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Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated. |
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Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated. |
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Office of Pesticide Programs Annual Report for 1994Date: January 1995
ABSTRACT: This Annual Report describes many of the efforts
and accomplishments of EPA's Office of Pesticide
Programs (OPP) during fiscal year 1994 (October 1,
1993 to September 30, 1994). It also describes
some of the opportunities and initiatives that OPP
will pursue during 1995.
NOTE: The following electronic version does not contain
the full graphics of the original version.
Information on obtaining paper or electronic
versions containing full graphics is provided in
the "Availability" section below.
ORIGINATOR: Environmental Protection Agency
Office of Pesticide Programs (7506C)
401 M Street, SW
Washington, DC 20460
AVAILABILITY: Paper copies including graphics (while supplies
remain) are available free of charge from the
National Center for Environmental Publications and
Information (NCEPI), telephone 513-489-8190 or fax
513-489-8695. An electronic version containing
full graphics is also being made available in
Adobe Acrobat(tm) Portable Document File (PDF)
format, version 1.0. You may obtain this file
from the Internet on EPA's gopher server,
GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or
using WWW (World Wide Web) on WWW.EPA.GOV. It may
also be downloaded from the Pesticide Special
Review and Reregistration Information System at
703-308-7224.
FOR FURTHER INFORMATION:
For more information about this and other
pesticide publications, please contact:
Communications Branch (7506C)
Office of Pesticide Programs
Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Ph: 703-305-5017
Fax: 703-305-5558
---------------------------------------------------------------
U.S. Environmental Protection Agency
Prevention, Pesticides and Toxic Substances (7506C)
Publication Number: EPA 735-R-95-001
January 1995
Office of Pesticide Programs Annual Report for 1994
Foreword
EPA's Office of Pesticide Programs (OPP) has been entrusted
with an important responsibility: safeguarding the health of the
American public and the environment from risks that may be caused
by pesticides. OPP also must make sure that pesticides are
regulated fairly and help ensure that effective measures for
controlling pests are available. OPP has assembled a diverse and
talented team of employees to manage these responsibilities.
This report is intended to explain how OPP is using its resources
to accomplish its mission.
From this report, several themes emerge:
o Partnerships and Teamwork: OPP cannot oversee pesticides by
itself. EPA's regional offices and the state and tribal
pesticide regulatory agencies have a fundamental role in
implementing and enforcing pesticide policies and educating
the public. Other important partners include the pesticide
industry and users, environmental and public interest
groups, the news media, additional EPA programs, and other
federal and international agencies. And ultimately, all of
us are partners because the personal choices that we make in
using pesticides are important factors affecting pesticide
risks.
o Customer Service, Streamlining, and Reinventing OPP: Many
projects are underway to help OPP serve its partners and
other "customers" more efficiently and effectively, and to
better protect public health and the environment. OPP
strives to make decisions openly, with public involvement,
and in a sensible, understandable manner.
o Sound Science and Data: Sound science and data provide the
foundation for OPP's decisions. OPP has required and
reviewed thousands of studies on the potential effects of
pesticides and their fate in the environment. OPP also
gathers much data on the use, effectiveness, and economics
of pesticides. OPP will continue to promote scientific
excellence and ensure that scientific data are accessible
and useful to EPA and the public.
o Pollution Prevention: OPP recognizes that it is neither
economical nor effective to solve problems after they have
been created. As a result, OPP is increasingly focusing on
preventing risks from pesticides in the environment.
Important elements of this approach include encouraging
safer means of pest control, reducing pesticide use and
exposure, and evaluating the effectiveness of protection
efforts.
I hope this report will help you understand what we
accomplished in 1994 and some of the many challenges that lie
ahead.
Sincerely,
/signed/
Daniel M. Barolo, Director
Office of Pesticide Programs
Dedication: This first annual report is dedicated to the
employees of OPP. They represent many disciplines, including
scientists, administrative staff, environmental protection
specialists, program analysts, and computer specialists.
Although we have a few miles to go, everyone in OPP should feel
proud of our efforts and, more importantly, the positive impact
our actions have on our public health, environmental and worker
safety goals.
Introduction
Pesticides differ from other classes of chemicals regulated
by EPA in several important ways. They are often intentionally
applied in the environment, rather than occurring as a byproduct
of industry or other human activity. They are used in a
remarkably diverse array of products, from insect repellents to
crop weed killers to household disinfectants to swimming pool
chemicals, to name a few. In addition, they are likely to be
found or used in nearly every home and business in the United
States. Although improper pesticide use may pose health risks,
many pesticides have public health benefits by killing potential
disease-causing organisms found in food, water, and other
settings.
Given the unique attributes of pesticides, EPA has found
that protecting public health and the environment from the risks
that pesticides may pose is a complex endeavor. To meet this
challenge, the Agency has developed an array of programs to
evaluate and reduce pesticide risks and promote safe pesticide
use. These programs must be flexible enough to reflect the wide
variety of existing pesticide products and uses, and must take
into account the benefits that pesticides offer to society.
State and tribal agencies and many other organizations, both
public and private, have been vital partners in this effort.
This report describes many of the efforts and
accomplishments of the Office of Pesticide Programs (OPP) during
the 1994 fiscal year (October 1, 1993 to September 30, 1994). It
also describes some of the opportunities and initiatives that OPP
will pursue in 1995.
Annual Report Structure
While OPP staff are formally organized into eight divisions
and a policy staff, this report is organized around the six major
activity areas used in the budget process:
1 - Registration
Making decisions about the registration (licensing) of
individual pesticide products, and assuring that decisions are
consistent and up-to-date.
2 - Reregistration
Bringing the scientific data base for older pesticide active
ingredients up to current standards, reassessing their regulatory
status, mitigating their risks, and documenting new decisions.
Assuring that products containing eligible active ingredients are
supported by valid data, are labeled correctly, and are
reregistered.
3 - Special Review
Conducting in-depth assessments of pesticides suspected of
posing unacceptable risks to public health or the environment.
4 - Field Implementation and Communications
Working with EPA regional offices, states, and tribal
organizations to implement pesticide programs, communicating with
the public about pesticide issues, and supporting compliance
efforts.
5 - Policy, Regulations, and Guidance
Developing pesticide policies and regulations, including
improvement of the quality of scientific information used to make
decisions.
6 - Information and Program Management
Managing pesticide information (including automated
information systems, computers and computer networks, and paper
and microfiche collections) and administering programs (including
human resources, facilities, finances, and budget planning).
Contents
Foreword
Introduction
Chapter 1: Registration
Overview Of Registration
New Registrations In 1994
Reduced-Risk Policy
Other 1994 Registration Achievements
Ensuring The Effectiveness Of Antimicrobial Pesticides
Retaining Minor Uses
Proposed Measures To Reduce Risks From Total Release Foggers
Addressing Risks From Spraying Pesticides Aboard Aircraft
Water Protection Measures For New
Pesticide Active Ingredients
Efforts To Improve Pesticide Labels
Pesticide Chemistry Laboratory Support For Registration
Reducing Unnecessary Requirements For Pesticide Registration
Agreement With California To Harmonize Pesticide Regulation
Improvements To Regulatory File System
Chapter 2: Reregistration
Steps In Reregistering Pesticides
1994 Reregistration Progress
Reducing Pesticide Spray Drift
Reassessment Of Dioxin Risks
Rejection Rate Analysis
Pesticide Chemistry Laboratory Support For Reregistration
Reducing Ecological Risks Under The "New Paradigm"
The Label Use Information System (LUIS)
Chapter 3: Special Review
1994 Formal Special Reviews And Follow-up Activities
Cancellation Of Mevinphos
Other Negotiated Risk Reduction Efforts
Other Cancellation Activities
Tolerance Revocations
Initiative To Reduce Risks To Birds
(Avian Granular Initiative)
Chapter 4: Field Implementation and Communications
A. Field Programs
Implementing The Worker Protection Standard
Endangered Species Protection Program
Protecting Ground Water
Certification And Training Of Pesticide Applicators
Disposal Of Suspended And Cancelled Pesticides
Promoting Integrated Pest Management
Guidance For Posting Of Outdoor Pesticide Applications
B. Communications, Public Response, and Coordination
Outreach And Communications Strategies
Responding To The Public
Congressional And Federal Coordination
Public Meetings
Pesticide Information Network
Agency Risk Management Communication Group
Scientific Presentations And Publications
International Coordination And Integration
Regional, State, And Tribal Liaison
Improving Internal Communication
C. Support For Compliance Activities
Support For The Lab Audit Program
Analysis Of Product Chemistry
Other Laboratory Support
Additional Support For Compliance Activities
Chapter 5: Policy, Regulations, and Guidance
Follow-Up To The National Academy Of Sciences (NAS)
Children's Study
Reduced Use/Risk Initiative
International Harmonization And Regulatory Coordination
Technical Assistance: AID/EPA Central American Project
Biological Pesticide Policy Highlights
Activities Related To Implementation Of The "Delaney Clause"
Standards For Pesticide Containers And Containment
Other Regulations Under Development
Legislative Proposals
Maintaining And Improving OPP's Science Base
Chapter 6: Information and Program Management
Operations, Maintenance And Integration
Of The Primary OPP Information Systems
Ecological Incident Monitoring And Reporting
Information And Records Management Activities
Human Resources Management
Resource Allocation And Financial Management
Chapter 7: Opportunities and Initiatives For 1995
Biological Pesticides And Promoting Risk Reduction
Opening Up OPP
Reinventing And Streamlining OPP's Organization
How To Obtain More Information
Pesticide Program Contacts
Chapter 1: Registration
This chapter describes the registration program, which
provides the foundation for nearly all OPP activities related to
pesticides. In addition to allowing the use of new pesticides,
this program includes many activities related to the ongoing
registration of existing pesticides, such as modifications to
where and how they may be used in order to reduce risks or in
response to requests by registrants. OPP also carried out a
number of special registration programs in 1994, which are
described in more detail in this chapter. These included
encouraging the registration of reduced-risk pesticides, ensuring
the effectiveness of antimicrobial pesticides, helping to retain
important minor use pesticides, proposing measures to reduce the
risks from total release foggers ("bug bombs") and from spraying
of pesticides aboard aircraft, improving pesticide labels,
reducing unnecessary registration requirements, and coordinating
registration activities with the State of California.
Overview Of Registration
EPA is responsible under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) for registering new pesticides and
ensuring that, when used according to label directions, they will
not cause unreasonable adverse effects to human health or the
environment. Pesticide registration decisions are based
primarily on EPA's evaluation of the test data provided by
applicants. EPA has established a number of requirements, such
as the Good Laboratory Practice Standards, that apply to both
registrants and testing facilities to ensure the quality and
integrity of pesticide data. Depending on the type of pesticide,
OPP can require more than 100 different kinds of specific tests.
