPP carries out each
year. The decisions made in 1994 are summa-
rized in the following table. Both approvals and
denials of the requests received by OPP are
included in the number of decisions.
1994 Registration Activities
Registration Activity
Registrations of new
pesticides
Additional registrations for
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 1 0 acres are to be tested
Decisions on approving tolerances, or maximum allowable
levels of a pesticide in food or animal feed. Tolerances (or
exemptions from tolerances) are required whenever a
pesticide is registered for use on a food or feed crop.
Decisions on approving 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.)
iJum^erof
ifi^isions};:!
31
782
3233
56
265
104
70
26
411
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1 -. REGISTRATION
Page 9
Ensuring The Effectiveness Of Antimicrobial Pesticides
While all pesticide products are required to
work as claimed by the manufacturer, EPA is
particularly concerned about the effectiveness, or
efficacy, of antimicrobial pesticides. Antimicro-
bial products are used to control "germs" such as
bacteria and fungi (molds and mildews) that can
cause odors, food spoilage, or infections. Not
only are they used in homes, but also in hospitals,
cafeterias, restaurants, and many other institu-
tions. Over the past several years, EPA has
implemented a comprehensive strategy to ensure
the efficacy of antimicrobial pesticides, placing
highest priority on those that have significant
public health uses. Among these efforts, EPA has:
Q Funded six cooperative agreements to develop
new or revise existing test methods for
determining the efficacy of antimicrobial •
public health products.
Q Implemented a pre- and post-registration
testing program. Six new sterilants were
Minor use pesticides are those that generate
relatively little income for their manufacturers
because they are used on limited acreages.
Increased costs of pesticide registrations, espe-
cially the costs associated with reregistering
pesticides, often result in registrants choosing to
cancel minor use registrations and not pursue
approval for new uses. However, minor use
pesticides are of major importance to growers in
producing many fruits, vegetables, and ornamen-
tal plants. In 1994, OPP continued to participate
in several activities to help preserve important
minor uses:
Q IR-4 Efforts. OPP supports the efforts of the
Interregional Research Project Number 4, or
IR-4 program, which is jointly funded by the
U.S. Department of Agriculture and the states.
IR-4 has generated data for many minor use
pesticides undergoing reregistration and has
committed to providing residue data to support
reregistration of an additional 250 high
priority pesticide food uses. OPP supports
increased IR-4 funding as the best way to
subjected to pre-registration testing l:his past
fiscal year, of which one has been registered
and the others are pending. Testing of hospital
disinfectants and products with tuberculocidal
claims is in'progress.
Q Administered the Antimicrobial Complaint
System to receive inquiries and complaints
from users and the public. The system
received more than 4,000 calls from medical
professionals and infection control personnel
in 1994. This system also provides valuable
information for assessing needed regulatory
changes, . •
Q Implemented comprehensive label improve-
ment programs to upgrade the label claims
and directions for products used against the
AIDS virus (HIV-1) and for tuberculocidal,
sanitizing, and pine oil products (household
disinfectants). ;
Retaining Minor Uses
protect minor uses without sacrificing health
and safety data development and reviews.
'. '
Q Data deferrals/waivers. OPP tries to be
flexible on the data required for registration
and reregistration of minor use pesticides, but
must also ensure that pesticides do not pose
unacceptable risks to people or the environ-
ment.
Q Crop grouping. OPP has supported the
establishment of tolerances (maximum
approved levels in food) for multiple related
crops based on residue data from a representa-
tive set of crops. This cuts the costs of
registering minor uses.
,
Q Legislation. In 1994, the Administration
proposed legislative changes to help retain
important minor uses, and encourage registra-
tion of new minor uses, as part of its Food
Safety Initiative. This proposal embodies
many elements from a proposal by the Minor
Crop Farmers Alliance (MCFA).
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OPPANNUAL REPORT
Proposed Measures To Reduce Risks From Total Release Foggers
Total release foggers — sometimes called
"bug bombs" — are pesticide products contain-
ing aerosol propellants that release all of their
contents at once to fumigate an area. They are
used in homes to kill cockroaches, fleas, and
other pests. On April 15, 1994, OPP proposed
new labeling requirements for total release
foggers based on information that demonstrated
that total release foggers, as currently labeled,
represent an unreasonable risk to users from fires
and explosions. The proposed rule would require
additional flammability label warnings and a
standard graphic symbol, representing fire and
explosion, to alert consumers to these potential
dangers. In addition, pesticide labels for these
products would include more detailed directions
for proper use. The proposed rule encourages
registrants to use other hazard communication
mechanisms to reinforce the required precaution-
ary language. OPP is reviewing comments on the
proposal and expects to issue a final rule in 1995.
Addressing Risks From Spraying Pesticides Aboard Aircraft
In late 1993, EPA became aware of several
incidents in which airline personnel and passen-
gers experienced adverse health effects after
being exposed to an insecticide treatment aboard
foreign-bound aircraft. Although the United
States has not required spraying since 1979,
several foreign countries do require the spraying
of incoming aircraft, with passengers and crew
present, prior to landing. Traditionally, passen-
gers are not told that this treatment will occur
until the spraying actually begins. The pesticide
used in these treatments is known as sumithrin.
Although EPA has data indicating that sumithrin
is generally low in toxicity to humans, the
Agency does not know how the chemical may
affect susceptible sub-populations. EPA is
particularly concerned that individuals who are
chemically sensitive, or who suffer from respira-
tory problems or allergies, may have adverse
reactions.
In March 1994, OPP issued a Data Call-In
Notice to the two registrants that still held U.S.
registrations for in-flight insecticide treatments
requiring them to either develop new toxicity
data or amend the pesticide label to delete the
aircraft use, Since then, both registrants have
removed the aircraft use from the label. Many
countries, however, continue to require in-flight
spray treatments. Recently, the U.S. Department
of Transportation (DOT) issued a proposed rule
to require notification to passengers at the time
they purchase their tickets. EPA continues to
work with the State Department and DOT to
encourage foreign countries to rescind the airline
spraying requirement. OPP is also preparing a
notice to registrants to ensure that pesticide labels
do not allow the use of other insecticides on
board aircraft with passengers and crew present.
Water Protection Measures For New Pesticide Active Ingredients
In 1994, OPP initiated a new approach for
registering pesticide active ingredients that sets
strong standards for ground and surface water
protection. The approach establishes clear criteria
that trigger voluntary suspension or cancellation
of the registration if water quality is adversely
affected. These criteria are based on an assess-
ment of the chemical and physical properties of
the pesticide and other factors indicating its
potential to contaminate water resources.
Acetochlor was the first pesticide registered
using this approach. Highlights of the water
protection approach include:
Q Requirements for analytical methods to detect
the presence of the pesticide in water, includ-
ing a low-cost immunoassay.
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1 - REGISTRATION
Q Early warning systems to prevent ground
water emergencies, including monitoring of
wells and surface water in several states.
Q Product stewardship programs to foster proper
use by customers and to prevent problems
from occurring. •
Efforts To Improve Pesticide Labels
Labeling is one of OPP's most important
tools for achieving its mission of protecting
human health and the environment. No other
pesticide document or publication has a more
direct impact on risk reduction or the potential to
prevent pollution. Over time, however, some
labels have become cluttered and confusing. In
response to needs expressed by OPP's customers
and an internal evaluation process, OPP formed a
Labeling Unit in July 1994. The goal of the unit
is to ensure that product labels are clear, techni-
cally accurate, and consistent. In 1994 the unit
accomplished the following:
Q Introduced a process for tracking and resolv-
ing short-term labeling problems and issued
responses to more than 50 requests for
guidance.
Q Established an electronic labeling policy
directory which contains over 300 easily
accessible documents.
•
Q Established a Labeling Bulletin Board system
for sharing information about labeling projects
with internal and external customers.
Q Helped finalize and release a comprehensive
Label Review Manual for use by internal and
external customers.
Q Initiated projects to improve consumer
labeling, test the electronic submission/
review/storage of labels, and revise OPP
regulations to allow certain information on
labels that consumers need to make more
informed choices.
Pesticide Chemistry Laboratory Support For Registration
OPP's pesticide registration program is
supported by two pesticide chemistry labs: the
Analytical Chemistry Laboratory (ACL) in
Beltsville, Maryland, and the Environmental
Chemistry Laboratory (ECL) in Bay St. Louis,
Mississippi. The labs support registration through
the food tolerance and environmental chemistry
methods validation programs, which ensure that
pesticide residues can be properly measured in
food and the environment.
The ACL has the lead responsibility for the
food tolerance methods validation program. In
fiscal year 1994, ACL validated a record 49 food
tolerance methods for registration. The ACL's
achievements also included the development of a
method for detecting residues of multiple
sulfonylurea pesticides in food using a new
technology called capillary zone electrophoresis,
which generated much interest among the
scientific community. The ECL has the lead
responsibility for the environmental chemistry
methods validation (ECMV) program. The
demand for environmental chemistry support for
new pesticides grew substantially in 1994, with
the primary emphasis being in the areas of
environmental fate and exposure and ecological
effects. The ECL completed seven ECMV
requests for new pesticides in 1994, including a
ten-fold lowering of the detection limit for the
pesticide acetochlor, allowing it to be more
readily detected in the environment. The ECL
also continued to provide support to the new,
low-cost technology for detecting pesticide
residues known as immunoassay tests.
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OPPANNUAL REPORT
Reducing Unnecessary Requirements For Pesticide Registration
In 1994, OPP continued to identify areas
where pesticide regulations could be reduced,
allowing OPP to better focus on high risk areas
and preventing undue burdens on the regulated
community. One area identified was the potential
exemption of certain low-risk pesticides from
registration requirements. In January 1994, OPP
established an exemption from registration
requirements under section 25(b) of FIFRA for
natural cedar pesticides labeled to repel
arthropods (other than ticks) or to retard mildew
growth. OPP concluded that use of these pesti-
cides poses negligible risks to human health and
the environment and that, as a result, the burden
imposed by regulation is not justified.
Subsequently, the Agency proposed a
second rule (also under section 25(b)) to exempt
31 additional low-risk substances from regula-
tion. Most of these were food items (such as
cinnamon, garlic, and mints) or substances
otherwise derived from natural sources. Under
the proposal, to be eligible for exemption these
substances could not be sold in formulations with
other pesticides or chemicals of concern, and
could not be labeled to control organisms posing
a risk to public health. The labels would be
required to list all ingredients. OPP will review
comments received and determine how to
proceed in 1995.
Agreement With California To Harmonize Pesticide Regulation
OPP and the Department of. Pesticide
Regulation of the California Environmental
Protection Agency began an initiative in 1994 to
harmonize and simplify federal and California
pesticide registration, and to exchange work
products to reduce duplication of effort and
expense. The first major milestone of this
initiative was the signing of a Memorandum of
Understanding (MOU) in May 1994. Under this
MOU, the agencies agreed to share reviews of
acute toxicology studies submitted by pesticide
registrants. The agreement sets out a plan to
reduce duplicative review of identical data,
improve coordination, and reduce the workload
of both agencies by allowing each agency to use
acute toxicity data reviews generated by the
other. Through this effort, products posing fewer
risks will be registered much faster and at less
cost, and older pesticides lacking adequate health
data will be more quickly removed from the
market.
Improvements To The Regulatory File System
Among OPP's most important files are the
regulatory "jackets" for each pesticide product
that has been federally registered. During fiscal .
year 1994, the Regulatory File Area implemented
several changes to improve service. In particular,
a computerized system that provides OPP users
with the ability to request jackets from their
workstations was activated. The new system has
been integrated with other OPP computer
systems, and provides status information on each
registration (such as cancelled, withdrawn, or
suspended). Under this system, files can be more
efficiently managed; for example, quick identifi-
cation of cancelled files facilitates their removal
to make room for new incoming files. 95% of file
room users have been trained to use the new
system and training will continue in 1995.
-------
Reregistration
The reregistration program is one of
OPP's largest and most visible programs. OPP
is required by law to reregister existing
pesticides originally registered when the
standards for government approval were less
stringent than they are today. This comprehen-
sive reevaluation of pesticide safety in light of
current standards is critical to protecting
human health and the environment. In 1988,
Congress amended the federal pesticide law to
strengthen and accelerate OPP's reregistration
program. The "FIFRA '88" amendments apply
OPP identified the pesticides to be reregis-
tered and issued comprehensive data requests to
registrants of those pesticides during Phases 1
through 4 of the accelerated reregistration
process. Reregistration is now in its final phase,
Phase 5, as OPP reviews the studies that are
being submitted, examines the health and
environmental effects of each reregistration case
(group of related pesticide active ingredients),
and attempts to mitigate effects of concern. This
evaluation and risk management process is
complete when OPP is satisfied that the pesticide,
used in accordance with approved labeling, will
to each product containing any active ingredient
registered before November 1, 1984. '
This chapter discusses the progress OPP is
making in reregistering pesticides, as well as
some related initiatives. These include efforts to
reduce the number of studies rejected by OPP,
reduce the risks posed' by pesticide spray drift,
more effectively assess and decrease ecological
effects, help understand and control dioxin risks,
and expand a database of label directions for
pesticides undergoing reregistration.
Steps In Reregistering Pesticides
not pose unreasonable risks to human health or
the environment. ;
OPP's conclusion about whether a.
pesticide's uses are eligible for reregistration is
presented in a Reregistration Eligibility\Decision,
or RED. About 14 months later, once certain
product-specific data and revised labeling are
submitted and approved, OPP begins reregister-
ing products containing the eligible pesticide(s).
A product will not be reregistered until OPP has
determined that all of its active ingredients are
eligible for reregistration.
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OPP ANNUAL REPORT;
1994 Reregistration Progress
During fiscal year 1994, OPP made
significant progress in administering the
reregistration program. Many decisions were
made resulting in significant risk reductions. The
program's investment in people, computer
systems and data gap identification is paying off
with steady production of the decisions needed to
complete the reregistration process.