Testing is needed to determine whether a pesticide has the
potential to cause adverse effects to humans, wildlife, fish, and
plants, including endangered species. Potential human risks,
which are identified using laboratory tests in animals, include
acute toxic reactions (such as poisoning and skin and eye
irritation) as well as possible long-term effects (such as
cancer, birth defects, and reproductive disorders). Data on the
fate of pesticides in the environment are also required so that
OPP can determine, among other things, whether a pesticide poses
a threat to groundwater or surface water (lakes, rivers, and
streams).
Most of OPP's testing requirements focus on "active
ingredients" of pesticide products. Active ingredients are those
substances that actually possess a pesticidal property -- that
is, they repel, destroy, or otherwise affect a pest. Most
pesticide products also contain other ingredients that do not
have pesticidal properties, such as solvents, carriers, aerosol
propellants, and dyes. Ingredients that are not active as
pesticides are called "inerts."
New Registrations In 1994
OPP registered 31 new pesticide active ingredients in fiscal
year 1994, more than half of which are considered to be reduced
risk pesticides. Reflecting the trend of recent years, a high
proportion of new ingredients -- 15, or nearly half -- were
biological pesticides. Biological pesticides include "microbial
pesticides," which are bacteria, viruses, or other microorganisms
used to control pests, and "biochemical pesticides," which
include pheromones (insect sex attractants), insect or plant
growth regulators, and hormones used as pesticides. Biological
pesticides generally pose less risk to health and the environment
than chemical pesticides, and as a result OPP imposes fewer
requirements on their registration. The following table
describes the pesticide active ingredients registered for the
first time in fiscal year 1994.
New Active Ingredients Registered in FY94
-----------------------------------------------------------------
Pesticide Registrant Pesticide Use(s) Biological
Name Type or Other
Reduced Risk
Pesticide?
-------------- ----------- ---------- --------- -------------
Acetochlor Monsanto Herbicide Corn
Agric. Co.;
Zeneca Ag
Products
Ampelomyces Ecogen Fungicide Grapes, Yes
quisqualis toma- (biological)
toes,
straw-
berries,
apples
Bacillus Gustafson Fungicide Cotton, Yes
subtilis (MBI grains (biological)
600)
C-9211 Rohm and Mildewcide Paints
Haas
Castor Oil Dinah Repellent Orna-
Pickett mental
plants
Checkmate CM Consep; Pheromone Fruits Yes
pheromone Bedoukian and nuts (biological)
Research
Corn Glutens Gardens Fungicide Turf Yes
Alive! (biological)
Cyproconazole Sandoz Agro Fungicide Turf
Inc.
Deltamethrin Roussel Insect- Feed
Uclaf; icide
AgrEvo
Environ
-mental
Health
Difeno- Ciba-Geigy Fungicide Wheat
conazole
DTEA Dow Anti- Water
Chemical microbial Systems
Floral Micro-Flo Phero- Corn Yes
Attractants mones (biological)
(seven (7 pheromones)
different
compounds)
Flumetsulam DowElanco Herbicide Corn and
soybeans
Gusano Crop Insect- Veget- Yes
(Alfalfa Genetics icidal ables (biological)
looper Inter- Virus
virus) national
Hexaflumuron DowElanco Insect- Termit- Yes
icide icide
Hydrogen SKW Plant Grapes
Cyanamide Trostberg Growth
AG Regulator
Imidacloprid Miles Insect- Turf
(NTN) icide
Irgarol 1051 Ciba-Geigy Anti- Anti-
microbial foulant
paints
Methyl PMC Bird Turf Yes
Anthranilate Specialties Repellent
Group
Pseudomonas Mauri Lab- Fungicide Mush- Yes
fluorescens oratories rooms (biological)
Strain NCIB
12089
Puccinia Tifton Herbicide All Yes
canaliculate Innovation crops (biological)
lagerheim
RYH-86-A Yoshitomi Slimicide Paper
Pharmaceut. mills
Industries
Tebuconazole Miles Fungicide Peanuts
Tufted Apple Bedoukian Pheromone Apples Yes
Bud Moth Research (biological)
pheromone
Turpentine DLT Lab- Insect- Non-Food
oratories icide Uses
----------------------------------------------------------------
Summary Statistics
o 31 new active ingredients registered
o 2 chemical active ingredients registered as "reduced-
risk pesticides"
o 15 were biological/biochemical pesticides
Reduced-Risk Policy
During fiscal year 1994, OPP implemented its voluntary
Reduced-Risk Pesticide Initiative. Under this effort, OPP
invites applicants seeking to register new pesticide active
ingredients to provide information on how their pesticide
presents opportunities for risk reduction. If OPP believes that
the pesticide demonstrates such potential, OPP accelerates the
registration process for the pesticide.
In March 1994, OPP registered the first pesticide under this
initiative. Hexaflumuron, developed by DowElanco, has the
potential to replace much larger amounts of the termiticide
chemicals traditionally used. This product is used with a
monitoring system so that the chemical is applied only after a
termite problem has been identified. In September 1994, OPP
registered the second reduced-risk pesticide, methyl
anthranilate. This bird repellent, marketed by PMC Specialties
Group, is registered for use on turf. Methyl anthranilate is
found in flower oils and in Concord and other grapes. This
product solves bird pest problems where existing bird control
toxicants and repellents cannot be used.
OPP will continue the voluntary initiative in its current
form for at least one additional year. During this time, OPP
will explore other types of incentives that could encourage the
development, registration, and use of lower-risk pesticide
alternatives. In addition, OPP will consider approaches for
expanding the current pilot program to other types of
registration applications.
Other 1994 Registration Achievements
Registering new pesticides for the first time is only one of
an enormous number of pesticide registration actions that OPP
carries out each year. The decisions made in 1994 are summarized
in the following table. Both approvals and denials of the
requests received by OPP are included in the number of decisions.
1994 Registration Activities
---------------------------------------------------------------
Registration Description of Activity Number of
Activity Decisions
------------------ -------------------------------- ---------
Registrations of First approval for use of 31
new pesticides pesticides not currently
registered in the United States.
Additional Registrations for new products 782
registrations containing pesticide ingredients
for previously already approved for proposed
registered uses.
pesticides
Amendments to Amendments, for example, to 3,233
existing reflect revised labels and
registrations changed formulations for
products already registered.
New uses for Approvals for uses of a 56
previously pesticide (such as on particular
registered food crops) for which it has
pesticides never been registered.
Emergency Decisions on granting emergency 265
exemptions exemptions to states or other
("Section 18s") federal agencies to allow use
for a limited period of
pesticides not registered for
those particular uses.
Experimental Use Decisions on permits that allow 104
Permits (EUPs) pesticide producers to test new
pesticide uses outside of the
laboratory; generally required
if more than 10 acres are to be
tested.
Tolerances Decisions on approving 70
tolerances, or maximum allowable
levels of a pesticide in food or
animal feed. Tolerances (or
exemptions from tolerances) are
required whenever a pesticide is
registered for use on a food or
feed crop.
Temporary Decision on approving 26
tolerances tolerances for experimental
purposes for an unregistered
pesticide.
Special Local Registrations of pesticide 411
Need products by state agencies for
Registrations specific uses not federally
("Section registered. (The pesticides must
24(c)s") be federally registered for
other uses.)
---------------------------------------------------------------
Ensuring The Effectiveness Of Antimicrobial Pesticides
While all pesticide products are required to work as claimed
by the manufacturer, EPA is particularly concerned about the
effectiveness, or efficacy, of antimicrobial pesticides.
Antimicrobial products are used to control "germs" such as
bacteria and fungi (molds and mildews) that can cause odors, food
spoilage, or infections. Not only are they used in homes, but
also in hospitals, cafeterias, restaurants, and many other
institutions. Over the past several years, EPA has implemented a
comprehensive strategy to ensure the efficacy of antimicrobial
pesticides, placing highest priority on those that have
significant public health uses. Among these efforts, EPA has:
o Funded six cooperative agreements to develop new or revise
existing test methods for determining the efficacy of
antimicrobial public health products.
o Implemented a pre- and post-registration testing program.
Six new sterilants were subjected to pre-registration
testing this past fiscal year, of which one has been
registered and the others are pending. Testing of hospital
disinfectants and products with tuberculocidal claims is in
progress.
o Administered the Antimicrobial Complaint System to receive
inquiries and complaints from users and the public. The
system received more than 4,000 calls from medical
professionals and infection control personnel in 1994. This
system also provides valuable information for assessing
needed regulatory changes.
o Implemented comprehensive label improvement programs to
upgrade the label claims and directions for products used
against the AIDS virus (HIV-1) and for tuberculocidal,
sanitizing, and pine oil products (household disinfectants).
Retaining Minor Uses
Minor use pesticides are those that generate relatively
little income for their manufacturers because they are used on
limited acreages. Increased costs of pesticide registrations,
especially the costs associated with reregistering pesticides,
often result in registrants choosing to cancel minor use
registrations and not pursue approval for new uses. However,
minor use pesticides are of major importance to growers in
producing many fruits, vegetables, and ornamental plants. In
1994, OPP continued to participate in several activities to help
preserve important minor uses:
o IR-4 Efforts. OPP supports the efforts of the Interregional
Research Project Number 4, or IR-4 program, which is jointly
funded by the U.S. Department of Agriculture and the states.
IR-4 has generated data for many minor use pesticides
undergoing reregistration and has committed to providing
residue data to support reregistration of an additional 250
high priority pesticide food uses. OPP supports increased
IR-4 funding as the best way to protect minor uses without
sacrificing health and safety data development and reviews.
o Data deferrals/waivers. OPP tries to be flexible on the
data required for registration and reregistration of minor
use pesticides, but must also ensure that pesticides do not
pose unacceptable risks to people or the environment.
o Crop grouping. OPP has supported the establishment of
tolerances (maximum approved levels in food) for multiple
related crops based on residue data from a representative
set of crops. This cuts the costs of registering minor
uses.
o Legislation. In 1994, the Administration proposed
legislative changes to help retain important minor uses, and
encourage registration of new minor uses, as part of its
Food Safety Initiative. This proposal embodies many
elements from a proposal by the Minor Crop Farmers Alliance
(MCFA).
Proposed Measures To Reduce Risks From Total Release Foggers
Total release foggers -- sometimes called "bug bombs" -- are
pesticide products containing aerosol propellants that release
all of their contents at once to fumigate an area. They are used
in homes to kill cockroaches, fleas, and other pests. On April
15, 1994, OPP proposed new labeling requirements for total
release foggers based on information that demonstrated that total
release foggers, as currently labeled, represent an unreasonable
risk to users from fires and explosions. The proposed rule would
require additional flammability label warnings and a standard
graphic symbol, representing fire and explosion, to alert
consumers to these potential dangers. In addition, pesticide
labels for these products would include more detailed directions
for proper use. The proposed rule encourages registrants to use
other hazard communication mechanisms to reinforce the required
precautionary language. OPP is reviewing comments on the
proposal and expects to issue a final rule in 1995.
Addressing Risks From Spraying Pesticides Aboard Aircraft
In late 1993, EPA became aware of several incidents in which
airline personnel and passengers experienced adverse health
effects after being exposed to an insecticide treatment aboard
foreign-bound aircraft. Although the United States has not
required spraying since 1979, several foreign countries do
require the spraying of incoming aircraft, with passengers and
crew present, prior to landing. Traditionally, passengers are
not told that this treatment will occur until the spraying
actually begins. The pesticide used in these treatments is known
as sumithrin. Although EPA has data indicating that sumithrin is
generally low in toxicity to humans, the Agency does not know how
the chemical may affect susceptible sub-populations. EPA is
particularly concerned that individuals who are chemically
sensitive, or who suffer from respiratory problems or allergies,
may have adverse reactions.
In March 1994, OPP issued a Data Call-In Notice to the two
registrants that still held U.S. registrations for in-flight
insecticide treatments requiring them to either develop new
toxicity data or amend the pesticide label to delete the aircraft
use. Since then, both registrants have removed the aircraft use
from the label. Many countries, however, continue to require in-
flight spray treatments. Recently, the U.S. Department of
Transportation (DOT) issued a proposed rule to require
notification to passengers at the time they purchase their
tickets. EPA continues to work with the State Department and DOT
to encourage foreign countries to rescind the airline spraying
requirement. OPP is also preparing a notice to registrants to
ensure that pesticide labels do not allow the use of other
insecticides on board aircraft with passengers and crew present.
Water Protection Measures For New Pesticide Active Ingredients
In 1994, OPP initiated a new approach for registering
pesticide active ingredients that sets strong standards for
ground and surface water protection. The approach establishes
clear criteria that trigger voluntary suspension or cancellation
of the registration if water quality is adversely affected.
These criteria are based on an assessment of the chemical and
physical properties of the pesticide and other factors indicating
its potential to contaminate water resources. Acetochlor was the
first pesticide registered using this approach. Highlights of
the water protection approach include:
o Requirements for analytical methods to detect the presence
of the pesticide in water, including a low-cost immunoassay.
o Early warning systems to prevent ground water emergencies,
including monitoring of wells and surface water in several
states.
o Product stewardship programs to foster proper use by
customers and to prevent problems from occurring.
Efforts To Improve Pesticide Labels
Labeling is one of OPP's most important tools for achieving
its mission of protecting human health and the environment. No
other pesticide document or publication has a more direct impact
on risk reduction or the potential to prevent pollution. Over
time, however, some labels have become cluttered and confusing.
In response to needs expressed by OPP's customers and an internal
evaluation process, OPP formed a Labeling Unit in July 1994. The
goal of the unit is to ensure that product labels are clear,
technically accurate, and consistent. In 1994 the unit
accomplished the following:
o Introduced a process for tracking and resolving short-term
labeling problems and issued responses to more than 50
requests for guidance.
o Established an electronic labeling policy directory which
contains over 300 easily accessible documents.
o Established a Labeling Bulletin Board system for sharing
information about labeling projects with internal and
external customers.
o Helped finalize and release a comprehensive Label Review
Manual for use by internal and external customers.
o Initiated projects to improve consumer labeling, test the
electronic submission/review/storage of labels, and revise
OPP regulations to allow certain information on labels that
consumers need to make more informed choices.
Pesticide Chemistry Laboratory Support For Registration
OPP's pesticide registration program is supported by two
pesticide chemistry labs: the Analytical Chemistry Laboratory
(ACL) in Beltsville, Maryland, and the Environmental Chemistry
Laboratory (ECL) in Bay St. Louis, Mississippi. The labs
support registration through the food tolerance and environmental
chemistry methods validation programs, which ensure that
pesticide residues can be properly measured in food and the
environment.
The ACL has the lead responsibility for the food tolerance
methods validation program. In fiscal year 1994, ACL validated a
record 49 food tolerance methods for registration. The ACL's
achievements also included the development of a method for
detecting residues of multiple sulfonylurea pesticides in food
using a new technology called capillary zone electrophoresis,
which generated much interest among the scientific community.
The ECL has the lead responsibility for the environmental
chemistry methods validation (ECMV) program. The demand for
environmental chemistry support for new pesticides grew
substantially in 1994, with the primary emphasis being in the
areas of environmental fate and exposure and ecological effects.
The ECL completed seven ECMV requests for new pesticides in 1994,
including a ten-fold lowering of the detection limit for the
pesticide acetochlor, allowing it to be more readily detected in
the environment. The ECL also continued to provide support to
the new, low-cost technology for detecting pesticide residues
known as immunoassay tests.
Reducing Unnecessary Requirements For Pesticide Registration
In 1994, OPP continued to identify areas where pesticide
regulations could be reduced, allowing OPP to better focus on
high risk areas and preventing undue burdens on the regulated
community. One area identified was the potential exemption of
certain low-risk pesticides from registration requirements. In
January 1994, OPP established an exemption from registration
requirements under section 25(b) of FIFRA for natural cedar
pesticides labeled to repel arthropods (other than ticks) or to
retard mildew growth. OPP concluded that use of these pesticides
poses negligible risks to human health and the environment and
that, as a result, the burden imposed by regulation is not
justified.
Subsequently, the Agency proposed a second rule (also under
section 25(b)) to exempt 31 additional low-risk substances from
regulation. Most of these were food items (such as cinnamon,
garlic, and mints) or substances otherwise derived from natural
sources. Under the proposal, to be eligible for exemption these
substances could not be sold in formulations with other
pesticides or chemicals of concern, and could not be labeled to
control organisms posing a risk to public health. The labels
would be required to list all ingredients. OPP will review
comments received and determine how to proceed in 1995.
Agreement With California To Harmonize Pesticide Regulation
OPP and the Department of Pesticide Regulation of the
California Environmental Protection Agency began an initiative in
1994 to harmonize and simplify federal and California pesticide
registration, and to exchange work products to reduce duplication
of effort and expense. The first major milestone of this
initiative was the signing of a Memorandum of Understanding (MOU)
in May 1994. Under this MOU, the agencies agreed to share
reviews of acute toxicology studies submitted by pesticide
registrants. The agreement sets out a plan to reduce duplicative
review of identical data, improve coordination, and reduce the
workload of both agencies by allowing each agency to use acute
toxicity data reviews generated by the other. Through this
effort, products posing fewer risks will be registered much
faster and at less cost, and older pesticides lacking adequate
health data will be more quickly removed from the market.
Improvements To The Regulatory File System
Among OPP's most important files are the regulatory
"jackets" for each pesticide product that has been federally
registered. During fiscal year 1994, the Regulatory File Area
implemented several changes to improve service. In particular, a
computerized system that provides OPP users with the ability to
request jackets from their workstations was activated. The new
system has been integrated with other OPP computer systems, and
provides status information on each registration (such as
cancelled, withdrawn, or suspended). Under this system, files
can be more efficiently managed; for example, quick
identification of cancelled files facilitates their removal to
make room for new incoming files. 95% of file room users have
been trained to use the new system and training will continue in
1995.
Chapter 2: Reregistration
The reregistration program is one of OPP's largest and most
visible programs. OPP is required by law to reregister existing
pesticides originally registered when the standards for
government approval were less stringent than they are today.
This comprehensive reevaluation of pesticide safety in light of
current standards is critical to protecting human health and the
environment. In 1988, Congress amended the federal pesticide law
to strengthen and accelerate OPP's reregistration program. The
"FIFRA '88" amendments apply to each product containing any
active ingredient registered before November 1, 1984.
This chapter discusses the progress OPP is making in
reregistering pesticides, as well as some related initiatives.
These include efforts to reduce the number of studies rejected by
OPP, reduce the risks posed by pesticide spray drift, more
effectively assess and decrease ecological effects, help
understand and control dioxin risks, and expand a database of
label directions for pesticides undergoing reregistration.
Steps In Reregistering Pesticides
OPP identified the pesticides to be reregistered and issued
comprehensive data requests to registrants of those pesticides
during Phases 1 through 4 of the accelerated reregistration
process. Reregistration is now in its final phase, Phase 5, as
OPP reviews the studies that are being submitted, examines the
health and environmental effects of each reregistration case
(group of related pesticide active ingredients), and attempts to
mitigate effects of concern. This evaluation and risk management
process is complete when OPP is satisfied that the pesticide,
used in accordance with approved labeling, will not pose
unreasonable risks to human health or the environment.
OPP's conclusion about whether a pesticide's uses are
eligible for reregistration is presented in a Reregistration
Eligibility Decision, or RED. About 14 months later, once
certain product-specific data and revised labeling are submitted
and approved, OPP begins reregistering products containing the
eligible pesticide(s). A product will not be reregistered until
OPP has determined that all of its active ingredients are
eligible for reregistration.
1994 Reregistration Progress
During fiscal year 1994, OPP made significant progress in
administering the reregistration program. Many decisions were
made resulting in significant risk reductions. The program's
investment in people, computer systems and data gap
identification is paying off with steady production of the
decisions needed to complete the reregistration process.
Several different stages of reregistration offer
opportunities to contribute to safer use of older pesticides.
New risks identified during the reregistration process may be
addressed by imposing interim risk reduction measures before the
scheduled REDs. The next important stage for reducing risks
occurs with the issuance of REDs. Many types of risk reductions
are required through REDs, and OPP completed an unprecedented
number of REDs this fiscal year, as detailed later in this
chapter. Finally, perhaps the most comprehensive risk reduction
impacts occur during the product reregistration stage. During
fiscal year 1994, program emphasis began shifting toward product
reregistration, as many more products became eligible. Product
reregistration will become even more important during the next
several years. Some of the principal accomplishments of the
reregistration program during fiscal year 1994 and cumulatively
are summarized below.
Annual and Cumulative Completion of REDs
The number of REDs completed per fiscal year has been
increasing steadily since the accelerated reregistration program
began. This number reached 34 in fiscal year 1994 for a
cumulative total of 81 completed REDs. A target of 40 more REDs
has been set for fiscal year 1995.
Number of REDs Completed:
FY91: 13
FY92: 15
FY93: 19
FY94: 34
--
Cumulative through FY94: 81
FY95 Goal: 40
FY95 Cumulative Goal: 121
Status of Reregistration Cases
OPP has completed a total of 81 REDs, representing one fifth
of the 405 chemical cases currently supported for reregistration.
Meanwhile, 207 of the original 612 cases are unsupported (meaning
that the registrants have decided not to complete and submit the
studies required for reregistration). Cases that remain
unsupported have been or will be cancelled.
Anatomy of the 81 REDs Completed
...Or, What "81 REDs Completed" Means...