Several different stages of reregistration ";
offer opportunities to contribute to safer use of
older pesticides. New risks identified during the
reregistration process may be addressed by '
imposing interim risk reduction measures before
the scheduled REDs. The next important stage
for reducing risks occurs with the issuance of
REDs. Many types of risk reductions are required
through REDs, and OPP completed an unprec-
edented number of REDs this fiscal year, as
detailed later in this chapter. Finally, perhaps the
most comprehensive risk reduction impacts occur
during the product reregistration stage. During
fiscal year 1994, program emphasis began
shifting toward product reregistration, as many
more products became eligible. Product
reregistration will become even more important
during the next several years. Some of the
principal accomplishments of the reregistration
program during fiscal year 1994 and cumula-
tively are summarized below.
Annual and Cumulative Completion of REDs
The number of REDs completed per fiscal year has been increasing steadily since the accelerated
reregistration program began. This number reached 34 in fiscal year 1994 for a cumulative total of 81
completed REDs. A target of 40 more REDs has been set for fiscal year 1995.
FY91 FY92 FY93 FY94
Per Fiscal YearD Cumulative
FY95
Goal
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2 - REREGISTRATION
Page 15
Status of Reregistration Cases
OPP has completed a total of. 81 REDs, representing one fifth of the 405 chemical cases currently
supported for reregistration. Meanwhile, 207 of the original 612 cases are unsupported (meaning that the
registrants have decided not to complete and submit the studies required for reregistration). Cases that
remain unsupported have been or will be cancelled.
324 more to go
REDs completed
207 unsupported
Anatomy of the 81 REDs Completed
...Or, What "81 REDs Completed" Means... \
•
The 81 REDs completed cover 120 active ingredients, 3,521 products, and 500 tolerances. They
represent 20% of all supported reregistration cases (a case consists of one or more related pesticide
active ingredients); 17.5% of all currently registered pesticide products; 19% of food use pesticides
(supported List A cases); and 9% of original List A tolerances reassessed. As described in the table
below, the completed REDs represent about two-thirds of the quantity of pesticides used (by volume)
in the United States, including about two-thirds of all homeowner-applied pesticides and 9 to 14% of
all pesticides used in agriculture.*
Amount of Pesticide Usage (by volume)
Covered By REDs Completed*
.
Homeowner
Applied
Fungicides
Herbicides
Insecticides
Antimicrobials
TOTAL 1
50% to 55%
4%
10% to 15%
99% +
65%
Agriculture
55% to 60%
4% to 7%
i%to2%
99% +
9% to 14%
Commercial/
Industrial and
Government
4% to 7%
16% to 30%
1%to3%
99% +
65%
TOTAL
40% to 48%
"
6% to 10%
4% to 10%
99%
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 pounds used
may not indicate the relative percent of market share or number of applications.
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Page 16
OPRANNUAL REPORT
Risk Reductions Achieved
Each Reregistration Eligibility Decision (RED) document issued in 1994 involved changes to
reduce the potential risks of the pesticide being evaluated. Risks can be reduced by cancelling prod-
ucts, declaring uses ineligible for reregistration, strengthening the requirements on product labeling, or
limiting the amount of pesticide residues that may remain in food by establishing, reducing or revok-
ing "tolerances" (enforceable maximum residue limits). Some of the risk reduction measures achieved
in the 34 REDs completed this fiscal year are described in the following table:
Number of REDs =
1
6
19
10
8
3
6
5
14
8
Risk Reduction Measures Required By RED ; - ; .
All products and uses voluntarily cancelled (mevinphos).
Restricted Use Pesticide classification added or maintained, so
that the pesticide may be used only by or under direct
supervision of a certified applicator.
Personal Protective Equipment requirements for pesticide
applicators strengthened or confirmed.
Restrictions that limit entry of workers into treated areas
(including Restricted Entry Intervals) strengthened or confirmed.
Limits/reductions/specifications regarding the amount,
frequency, or rate of application required.
Use Directions on labeling strengthened or made more specific.
Other 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 a
tolerance) for each different type of food or
animal feed on which it may be used. The
number of tolerances for the List A pesticides
(which represent the most significant food use
pesticides) was about 5,600 in November 1988,
when the accelerated reregistration program
began. Since then, about 500 (or 9%) List A
pesticide tolerances have been reassessed as part
of the reregistration process. About 600 more List
A tolerances are associated with active ingredi-
ents no longer supported for reregistration; these
active ingredients ultimately will be cancelled
and their tolerances revoked. During the past
several years, some new tolerances have been
.added for the List A chemicals, while others have
been revoked. OPP estimates that approximately
4,500 tolerances for List A pesticides still need to
be reassessed during reregistration.
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2 - REREGISTRATION
Page 17
mi
Data Call-in (DCI) Notices
OPP has issued. 453 comprehensive Data Call-in (DCI) notices under the reregistration program
to obtain studies needed to assess potential health and environmental risks. As Phase 4 of reregistration
has been completed, which involved issuing DCIs to complete pesticide databases, the number of DCIs
issued per year has decreased. OPP issued 77 DCIs in 1994. ' ''
Status Of Studies Received
Registrants have responded to DCIs and other requirements by submitting more than 19,000
studies in support of reregistration. Review of these studies is essential for making reregistration ,
decisions. By end of fiscal 1994, OPP had reviewed more than 11,500 of -the studies, including nearly
7,000 of the approximately 9,000 studies received for List A pesticides. The cumulative numbers of
studies received, reviewed and awaiting review by scientific discipline are shown in the following
figures for the List A pesticides and for all pesticides undergoing reregistration.
Study Review Status For List A Pesticides
3,000
2,500
2,000
1,500
1,000
500
0
Received H
Reviewed d
Awaiting ReviewQ
Residue'Chemistry
2,632
2,118
514
Environ. Fate
2,140
1,349
f
791
Reentry Non-Dietary
. 209
51
158
ToxNon-CORT"
1,515
1,238
277
Tox-CORT
738
658
80
Eco Effects
1,742
1^363 j
I
377
* Tox-CORT - Chronic feeding, carcinogenicity (oncogenicity), reproduction,'
and developmental toxicity (teratology) studies.
**Tox Non-CORT - Studies other than CORT studies that measure the toxicity of
pesticides. : " ! :
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Page 18
OPPANNUAL REPORT
Study Review Status For All Pesticides
Undergoing Reregistration (Lists A, B, C, and D)
Received &
Reviewed Q
Awaiting ReviewQ
Residue Chemistry
4,250
2,709
1,541
Environ. Fate
3,741
1,960
1,781
Reentry Non-Dletarj
268
55
213
Tox Non-CORT
5,045
2,721
2,324
Tox-CORT
1,777
1,127
650
Eco Effects
4,304
2,930
1,374
Tox-CORT -
Tox Non-CORT -
Suspensions
Chronic feeding, carcinogenicity (oncogenicity), reproduction,
and developmental toxicity (teratology) studies.
Studies other than CORT studies that measure the toxicity of
pesticides.
When pesticide registrants fail to submit
studies requked for reregistration in a timely
way, EPA's Office of Enforcement and Compli-
ance Assurance (OECA) can issue Notices of
Intent to Suspend (NOITS) product registrations.
NOTTS serve as an effective mechanism for
bringing about compliance with EPA's data
requirements for reregistration; in most instances
companies comply with the NOITS by submit-
ting the missing studies. If companies fail to
comply by either submitting the required studies,
voluntarily withdrawing their product registra-
tions, or requesting a hearing, EPA can issue
suspensions.
During fiscal year 1994, EPA issued NOITS
to 179 companies. The Agency eventually
withdrew 128 of these NOITS because the
companies achieved compliance. However, EPA
also issued 47 suspensions, and in four other
cases is responding to requests for hearings to
resolve questions about the Agency's data
requirements. These fiscal year 1994 actions
bring the total number of NOITS issued since
1989 to 779, and the number of suspensions to
301. In most of the remaining 478 cases,
compliance has been achieved,.while hearings
continue to resolve remaining issues in some of
the cases.
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2-REREGISTRATION
Page 19
m)
Voluntary Cancellations
In some instances, registrants have responded to reregistration requirements by withdrawing
support for pesticide active ingredients and products. Reregistration cases have dropped overall from
612 cases in 1988 to 405 today. Registered products declined during the early 1990s from approxi-
mately 45,000 to about 20,000 subject to reregistration. This initial decline represented pesticides with
little or no use; more than 19,000 of these pesticides had not been produced in the three years prior to
their cancellation. As product reregistration proceeds (please see below), a significant number of
additional products are being voluntarily cancelled by their registrants. !
Product Reregistration
While REDs are OPP's major reregistration output, much of the real world impact of eligibility
decisions and risk reduction requirements does not occur until products are reregistered. This occurs at
least 14 months after a RED is issued because of the time required for registrants to submit product-
specific data and labels and for OPP to review them. A,s of October 1994, OPPhad reregistered over
600 products, granted a greater number of voluntary cancellations (925), amended 11 existing registra-
tions, and suspended 449 products. Reregistration decisions are pending on a total of 980 products.
Activity in this important area will increase dramatically during the next several years.
Status of Product Reregistration
980
925
449
601
CD Pending Q Cancelled E\j Reregistered
• Amended H Suspended
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Page 20
OPP ANNUAL REPbRfr
Rejection Rate Analysis
In 1991, OPP discovered that the submis-
sion of unacceptable studies was the mos,t
significant factor delaying reregistration. Repeat-
ing studies can add years to the reregistration
process, significantly increase the OPP's admin-
istrative and science review costs, and cost
registrants millions of dollars. To address the
high rate of rejection pf studies submitted during
reregistration, OPP developed the Rejection Rate
Analysis.
OPP's analysis, which involves the active
cooperation of the pesticide industry, and the IR-4
program, is an intensive effort to identify and
resolve the underlying problems that most ,
frequently cause studies to be rejected. The :
resulting reports for each discipline — including
Residue Chemistry, Worker Exposure, Toxicol-
ogy, and Environmental Fate — are designed to
make sure that future studies will be acceptable
to the Agency.
By 1994, two years after the first Rejection
Rate Analysis chapter was published by OPP, the
quality of studies submitted to OPP was improv-
ing. For example, processing studies, which
initially had the highest rejection rate among
residue chemistry studies, improved from a 29%
rejection rate before the analysis to a 16% rate
afterwards. The second most often rejected study,
plant metabolism, improved dramatically from a
27% rejection rate before the analysis to only 8%
after. Improvements such as these will assist OPP
in making reregistration decisions in a more
timely way,
.The next milestone in the Rejection Rate
Analysis will be publication of the final chapter
on Ecological Effects in 1995. EPA and industry
scientists first met in April 1994 to improve
understanding of factors leading to ecological
effects study rejection. This effort became a
forum for expressing divergent perspectives on
the way risk to birds is assessed. The analysis
discovered that rejection rates for some testing
requirements have decreased over time, but that
rates for others have not. On average, the rate at
which OPP rejects ecological effects studies has
declined from 36% prior to 1986 to the current
rate of 20%.
While some testing issues have been
resolved through the Rejection Rate Analysis,
others remain to be addressed by future
workgroups that OPP hopes will involve contin-
ued public participation.
Pestic e Chemistry Laboratory Support For Reregistration
In addition to supporting pesticide registra-
tion (as described in chapter 1), OPP's two
pesticide chemistry labs provide support for the
reregistration program. The Analytical Chemistry
Laboratory validated one food tolerance method
for reregistration in 1994. Approximately five to
ten methods are expected in 1995. The Environ-
mental Chemistry Laboratory (ECL) completed
four analytical method validations for pesticides
in soil and water under the reregistration program
in fiscal year 1994. In addition, the ECL devel-
oped a multianalyte method for detecting nine
sulfonylurea pesticides in water. The ECL also
prepared a draft of the new environmental
chemistry methods manual, which will contain
all of the EPA validated and non-validated soil
and water methods.
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2 - REREGISTRATION
Page 21
Reducing Pesticide Spray Drift
Aerial or ground application of pesticides
may lead to drift off the site of intended applica-
tion and result in exposure to workers, nearby
residents, nontarget plants, and other ecological
resources. To better understand the factors which
affect spray drift, OPP worked closely in 1994
with the Spray Drift Task Force (SDTF), a
coalition of 32 pesticide registrants. The SDTF is
conducting extensive research into the factors
that contribute to and can control spray drift. The
information generated by the task force will
greatly enhance OPP's ability to assess exposure
resulting from spray drift, prevent excessive
spray drift, and reduce risks caused by drift.
These data will help fulfill requirements of
pesticide registration. 1994 highlights include:
Q EPA's Office of Research and Development
(ORD), the U.S. Department of Agriculture
Dioxins comprise a group of chemically-
similar, highly toxic compounds that are of
concern to EPA. Because some pesticides have
been found to be contaminated with low levels of
dioxins, OPP has contributed to EPA's exhaustive
reassessment of dioxin risks conducted since
1991. OPP's Environmental Chemistry Labora-
tory performed a number of analyses of animal
tissue in 1994 as part of the reassessment, and
helped review dioxin sampling and analysis
methods. In September 1994, the Agency
publicly released a draft version of the reassess-
ment of dioxin risks and issued a voluntary call
for additional information. The report highlighted
not only cancer concerns but also possible
reproductive, developmental, and immunological
effects detected in animals.
OPP has taken several steps to ensure that
pesticides do not contain dioxins at levels that
pose unreasonable risks to public health or the
environment. In 1987, OPP issued two data call-
ins that applied to 161 active ingredients. Of
(USDA), and the SDTF signed a Cooperative
Research and Development Agreement in
March 1994. •'• ','•••.
Q OPP is providing input to spray drift modeling
efforts under the cooperative research agree-
ment. The models developed will enable
optimal use of spray drift data and provide
options for reducing drift and managing risk:
Q A conference was held in June 1994 to discuss
the SDTF's preliminary data on drift from
airblast applications to tree crops and to '
identify additional research priorities. Orchard
crop specialists from the United States and
Europe attended.
Q OPP reviewed the first official data subimis- •
sion of the SDTF.