The 81 REDs completed cover 120 active ingredients, 3,521
products, and 500 tolerances. They represent 20% of all
supported reregistration cases (a case consists of one or more
related pesticide active ingredients); 17.5% of all currently
registered pesticide products; 19% of food use pesticides
(supported List A cases); and 9% of original List A tolerances
reassessed. As described in the table below, the completed REDs
represent about two-thirds of the quantity of pesticides used (by
volume) in the United States, including about two-thirds of all
homeowner-applied pesticides and 9 to 14% of all pesticides used
in agriculture.
Amount of Pesticide Usage (by volume)
Covered By REDs Completed*
---------------------------------------------------------------
Homeowner Agriculture Commercial/ TOTAL
Applied Industrial
and
Government
------------- ----------- ----------- ----------- ---------
Fungicides 50% to 55% 55% to 60% 4% to 7% 40 to 48%
Herbicides 4% 4% to 7% 16% to 30% 6% to 10%
Insecticides 10% to 15% 1% to 2% 1% to 3% 4% to 10%
Anti- 99% + 99% + 99% + 99%
microbials
TOTAL 65% 9% to 14% 65% 65%
---------------------------------------------------------------
* Please note that the REDs completed for the two
antimicrobial cases -- bleach (sodium and calcium
hypochlorite) and chlorine -- account for a large proportion
of the usage of antimicrobials and the overall usage of
pesticides covered by the REDs completed so far. Note, too,
that the pounds used may not indicate the relative percent
of market share or number of applications.
Risk Reductions Achieved
Each Reregistration Eligibility Decision (RED) document
issued in 1994 involved changes to reduce the potential risks of
the pesticide being evaluated. Risks can be reduced by
cancelling products, declaring uses ineligible for
reregistration, strengthening the requirements on product
labeling, or limiting the amount of pesticide residues that may
remain in food by establishing, reducing or revoking "tolerances"
(enforceable maximum residue limits). Some of the risk reduction
measures achieved in the 34 REDs completed this fiscal year are
described in the following table:
----------------------------------------------------------------
Number of REDs Risk Reduction Measures Required By RED
---------------- ----------------------------------------------
1 All products and uses voluntary cancelled
(mevinphos).
6 Restricted Use Pesticide classification added
or maintained, so that the pesticide may be
used only by or under the direct supervision
of a certified applicator.
19 Personal Protective Equipment requirements for
pesticide applicators strengthened or
confirmed.
10 Restrictions that limit entry of workers into
treated areas (including Restricted Entry
Intervals) strengthened or confirmed.
8 Limits/reductions/specifications regarding the
amount, frequency, or rate of application
required.
3 Use Directions on labeling strengthened or
made more specific.
6 Other user safety measures required.
5 Label Advisory or other measures to protect
ground or surface water required.
14 Environmental Hazard statements to reduce
ecological risks strengthened.
8 Tolerances revised (reduced, revoked, or newly
approved).
----------------------------------------------------------------
Tolerances Reassessed
As part of reregistration, OPP is reassessing pesticide
tolerances, or maximum residue limits in food and feed. A
pesticide must have a tolerance (or be granted an exemption from
a tolerance) for each different type of food or animal feed on
which it may be used. The number of tolerances for the List A
pesticides (which represent the most significant food use
pesticides) was about 5,600 in November 1988, when the
accelerated reregistration program began. Since then, about 500
(or 9%) List A pesticide tolerances have been reassessed as part
of the reregistration process. About 600 more List A tolerances
are associated with active ingredients no longer supported for
reregistration; these active ingredients ultimately will be
cancelled and their tolerances revoked. During the past several
years, some new tolerances have been added for the List A
chemicals, while others have been revoked. OPP estimates that
approximately 4,500 tolerances for List A pesticides still need
to be reassessed during reregistration.
Data Call-In (DCI) Notices
OPP has issued 453 comprehensive Data Call-In (DCI) notices
under the reregistration program to obtain studies needed to
assess potential health and environmental risks. As Phase 4 of
reregistration has been completed, which involved issuing DCIs to
complete pesticide databases, the number of DCIs issued per year
has decreased. OPP issued 77 DCIs in 1994.
Status Of Studies Received
Registrants have responded to DCIs and other requirements by
submitting more than 19,000 studies in support of reregistration.
Review of these studies is essential for making reregistration
decisions. By end of fiscal 1994, OPP had reviewed more than
11,500 of the studies, including nearly 7,000 of the
approximately 9,000 studies received for List A pesticides. The
cumulative numbers of studies received, reviewed and awaiting
review by scientific discipline are shown in the following tables
for the List A pesticides and for all pesticides undergoing
reregistration.
Status Review Status For List A Pesticides
--------------------------------------------------------------
Study Type Received Reviewed Awaiting
Review
----------------------------- ---------- --------- --------
Residue Chemistry 2,632 2,118 514
Environmental Fate 2,140 1,349 791
Reentry Non-Dietary 209 51 158
Toxicology, Non-CORT** 1,515 1,238 277
Toxicology, CORT* 738 658 80
Ecological Effects 1,742 1,365 377
--------------------------------------------------------------
Status Review Status For All Pesticides
Undergoing Reregistration (Lists A, B, C, and D)
--------------------------------------------------------------
Study Type Received Reviewed Awaiting
Review
----------------------------- ---------- --------- --------
Residue Chemistry 4,250 2,709 1,541
Environmental Fate 3,741 1,960 1,781
Reentry Non-Dietary 268 55 213
Toxicology, Non-CORT** 5,045 2,721 2,324
Toxicology, CORT* 1,777 1,127 650
Ecological Effects 4,304 2,930 1,374
--------------------------------------------------------------
* Tox., CORT - Chronic feeding, carcinogenicity
(oncogenicity), reproduction, and
developmental toxicity (teratology) studies.
** Tox., Non-CORT - Studies other than CORT studies that measure
the toxicity of pesticides.
Suspensions
When pesticide registrants fail to submit studies required
for reregistration in a timely way, EPA's Office of Enforcement
and Compliance Assurance (OECA) can issue Notices of Intent to
Suspend (NOITS) product registrations. NOITS serve as an
effective mechanism for bringing about compliance with EPA's data
requirements for reregistration; in most instances companies
comply with the NOITS by submitting the missing studies. If
companies fail to comply by either submitting the required
studies, voluntarily withdrawing their product registrations, or
requesting a hearing, EPA can issue suspensions.
During fiscal year 1994, EPA issued NOITS to 179 companies.
The Agency eventually withdrew 128 of these NOITS because the
companies achieved compliance. However, EPA also issued 47
suspensions, and in four other cases is responding to requests
for hearings to resolve questions about the Agency's data
requirements. These fiscal year 1994 actions bring the total
number of NOITS issued since 1989 to 779, and the number of
suspensions to 301. In most of the remaining 478 cases,
compliance has been achieved, while hearings continue to resolve
remaining issues in some of the cases.
Voluntary Cancellations
In some instances, registrants have responded to
reregistration requirements by withdrawing support for pesticide
active ingredients and products. Reregistration cases have
dropped overall from 612 cases in 1988 to 405 today. Registered
products declined during the early 1990s from approximately
45,000 to about 20,000 subject to reregistration. This initial
decline represented pesticides with little or no use; more than
19,000 of these pesticides had not been produced in the three
years prior to their cancellation. As product reregistration
proceeds (please see below), a significant number of additional
products are being voluntarily cancelled by their registrants.
Product Reregistration
While REDs are OPP's major reregistration output, much of
the real world impact of eligibility decisions and risk reduction
requirements does not occur until products are reregistered.
This occurs at least 14 months after a RED is issued because of
the time required for registrants to submit product-specific data
and labels and for OPP to review them. As of October 1994, OPP
had reregistered over 600 products, granted a greater number of
voluntary cancellations (925), amended 11 existing registrations,
and suspended 449 products. Reregistration decisions are pending
on a total of 980 products. Activity in this important area will
increase dramatically during the next several years.
Rejection Rate Analysis
In 1991, OPP discovered that the submission of unacceptable
studies was the most significant factor delaying reregistration.
Repeating studies can add years to the reregistration process,
significantly increase OPP's administrative and science review
costs, and cost registrants millions of dollars. To address the
high rate of rejection of studies submitted during
reregistration, OPP developed the Rejection Rate Analysis.
OPP's analysis, which involves the active cooperation of the
pesticide industry and the IR-4 program, is an intensive effort
to identify and resolve the underlying problems that most
frequently cause studies to be rejected. The resulting reports
for each discipline -- including Residue Chemistry, Worker
Exposure, Toxicology, and Environmental Fate -- are designed to
make sure that future studies will be acceptable to the Agency.
By 1994, two years after the first Rejection Rate Analysis
chapter was published by OPP, the quality of studies submitted to
OPP was improving. For example, processing studies, which
initially had the highest rejection rate among residue chemistry
studies, improved from a 29% rejection rate before the analysis
to a 16% rate afterwards. The second most often rejected study,
plant metabolism, improved dramatically from a 27% rejection rate
before the analysis to only 8% after. Improvements such as these
will assist OPP in making reregistration decisions in a more
timely way.
The next milestone in the Rejection Rate Analysis will be
publication of the final chapter on Ecological Effects in 1995.
EPA and industry scientists first met in April 1994 to improve
understanding of factors leading to ecological effects study
rejection. This effort became a forum for expressing divergent
perspectives on the way risk to birds is assessed. The analysis
discovered that rejection rates for some testing requirements
have decreased over time, but that rates for others have not. On
average, the rate at which OPP rejects ecological effects studies
has declined from 36% prior to 1986 to the current rate of 20%.
While some testing issues have been resolved through the
Rejection Rate Analysis, others remain to be addressed by future
workgroups that OPP hopes will involve continued public
participation.
Pesticide Chemistry Laboratory Support For Reregistration
In addition to supporting pesticide registration (as
described in chapter 1), OPP's two pesticide chemistry labs
provide support for the reregistration program. The Analytical
Chemistry Laboratory validated one food tolerance method for
reregistration in 1994. Approximately five to ten methods are
expected in 1995. The Environmental Chemistry Laboratory (ECL)
completed four analytical method validations for pesticides in
soil and water under the reregistration program in fiscal year
1994. In addition, the ECL developed a multianalyte method for
detecting nine sulfonylurea pesticides in water. The ECL also
prepared a draft of the new environmental chemistry methods
manual, which will contain all of the EPA validated and non-
validated soil and water methods.
Reducing Pesticide Spray Drift
Aerial or ground application of pesticides may lead to drift
off the site of intended application and result in exposure to
workers, nearby residents, nontarget plants, and other ecological
resources. To better understand the factors which affect spray
drift, OPP worked closely in 1994 with the Spray Drift Task Force
(SDTF), a coalition of 32 pesticide registrants. The SDTF is
conducting extensive research into the factors that contribute to
and can control spray drift. The information generated by the
task force will greatly enhance OPP's ability to assess exposure
resulting from spray drift, prevent excessive spray drift, and
reduce risks caused by drift. These data will help fulfill
requirements of pesticide registration. 1994 highlights include:
o EPA's Office of Research and Development (ORD), the U.S.
Department of Agriculture (USDA), and the SDTF signed a
Cooperative Research and Development Agreement in March
1994.
o OPP is providing input to spray drift modeling efforts under
the cooperative research agreement. The models developed
will enable optimal use of spray drift data and provide
options for reducing drift and managing risk.
o A conference was held in June 1994 to discuss the SDTF's
preliminary data on drift from airblast applications to tree
crops and to identify additional research priorities.
Orchard crop specialists from the United States and Europe
attended.
o OPP reviewed the first official data submission of the SDTF.
Reassessment Of Dioxin Risks
Dioxins comprise a group of chemically-similar, highly toxic
compounds that are of concern to EPA. Because some pesticides
have been found to be contaminated with low levels of dioxins,
OPP has contributed to EPA's exhaustive reassessment of dioxin
risks conducted since 1991. OPP's Environmental Chemistry
Laboratory performed a number of analyses of animal tissue in
1994 as part of the reassessment, and helped review dioxin
sampling and analysis methods. In September 1994, the Agency
publicly released a draft version of the reassessment of dioxin
risks and issued a voluntary call for additional information.
The report highlighted not only cancer concerns but also possible
reproductive, developmental, and immunological effects detected
in animals.
OPP has taken several steps to ensure that pesticides do not
contain dioxins at levels that pose unreasonable risks to public
health or the environment. In 1987, OPP issued two data call-ins
that applied to 161 active ingredients. Of those, 92 have been
cancelled or are no longer being supported for reregistration.
To date, OPP has reviewed submissions regarding the manufacturing
processes of 43 of the supported active ingredients and
determined that dioxins are unlikely to be formed. Through
analysis of production samples, nine other active ingredients
were found not to contain dioxin impurities. Thus, of the 161
originally subject to review, 144 are no longer of concern.
As of 1994, four of the remaining 17 active ingredients have
been found to have manufacturing processes which produced levels
of dioxins slightly above what is known as the Level of
Quantification. Based on assessments using the "Toxicity
Equivalent Factor" approach, OPP believes that the levels of
dioxins in these four active ingredients pose a negligible risk
to human health. OPP expects to complete review of the
manufacturing processes of the remaining 13 chemicals by the end
of 1995.
Reducing Ecological Risks Under The "New Paradigm"
In March 1992, EPA established an internal task force to
review and assess the role of ecological and environmental fate
data in OPP's regulatory process. One of the task force's
accomplishments was the development of an approach known as the
"New Paradigm." This approach is intended to strengthen the
Agency's efforts to prevent adverse effects to the environment
from pesticides, while simultaneously accelerating pesticide
reregistration. The strategy of this program is to reduce risks
more quickly when the Agency receives information that pesticides
may be causing adverse environmental effects, rather than
requesting and waiting for additional studies to be submitted.
This emphasis led OPP to develop a paper providing
preliminary guidance on risk reduction strategies and monitoring
programs, including a format for registrants to follow when
submitting mitigation and monitoring proposals. OPP then
initiated a number of outreach activities related to risk
mitigation and monitoring, such as presentations at workshops and
scientific conferences and wide distribution of the document to
pesticide registrants during the registration and reregistration
processes. As a result of this effort, the regulated community
has submitted improved mitigation proposals. Many are now
following OPP's proposed format, which has led to the submission
of more clearly defined and justified mitigation measures. In
addition, OPP has incorporated environmental risk mitigation in
almost half of the documents issued through the reregistration
process. This approach of requiring risk mitigation and
monitoring applies during the registration of new pesticides as
well.
The Label Use Information System (LUIS)
The Label Use Information System (LUIS) is a product-level
database of pesticide label directions. It contains detailed
information on registered sites, application methods, application
rates, and limitations on the use of pesticides (e.g., preharvest
intervals, reentry intervals). LUIS information can be reported
by active ingredient to support chemical regulatory decisions; it
can also be reported by product to monitor product compliance
with regulatory decisions. In addition, the database can be used
to help locate labels which match a specified parameter. In
1994, OPP completed initial entry of information for most
pesticides undergoing reregistration. During 1995, OPP will
complete initial data entry and begin expanding LUIS capabilities
so it can support registration and Special Review as well
reregistration. Eventually, it will be linked to other pesticide
data systems and made available electronically to all OPP staff.
Chapter 3: Special Review
Special Review is EPA's formal process for determining
whether the use of a pesticide poses unreasonable risks to people
or the environment. In making this determination, EPA must
consider the pesticide's risks and benefits. Special Review is
designed to allow formal public input to the decision-making
process. A Special Review can result in a decision to cancel,
restrict, or continue the pesticide uses in question.
The Special Review process is set in motion when EPA has
reason to believe that the use of a registered pesticide poses
significant risks to people or the environment. Over 100
pesticides or groups of closely related pesticides have been
evaluated through the Special Review process. While
reregistration applies to all older pesticides, Special Review is
applied to those pesticides of particularly serious concern.
1994 Formal Special Reviews And Follow-up Activities
Inorganic arsenicals. OPP concluded the Special Review for
inorganic arsenicals by publishing a Notice of Final
Determination. All affected uses (uses other than as wood
preservatives and sealed ant baits) were voluntarily
cancelled as a result of the Special Review. This action
culminated a Special Review initiated in 1978 because of
concerns about risks of cancer, reproductive and fetal
effects, and mutagenicity (genetic effects).
EBDCs. OPP completed a Special Review for a group of
fungicides known as the EBDCs in 1992 by cancelling a number
of uses and placing restrictions on the remaining uses.
Subsequently, a registrant requested a change in certain of
the restrictions. In 1994, OPP helped support the hearing
that responded to the request, which resulted in an
amendment allowing the use of more than one EBDC on a crop
during the course of the growing season, as long as the
total amount of pesticide applied does not exceed the
maximum amount allowable from any one EBDC application.
Carbofuran. OPP also revisited the Special Review for the
granular formulation of the insecticide carbofuran when
registrants requested an extension of uses for rice, corn,
and sorghum. OPP published a proposal in the Federal
Register which would allow for a maximum of two more years
of use on rice but no more use on corn and sorghum. OPP
began phasing out most uses of carbofuran in 1991 because of
risks of bird poisonings.
Cancellation Of Mevinphos
OPP continues to reduce risks by means other than the
traditional Special Review process, particularly through
negotiated settlements. The agreement to cancel all uses of the
agricultural insecticide mevinphos -- one of the most acutely
toxic pesticides produced in the United States -- exemplifies how
such actions can achieve substantial protection of human health
and the environment.
In response to planned actions by OPP and the State of
California to remove mevinphos from the market, the registrant
requested that its registrations be cancelled. The registrant
also agreed to a voluntary recall of all product still in the
channels of trade after sale and distribution of product was no
longer allowed. The cancellation was based on OPP's
determination that the risks to agricultural workers were
unacceptable. Poisoning data from California and other states
showed that even when workers followed stringent label
restrictions, an alarming number of poisoning incidents occurred.
From 1982 through 1992, California (where about half of U.S. use
of mevinphos occurred) recorded 594 poisonings associated with
the use of mevinphos alone and in combination with other
pesticides. Mevinphos alternatives are significantly less risky
to workers than mevinphos.
Other Negotiated Risk Reduction Efforts
During fiscal year 1994, OPP successfully negotiated for the
reduction of health risks associated with several pesticides in
addition to mevinphos:
PCNB. Registrants agreed to lower levels of two
carcinogenic contaminants, HCB and PCB, in their products,
bringing dietary risk down to the negligible level.
Metrex. OPP negotiated a settlement with the registrant
because of concerns about the risk posed by failure of this
hospital sterilant to work properly. The settlement imposed
label requirements for longer contact times with treated
surfaces and higher treatment temperatures to ensure that
treated medical instruments were adequately sterilized.
Simazine. Twenty-two registrations of simazine used as an
algicide in swimming pools were voluntarily cancelled after
OPP approached registrants about unacceptable cancer risk to
swimmers. OPP subsequently cancelled the remaining swimming
pool simazine products when their registrants declined to
join the voluntary cancellation.
Other Cancellation Activities
In addition to the negotiated settlements described
previously, OPP handled several cancellation actions in 1994.
Two (for TBT fluoride and mercury compounds used on turf) were
voluntary actions prompted by the registrants' decision not to
develop required data. OPP also amended the earlier cancellation
notices for the herbicide methazole (to extend the existing
stocks period) and for Wipeout, a medical sterilant containing
glutaraldehyde (to add new risks of concern).
Tolerance Revocations
OPP continued to propose or finalize revocations of
tolerances (maximum residues allowed in food) for pesticides
cancelled through Special Review or for other reasons. OPP
generally revokes tolerances some time after the uses are
cancelled to allow legally treated foods to move through the
marketplace and to account for possible foreign use on imported
food. OPP proposed or finalized tolerance revocations and
revisions for eight active ingredients in 1994: arsenic acid,
carbophenothion, DDVP, diallate, dicofol, PCNB, perthane, and
ronnel.
Initiative To Reduce Risks To Birds (Avian Granular Initiative)
OPP continued to track the progress of the voluntary risk
reduction initiative begun in 1992 for granular pesticide
formulations posing risks to birds. OPP prepared a progress
report that describes the voluntary risk reduction proposals
received from seven registrants. The proposals include lower
application rates, reduced number of applications, and use of
application methods designed to reduce the number of exposed
granules in end rows. Granular pesticides can be eaten by birds
feeding in agricultural areas.
Chapter 4: Field Implementation and Communication
The major regulatory areas discussed by the first three
chapters -- registration, reregistration, and Special Review --
primarily involve interaction with pesticide registrants, though
many other organizations are also affected by and involved with
OPP's decisions in these areas. In this chapter, the emphasis
shifts to regulatory programs directed at pesticide users and
implemented in the field. This chapter also discusses how OPP
shares information with pesticide users and the myriad of other
organizations and citizens interested in pesticides. Finally,
this chapter discusses OPP's support for efforts to ensure
compliance with pesticide requirements. All of these efforts
complement the pesticide regulatory programs described in the
first three chapters by improving the safety with which
pesticides are used, and by making the public aware of the risks
and benefits of pesticides and the availability of alternatives.
A. Field Programs
The major field programs that OPP implements, as described
in more detail in this chapter, are the Worker Protection
Standard, the Endangered Species Protection Program, ground water
protection programs, certification and training of pesticide
applicators, and disposal of suspended and cancelled pesticides
(completed in 1994). Voluntary field efforts in 1994 included
promoting integrated pest management (IPM) and drafting guidance
for states for posting of residential and commercial pesticide
applications.
Implementing The Worker Protection Standard
OPP revised the Worker Protection Standard (WPS) for
agricultural pesticides in 1992 and it became fully effective on
January 1, 1995. The Standard represents a major strengthening
of national efforts to safeguard agricultural workers.