Reassessment Of Diox
n Risks
those, 92 have been cancelled or are no longer
being supported for reregistration. To date, OPP
has reviewed submissions regarding the manufac-
turing processes of 43 of the supported active
ingredients and determined that dioxins are
. unlikely to be formed. Through analysis of
production samples, nine other active ingredients
were found not to contain dioxin impurities.
Thus, of the 161 originally subject to review, 144
are no longer of concern.
As of 1994, four of the remaining 17 active
ingredients have been found to have manufactur-
ing processes which produced levels of dioxins
slightly above what is known as the Level of
Quantification. Based on assessments using the
"To'xicity Equivalent Factor" approach, OPP
believes that the levels of dioxins in these ifour
active ingredients pose a negligible risk "to human
health. OPP expects to complete review of the
manufacturing processes of the remaining 13
chemicals by the end of 1995.
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Page 22
OPP ANNUAL REPORT!
Reducing Ecological Risks Under The "New Paradigm"
In March 1992, EPA established an internal
task force to review and assess the role of
ecological and environmental fate data in OPP's
regulatory process. One of the task force's
accomplishments was the development of an
approach known as the "New Paradigm." This
approach is intended to strengthen the Agency's
efforts to prevent adverse effects to the environ-
ment from pesticides, while simultaneously
accelerating pesticide reregistration. The strategy
of this program is to reduce risks more quickly
when the Agency receives information that
pesticides may be causing adverse environmental
effects, rather than requesting and waiting for
additional studies to be submitted.
This emphasis led OPP to develop a paper
providing preliminary guidance on risk reduction
strategies and monitoring programs, including a
The Label Use Information System (LUIS)
The Label Use Information System (LUIS)
is a product-level database of pesticide label
directions. It contains detailed information on
registered sites, application methods, application
rates, and limitations on the use of pesticides
(e.g., preharvest intervals, reentry intervals).
LUIS information can be reported by active
ingredient to support chemical regulatory
decisions; it can also be reported by product to
monitor product compliance with regulatory
decisions. In addition, the database can be used
format for registrants to follow when submitting
mitigation and monitoring proposals. OPP then
initiated a number of outreach activities related
to risk mitigation and monitoring, such as
presentations at workshops and scientific confer-
ences and wide distribution of the document to
pesticide registrants during the registration and
reregistration processes. As a result of this effort,
the regulated community has submitted improved
mitigation proposals. Many are now following
OPP's proposed format, which has led to the
submission of more clearly defined and justified
mitigation measures. In addition, OPP has
incorporated environmental risk mitigation in
almost half of the documents issued through the
reregistration process. This approach of requiring
risk mitigation and monitoring applies during the
registration of new pesticides as well.
to help locate labels which match a specified
parameter. In 1994, OPP completed initial entry
of information for most pesticides undergoing
reregistration. During 1995, OPP will complete
initial data entry and begin expanding LUIS
capabilities so it can support registration and
Special Review as well reregistration. Eventually,
it will be linked to other pesticide data systems
and made available electronically to all OPP
staff.
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Special Review
Special Review is EPA's formal process for
determining whether the use of a pesticide poses
unreasonable risks to people or the environment.
In making this determination, EPA must consider
the pesticide's risks and benefits. Special Review
is designed to allow formal public input to the
decision-making process. A Special Review can
result in a decision to cancel, restrict, or continue
the pesticide uses in question.
Inorganic arsenicals. OPP concluded the
Special Review for inorganic arsenicals by
publishing a Notice of Final Determination. All
affected uses (uses other than as wood preserva-
tives and sealed ant baits) were voluntarily
cancelled as a result of the Special Review. This
action culminated a Special Review initiated in
1978 because of concerns about risks of cancer,
reproductive and fetal effects, and mutagenicity
(genetic effects).
EBDCs. OPP completed a Special Review
for a group of fungicides known as the EBDCs in
1992 by cancelling a number of uses and placing
restrictions on the remaining uses. Subsequently, a
registrant requested a change in certain of the
restrictions. In 1994, OPP helped support the
hearing that responded to the request, which
The Special Review process is set in motion
when EPA has reason to believe that the use of a
registered pesticide poses significant risks to
people or the environment. Over 100 pesticides or
groups of closely related pesticides have been
evaluated through the Special Review process.
While reregistration applies to all older pesticides,
Special Review is applied to those pesticides of
particularly serious concern.
1994 Formal Special Reviews And Follow-up Activities
resulted in an amendment allowing the use of
more than one EBDC on a crop during the course
of the growing season, as long as the total amount
of pesticide applied does not exceed the maxi-
mum amount allowable from any one EBDC
application.
Carbofuran. OPP also revisited the Special
Review for the granular formulation of the
insecticide carbofuran when registrants requested
an extension of uses for rice, corn, and sorghum.
OPP published a proposal in the Federal Register
which would allow for a maximum of two more
years of use on rice but no more use on corn and
sorghum. OPP began phasing out most uses of
carbofuran in 1991 because of risks of bird
poisonings.
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Page 24
OPP ANNUAL REPORT
Cancellation Of Mevinphos
OPP continues to reduce risks by means
other than the traditional Special Review process,
particularly,through negotiated settlements. The
agreement to cancel all uses of the agricultural
insecticide mevinphos — one of the most acutely
toxic pesticides produced in the United States —
exemplifies how such actions can achieve
substantial protection of human health and the
environment.
In response to planned actions by OPP and
the State of California to remove mevinphos from
the market, the registrant requested that its
registrations be cancelled. The registrant also
agreed to a voluntary recall of all product still in
Other Negotiated Risk Reduction Efforts
During fiscal year 1994, OPP successfully
negotiated for the reduction of health risks
associated with several pesticides in addition to
mevinphos:
PCNB. Registrants agreed to lower levels of
two carcinogenic contaminants, HCB and PCB, in
their products, bringing dietary risk down to the
negligible level.
Metrex. OPP negotiated a settlement with
the registrant because of concerns about the risk
posed by failure of this hospital sterilant to work
properly. The settlement imposed label require-
Other Cancellation Activities
In addition to the negotiated settlements
described previously, OPP handled several
cancellation actions in 1994. Two (for TBT
fluoride and mercury compounds used on turf)
were voluntary actions prompted by the regis-
trants' decision not to develop required data. OPP
the channels of trade after sale and distribution of
product was no longer allowed. The cancellation
was based on OPP's determination that the risks to
agricultural workers were unacceptable. Poisoning
data from California and other states showed that
even when workers followed stringent label
restrictions, an alarming number of poisoning
incidents occurred. From 1982 through 1992,
California (where about half of U.S. use of
mevinphos occurred) recorded 594 poisonings
associated with'the use of mevinphos alone and in
combination with other pesticides. Mevinphos
alternatives are significantly less risky to workers
than mevinphos. .
ments for longer contact times with treated
surfaces and higher treatment temperatures to
ensure that treated medical instruments were
adequately sterilized.
Simazine. Twenty-two registrations of
simazine used as an algicide in swimming pools
were voluntarily cancelled after OPP approached
registrants about unacceptable cancer risk to
swimmers. OPP subsequently cancelled the
remaining swimming pool simazine products
when their registrants declined to join the volun-
tary cancellation.
also amended the earlier cancellation notices for
the herbicide methazole (to extend the existing
stocks period) and for Wipeout, a medical sterilant
containing glutaraldehyde (to add new risks of
concern).
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3 ^ SPECIAL REVIEW
Page 25
Tolerance Revocations
OPP continued to propose or finalize
revocations of tolerances (maximum residues
allowed in food) for pesticides cancelled through
Special Review or for other reasons. OPP gener-
ally revokes tolerances some time after the uses
are cancelled to allow legally treated foods to
move through the marketplace and to account for
possible foreign use on imported food. OPP
proposed or finalized tolerance revocations and
revisions for eight active ingredients in 1994:
arsenic acid, carbopheriothion, DDVP, diallate,
dicofol, PCNB, perthane, and ronnel.
Initiative To Reduce Risks To Birds (Avian Granular Initiative)
OPP continued to track the progress of the
voluntary risk reduction initiative begun in 1992
for granular pesticide formulations posing risks to
birds. OPP prepared a progress report that
describes the voluntary risk reduction proposals
received from seven registrants. The proposals
include lower application rates, reduced number
of applications, and use of application methods
designed to reduce the number of exposed
granules in end rows. Granular pesticides can be
eaten by birds feeding in agricultural areas.
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OPP ANNUAL REPORT;
-------
Field Implementation
and Communication
The major regulatory areas discussed by the
first three chapters — registration, reregistration,
and Special Review — primarily involve interac-
tion with pesticide registrants, though many other
organizations are also affected by and involved
with OPP's decisions in these areas. In this
chapter, the emphasis shifts to regulatory pro-
grams directed at pesticide users and imple-
mented in the field. This chapter also discusses
how OPP shares information with pesticide users
and the myriad of other organizations and
citizens interested in pesticides. Finally, this
chapter discusses OPP's support for efforts to
ensure compliance with pesticide requirements.
All of these efforts complement the pesticide
regulatory programs described in the first three
chapters by improving the safety with which
pesticides are used, and by making the public
aware of the risks and benefits of pesticides and
the availability of alternatives.
A. Field Programs
The major field programs that OPP imple-
ments, as described in more detail in this chapter,
are the Worker Protection Standard, the Endan-
gered Species Protection Program, ground water
protection programs, certification and training of
pesticide applicators, and disposal of suspended
and cancelled pesticides (completed in 1994).
Voluntary field efforts in 1994 included promot-
ing integrated pest management (IPM) and
drafting guidance for states for posting of
residential and commercial pesticide applications.
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OPP ANNUAL REPORT
Implementing The Worker Protection Standard
OPP revised the Worker Protection Stan-
dard (WPS) for agricultural pesticides in 1992
and it became fully effective on January 1, 1995.
The Standard represents a major strengthening of
national efforts to safeguard agricultural workers.
Agricultural employers are required to follow
new measures to protect their employees,
including safety training, notifications about
pesticide applications, provisions for washing
facilities, and maintenance of protective equip-
ment. OPP believes that the WPS will substan-
tially reduce the risk of pesticide poisonings and
injuries among agricultural workers and pesticide
handlers.
In 1994, OPP carried out a number of
Worker Protection activities in preparation for
full implementation in 1995, many of which
included the participation of EPA's ten regional
offices. OPP:
Q Worked with pesticide registrants to ensure
that the labeling of all agricultural pesticides
was revised to convey stronger worker
protection requirements, such as restrictions
on entry to treated areas and use of personal
protective equipment.
Q Continued to work with the states, USDA's
Cooperative Extension Service, and the
agricultural community to help employers
obtain the information and assistance they
need. Over 1.7 million copies of OPP's
Agricultural Worker Training Handbook have
been distributed, as well as thousands of the
How To Comply Manual and the Pesticide
Handler Training Handbook. A number of
other publications, videos, and training
materials are available.
Q Developed a voluntary program to issue
training verification cards to workers and
handlers to promote safety training for
agricultural workers and to make it easier for
agricultural employers to ensure that their
workers have been trained. To date, 40 states,
Puerto Rico, and two tribes have agreed to
participate in the program, with more expected
to join.
Q Met directly with more than 25 organizations
affected by the WPS to resolve problems and
improve implementation of the standard. EPA
held workshops on the WPS and conducted
periodic meetings and discussions with
agricultural groups.
Q Approved the first exception to the WPS. For
a two-year period and under specified condi-
tions, the exception allows early entry into
pesticide-treated areas in greenhouses to
harvest cut roses. The WPS establishes a
process for OPP to approve requests for
exceptions if the benefits of the exception
outweigh the costs (including any health risks)
attributable to the exception.
Q Evaluated certain WPS provisions where
change or flexibility may be needed to make
sure that workers are protected and that the
requirements are fair and achievable. OPP has
proposed changes to the WPS in the following
areas and, based on public comments, expects
. to finalize them in the spring of 1995:
4 Strengthened safety training requirements.
•* Reduced requirements for crop advisors.
* Reduced restrictions for lower risk
pesticides.
* Reduced requirements for irrigation activi-
ties.
+ Reduced requirements for other activities
that result in limited contact to pesticides.
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FIELD IMPLEMENTATION AND COMMUNICATION
Page 29
The primary goal of OPP's Endangered
Species Protection Program (ESPP) is to protect
federally listed threatened and endangered
species from the direct and indirect impacts of
pesticide use. As mandated by the 1988 amend-
ments to the Endangered Species Act, this goal is
to be accomplished while minimizing the burden
on pesticide users. Currently, OPP is carrying out
an interim, non-regulatory program to protect
endangered species while finalizing an endan-
gered species protection regulation.
The ESPP was very productive in 1994.
OPP produced and widely distributed many
materials supporting and promoting the voluntary
program, and is currently distributing 240
county-specific pamphlets in 22 states and Puerto
Rico that describe voluntary measures pesticide
users can take to avoid affecting threatened and
endangered species with pesticides. OPP also
completed fact sheets about eight additional
endangered species, such as the Bald Eagle and
Whooping Crane, bringing the total number of
species fact sheets to 45. OPP also continued the
operation of a toll-free endangered species
hotline to provide more information about the
program.
In implementing the endangered species
program in 1994, OPP worked closely with EPA
regions, states, and other federal agencies, such
Ground water provides about one-fourth of
all water used in the United States and is the
source of drinking water for about half the U.S.
population. It also is a vital component of the
ecosystem. For example, ground water often
flows into surface water systems that are habitats
for fish, sustain wetlands, and support commerce.
OPP has several programs in place to protect this
critical natural resource from pesticide contami-
nation.
1
V
Endangered Species. Protection F
rogram
as the U.S. Fish and Wildlife Service (FWS).
This cooperation was exemplified by efforts to ,
protect the Wyoming Toad, an endangered
species known to occur in the wild only in
Albany County, Wyoming. The Wyoming
Department of Agriculture, FWS, EPA's Region 8
Office, and OPP forged an agreement with local .
landowners and officials to postpone pesticide
use on land within the toad's range until the land
could be surveyed for potential habitat. No new
toad populations were found on private lands,
and pesticide applications resumed in areas
where the toad was not found. The case serves as
a model for the cooperation of landowners and
federal, state, and local governments to imple-
ment the Endangered Species Act.
OPP also provided extensive comments on
the Fish and Wildlife Service'^ draft Biological
Opinion, which addresses the potential impacts
of all uses of 15 major agricultural pesticides. In
addition, OPP has begun requesting endangered
species data from registrants on particular
registration requests. Registrants may form a task
force to supply the necessary data to cover all
pesticide use sites.. The next major step is to
announce the final regulation and program by
publishing a Notice in the Federal Register. OPP
spent much of .1994 working with FWS and the
U.S. Department of Agriculture to develop the
final plans for the ESPP.
Protecting Groun
d Water
The centerpiece of OPP's strategy is a
cooperative effort to develop State Management
Plans (SMPs) to prevent ground-water pollution
from pesticides. An important step in this
approach has been the development of "Generic"
SMPs, which aim to create the capacity for
protecting ground water regardless of the
pesticide. Forty-six states have submitted draft
Generic plans to the EPA regions, and the regions
have provided comments on most of these plans.
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OPPANNUALREPOR
Final regional concurrence on all Generic plans
is expected January 1996. The next major step
will be the requirement that states develop
pesticide-specific SMPs for those pesticides
found to leach into ground water. OPP has
received comments on a draft rule for pesticide-
specific SMPs from all ten EPA regions and
expects to issue a Notice of Proposed
Rulemaking (NPRM) during 1995. OPP also
works closely with EPA's Office of Water to
ensure that the pesticide SMP program will
complement the Agency's Comprehensive State
Ground Water Protection Program.
Another important feature of OPP's
strategy has been to establish procedures during
registration and reregistration to evaluate a
pesticide's potential to contaminate ground water.
In 1994, OPP began to implement a new ap-
proach that achieves early mitigation .of ground-
Certification And Training Of Pesticide Applicators
When OPP designates some or all uses of a
pesticide as "Restricted," then the pesticide may
be used only by or under the direct supervision of
certified users. Certification Programs are
conducted by states, territories, and tribes and are
designed to ensure that users of the most risky
pesticides are knowledgeable about their risks
and uses. OPP sets national standards for the
programs, which certify over one million applica-
tors nationwide.
In 1994, OPP continued to work to revise
its national standards to better ensure continued
competency of certified applicators. To assist the
Disposal Of Suspended And Cancelled Pesticides
In 1994, OPP completed its disposal
program for suspended and cancelled pesticides,
thus removing the risks posed by unused stocks of
these pesticides. Prior to the 1988 revisions of the
Federal Insecticide, Fungicide, and Rodenticide
Act, OPP was required to accept suspended and
cancelled pesticide products for disposal if
requested by holders. 2,4,5-T and silvex pesti- ,
water risks. In cases such as the registration of
acetochlor, OPP required that registrants better
target the use of pesticides and conduct follow-up
monitoring to protect ground water .quality. OPP
continues to track evidence of ground water
contamination through its Pesticides and Ground
Water Data Base.
Furthermore, OPP expects to issue a final
rule in 1995 that would add criteria for classify-
ing a pesticide for restricted use if any of its
ingredients has the potential for contaminating
ground water on a widespread basis. Pesticide
products" classified for restricted use may be
purchased and used only- by- certified pesticide
applicators or individuals under their supervision.
OPP believes that a pesticide is less likely to
contaminate ground water if it is used only by
trained applicators.
state, territory and tribal governments in conduct-
ing certification programs, OPP also continued
cooperative agreements and provided funding to
64 governments. OPP also provided funding to
state extension coordinators through the U.S.
Department of Agriculture to conduct certifica-
tion training programs. Training covers general
areas of pesticide use as well as specific uses for
which a person wishes to become certified. For
example, training to become certified to apply
pesticides to structures (such as schools, houses,
and office buildings) includes information about
ventilating structures prior to re-occupation.
cides were suspended and cancelled prior to 1988
because of concerns about dioxin contamination.
OPP accepted about 300 tons of granular 2,4,5-T/
silvex materials and 30,000 gallons of liquid
materials from several hundred holders at a
hazardous waste storage facility. On May 27,
1994, OPP disposed of the last of these 2,4,5-T/
silvex stocks at a hazardous waste incinerator.
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4 - FIELD IMPLEMENTATION AND COMMUNICATION
Promoting Integrated Pest Management
Integrated Pest Management, or IPM,
involves the carefully managed use of an array of
pest control tactics — including biological,
cultural, and chemical methods — to achieve the
best results with the least disruption of the
environment. IPM relies upon an understanding
of life cycles of pests and their interactions with
the environment. Biological control refers to'
using natural enemies of the pest, such as
employing ladybugs to control aphids. Cultural
control involves practices of cultivation, crop
rotation, and other methods that prevent or
control pests. IPM also involves the judicious use
of chemical pesticides, if necessary.
OPP's IPM accomplishments extended to
both the urban and agricultural sectors. In the
urban arena, OPP published Pest Control in the
School Environment: Adopting Integrated Pest
Management. This creatively illustrated booklet,
already in wide circulation, will be provided to
every school district in the United States by the
end of 199-5. Companion training videos, pro-
duced in cooperation with Texas A&M Univer-
sity, should be finished during the spring of 1995.
OPP also edited and published, through Lewis
Publishing Company, Integrated Pest Manage-
ment for Turf Grass and Ornamentals. This book
is the most up-to-date and comprehensive
publication on the subject and has already been
widely accepted within the professional landscape
community.
In the agricultural sector, OPP has hosted a
series of commodity-specific workshops to inform
growers about existing IPM techniques and help
identify impediments to IPM adoption. The
proceedings from this year's peanut, stored
commodity, and potato workshops, along with
those developed during 1993, are being used to
help frame the Agency's position on agricultural
legislation (such as the Farm Bill).
Guidance For Posting Of Outdoor Pesticide Applications
During 1994, OPP began the development
of draft guidance for states and local jurisdictions
regarding "posting" of outdoor residential and
commercial pesticide applications. Posting refers
to the placement of signs at visible entry areas to
inform bystanders that a pesticide has been
recently applied. This guidance is being devel-
oped to help harmonize such state and local
programs. OPP hopes that such guidance will
help lead to better consumer awareness and
understanding of posting, increased compliance
with posting requirements, and reduced burdens
upon lawn care professionals who sometimes
must deal with a confusing array of differing
requirements. OPP intends to publish a draft in
the Federal Register for public comment in 1995.
B. Communications, Public Response, and Coordination
Outreach to the public is vital to the
mission of OPP. By the term "public," OPP means
all constituents affected by or interested in
pesticide issues — not only states, tribes, and
EPA regions, but also citizens, environmental and
public interest groups, industry and trade associa-
tions, pesticide users, Congressional staff,
medical and health representatives, academia,
international organizations, other federal agen-
cies, and the media. This section describes several
of the ways that OPP provides information to the
public, responds to inquiries, and in turn obtains
valuable public input.
OPP's approach to communications is to
make information widely available, easily
accessible, and suited to different public prefer-
ences. To accomplish this, OPP issues announce-
ments 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 Congres-
sional testimony. I
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Page 32
OPP ANNUALRERPRT
Outreach And Communications Strategies
In 1994, OPP issued more than 50 an-
nouncements inform the public about OPP's
major regulatory and policy decisions Each
announcement is planned using a communica-
tions strategy, and often entails a press notice and
additional outreach materials, such as fact sheets
or questions and answers. OPP also made special
efforts during the past year to make the public
aware of available information resources and to
provide general pesticide information. In June,
OPP issued a Pesticide Regulation Notice (PR -
94-3) that summarizes the many avenues one can
take to obtain information from OPP. Another
accomplishment this year was the preparation of
OPP's first catalog of pesticide publications. OPP
distributed both documents extensively, and they
continue to be widely requested. OPP also
continued to distribute other documents to the
public with the help of the National Center for
Responding To The Public
Freedom of Information Act Requests
OPP responds to specific technical or
complicated information requests from the public
under the Freedom of Information Act (FOIAX
OPP continues to receive the highest number of
FOIA requests of any program within EPA, and
in fiscal year 1994 received 1,578 requests.
Despite this heavy workload, OPP was able to
reduce its backlog of FOIA requests by more
than half. The majority of requestors receive all
of the records they request, with the most
common requests being for science reviews of
registration data, administrative files for pesti-
cide products, and product labels.
OPP Public Docket
OPP has established four dockets, operated
by a contractor, to house the regulatory notices,
background documents, and public comments on
OPP activities. These consist of the Federal
Register, Special Review, Registration Standard,
and Special Program Dockets. Thousands of
requests were received in 1994 for docket
information —• by letter (over 1,000 requests),
telephone (over 2,000 requests), and in person.
Citizens account for the largest number of
requests for docket information.
Environmental Publications and Information; for
example, OPP distributed over 45,000 copies of
the booklet Healthy Lawn, Healthy Environment:
Caring for Your Lawn in an Environmentally
Friendly Way and over 15,000 copies of the
booklet Citizen's Guide to Pesticides.
Protecting children from pesticide poison-
ing continues to be an important focus of OPP's
outreach efforts. Working with the Poison
Prevention Council and the Consumer Product
Safety Commission, OPP has participated over
the past three years in the activities leading to
Poison Prevention Week. Through this mecha-
nism, each year OPP distributes thousands of
copies of fact sheets on pesticides and child
safety and on using insect repellents safely (both
in English and Spanish) to medical establish-
ments and the general public.
National Pesticides Tele-
communications Network (NPTN)
NPTN is a toll-free telephone service
available to provide a variety of impartial
information about pesticides to anyone in the
United States, Puerto Rico, and the Virgin
Islands. The service operates Monday through
Friday from 8:00 a.m. to 6:00 p.m. (Central
Standard Time). NPTN provided services to more
than 25,000 callers during fiscal year 1994,
including approximately 1,300 calls concerning
pesticide incidents. The remaining calls were
requests for general information on pesticide
products and issues concerning health, safety, and
use.
National Pesticide Medical
Monitoring Program (NPMMP)
The NPMMP, located at Oregon State
University, provides information and referrals on
the clinical toxicology of pesticides and analyti-
cal services for both biological and environmen-
tal samples. Consultations are given to both
possible victims and health care professionals.
NPMMP handles 200 to 300 cases per year.
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4 - FIELD IMPLEMENTATION AND COMMUNICATION
Page 33
Letters
OPP also responded to a substantial number
of letters to the Agency on pesticide-related
issues, including letter campaigns on subjects
Congressional interest and oversight in
pesticide and food safety issues continues at a
high level as OPP responded to almost 400
inquiries over the past year. OPP also prepared
testimony and briefing materials for eight
Congressional hearings concerning pesticide
issues (such as pesticide exports/food safety and
worker protection standards). During the past
year, OPP assisted the General Accounting Office
(GAO) and EPA's Inspector General (IG) office
with seven ongoing evaluations of the pesticide
OPP continues to seek ways to provide
meaningful opportunities for the public to meet
with the Agency and discuss pesticide issues of
concern. OPP held several meetings during 1994,
some on a quarterly basis, with a variety of
constituent groups. OPP hosted regular meetings
with environmental and public interest groups
during the year, and set up several on topics of
special interest, such as international issues and
the farmworker protection program. OPP also
The Pesticide Information Network (PIN) is
a computerized, on-line collection of files
containing current and historic pesticide informa-
tion. This system is designed to enhance OPP's
data gathering efforts; aid state agencies and
others in obtaining needed information on a
timely basis, thereby improving their ability to
respond to local pesticide situations and federal
requirements; save OPP resources through
automated dissemination and updating of public
information; and enhance cooperative efforts
between EPA and other federal agencies through
a convenient method of information sharing.
such as food safety, pesticides and children, the
Delaney clause, livestock predator pesticides,
and worker protection.
Congressional And Federal Coor
dination
program's activities: EPA's decision on
carbofuran; a survey of EPA actions related to
EBDC uses; EPA's process for reinventing
tolerances for cancelled pesticides; EPA's
collection of user fees; the Chief Financial
Officer's audit of the fiscal year 1994 financial
statement; environmental laws and regulations
pertaining to agriculture; and the federal
government's compliance with the Endangered
Species Act.
Public Meetings
held quarterly meetings with the American Crop
Protection Association (formerly NACA).
Additionally, OPP conducted two large-scale
workshops in 1994 for a broad spectrum of
participants, with one workshop focusing on
general pesticide issues and the other on reducing
pesticide use and risk. Looking ahead, OPP will
seek opportunities for more in-depth discussions
of critical program policies and issues with a
cross-section of constituent groups.
Pesticide Information Network
In 1994, OPP worked to upgrade the ,
system, and the revised PIN is expected to open
in early 1995. The PIN will contain several
different types of information. These wiill consist
of the Pesticide Monitoring Inventory (PMI)
(including the Pesticides in Ground Water
Database), the Ecological Incident Information
System (EIIS) (described in more detail in
chapter 6), an Environmental Fate and Ecologi-
cal Effects compilation, a Regulatory Status
database, the Certification and Training
Bibliography, and a Biological Pesticides data
set. \. ••. .