Agricultural employers are required to follow new measures to
protect their employees, including safety training, notifications
about pesticide applications, provisions for washing facilities,
and maintenance of protective equipment. OPP believes that the
WPS will substantially reduce the risk of pesticide poisonings
and injuries among agricultural workers and pesticide handlers.
In 1994, OPP carried out a number of Worker Protection
activities in preparation for full implementation in 1995, many
of which included the participation of EPA's ten regional
offices. OPP:
o Worked with pesticide registrants to ensure that the
labeling of all agricultural pesticides was revised to
convey stronger worker protection requirements, such as
restrictions on entry to treated areas and use of personal
protective equipment.
o Continued to work with the states, USDA's Cooperative
Extension Service, and the agricultural community to help
employers obtain the information and assistance they need.
Over 1.7 million copies of OPP's "Agricultural Worker
Training Handbook" have been distributed, as well as
thousands of the "How To Comply Manual" and the "Pesticide
Handler Training Handbook." A number of other publications,
videos, and training materials are available.
o Developed a voluntary program to issue training verification
cards to workers and handlers to promote safety training for
agricultural workers and to make it easier for agricultural
employers to ensure that their workers have been trained.
To date, 40 states, Puerto Rico, and two tribes have agreed
to participate in the program, with more expected to join.
o Met directly with more than 25 organizations affected by the
WPS to resolve problems and improve implementation of the
standard. EPA held workshops on the WPS and conducted
periodic meetings and discussions with agricultural groups.
o Approved the first exception to the WPS. For a two-year
period and under specified conditions, the exception allows
early entry into pesticide-treated areas in greenhouses to
harvest cut roses. The WPS establishes a process for OPP to
approve requests for exceptions if the benefits of the
exception outweigh the costs (including any health risks)
attributable to the exception.
o Evaluated certain WPS provisions where change or flexibility
may be needed to make sure that workers are protected and
that the requirements are fair and achievable. OPP has
proposed changes to the WPS in the following areas and,
based on public comments, expects to finalize them in the
spring of 1995:
-- Strengthened safety training requirements.
-- Reduced requirements for crop advisors.
-- Reduced restrictions for lower risk pesticides.
-- Reduced requirements for irrigation activities.
-- Reduced requirements for other activities that result
in limited contact to pesticides.
Endangered Species Protection Program
The primary goal of OPP's Endangered Species Protection
Program (ESPP) is to protect federally listed threatened and
endangered species from the direct and indirect impacts of
pesticide use. As mandated by the 1988 amendments to the
Endangered Species Act, this goal is to be accomplished while
minimizing the burden on pesticide users. Currently, OPP is
carrying out an interim, non-regulatory program to protect
endangered species while finalizing an endangered species
protection regulation.
The ESPP was very productive in 1994. OPP produced and
widely distributed many materials supporting and promoting the
voluntary program, and is currently distributing 240 county-
specific pamphlets in 22 states and Puerto Rico that describe
voluntary measures pesticide users can take to avoid affecting
threatened and endangered species with pesticides. OPP also
completed fact sheets about eight additional endangered species,
such as the Bald Eagle and Whooping Crane, bringing the total
number of species fact sheets to 45. OPP also continued the
operation of a toll-free endangered species hotline to provide
more information about the program.
In implementing the endangered species program in 1994, OPP
worked closely with EPA regions, states, and other federal
agencies, such as the U.S. Fish and Wildlife Service (FWS). This
cooperation was exemplified by efforts to protect the Wyoming
Toad, an endangered species known to occur in the wild only in
Albany County, Wyoming. The Wyoming Department of Agriculture,
FWS, EPA's Region 8 Office, and OPP forged an agreement with
local landowners and officials to postpone pesticide use on land
within the toad's range until the land could be surveyed for
potential habitat. No new toad populations were found on private
lands, and pesticide applications resumed in areas where the toad
was not found. The case serves as a model for the cooperation of
landowners and federal, state, and local governments to implement
the Endangered Species Act.
OPP also provided extensive comments on the Fish and
Wildlife Service's draft Biological Opinion, which addresses the
potential impacts of all uses of 15 major agricultural
pesticides. In addition, OPP has begun requesting endangered
species data from registrants on particular registration
requests. Registrants may form a task force to supply the
necessary data to cover all pesticide use sites. The next major
step is to announce the final regulation and program by
publishing a Notice in the Federal Register. OPP spent much of
1994 working with FWS and the U.S. Department of Agriculture to
develop the final plans for the ESPP.
Protecting Ground Water
Ground water provides about one-fourth of all water used in
the United States and is the source of drinking water for about
half the U.S. population. It also is a vital component of the
ecosystem. For example, ground water often flows into surface
water systems that are habitats for fish, sustain wetlands, and
support commerce. OPP has several programs in place to protect
this critical natural resource from pesticide contamination.
The centerpiece of OPP's strategy is a cooperative effort to
develop State Management Plans (SMPs) to prevent ground-water
pollution from pesticides. An important step in this approach
has been the development of "Generic" SMPs, which aim to create
the capacity for protecting ground water regardless of the
pesticide. Forty-six states have submitted draft Generic plans
to the EPA regions, and the regions have provided comments on
most of these plans. Final regional concurrence on all Generic
plans is expected January 1996. The next major step will be the
requirement that states develop pesticide-specific SMPs for those
pesticides found to leach into ground water. OPP has received
comments on a draft rule for pesticide-specific SMPs from all ten
EPA regions and expects to issue a Notice of Proposed Rulemaking
(NPRM) during 1995. OPP also works closely with EPA's Office of
Water to ensure that the pesticide SMP program will complement
the Agency's Comprehensive State Ground Water Protection Program.
Another important feature of OPP's strategy has been to
establish procedures during registration and reregistration to
evaluate a pesticide's potential to contaminate ground water. In
1994, OPP began to implement a new approach that achieves early
mitigation of ground-water risks. In cases such as the
registration of acetochlor, OPP required that registrants better
target the use of pesticides and conduct follow-up monitoring to
protect ground water quality. OPP continues to track evidence of
ground water contamination through its Pesticides and Ground
Water Data Base.
Furthermore, OPP expects to issue a final rule in 1995 that
would add criteria for classifying a pesticide for restricted use
if any of its ingredients has the potential for contaminating
ground water on a widespread basis. Pesticide products
classified for restricted use may be purchased and used only by
certified pesticide applicators or individuals under their
supervision. OPP believes that a pesticide is less likely to
contaminate ground water if it is used only by trained
applicators.
Certification And Training Of Pesticide Applicators
When OPP designates some or all uses of a pesticide as
"Restricted," then the pesticide may be used only by or under the
direct supervision of certified users. Certification Programs
are conducted by states, territories, and tribes and are designed
to ensure that users of the most risky pesticides are
knowledgeable about their risks and uses. OPP sets national
standards for the programs, which certify over one million
applicators nationwide.
In 1994, OPP continued to work to revise its national
standards to better ensure continued competency of certified
applicators. To assist the state, territory and tribal
governments in conducting certification programs, OPP also
continued cooperative agreements and provided funding to 64
governments. OPP also provided funding to state extension
coordinators through the U.S. Department of Agriculture to
conduct certification training programs. Training covers general
areas of pesticide use as well as specific uses for which a
person wishes to become certified. For example, training to
become certified to apply pesticides to structures (such as
schools, houses, and office buildings) includes information about
ventilating structures prior to re-occupation.
Disposal Of Suspended And Cancelled Pesticides
In 1994, OPP completed its disposal program for suspended
and cancelled pesticides, thus removing the risks posed by unused
stocks of these pesticides. Prior to the 1988 revisions of the
Federal Insecticide, Fungicide, and Rodenticide Act, OPP was
required to accept suspended and cancelled pesticide products for
disposal if requested by holders. 2,4,5-T and silvex pesticides
were suspended and cancelled prior to 1988 because of concerns
about dioxin contamination. OPP accepted about 300 tons of
granular 2,4,5-T/silvex materials and 30,000 gallons of liquid
materials from several hundred holders at a hazardous waste
storage facility. On May 27, 1994, OPP disposed of the last of
these 2,4,5-T/silvex stocks at a hazardous waste incinerator.
Promoting Integrated Pest Management
Integrated Pest Management, or IPM, involves the carefully
managed use of an array of pest control tactics -- including
biological, cultural, and chemical methods -- to achieve the best
results with the least disruption of the environment. IPM relies
upon an understanding of life cycles of pests and their
interactions with the environment. Biological control refers to
using natural enemies of the pest, such as employing ladybugs to
control aphids. Cultural control involves practices of
cultivation, crop rotation, and other methods that prevent or
control pests. IPM also involves the judicious use of chemical
pesticides, if necessary.
OPP's IPM accomplishments extended to both the urban and
agricultural sectors. In the urban arena, OPP published "Pest
Control in the School Environment: Adopting Integrated Pest
Management." This creatively illustrated booklet, already in wide
circulation, will be provided to every school district in the
United States by the end of 1995. Companion training videos,
produced in cooperation with Texas A&M University, should be
finished during the spring of 1995. OPP also edited and
published, through Lewis Publishing Company, "Integrated Pest
Management for Turf Grass and Ornamentals." This book is the most
up-to-date and comprehensive publication on the subject and has
already been widely accepted within the professional landscape
community.
In the agricultural sector, OPP has hosted a series of
commodity-specific workshops to inform growers about existing IPM
techniques and help identify impediments to IPM adoption. The
proceedings from this year's peanut, stored commodity, and potato
workshops, along with those developed during 1993, are being used
to help frame the Agency's position on agricultural legislation
(such as the Farm Bill).
Guidance For Posting Of Outdoor Pesticide Applications
During 1994, OPP began the development of draft guidance for
states and local jurisdictions regarding "posting" of outdoor
residential and commercial pesticide applications. Posting
refers to the placement of signs at visible entry areas to inform
bystanders that a pesticide has been recently applied. This
guidance is being developed to help harmonize such state and
local programs. OPP hopes that such guidance will help lead to
better consumer awareness and understanding of posting, increased
compliance with posting requirements, and reduced burdens upon
lawn care professionals who sometimes must deal with a confusing
array of differing requirements. OPP intends to publish a draft
in the Federal Register for public comment in 1995.
B. Communications, Public Response, and Coordination
Outreach to the public is vital to the mission of OPP. By
the term "public," OPP means all constituents affected by or
interested in pesticide issues -- not only states, tribes, and
EPA regions, but also citizens, environmental and public interest
groups, industry and trade associations, pesticide users,
Congressional staff, medical and health representatives,
academia, international organizations, other federal agencies,
and the media. This section describes several of the ways that
OPP provides information to the public, responds to inquiries,
and in turn obtains valuable public input.
OPP's approach to communications is to make information
widely available, easily accessible, and suited to different
public preferences. To accomplish this, OPP issues announcements
and publications for both general and scientific audiences,
provides information by telephone and electronic network,
responds to written requests for information, maintains a public
docket for walk-in visitors, holds public meetings, and presents
speeches and Congressional testimony.