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Page 34
OPP ANNUAL REPORT
Agency Risk Management Communication Group
Sclent c Presentations And Publications
OPP actively participated during 1994 in
the Agency Ecological Risk Management
Communication Group, which was formed to
address EPA's difficulties in using the assess-
ments of ecological risks to properly manage
those risks. The first major project of the Group,
completed in 1994, was to write a document that
would help risk managers throughout the Agency
make decisions that include a consideration of
OPP believes that sound scientific informa-
tion is the cornerstone for assessing and manag-
ing risks, as will he described in chapter 5. OPP
scientists continue to contribute to the develop-
ment and application of their varied scientific
disciplines, including hydrology, biology,
agronomy, chemistry, toxicology, and many
others. In 1994, OPP scientists presented several
dozen papers and posters at a number of profes-
sional meetings of organizations such as:
Q American Chemical Society
Q American Society of Agronomy
Q American Phytopathological Association
Q International Union of Pure and Applied
Chemistry
International Coordination And Integration
This section describes OPP's efforts to
inform foreign governments about the status of
U.S. pesticides and OPP programs. The purpose
of these efforts is to help foreign governments,
especially those that have not yet developed
extensive pesticide regulatory and information-
gathering programs, make informed choices
about the use of pesticides in their countries. Not
ecological risk. The document is introductory in
nature and contains a great deal of basic informa-
tion about the value of ecological resources,
determining what resources should be protected,
understanding the involvement of a risk manager
in the risk assessment process, and using a risk
assessment for risk decision-making. The Group
also hopes that experienced risk managers will
benefit from the document.
Q Society of Environmental Toxicology and
Chemistry
Q Society of Quality Assurance
Q Soil Science Society of America
OPP scientists served as editors for a book
titled Agrichemical Environmental Fate State of
the Art, which is scheduled to be released in May
1995. They also published a number of profes-
sional papers, including several that appeared in
conference proceedings and symposiums of
associations listed above and in journals like the
Journal of Invertebrate Pathology and Environ-
mental Toxicology and Chemistry. In addition,
OPP scientists lectured at Clemson University,
the University of Maryland, and other universi-
ties and organizations.
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.
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4 - FIELD IMPLEMENTATION AND COMMUNICATION
Page 35
Export Notification for
Unregistered Pesticides
For all exports of pesticides not registered
in the United States, federal pesticide law
(FIFRA section 17(a)) requires the U.S. exporter
to obtain a statement from the buyer acknowledg-
ing that the product is unregistered in the U.S.
The exporter must then submit this statement to
OPP, and OPP forwards a copy to the importing
government. In 1994, OPP transmitted approxi- •
mately 1,600 export notifications to the govern-
ments of importing countries.
Information Exchange with
Foreign Countries
Another provision of federal pesticide law,
FIFRA section 17(b), requires OPP to operate an
information-sharing program with health and
environmental agencies in other countries.
Through this program, OPP sends information
notices to other governments on important
regulatory decisions made in the United States
related to pesticides, food safety, and pest
management. In 1994, OPP transmitted several
notices of major regulatory actions on specific
pesticides, such as the voluntary cancellation of
mevinphos, and other pesticide documents.
Section 17(b) notifications are distributed directly
to the pesticide regulatory authorities in approxi-
mately 140 countries.
Regional Coordination
Staff in each of EPA's 10 regional offices
are OPP's primary connection to state, territorial,
and tribal governments. They negotiate coopera-
tive agreements for OPP's field programs, assist
the governments in developing and implementing
programs, and oversee accomplishments and
commitments made by the states, territories and
tribes. Additionally, regional staff communicate
OPP's programs and policies to the public and in
turn provide OPP with information from the
public. Clearly, OPP's regional counterparts are
critical to the success of developing, implement1
ing and communicating OPP programs and
actions. Therefore, OPP works to ensure that the
regional offices are involved in or informed of all
OPP activities.
Prior Informed Consent (PIC)
i
EPA is a participant in this program
developed by the United Nations Environment
Programme (UNEP) and the U.N. Food and
Agriculture Organization (FAO) to promote the
safe management of chemicals. PIC establishes a
mechanism whereby importing countries can
receive information about pesticides and indus-
trial chemicals and then determine whether to
allow, restrict, or prohibit future imports of the
chemicals. In 1994, EPA formally nominated
mevinphos for inclusion on the UN list of banned
pesticides because it was voluntary cancelled in
1994 (see the Special Review chapter for more
information). In addition, work progressed
internationally toward making PIC a legally
binding instrument. Formal negotiations toward
an international treaty are expected to occur
during 1995 and 1996.
International Visitors
OPP has an ongoing program to arrange
meetings for foreign visitors to discuss U.S.
pesticide policies and scientific evaluation
procedures. During the past year, OPP received
95 visitors from 23 nations. The majority of
visitors came from Japan, South Korea, and the
People's Republic of China.
Regional, State', And Tribal Liaison
State and Territorial Programs
r
States and territories are true partners with
OPP in carrying out the functions of protecting
human health and the environment. They assist in
developing and implementing many of OPP's
field programs, and they enforce OPP's regula-
tions and pesticide labeling and use require-
ments. To ensure that programs are successful,
direct communication among these governments
is often necessary. To accomplish this, OPP in
1994 continued a cooperative agreement with the
Association of American Pesticide Control
Officials (AAPCO) to maintain the Stale FIFRA
Issues Research and Evaluation Group
(SFIREG). SFIREG meets periodically .with OPP
to develop pesticide programs and discuss
implementation and enforcement issues of
concern to the states and territories.
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**
PagCM'
OPPANNUALREPORt
Improv ng Internal Communications
Tribes
Native American tribal governments have
sovereign rights and certain specific assurances
from the federal government under treaties. A
considerable diversity exists among the tribes.
Some have land areas and populations compa-
rable to many of the smaller states, whereas
others have fewer than 50 tribal members and
100 acres of land. The capacity of the tribal
governments to carry out environmental regula-
tory programs also varies significantly from tribe
to tribe.
OPP's major effort with tribes has been to
assist them in building the capacity to conduct
regulatory and field programs for pesticides. In
1994, OPP participated in the Native American
Environmental Conference to demonstrate
different ways in which tribes can implement
OPP programs. OPP also funded an environmen-
The OPP Committee on Networking,
Education, Communication, and Training
Strategy (OPP CONECTS) made a significant
effort in 1994 to improve internal communica-
tions. Based on recommendations of the commit-
tee to OPP management in June, two new
initiatives are underway. OPP PULSE, a publica-
tion "by OPP staff, for OPP staff," began publica-
tion in September. The OPP LINKS series, in
which each OPP division educates the others
tal scholarship program to assist college students
studying environmental sciences and interested in
addressing Native Americans issues. OPP also
addressed Native American issues by assigning
one employee to work at the Administration for
Native Americans and another to work with
EPA's Office of Civil Rights.
In addition, OPP attempts to address
specific issues uniquely affecting Native Ameri-
cans. In 1994, OPP began a project involving
other state and federal authorities to address
potential pesticide exposure by members of the
California Indian Basketweavers Association
(CIBA). CIBA members expressed concern to the
Agency about their potential exposure to pesti-
cides from contact with native plant materials
used in traditional basketweaving.
about its roles and responsibilities, often in
innovative and creative ways, began in October.
Both initiatives are helping OPP staff better
understand the work of other divisions and gain a
sense of how they fit into the larger picture. The
two initiatives also give staff members the
opportunity to share what they do and what they
know with the rest of the program, making OPP a
less impersonal workplace.
C. Support For Compliance Activities
Compliance activities — such as helping
regulated entities understand and meet applicable'
requirements, verifying that requirements are
met, and taking enforcement action when they
are not — are indispensable parts of EPA
programs to protect public health and the
environment. OPP provides support to Agency
pesticide compliance activities, which are
directed by the Office of Enforcement and
Compliance Assurance (OECA). (Pesticide
compliance activities formerly were coordinated
by the Office of Compliance Monitoring, which
was integrated into the newly-created OECA in
1994.) -'""'•••'
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4 - FIELD IMPLEMENTATION AND COMMUNICATION
Page 37
OPP relies on data submitted by registrants
to make regulatory decisions involving product
registrations, tolerances, use restrictions and
requirements, and other areas. EPA conducts a
program to inspect and audit the laboratories that
produce these data. Important components of the
lab audit program are the Good Laboratory
Practice Standards (GLPS), which are designed to
ensure the quality and integrity of pesticide data.
OPP's pesticide chemistry laboratories are
essential for verifying the description and amount
of active ingredients provided by registrants on
pesticide product labels. During 1994, OPP
analyzed a large number of new pesticide product
samples, both for technical and end-use formula-
OPP's two pesticide chemistry labs often
provide high priority support for other enforce-
ment efforts. In 1994, OPP supported seven
external EPA region/state projects: Craven
Laboratories investigation with the Department
of Justice; State of New York investigation of
DCPA contamination of the Suffolk County
drinking water supply; State of Florida's investi-
gation of alleged benomyl damage in green-
houses; State of Oklahoma's analysis of dioxin/
furan samples; EPA Region 5 and Region 7
In addition to laboratory support, OPP
often contributes expertise and records for
compliance activities. One example of this in
1994 was OPP's work on the Raid Max Roach
Bait enforcement case. In this case, EPA alleged
that S.C. Johnson & Son, Inc., the manufacturer,
began illegally marketing this product in new
design packaging without first receiving EPA
approval. This information contributed to EPA
Region 5 issuing a Stop Sale, Use, or Removal
Support For The Lab Audit Program
In 1994, 43 GLPS inspections were conducted
for OPP, and OPP scientists assisted in three of
the inspections. Targeted areas included, product
chemistry, residue chemistry, environmental fate,
toxicology, and antimicrobial testing. As a result
of the inspections, EPA developed four GLPS
enforcement cases involving four laboratories
and thirteen registrants or sponsors, and revoked
the registrations of two products.
Analysis Of Product Chemistry
tions, to verify registrant label claims. The
methods used to perform the analyses are
published in an EPA manual of methods by the
Association of Official Analytical Chemists
(AOAC) International and used by state agencies
and other organizations.
Other Laboratory Support
investigation of the WTI incinerator in Ohio;
Louisiana Board of Regents request to review
technical proposals; and EPA Region 3's request
to analyze samples for diatomaceous earth. The
pesticide chemistry labs supported several other
external projects, including the Central American
Lab Project; Gulf of Mexico Project; U.S. State
Department Project in Russia; two EPA Office of
Research and Development Dioxin Projects; U.S.
Army air samples from the Mideast (dioxins);
and air samples from Croatia (dioxins).
Additional Support For Compliance Activities
Order to S.C. Johnson to immediately halt the
sale and distribution of the product. EPA also
requested that the company voluntarily recall all
unapproved Raid Max Roach Bait products in the
hands of consumers and in the channels of trade.
Another example was OPP's work on the recall
by the registrant of Natrapel Insect Repellent
products because of potential bacterial contami-
nation.
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Page 38
OPP ANNUAL REPqRT]
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Policy, Regulations,
And Guidelines
OPP's fifth major program area involves
developing regulations and other policies for
pesticides. These efforts are intended to help
develop and implement national legislation
passed by Congress, to improve the quality of
pesticide regulation (which can include both
formulating new policies and streamlining
existing ones), and to augment the quality of
OPP's scientific information. In some cases, OPP
finds that policies are needed to address newly-
discovered concerns, or to keep up with techno-
logical advances in pest control, such as in the
area of genetically-engineered biological pesti-
cides. Wherever possible, OPP encourages public
participation in the development of policies.
Federal policies can be regulatory (promul-
gated by regulation) or non-regulatory. Regula-
tions are published in the Federal Register for
formal public notice and comment and incorpo-
rated into the Code of Federal Regulations.
Regulations proposed or finalized in 1994 and
discussed in this chapter include those related to
biological pesticides and pesticide containers.
Non-regulatory programs, in general, are not
directly mandated by law and do not impose
legally enforceable requirements. A prime
example, discussed in more detail below, is
OPP's voluntary pesticide environmental stew-
ardship partnership. Policies often include both
regulatory and nonregulatory components, such
as OPP's international coordination effprts and
OPP's response to the National Academy of
Sciences report on children and pesticides.
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OPPANNUALREPpRt
Follow-up To The National Academy Of Sciences (NAS) Children's Study
EPA, the Food and Drug Administration
(FDA), and the U.S. Department of Agriculture
(USDA) are working together to address the
concerns identified by the June 1993 National
Academy of Sciences report, Pesticides in the
Diets of Infants and Children. The Academy
concluded that exposure of children to pesticides
is substantially different from that of adults and
that the federal government should do more to
address the unique risks posed to children. To
provide additional measures of protection for
children, the Academy recommended numerous
changes to the way the federal government
safeguards the nation's food supply.
OPP is moving ahead to implement many
of the NAS recommendations. Additional
toxicological studies will be included in the
standard battery of testing requirements (known
as the part 158 requirements) that are under
Reduced Use/Risk Initiative
The Pesticide Use/Risk Reduction Initiative
announced in June 1993 is a joint effort with
EPA, USDA, and FDA to reduce the use and
risks of pesticides. As part of the initiative, a
voluntary program called "Pesticide Environ-
mental Stewardship Partnership - PEST SMART"
has been created to form partnerships with all
affected interests (including commodity organi-
zations and public interest groups) and develop
plans which will reduce the risks posed by
pesticides while maintaining cost-effective pest
control methods.
In December 1994, the Administration
announced the initial partners (grower groups and
utility companies) in the program. In forming this
partnership, the federal agencies and the partici-
pating groups and companies agree that environ-
mental stewardship is an integral part of pest
management practices. Specifically, the partners
have agreed to a number of guiding principles
revision. OPP plans to collect data on immune
functions, nervous system development and
toxicity, and visual systems. In addition, the OPP
has completed an analysis of the utility of
including in utero exposure in long-term toxicol-
ogy studies. EPA and FDA have completed plans
to standardize the reporting of pesticide levels in
food and to store these data in a centralized
National Pesticide Residue Monitoring Database,
though additional funding is needed to proceed.
OPP is working closely with USDA on the design
of future USDA national food consumption
surveys to ensure that the eating habits of infants
and children are adequately represented. OPP is
also exploring ways to combine the risks from
multiple sources of exposure. These include
combining the risks posed from chemicals with
similar mechanisms of action as well as several
routes of exposure, including both nondietary and
dietary routes.
that will shape pest management. In summary,
the principles state that (1) pesticide users will
continue to work towards pest management
practices that reduce risks and to minimize the
pesticide use where desirable and practicable; (2)
users will continue to develop and implement
regional pesticide environmental stewardship
plans; (3) the federal government will seek to
foster effective alternative pest management
technologies and practices; (4) and the federal
government will integrate the environmental
stewardship plans into its agricultural and
environmental policies and programs.