Outreach And Communications Strategies
In 1994, OPP issued more than 50 announcements inform the
public about OPP's major regulatory and policy decisions Each
announcement is planned using a communications strategy, and
often entails a press notice and additional outreach materials,
such as fact sheets or questions and answers. OPP also made
special efforts during the past year to make the public aware of
available information resources and to provide general pesticide
information. In June, OPP issued a Pesticide Regulation Notice
(PR 94-3) that summarizes the many avenues one can take to obtain
information from OPP. Another accomplishment this year was the
preparation of OPP's first catalog of pesticide publications.
OPP distributed both documents extensively, and they continue to
be widely requested. OPP also continued to distribute other
documents to the public with the help of the National Center for
Environmental Publications and Information; for example, OPP
distributed over 45,000 copies of the booklet "Healthy Lawn,
Healthy Environment: Caring for Your Lawn in an Environmentally
Friendly Way" and over 15,000 copies of the booklet "Citizen's
Guide to Pesticides."
Protecting children from pesticide poisoning continues to be
an important focus of OPP's outreach efforts. Working with the
Poison Prevention Council and the Consumer Product Safety
Commission, OPP has participated over the past three years in the
activities leading to Poison Prevention Week. Through this
mechanism, each year OPP distributes thousands of copies of fact
sheets on pesticides and child safety and on using insect
repellents safely (both in English and Spanish) to medical
establishments and the general public.
Responding To The Public
Freedom of Information Act (FOIA) Requests
OPP responds to specific technical or complicated
information requests from the public under the Freedom of
Information Act. OPP continues to receive the highest number of
FOIA requests of any program within EPA, and in fiscal year 1994
received 1,578 requests. Despite this heavy workload, OPP was
able to reduce its backlog of FOIA requests by more than half.
The majority of requestors receive all of the records they
request, with the most common requests being for science reviews
of registration data, administrative files for pesticide
products, and product labels.
OPP Public Docket
OPP has established four dockets, operated by a contractor,
to house the regulatory notices, background documents, and public
comments on OPP activities. These consist of the Federal
Register, Special Review, Registration Standard, and Special
Program Dockets. Thousands of requests were received in 1994 for
docket information -- by letter (over 1,000 requests), telephone
(over 2,000 requests), and in person. Citizens account for the
largest number of requests for docket information.
National Pesticides Telecommunications Network (NPTN)
NPTN is a toll-free telephone service available to provide a
variety of impartial information about pesticides to anyone in
the United States, Puerto Rico, and the Virgin Islands. The
service operates Monday through Friday from 8:00 a.m. to 6:00
p.m. (Central Standard Time). NPTN provided services to more
than 25,000 callers during fiscal year 1994, including
approximately 1,300 calls concerning pesticide incidents. The
remaining calls were requests for general information on
pesticide products and issues concerning health, safety, and use.
National Pesticide Medical Monitoring Program (NPMMP)
The NPMMP, located at Oregon State University, provides
information and referrals on the clinical toxicology of
pesticides and analytical services for both biological and
environmental samples. Consultations are given to both possible
victims and health care professionals. NPMMP handles 200 to 300
cases per year.
Letters
OPP also responded to a substantial number of letters to the
Agency on pesticide-related issues, including letter campaigns on
subjects such as food safety, pesticides and children, the
Delaney clause, livestock predator pesticides, and worker
protection.
Congressional And Federal Coordination
Congressional interest and oversight in pesticide and food
safety issues continues at a high level as OPP responded to
almost 400 inquiries over the past year. OPP also prepared
testimony and briefing materials for eight Congressional hearings
concerning pesticide issues (such as pesticide exports/food
safety and worker protection standards). During the past year,
OPP assisted the General Accounting Office (GAO) and EPA's
Inspector General (IG) office with seven ongoing evaluations of
the pesticide program's activities: EPA's decision on
carbofuran; a survey of EPA actions related to EBDC uses; EPA's
process for reinventing tolerances for cancelled pesticides;
EPA's collection of user fees; the Chief Financial Officer's
audit of the fiscal year 1994 financial statement; environmental
laws and regulations pertaining to agriculture; and the federal
government's compliance with the Endangered Species Act.
Public Meetings
OPP continues to seek ways to provide meaningful
opportunities for the public to meet with the Agency and discuss
pesticide issues of concern. OPP held several meetings during
1994, some on a quarterly basis, with a variety of constituent
groups. OPP hosted regular meetings with environmental and
public interest groups during the year, and set up several on
topics of special interest, such as international issues and the
farmworker protection program. OPP also held quarterly meetings
with the American Crop Protection Association (formerly NACA).
Additionally, OPP conducted two large-scale workshops in 1994 for
a broad spectrum of participants, with one workshop focusing on
general pesticide issues and the other on reducing pesticide use
and risk. Looking ahead, OPP will seek opportunities for more
in-depth discussions of critical program policies and issues with
a cross-section of constituent groups.
Pesticide Information Network
The Pesticide Information Network (PIN) is a computerized,
on-line collection of files containing current and historic
pesticide information. This system is designed to enhance OPP's
data gathering efforts; aid state agencies and others in
obtaining needed information on a timely basis, thereby improving
their ability to respond to local pesticide situations and
federal requirements; save OPP resources through automated
dissemination and updating of public information; and enhance
cooperative efforts between EPA and other federal agencies
through a convenient method of information sharing.
In 1994, OPP worked to upgrade the system, and the revised
PIN is expected to open in early 1995. The PIN will contain
several different types of information. These will consist of
the Pesticide Monitoring Inventory (PMI) (including the
Pesticides in Ground Water Database), the Ecological Incident
Information System (EIIS) (described in more detail in chapter
6), an Environmental Fate and Ecological Effects compilation, a
Regulatory Status database, the Certification and Training
Bibliography, and a Biological Pesticides data set.
Agency Risk Management Communication Group
OPP actively participated during 1994 in the Agency
Ecological Risk Management Communication Group, which was formed
to address EPA's difficulties in using the assessments of
ecological risks to properly manage those risks. The first major
project of the Group, completed in 1994, was to write a document
that would help risk managers throughout the Agency make
decisions that include a consideration of ecological risk. The
document is introductory in nature and contains a great deal of
basic information about the value of ecological resources,
determining what resources should be protected, understanding the
involvement of a risk manager in the risk assessment process, and
using a risk assessment for risk decision-making. The Group also
hopes that experienced risk managers will benefit from the
document.
Scientific Presentations And Publications
OPP believes that sound scientific information is the
cornerstone for assessing and managing risks, as will be
described in chapter 5. OPP scientists continue to contribute to
the development and application of their varied scientific
disciplines, including hydrology, biology, agronomy, chemistry,
toxicology, and many others. In 1994, OPP scientists presented
several dozen papers and posters at a number of professional
meetings of organizations such as:
o American Chemical Society
o American Society of Agronomy
o American Phytopathological Association
o International Union of Pure and Applied Chemistry
o Society of Environmental Toxicology and Chemistry
o Society of Quality Assurance
o Soil Science Society of America
OPP scientists served as editors for a book titled
"Agrichemical Environmental Fate State of the Art," which is
scheduled to be released in May 1995. They also published a
number of professional papers, including several that appeared in
conference proceedings and symposiums of associations listed
above and in journals like the "Journal of Invertebrate
Pathology" and "Environmental Toxicology and Chemistry." In
addition, OPP scientists lectured at Clemson University, the
University of Maryland, and other universities and organizations.
International Coordination And Integration
This section describes OPP's efforts to inform foreign
governments about the status of U.S. pesticides and OPP programs.
The purpose of these efforts is to help foreign governments,
especially those that have not yet developed extensive pesticide
regulatory and information-gathering programs, make informed
choices about the use of pesticides in their countries. Not only
do these efforts benefit citizens of foreign nations, but they
also benefit Americans by helping to ensure the safety of
imported food and other commodities treated with pesticides. In
addition, these efforts help to protect wildlife, like migratory
birds, that cross international borders.
Export Notification for Unregistered Pesticides
For all exports of pesticides not registered in the United
States, federal pesticide law (FIFRA section 17(a)) requires the
U.S. exporter to obtain a statement from the buyer acknowledging
that the product is unregistered in the U.S. The exporter must
then submit this statement to OPP, and OPP forwards a copy to the
importing government. In 1994, OPP transmitted approximately
1,600 export notifications to the governments of importing
countries.
Information Exchange with Foreign Countries
Another provision of federal pesticide law, FIFRA section
17(b), requires OPP to operate an information-sharing program
with health and environmental agencies in other countries.
Through this program, OPP sends information notices to other
governments on important regulatory decisions made in the United
States related to pesticides, food safety, and pest management.
In 1994, OPP transmitted several notices of major regulatory
actions on specific pesticides, such as the voluntary
cancellation of mevinphos, and other pesticide documents.
Section 17(b) notifications are distributed directly to the
pesticide regulatory authorities in approximately 140 countries.
Prior Informed Consent (PIC)
EPA is a participant in this program developed by the United
Nations Environment Programme (UNEP) and the U.N. Food and
Agriculture Organization (FAO) to promote the safe management of
chemicals. PIC establishes a mechanism whereby importing
countries can receive information about pesticides and industrial
chemicals and then determine whether to allow, restrict, or
prohibit future imports of the chemicals. In 1994, EPA formally
nominated mevinphos for inclusion on the UN list of banned
pesticides because it was voluntary cancelled in 1994 (see the
Special Review chapter for more information). In addition, work
progressed internationally toward making PIC a legally binding
instrument. Formal negotiations toward an international treaty
are expected to occur during 1995 and 1996.
International Visitors
OPP has an ongoing program to arrange meetings for foreign
visitors to discuss U.S. pesticide policies and scientific
evaluation procedures. During the past year, OPP received 95
visitors from 23 nations. The majority of visitors came from
Japan, South Korea, and the People's Republic of China.
Regional, State, And Tribal Liaison
Regional Coordination
Staff in each of EPA's 10 regional offices are OPP's primary
connection to state, territorial, and tribal governments. They
negotiate cooperative agreements for OPP's field programs, assist
the governments in developing and implementing programs, and
oversee accomplishments and commitments made by the states,
territories and tribes. Additionally, regional staff communicate
OPP's programs and policies to the public and in turn provide OPP
with information from the public. Clearly, OPP's regional
counterparts are critical to the success of developing,
implementing and communicating OPP programs and actions.
Therefore, OPP works to ensure that the regional offices are
involved in or informed of all OPP activities.