. The partnerships represent a major step in
the overall federal efforts to encourage environ-
mental stewardship. OPP is actively seeking
additional pesticide user groups, from both
agricultural and non-agricultural sectors, to
participate. The voluntary measures will help
prevent pollution and reducejpotential risks to
both people and the environment from pesticides.
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5 - POLICY, REGULATIONS, AND GUIDELINES
m
International Harmonization And Regulatory Coordination
OPP's international harmonization projects
aim to develop common or compatible interna-
tional approaches to pesticide review, registration
and standards-setting. The benefits of making
pesticide regulatory programs more consistent
internationally include improved safety of food
imported into the United States, reduced regula-
tory burden on national governments, upgrading
of supporting science, fewer trade problems, and
reduced costs for registrants.
OECD Pesticide Program
OPP worked closely with other member
countries of the Organization for Economic
Cooperation and Development (OECD) to
establish a Pesticide Forum and pesticide work
program. For the first time, the Forum brings
government pesticide regulators together to
address common problems and achieve greater
harmonization of policies and procedures. The
Pesticide Forum is working in five areas:
reregistration, data requirements, risk reduction,
test guidelines, and hazard assessment. Under
reregistration, for example, the United States
served as the lead country for the Pilot Project to
Compare Pesticide Data Reviews. The pilot
project has led to a number of follow-up activi-
ties to expand the exchange and use of national
data reviews. As a result of Forum efforts,
countries are gaining a much better understand-
ing of each other's practices.
Intergovernmental Forum
on Chemical Safety
The United States participated in the June
1992 United Nations Conference on Environment
and Development (UNCED) held in Rio de
Janeiro, Brazil. The conference report "UNCED
Agenda 21" made comprehensive recommenda-
tions for better coordination and management of
environmental risks. Chapter 19 of Agenda 21
covers the environmentally sound management
of toxic chemicals.
-
In May 1994, governments and international
organizations meeting in Stockholm, Sweden agreed
to continue the Intergovernmental Forum on
Chemical Safety (IFCS) to improve the management
of international chemical safety activities. The
United States is working to implement the many
Agenda 21 and IFCS recommendations, including
the assessment of several hundred priority chemi-
cals by the year 2000. These new assessments are
intended primarily to meet the needs of developing
countries. The IFCS is also moving to implement
Agenda 21 recommendations for improvements in
harmonization of classification and labeling,
information exchange and prior informed consent,
risk reduction, and strengthening national capabili-
ties. |
Canada/U.S. Technical \
Working Group on Pesticides
The Canada-U.S. Trade Agreement
(CUSTA) directs the countries to work toward
equivalence of pesticide standards. To assist in
this effort, CUSTA established a Technical
Working Group on Pesticides, currently co-
chaired by OPP and the Chemical Evaluation
Division of Health Canada's Food Directorate.
Pilot projects in progress in 1994 included: 1)
parallel registration review of tebufenozide, an
insect growth regulator, in Canada and the
United States; 2) harmonization of maximum
residue limits (tolerances) for four chemical/crop
combinations; and 3) cooperative reevaluation of
heavy-duty wood preservatives. Subgroups of the
Technical Working Group have also beep formed
to address specific environmental, lexicological,
and occupational exposure issues.
Technical Assistance: AID/EPA Central American Project
The AID/EPA Central American Project is a
pilot technical project involving EPA, the U.S.
Agency for International Development (AID),
FDA, and USDA. It is designed to enhance
Central American efforts to improve pesticide
safety and pest management practices. During
1994, EPA participated in regional technical
workshops in Central America to provide
information about integrated pest management,
safe pesticide use practices, and U.S. pesticide/
food safety import requirements. EPA imple-
mented a short-term assistance program in El
Salvador to identify and manage old pesticide
storage sites. EPA also provided technical
assistance to the Government of Ecuador to assist
them in dealing with the "Taura Syndrome," a
condition causing high shrimp mortality in
shrimp farms in the Gulf of Guayaquil.
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Page 42
OPP ANNUAL REpORt
Biological Pesticide Policy Highlights
EPA believes that many biological pesti-
cides are less hazardous than traditional chemical
methods of pest control, and in 1994 the Agency
continued to take steps to encourage their
development and use. This section summarizes
those efforts. EPA expects that as biological and
other safer pesticides are brought to market, they
will displace an older generation of more toxic
chemical pesticides.
Pheromone Regulatory Relief Policy
Insect pheromones are a class of biochemi-
cal pesticides and are considered to be reduced
risk pesticides. They are used to disrupt the
mating of insect pests that infest agricultural
crops. As part of its efforts to provide regulatory
relief for pheromones, OPP published a final rule
expanding the allowable acreage from 10 acres to
250 acres for testing without obtaining an
Experimental Use Permit (EUP) from OPP. OPP
also published an exemption from the require-
ment of a tolerance for certain formulations of
pheromones and their inert ingredients based on
low risks to people. These rules applied to solid
matrix dispensers (such as those made of plastic)
that can be retrieved from fields. OPP is consid-
ering further expanding the exemption for testing
of certain groups of pheromones to include all
broadcast formulations for experimental testing
on up to 250 acres.
Final Rule on the Testing
of Microbial Pesticides
EPA published a final rule on September 1,
1994, that amends the Agency's experimental use
permit regulations and modifies prior policy
regarding small scale testing of microbial
pesticides. Microbial pesticides consist of
microorganisms such as bacteria, fungi, viruses,
or protozoans used to control pests. The rule will
codify existing policy that requires notification to
OPP prior to initiating small-scale field tests with
certain genetically modified microbial pesticides.
This rule reduces the regulatory burden of testing
microbial pesticides compared to existing policy,
while preserving sufficient federal oversight to
prevent unreasonable adverse effects from testing
of microbial pesticides.
Proposed Regulation Of Plant-Pesticides
The Agency has proposed a number of
actions to regulate certain novel pesticidal
substances genetically introduced into plants for
the purpose of protecting them against pests and
disease. These substances have been designated
plant-pesticides. The proposed regulations, issued
in November 1994, address plant-pesticideS and
not the plants themselves.
EPA is proposing to exempt three types of
low risk plant-pesticides from registration
requirements:
1) Plant-pesticides derived from a closely related
plant (e.g., those taken from one corn plant
and engineered into another corn plant).
2) Plant-pesticides that act primarily by affecting
the plant (e.g., plants that have been engi-
neered to produce a thicker, more pest-
resistant outer layer of wax) rather than by
having a direct toxic effect.
3) Plant-pesticides consisting of certain compo-
nents of viruses called viral coat proteins, and
the genetic material needed to create the coat
proteins. Scientists are now able to transfer
genes from a virus into the plant so that the
plant can produce viral coat proteins. These
proteins provide the plant with resistance to
infection by disease-causing plant-viruses.
EPA is proposing to exempt three catego-
ries of low risk plant-pesticides (including
associated genetic material) from the requirement
to obtain a tolerance:
1) Plant-pesticides derived from closely related
plants.
2) Plant-pesticides not derived from closely
related plants, as long as the plant-pesticide
would not result in substantially different
exposure through food (e.g., those taken from
a highly consumed crop such as corn and
engineered into another crop such as egg-
plant).
3) Coat proteins from plant viruses.
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5 - POLICY, REGULATIONS, AND GUIDELINES
Activities Related To Implementation Of The "Delaney Clause"
In 1992, the Ninth Circuit Court of Appeals
issued a decision in the Les v Reilly case mandat-
ing a strict interpretation of the Delaney clause of
the Federal Food, Drug and Cosmetic Act
(FFDCA). According to the court, the Delaney
clause forbids EPA approval of food additive
regulations if the pesticide has been found to
induce cancer, regardless of the degree of risk to
the public. (Food additive regulations are
maximum residue limits, or tolerances, for
processed food and are required if a pesticide is
used or becomes concentrated in processed food.)
The Delaney clause does not apply to tolerances
for raw agricultural commodities. EPA has taken
a number of actions to achieve full and continu-
ing compliance with the Delaney clause, and in
fiscal year 1994:
Q Proposed to revoke food additive regulations
for a number of pesticides found to cause
cancer. OPP proposed the revocation of 26
tolerances of 7 pesticides on July 1, 1994. OPP
expects to propose the revocation a number of
other tolerances in 1995.
In February 1994, OPP proposed the
"Standards for Pesticide Containers and Contain-
ment." These measures are intended to protect
human health and the environment by reducing
exposure to pesticides and reducing production of
wastes when pesticide containers are stored,
handled, and refilled. The standards are a result
of Congressional amendments to FIFRA in 1988,
which authorized EPA to issue regulations in two
areas of concern: pesticide container design
standards and residue removal standards. The
proposed rule would establish standards for the
Q Revoked tolerances for dichlorvos (DDVP) on
bagged commodities, for dicofol on tea, and
mancozeb on washed raisins. A temporary
stay of the revocation is in effect for DDVP
and dicofol.
i
Q Issued a notice to registrants (PR Notice 93-
12) explaining the revised policy that dried
hops are a raw agricultural commodity (RAC),
and therefore no longer subject to the Delaney
clause. Two tolerances were subsequently
established for dried hops as a RAC.
Q Published in the Federal Register an updated
list of pesticides potentially affected by the
Delaney clause.
Q Issued a Federal Register Notice explaining
OPP's policy to delay action on pending
petitions and registration actions subject to the
Delaney clause until Delaney policy issues are
resolved.
Standards For Pesticide Containers And Containment
removal of pesticides from the containers and the
rinsing of the containers and would facilitate safe
use, refill, and disposal of containers. The rule
also would establish requirements for the
containment of stationary bulk containers and
pesticide dispensing areas.
OPP reviewed and summarized approxi-
mately 200 public comments and entered them
into an issue-oriented data base. A workgroup is
being re-established to finalize the rule, w,hich is
expected to take 18 months. I
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OPP ANNUAL R^PpffT:
Other Regulations Under Development
In 1994, OPP continued to develop a
number of regulations designed to increase
protection of human health and the environment.
Tolerances and Food Safety
OPP is reinventing its processes for
establishing tolerances and estimating risks to
consumers (including children) from exposure to
pesticide residues in food. Thus far, eight
potential procedural changes have been identi-
fied. OPP is considering taking into account
factors such as those known to reduce pesticide
residues in foods between the time crops are
harvested and eaten (e.g., storage, processing,
washing, peeling, and cooking) when .setting
tolerances. The resulting tolerances would more
closely reflect real exposure to pesticide residues
in food. OPP expects to issue an Advance Notice
of Proposed Rulemaking (ANPRM) in the spring
of 1995.
Revised Pesticide Registration
Data Requirements (Part 158)
In 1994, OPP provided draft comprehen-
sive revisions to data requirements for registering
pesticides (Part 158 of the Code of Federal
Regulations) to the EPA Scientific Advisory
Panel (SAP) for review in preparation for
proposed rulemaking in early 1995. Much of this
proposed rule would implement changes already
Legisla ive Proposals
OPP played a lead role in working with
USDA, FDA and the ^hite House domestic
policy staff to draft comprehensive pesticide and
food safety legislative reforms advanced by the
Administration, preparing for Congressional
hearings on the proposals, and conducting
numerous communications and outreach activi-
ties. OPP also performed a preliminary cost
analysis and analyzed other bills advanced in the
103rd Congress. The Administration proposals
aim to provide authorities under both the Federal
Food, Drug, and Cosmetic Act (FFDCA) and the
Federal Insecticide, Fungicide, and Rodenticide
adopted in OPP in the course of registration and
reregistration. The revisions would ensure that
comprehensive data packages are supplied to ,
OPP so that each pesticide can be evaluated using
current health and environmental standards.
Reporting of Pesticide Incidents
(6(a)(2) Rule) !
Section 6(a)(2) of federal pesticide law
requires registrants to report to OPP incidents
related to pesticide use or other information
related to potential adverse effects of pesticides.
This information is important in helping OPP
decide if action should be taken to reduce the
risks posed by a particular pesticide. In 1994,
OPP worked to finalize the proposed 6(a)(2) rule,
which would clarify the incident reporting
obligations of registrants. OPP expects to publish
the final rule in mid-1995. (Chapter 6 provides
further discussion of 6(a)(2) activities during
1994.)
Protecting Endangered Species
and Ground Water
As described in more detail in chapter 4,
OPP continued to work on a final regulation to
protect federally listed threatened and endan-
gered species from the impacts of pesticide use
and to draft several regulations to further protect
ground water resources.
Act (FIFRA) to enable regulatory agencies to
take prompt action to reduce risks to health and
the environment, and to promote development of
safer methods of pest control.
Notably, the Administration's legislation
would replace the "Delaney clause" of the
FFDCA with a consistent, health-based standard
for setting tolerances for pesticide residues in all
types of food. Other FFDCA proposals respond to
the recommendations of the National Academy of
Sciences report Pesticides in the Diets of Infants
and Children; call for a review of all existing
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5 - POLICY, REGULATIONS, AND GUIDELINES
tolerances against the new, health-based standard;
and enhance FDA's enforcement powers. FIFRA
proposals include registration "sunset" provi-
sions; incentives for development and registration
of reduced risk and minor use pesticides; support
for risk and use reduction and IPM activities;
streamlined cancellation and suspension proce-
dures; export restrictions; record-keeping for all
agricultural pesticide use; additional fees to
support FIFRA '88 reregistration; enhanced
OPP's critical decisions rely upon the
scientific information and judgment about those
pesticides. OPP invests considerable effort in
obtaining the best scientific information available
and working with other experts within and
outside of government to make sure its standards
reflect the latest scientific thinking. This section
describes some of OPP's efforts in 1994 to build
upon its scientific base.
Ecological Effects Pesticide
Toxicity Database
Over the past two years, OPP has devel-
oped a database to provide a rapidly accessible
source of ecotoxicity data for all pesticides in use
nationwide. Ecotoxicity data consist of informa-
tion about the toxicity of pesticides to birds,
mammals, fish, plants, and other organisms. The
database will track, record, and summarize OPP's
vast library of toxicological data, which until
now has been available only in paper format, and
should prove to be an extremely valuable tool for
assessing the risks associated with various
alternative pesticide uses. OPP has already
provided database information to EPA regions
and other offices, USD A, the U.S. Fish and
Wildlife Service, a number of state agencies, and
others. The database will also allow OPP to more
efficiently complete registration and
reregistration actions. The database currently
contains over 7,000 toxicity records for 300
major use pesticides and is about halfway
completed. OPP plans to incorporate this data-
base into the Pesticide Information Network
(described in chapter 4) and other publicly
available data sources.
enforcement for FIFRA violations; and a number
of other regulatory tools. ;
The Administration's proposals were
introduced into the 103rd Congress, but no final
action was taken before the close of the session.
OPP expects a number of these issues to resur-
face in the next Congress, either as independent
legislation or in the context of the 1995 Farm
Bill.
Maintaining And Improving OPP's Science Base
National Water-Quality
Assessment Program
OPP scientists have worked closely with
the U.S. Geological Survey's National Water-
Quality Assessment (NAWQA) Program over the
past several years. NAWQA is describing the
status and trends in a representative part of the
nation's ground and surface waters. One product
from the joint efforts is the publication entitled
Summary of National Standards and Guidelines
For Pesticides in Water, Bed Sediment and
Aquatic Organisms and Their Application to
Water-Quality Assessments. This publication
summarizes current national standards arid
guidelines, and provides definitions, originating
agencies, statutory authorities, regulatory status,
applicable sampling media, beneficial use and
resource protected, and full citations of published
documentation. An entire issue of Reviews of
Environmental Contamination and Toxicology
has been dedicated to the publication.
EPA's Contaminated Sediment
Management Strategy
!
OPP has actively participated in the
Agency's Contaminated Sediment Management
Strategy, published August 1994. OPP scientists
have served on various Agency committees
covering a wide range of topics from toxicity,
testing to use of sediment water quality criteria.
They have also worked closely with EPA's Office
of Pollution Prevention and Toxics to provide a
Prevention, Pesticides and Toxic Substances
policy, as well as a scientific position on the
Strategy.
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Page 46
OPPANNUAL REPORT
Health Effects Research
and Guidelines
OPP participated in a number of projects in
1994 to advance scientific knowledge and
understanding of the health effects of pesticides.
Some of these projects included:
Q Drafting and sharing publicly the test guide-
lines for reproduction and developmental
toxicity studies. OPP is finalizing the guide-
lines based on public comment. OPP has also
developed Standard Evaluation Procedures
(SEPs) for reproduction and developmental
toxicity studies and is gathering public
comment. These procedures should standard-
ize how the studies are evaluated both by
industry and EPA.
Q Holding an Ocular Toxicity Workshop to
explore testing options for the adverse eye
effects associated with organophosphate
pesticides. OPP and pesticide registrants
discussed the protocols and feasibility of
several proposed tests.
Q Convening a workshop with leading research-
ers to obtain comment on draft revisions to the
guidelines (known as the Subdivision K
guidelines) for assessing pesticide exposure to
people in both work and residential settings;
Q Working with the International Life Sciences
Institute (ILSI) to explore a number of
contentious scientific issues. Among the most
important ones are the significance of mam-
mary and bladder tumors in laboratory animals
and how to interpret certain effects in labora-
tory animals found at extremely high doses of
pesticides (the Maximum Tolerated Dose, or
MTD, issue).
Q Drafting and distributing for preliminary
comment revised guidelines for performing
toxicology metabolism studies. The new
guidelines will have a tiered system of testing.
OPP plans to hold a workshop on the guide-
lines in May 1995.
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Information and
Program Management
OPP's information and program manage-
ment efforts are not as publicly visible as some of
its other programs, but without them none of the
other programs could operate. The buildings that
OPP occupies, the supplies and equipment it
uses, the funds it administers, the systems for
processing and storing the vast amounts of
information that OPP uses, and the staff itself —
all of these critical program components are
managed under this program area. This section
describes some of the information and program
management achievements during 1994.
Operations, Maintenance And Integration Of The Primary OPP Information Systems
In 1994, OPP finished major parts of its
automated information management infrastruc-
ture. All OPP employees are now equipped with
personal computers linked via a high-speed local
area network (LAN). Detailed and summary
information about pesticide chemicals; products
and their uses, registrants, "registration action
requests, tolerances, reregistration status, and
other information is available through the LAN.
Electronic mail (email), .scheduling, word
processing, spreadsheet, and other software
packages are also available. This infrastructure is
reliable and has greatly improved internal
communication and data-sharing in OPP.
Additionally, OPP completed the integra-
tion of several computer systems used to manage
the pesticide reregistration process into an
improved system called the Chemical Review
Management System (CRMS). OPP used CRMS
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Page 48
OPP ANNLJAL REPORT
Pestici e Incident Reporting/6(a)(2) Activities
in preparing the Reregistration' Report Cards sent
to each registrant involved in reregistering a
pesticide. Major improvements were also added
to the Pesticide Regulatory Action Tracking
System (PRATS), which OPP uses to help
manage the flow of registration actions through,
the program. The improvements added capabili-
ties for priority planning, scheduling, and
performance analysis.
Section 6(a)(2) of federal pesticide law
requires registrants to report to EPA incidents,
studies, or other information indicating new
potential adverse effects of registered pesticides.
This information is important in helping EPA
decide if action should be taken to reduce the
risks posed by a particular pesticide.
The number of 6(a)(2) submissions to OPP
increased in 1994 to approximately 700 covering
4,500 individual incident reports. OPP's 6(a)(2)
Team screened 755 adverse effects submissions,
Ecological Incident Monitoring And Reporting
In 1994, OPP completed the development
of the Ecological Incident Information System
(EIIS). OPP expects that this system will play an
essential role in understanding how poisoning
incidents involving nontarget species (uninten-
tionally affected animals and plants) occur and
will help OPP to reduce environmental risks.
This database is a compilation of the information
currently used for completing risk assessments. A
total of 630 incidents have been entered into the
database, including the most recently reviewed
pesticide, carbofuran. Based on the data entered
to date, over 101 active ingredients have caused
adverse effects to 1,300 species of nontarget
organisms.
Other major improvements to the auto-
mated information management infrastructure in
1994 included upgrading the staff personal
computers, completing the major preparatory
steps for integrating all the OPP-wide computer
systems into one umbrella system, aggressively
pursuing electronic submission of detailed data
critical to science studies, and adding more
software to the network.
which were primarily studies and preliminary
reports of possible adverse effects from studies
not yet completed. As a result of screening, 20%
of the submissions were determined to warrant
expedited review. Of those, about 20% resulted in
label changes to reduce risks, mostly in cases of
new findings of acute toxicology studies, and 8%
showed a new adverse effect that is being
addressed by Special Review, an imminent
reregistration decision, or risk mitigation mea-
sures. The remainder are in further stages of
review or required no further action.
In response to substantial interest in the
EIIS, OPP has distributed the software to 175
state and federal agencies as well as to private
industry. OPP contacted over 75% of the state
agencies who are responsible for collecting the
data. OPP has presented its efforts at professional
meetings and to other federal agencies such as
the National Biological Survey (NBS). OPP has
also initiated cooperative agreement efforts
between EPA, NBS, and the Fish and Wildlife
Service and is developing a standardized protocol
for ecological incident monitoring and reporting.
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6 - INFORMATION AND PROGRAM MANAGEMENT
Page 49
OPP receives and generates an enormous
number of documents each year, such as studies
submitted regarding the effects of pesticides and
OPP's review of these studies. These records
must be properly managed to ensure timely,
appropriate decisions and for future reference.
OPP's human resources efforts included
hiring, training, and promoting staff. More than
half of OPP employees received some form of
technical, career, or management development
training in 1994. Another human resource effort
was that of the Cultural Diversity Task Force.
The. Task Force is committed to valuing OPP
employees regardless of physical attributes,
ethnicity, or sexual orientation. Three subcom-
mittees have been formed: Communications,
Planning, and Outreach. In 1994, the Communi-
cations Committee educated OPP staff on the
Information And Records Management Activities
Significant accomplishments were made in OPP's
records management program in 1994. OPP
conducted regular training for its network of
records management liaison offices and drafted
major changes to the records retention schedule
for review by the National Archives.
Human Resources Mana
gement
mission of the task force. The Planning Commit-
tee determined that the task force should focus
on recruiting and retaining minorities, develop-
ing careers for minorities, and ensuring unbiased
reviews for minorities eligible for promotion. In
1994, the committee participated in drafting a
Diversity Plan that should be finalized in early
1995. The Outreach Committee developed a
database of potential applicants that will be made
accessible to all managers to help them find
qualified applicants.
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Page 50
OPP ANNUAL REPORT:
Resource Allocation And Financial Management
OPP resources are allocated in three
distinct phases: budget formulation, planning,
and execution. During any given year, OPP is
formulating a budget two years in advance,
planning a budget for the upcoming year, and
executing a budget for the current year.
Budget Formulation
Budget formulation is the process of
developing the budget submitted by the President
to Congress each year. During fiscal year (FY)
1994, OPP prepared the submission of the FY
1996 budget. OPP worked with the
Administrator's office to develop the budget,
investing in some areas and disinvesting from
others, based on Agency priorities and objectives.
OPP's major proposed areas of investment are
ecological protection (including reducing
pesticide use/risk and building tribal capacity),
food safety, and implementation of the Worker
Protection Standard. These investments are to be
accompanied by disinvestments from registration
and reregistration, by completion of some efforts,
and by streamlining efficiencies. The budget will
then be reviewed by OMB and ultimately
become part of the President's Budget. After
Congressional review and ratification, it becomes
the Congressional Budget. Ideally, the final
budget is approved with the signing of the
Appropriations Bill by the President prior to
October 1 (the beginning of the new fiscal year).
Budget Planning
The planning process starts about nine to
12 months before funds are actually appropriated
by Congress; OPP began FY 1995 planning in
January 1994. The participants include a Senior
Management Board, a Steering Committee, six
Program Area Workgroups (PAWs), and coordi-
nators from each of OPP's divisions. The PAWs
identify resources needed to fund Program Area
activities and prioritize those activities. The
Steering Committee then makes recommenda-
tions based on the PAW efforts to the Senior
Management Board, which integrates the area
plans into the OPP Resource Management Plan.
This plan describes the projects to be performed
and their level of funding for the upcoming fiscal
year.
For FY 1995, the OPP planning process
allocated $18.2 million for headquarters contracts
and grants, $3.3 million in expenses, and $52
million in salaries for approximately 785 employ-
ees. The planning process incorporated reduc-
tions requested by Congress, the conversion of
some contractor functions to OPP staff, "buy-
outs" to facilitate staff reductions, and implemen-
tation of the new pilot division. Nondiscretionary
state grants and assistance, which are allocated
outside of the OPP planning process, totalled $15
million.
Budget Execution
After the Appropriations Bill is signed by
the President, the EPA Comptroller issues a new
Operating Plan, which is executed by each
Agency office. In executing the budget, OPP
must carefully monitor expenditure of all funds,,
track compliance with budget plans, and coordi-
nate appropriate Agency financial reports. During
1994, OPP obligated (spent) $93 million dollars.
These funds consisted of $52 million in travel
expenses and salaries for approximately 785
employees; $26 million for contracts, interagency
agreements, grants, and expenses; and $15
million for grants and support to regions and
states. In 1994, OPP continued to collect several
types of funds from pesticide registrants, which
supplement Congressional appropriations. The
collected funds consisted of $2.1 million in
tolerance fees, $14.1 million in annual registra-
tion maintenance fees, and $800,000 in
reregistration fees. The collected fees are placed
in revolving funds that may be used over multiple
years, whereas most Congressional appropria-
tions must be used within two years.
In 1994, OPP improved its systems for
using the revolving funds and helped carry out
financial management responsibilities, such as
those under the Chief Financial Officer's Act and
the Government Performance and Results Act.
OPP also continued to fully use available
resources to meet mission goals. The distribu-
tions of staff effort and discretionary funding
among the six program areas are illustrated in the
figures on the following two pages.
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6 - INFORMATION AND PROGRAM MANAGEMENT
Page 51
1994 Staff Effort
Per Program Area
(Total = 767)
241
189
120
78
Registration
Reregistration
Special Review
69
Field Implementation and
Communications
Policy, Regulations, and
Guidance
Information and Program
Management
This chart indicates the approximate
distribution of OPP staff effort to the six program
areas. The chart 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. i
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Page 52
OPPANNUAL REPORT
Funds Expended in 1994
By the Six Program Areas
33%
3% A
13%
11%
24%
16%
Registration ///// Field Implementation and
Reregistration
Special Review
Communications
Policy, Regulations, and
Guidance
Information and Program
Management
In 1994, OPP expended approximately
$14.2 million allocated through the program area
budget process. These "discretionary" funds were
used for external contracts. This chart shows how
these funds were distributed among the different
program areas.
(Other major pesticide expenditures not
reflected in this chart are travel expenses;
salaries; grants and other assistance to states,
regions, and other organizations; and set-asides
for special projects, such as pesticide disposal.)
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Opportunities and
Initiatives For 1995
In addition to continuing the work previ-
ously described throughout this report, OPP
expects to pursue several important opportunities
OPP is taking several measures to promote
biological and other potentially safer pesticides,
such as waiving data requirements, where
possible, and placing a high priority on complet-
ing needed scientific reviews. OPP is also
encouraging alternatives to pesticides and other
ways of reducing pesticide use and risks. Two
important new opportunities for continuing
progress in these areas are the creation of a pilot
division and the Memorandum of Understanding
between EPA and the U.S. Department of
Agriculture.
and initiatives during 1995. This section high-
lights some of those opportunities. j
Biological Pesticides And Promoting Risk Reduction
Creation of the Pilot Division
EPA has established a pilot, multi-disci-
plinary division of 33 employees within OPP to
promote reduced pesticide use, encourage:
development and use of safer pesticides, and
accelerate registration of new biological pesti-
cides. The Biopesticides and Pollution Preven-
tion Division (BPPD) is responsible for: (1) all
registration and reregistration actions for biologi-
cal pesticides; (2) Integrated Pest Management
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Page 54
OPP ANNUAL REPORT!
(IPM) programs and strategies; and (3) continued
development of pesticide pollution prevention
activities, including the Pesticide Environmental
Stewardship Partnership.
In accordance with the Administration's
National Performance Review (highlighted in the
Vice-President's report on reinventing govern-
ment), the pilot division will have a streamlined
structure which exceeds the goal of 11:1 staff to
management ratio. Small, self-directed and
empowered teams are being formed as an
alternative management structure. The approach
is designed to promote staff development and
OPP productivity for all science reviews and
administrative processes for registration and
reregistration actions, providing team leadership
opportunities and allowing OPP to test and
evaluate new methods of operation to assist with
the overall streamlining of OPP scheduled for
1996.
Opening Up OPP
OPP has several projects underway to
"open up OPP" — that is, to allow everyone to
obtain information from OPP more easily, and to
participate in and understand OPP's decision-
making process. OPP strongly believes that a
well-informed public will make wiser choices
involving pesticides and will help improve the
quality of federal pesticide actions.
Electronic Dissemination
Of Information
OPP continues to experiment with innova-
tive ways of making information available to
affected organizations and the general public.
EPA/USDA Memorandum
Of Understanding (MOU)
/
Under this MOU, signed in August 1994 by
EPA Administrator Carol Browner and Depart-
ment of Agriculture Secretary Mike Espy, the two
agencies agree to work in collaboration to
provide the agricultural community with pest :
management practices to reduce the risks :
associated with pesticides. The agreement will
increase USDA research for alternative methods
for pest control and establish practical means for
transferring these tools to the farmer. Each year,
USDA will identify those crop/pest/control
combinations which are potentially Vulnerable
for the producer (i.e., situations where growers
have few effective alternatives or where pest
resistance limits effective pest management);
Similarly, EPA will identify agricultural pesti-
cides for which it is considering regulatory action
that would affect their availability or use.
Together, USDA and EPA will expedite research,
development, education and registration, if
necessary, to meet these priority needs.
The Agency's Email (electronic mail) Integration
Pilot this year extended OPP's realm of commu-
nications to include EPA regional offices and
made possible the exchange of Internet messages.
Internet is a telecommunications system that
connects thousands of c'omputer networks and
literally millions of computer users. Early in
calendar year 1995, OPP expects to complete the
process enabling all OPP personnel to easily
communicate with anyone on the worldwide
Internet. OPP has also begun to make some of its
publications available on the Internet.
During fiscal year 1994, OPP also piloted
the new Pesticide Special Review and
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7- OPPORTUNITIES AND INITIATIVES FOR 1995
m)
Reregistration Information System, an electronic
bulletin board system (BBS) available free of
charge to any member of the public who has
access to a PC with a modem. This BBS contains
recent Reregistration Eligibility Decision (RED)
documents and all the RED fact sheets. Other
files available for downloading include basic
information explaining reregistration and Special
Review, lists of pesticides under review and the
appropriate Chemical Review Managers' names
and telephone numbers, the Rainbow Report (or
Status of Pesticides in Reregistration and Special
Review), and OPP Selected Terms and Acronyms.
Additional documents to be added soon include
this Annual Report, the Rejection Rate Analysis
chapters, and the quarterly Pesticide
Reregistration Progress Report. To reach this
BBS from a PC with modem, dial 1-703-308-
7224. The BBS also can be reached on the
Internet via FEDWORLD.GOV. EPA's "gopher
server," EARTHl.EPA.GOV, is another source of
these electronic files. The Sysop, or system
operator, welcomes comments, questions and
feedback.
Public Involvement in Risk Decisions
Achieving risk reduction through negotia-
tions with pesticide registrants can lead to
quicker action than formal Special Review
procedures; however, it has been criticized for
not always providing an adequate opportunity for
public involvement. OPP published a notice in
the Federal Register in 1994 that described a
number of ways OPP would be making the
process more open, including a process for public
comment on proposed agreements with regis-
trants. OPP will continue this process in the
coming year. OPP is also exploring avenues for
expanding its efforts to include the public in
pesticide registration decision-making.
The Aquatic Risk Assessment
And Mitigation Dialogue Group
To help implement the "New Paradigm" for
pesticide regulatory decisions (described in
chapter 2), OPP organized a workgroup known as
the Aquatic Risk Assessment and Mitigation
Dialogue Group with the joint sponsorship of the
American Crop Protection Association (formerly
NACA). The group consisted of representatives
from the pesticide industry, academia, environ-
mental groups, OPP, and EPA's Office of Re-
search and Development (ORD). The group met
seven times in 1993 and 1994 to promote an
open scientific dialogue about the assessment and
mitigation of risks to aquatic organisms posed by
pesticides. The primary topics discussed by the
Dialogue Group were ecological effects and
exposure characterization, integrated risk
characterization, and mitigation practices to
reduce the risk of pesticides to aquatic resources.
Subgroups researched a variety of topics, such as
how to better employ existing data in risk
assessments, how to improve pesticide risk
assessment methodology, and cataloguing
pragmatic short-term mitigation practices. Long-
term needs for mitigation and monitoring were
also discussed. The Group reached a number of
conclusions and recommendations in a final
report issued in November 1994. |
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Page 56
OPP ANNUAL REPORT
Reinventing And Streamlining OPP's Organization
As part of the efforts to "reinvent" and
flatten the federal government structure and to
increase responsiveness, OPP has undertaken
twenty major streamlining projects in four main
areas. Progress through fiscal year 1994 is
summarized for each project in the table below;
This broad range of activities is overseen by an
OPP Streamlining Council, composed of the
senior program managers, and an Employee
Advisory Group, representing the staff.
Streamlining Project
OPP Streamlining Projects
Current Status
Review and Evaluate OPP Program
Survey Customer Satisfaction
Preliminary test complete. Full surveys of
regulated community and general public to
begin in FY 95. Surveys of state's/regions
completed in FY 94.
Perform Outside Management Review
Pre-test complete. Interviews of 160 OPP
staff began in mid-October 1994. Final report
submitted in January 1995.
Upgrade Monitoring of Performance vs. Plan
Performance to be measured against FY 95
resource allocation plans.
Revise Core Production Processes in OPP
Drop Activities Contributing Little to Risk
Reduction
Identification of candidate processes
complete. Winnowing process underway.
Increase Delegations and Empowerment
Many redelegations completed; others in
progress. Allows quicker decision-making and
fewer layers of review.
Streamline Correspondence Management Project getting underway.
Pilot a "Living RED"
Test effort to maintain a continually updated,
automated OPP regulatory and scientific
position about a specific pesticide. Pilot
pesticide selected, and prototype system
under development.
Standardize Science Review Documentation
Pilot efforts completed in 1994. Two
subgroups now focusing on review content
and on technology for storing, indexing, and
retrieving reviews.
Automate Product Manager Team Operations Electronic letterhead and concurrence copies
now used to simplify correspondence. Work to
further automate correspondence underway.
Use Quality Circles in Health Effects Division Pilot under development for non-supervisory
quality management in.science review
division. :
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7 - OPPORTUNITIES AND INITIATIVES FOR 1995
OPP Streamlining Projects (cont.)
I Streamlining Project
Current Status . ' - ;.' - "
Implement Human Resources Initiatives
Implement Diversity Initiatives ,
Develop New Performance Appraisal System
Appraise Supervisory Performance by Staff
Establish Multiple Career Tracks
Implement Administrative Support Career
Management System
Redefine Leadership Needs in
Streamlined Organization.
Develop Staff Rotation Program
Develop Comprehensive Training Strategy
Draft OPP Diversity Plan completed and
circulated for comment throughout OPP.
Revisions in response to comment underway.
First plan implementation in 1995.
OPP working jointly with Office of Pollution
Prevention and Toxics. Staff survey planned
for early 1995; full pilot to be in place for 1996
standards.
Full OPP-wide implementation began in
September 1994.
OPP effort, which depends upon Agency-wide
progress, is in beginning stages.
System approved and implementation
underway.
OPP effort is in beginning stages.
• , : I , . - •.
OPP effort is in beginning stages.
OPP-wide survey of training needs has
begun.
Streamline OPP Organization
Establish Biopesticides and
Pollution Prevention Division
Realign Organization to Meet
Streamlining Mandates
Pilot operations began in October 1994i
Divisional reorganization, plans completed
3/94. Overall OPP streamlining plan to be
developed by 2/95 by Streamlining Council.
Registration Streamlining
In September 1994, OPP released its plan
for streamlining several aspects of the registra-
tion process. Two major areas for improvement
identified are amendments to pesticide product
registrations and other process changes. In the
first area, OPP is proposing to expand the types
of amendments which may be accomplished by
notification. Under a notification system, a
pesticide registrant may modify its pesticide label
without prior approval so long as it notifies OPP
of its action and fulfills OPP label requirements.
This notification process will be limited to minor
changes that do not increase risks. OPP is also
proposing to simplify the notification process.
Other potential areas for improving the registra-
tion process include streamlining the review, of
acute toxicity studies, self-certification by
registrants for products with low acute toxicity,
strengthening precautionary labeling statements,
and expediting the review of products similar to
products already registered ("me-too" registra-
tions).
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Page 58
OPP ANNUAL REPORT;
How To Obtain
More Information
The Office of Pesticide Programs (OPP)
wishes to provide timely and consistent informa-
tion to the public and offers a variety of ways to
do so. If you would like additional information
on subjects discussed in this report or other
topics, here are some sources available to you:
OPP Public Docket — OPP's docket houses
the regulatory notices, background documents
and public comments on OPP activities. The
Docket is open to the public from 8:00 a.m. to
4:30 p.m., Monday through Friday, and is located
in Room 1132 of Crystal Mall #2, 1921 Jefferson
Davis Highway, Arlington, Virginia (near the
Crystal City subway station), telephone 703 305-
5805.
National Pesticides Telecommunications
Network (NPTN") — NPTN is a toll-free tele-
phone service which provides general informa-
tion about pesticides and is available to anyone
in the United States, Puerto Rico and the Virgin
Islands (Monday-Friday, 8:00 a.m. to 6:00 p.m.
CST)at 1800858-7378.
Catalog of OPP Publications and Other
Information Media — This catalog provides a
listing of hundreds of pesticide publications,
including science chapters, fact sheets, etc., and
is available from EPA's Public Information
Center, 401 M Street, S.W., Washington, D.C.
20460 (Telephone 202 260-2080); or the Na-
tional Center for Environmental Publications
and Information (NCEPI), P.O. Box 42419,
Cincinnati, Ohio 45242-2419 (Telephone 513
891-6561 or Fax 513 891-6685).
Pesticide Regulation (PR^ Notice 94-3 —
This document provides general guidance for
obtaining a variety of OPP records and publica-
tions. It provides key information and contacts
for many resources available to the public
(including Pesticide Dockets, Freedom of
Information Act, the pesticide hotline, and on-
line databases). Lists of OPP program contacts
are included to help direct public requests
regarding specific chemicals or policy issues. PR
94-3 can be obtained from:
Communications Branch, FOD (7506C)
Office of Pesticide Programs, U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
(703 305-5017)
Communications Branch — Recent
announcements and copies of non-technical
brochures and fact sheets on pesticide issues can
be obtained from the Communications Branch, as
listed above.
Electronic Availability of Pesticide
Reregistration Documents — Many reregistration
and Special Review documents are available
through an electronic bulletin board system,
which can be reached via modem at 1 703 308-
7224. They are also available through the Internet
via FEDWORLD.GOV and via EPA's gopher
server, EARTHl.EPA.GOV. A fact sheet describ-
ing these services can be obtained from the
Public Docket, NCEPI, or the Communications
Branch.
Pesticide Information Network (PIN) —
The PIN is an interactive database containing
current and historic pesticide information. It is
free and operational 24 hours per day, seven days
per week. It can be reached via modem and
communications software at 1 703 305-5919.
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OPP ANNUAL REPORT
Pesticide Program Contacts
The following is a listing of OPP's senior managers as of January 1995, as well as the
managers of OPP's parent office, the Office of Prevention, Pesticides and Toxic Substances (OPPTS).
All OPP telephone area codes are 703.
Office of Prevention, Pesticides and Toxic Substances !
Lynn R. Goldman, M.D., Assistant Administrator (202) 260-2902
Susan H. Wayland, Deputy Assistant Administrator (202) 260-2910
James V. Aidala, Associate Assistant Administrator (202) 260-2897
I
: " • • I
Office of Pesticide Programs .
Daniel M. Barolo, Director : 305-7090
Penny Fenner-Crisp, Acting Deputy Director .....: 305-705*2
Policy and Special Projects Staff Field Operations Division
Anne Lindsay, Director 305-7102 William Jordan, Acting Director 305-7410
Biological and Economic Analysis Division Health Effects Division
i •
Allen L. Jennings, Director 305-8200 Stephanie R. Irene, Acting Director 305-7351
Richard D. Schmitt, Deputy Director ...305-7351
Biopesticides and Pollution • [
Prevention Division Program Management and Support Division
Janet L. Andersen, Acting Director 308-8712 Frank T. Sanders, Acting Director '. 305-5440
Flora Chow, Acting Deputy Director 308-8712 Norman W. Chlosta, Deputy Director ... 305-5440
Environmental Fate and Effects Division Registration Division
Anne L. Barton, Director 305-7695 Stephen L. Johnson, Director.. ....305-5447
Paul F. Schuda, Deputy Director 305-7695 Lois A. Rossi, Acting Deputy Director..305-5447
Special Review and Reregistration Division
,
Peter P. Caulkins, Acting Director 305-8000
* U.S. GOVERNMENT PRINTING OFFICE: 1995- 620 - 830 / 82060
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