State and Territorial Programs
States and territories are true partners with OPP in
carrying out the functions of protecting human health and the
environment. They assist in developing and implementing many of
OPP's field programs, and they enforce OPP's regulations and
pesticide labeling and use requirements. To ensure that programs
are successful, direct communication among these governments is
often necessary. To accomplish this, OPP in 1994 continued a
cooperative agreement with the Association of American Pesticide
Control Officials (AAPCO) to maintain the State FIFRA Issues
Research and Evaluation Group (SFIREG). SFIREG meets
periodically with OPP to develop pesticide programs and discuss
implementation and enforcement issues of concern to the states
and territories.
Tribes
Native American tribal governments have sovereign rights and
certain specific assurances from the federal government under
treaties. A considerable diversity exists among the tribes.
Some have land areas and populations comparable to many of the
smaller states, whereas others have fewer than 50 tribal members
and 100 acres of land. The capacity of the tribal governments to
carry out environmental regulatory programs also varies
significantly from tribe to tribe.
OPP's major effort with tribes has been to assist them in
building the capacity to conduct regulatory and field programs
for pesticides. In 1994, OPP participated in the Native American
Environmental Conference to demonstrate different ways in which
tribes can implement OPP programs. OPP also funded an
environmental scholarship program to assist college students
studying environmental sciences and interested in addressing
Native Americans issues. OPP also addressed Native American
issues by assigning one employee to work at the Administration
for Native Americans and another to work with EPA's Office of
Civil Rights.
In addition, OPP attempts to address specific issues
uniquely affecting Native Americans. In 1994, OPP began a
project involving other state and federal authorities to address
potential pesticide exposure by members of the California Indian
Basketweavers Association (CIBA). CIBA members expressed concern
to the Agency about their potential exposure to pesticides from
contact with native plant materials used in traditional
basketweaving.
Improving Internal Communications
The OPP Committee on Networking, Education, Communication,
and Training Strategy (OPP CONECTS) made a significant effort in
1994 to improve internal communications. Based on
recommendations of the committee to OPP management in June, two
new initiatives are underway. "OPP PULSE," a publication 'by OPP
staff, for OPP staff,' began publication in September. The OPP
LINKS series, in which each OPP division educates the others
about its roles and responsibilities, often in innovative and
creative ways, began in October. Both initiatives are helping
OPP staff better understand the work of other divisions and gain
a sense of how they fit into the larger picture. The two
initiatives also give staff members the opportunity to share what
they do and what they know with the rest of the program, making
OPP a less impersonal workplace.
C. Support For Compliance Activities
Compliance activities -- such as helping regulated entities
understand and meet applicable requirements, verifying that
requirements are met, and taking enforcement action when they are
not -- are indispensable parts of EPA programs to protect public
health and the environment. OPP provides support to Agency
pesticide compliance activities, which are directed by the Office
of Enforcement and Compliance Assurance (OECA). (Pesticide
compliance activities formerly were coordinated by the Office of
Compliance Monitoring, which was integrated into the newly-
created OECA in 1994.)
Support For The Lab Audit Program
OPP relies on data submitted by registrants to make
regulatory decisions involving product registrations, tolerances,
use restrictions and requirements, and other areas. EPA conducts
a program to inspect and audit the laboratories that produce
these data. Important components of the lab audit program are
the Good Laboratory Practice Standards (GLPS), which are designed
to ensure the quality and integrity of pesticide data. In 1994,
43 GLPS inspections were conducted for OPP, and OPP scientists
assisted in three of the inspections. Targeted areas included
product chemistry, residue chemistry, environmental fate,
toxicology, and antimicrobial testing. As a result of the
inspections, EPA developed four GLPS enforcement cases involving
four laboratories and thirteen registrants or sponsors, and
revoked the registrations of two products.
Analysis Of Product Chemistry
OPP's pesticide chemistry laboratories are essential for
verifying the description and amount of active ingredients
provided by registrants on pesticide product labels. During
1994, OPP analyzed a large number of new pesticide product
samples, both for technical and end-use formulations, to verify
registrant label claims. The methods used to perform the
analyses are published in an EPA manual of methods by the
Association of Official Analytical Chemists (AOAC) International
and used by state agencies and other organizations.
Other Laboratory Support
OPP's two pesticide chemistry labs often provide high
priority support for other enforcement efforts. In 1994, OPP
supported seven external EPA region/state projects: Craven
Laboratories investigation with the Department of Justice; State
of New York investigation of DCPA contamination of the Suffolk
County drinking water supply; State of Florida's investigation of
alleged benomyl damage in greenhouses; State of Oklahoma's
analysis of dioxin/furan samples; EPA Region 5 and Region 7
investigation of the WTI incinerator in Ohio; Louisiana Board of
Regents request to review technical proposals; and EPA Region 3's
request to analyze samples for diatomaceous earth. The pesticide
chemistry labs supported several other external projects,
including the Central American Lab Project; Gulf of Mexico
Project; U.S. State Department Project in Russia; two EPA Office
of Research and Development Dioxin Projects; U.S. Army air
samples from the Mideast (dioxins); and air samples from Croatia
(dioxins).
Additional Support For Compliance Activities
In addition to laboratory support, OPP often contributes
expertise and records for compliance activities. One example of
this in 1994 was OPP's work on the Raid Max Roach Bait
enforcement case. In this case, EPA alleged that S.C. Johnson &
Son, Inc., the manufacturer, began illegally marketing this
product in new design packaging without first receiving EPA
approval. This information contributed to EPA Region 5 issuing a
Stop Sale, Use, or Removal Order to S.C. Johnson to immediately
halt the sale and distribution of the product. EPA also
requested that the company voluntarily recall all unapproved Raid
Max Roach Bait products in the hands of consumers and in the
channels of trade. Another example was OPP's work on the recall
by the registrant of Natrapel Insect Repellent products because
of potential bacterial contamination.
Chapter 5: Policy, Regulations, and Guidelines
OPP's fifth major program area involves developing
regulations and other policies for pesticides. These efforts are
intended to help develop and implement national legislation
passed by Congress, to improve the quality of pesticide
regulation (which can include both formulating new policies and
streamlining existing ones), and to augment the quality of OPP's
scientific information. In some cases, OPP finds that policies
are needed to address newly-discovered concerns, or to keep up
with technological advances in pest control, such as in the area
of genetically-engineered biological pesticides. Wherever
possible, OPP encourages public participation in the development
of policies.
Federal policies can be regulatory (promulgated by
regulation) or non-regulatory. Regulations are published in the
Federal Register for formal public notice and comment and
incorporated into the Code of Federal Regulations. Regulations
proposed or finalized in 1994 and discussed in this chapter
include those related to biological pesticides and pesticide
containers. Non-regulatory programs, in general, are not
directly mandated by law and do not impose legally enforceable
requirements. A prime example, discussed in more detail below,
is OPP's voluntary pesticide environmental stewardship
partnership. Policies often include both regulatory and
nonregulatory components, such as OPP's international
coordination efforts and OPP's response to the National Academy
of Sciences report on children and pesticides.
Follow-up To The National Academy Of Sciences (NAS) Children's
Study
EPA, the Food and Drug Administration (FDA), and the U.S.
Department of Agriculture (USDA) are working together to address
the concerns identified by the June 1993 National Academy of
Sciences report, "Pesticides in the Diets of Infants and
Children." The Academy concluded that exposure of children to
pesticides is substantially different from that of adults and
that the federal government should do more to address the unique
risks posed to children. To provide additional measures of
protection for children, the Academy recommended numerous changes
to the way the federal government safeguards the nation's food
supply.
OPP is moving ahead to implement many of the NAS
recommendations. Additional toxicological studies will be
included in the standard battery of testing requirements (known
as the part 158 requirements) that are under revision. OPP plans
to collect data on immune functions, nervous system development
and toxicity, and visual systems. In addition, OPP has completed
an analysis of the utility of including in utero exposure in
long-term toxicology studies. EPA and FDA have completed plans
to standardize the reporting of pesticide levels in food and to
store these data in a centralized National Pesticide Residue
Monitoring Database, though additional funding is needed to
proceed. OPP is working closely with USDA on the design of
future USDA national food consumption surveys to ensure that the
eating habits of infants and children are adequately represented.
OPP is also exploring ways to combine the risks from multiple
sources of exposure. These include combining the risks posed
from chemicals with similar mechanisms of action as well as
several routes of exposure, including both nondietary and dietary
routes.
Reduced Use/Risk Initiative
The Pesticide Use/Risk Reduction Initiative announced in
June 1993 is a joint effort with EPA, USDA, and FDA to reduce the
use and risks of pesticides. As part of the initiative, a
voluntary program called "Pesticide Environmental Stewardship
Partnership - PEST SMART" has been created to form partnerships
with all affected interests (including commodity organizations
and public interest groups) and develop plans which will reduce
the risks posed by pesticides while maintaining cost-effective
pest control methods.
In December 1994, the Administration announced the initial
partners (grower groups and utility companies) in the program.
In forming this partnership, the federal agencies and the
participating groups and companies agree that environmental
stewardship is an integral part of pest management practices.
Specifically, the partners have agreed to a number of guiding
principles that will shape pest management. In summary, the
principles state that (1) pesticide users will continue to work
towards pest management practices that reduce risks and to
minimize the pesticide use where desirable and practicable; (2)
users will continue to develop and implement regional pesticide
environmental stewardship plans; (3) the federal government will
seek to foster effective alternative pest management technologies
and practices; (4) and the federal government will integrate the
environmental stewardship plans into its agricultural and
environmental policies and programs.
The partnerships represent a major step in the overall
federal efforts to encourage environmental stewardship. OPP is
actively seeking additional pesticide user groups, from both
agricultural and non-agricultural sectors, to participate. The
voluntary measures will help prevent pollution and reduce
potential risks to both people and the environment from
pesticides.
International Harmonization And Regulatory Coordination
OPP's international harmonization projects aim to develop
common or compatible international approaches to pesticide
review, registration and standards-setting. The benefits of
making pesticide regulatory programs more consistent
internationally include improved safety of food imported into the
United States, reduced regulatory burden on national governments,
upgrading of supporting science, fewer trade problems, and
reduced costs for registrants.
OECD Pesticide Program
OPP worked closely with other member countries of the
Organization for Economic Cooperation and Development (OECD) to
establish a Pesticide Forum and pesticide work program. For the
first time, the Forum brings government pesticide regulators
together to address common problems and achieve greater
harmonization of policies and procedures. The Pesticide Forum is
working in five areas: reregistration, data requirements, risk
reduction, test guidelines, and hazard assessment. Under
reregistration, for example, the United States served as the lead
country for the Pilot Project to Compare Pesticide Data Reviews.
The pilot project has led to a number of follow-up activities to
expand the exchange and use of national data reviews. As a
result of Forum efforts, countries are gaining a much better
understanding of each other's practices.
Intergovernmental Forum on Chemical Safety
The United States participated in the June 1992 United
Nations Conference on Environment and Development (UNCED) held in
Rio de Janeiro, Brazil. The conference report "UNCED Agenda 21"
made comprehensive recommendations for better coordination and
management of environmental risks. Chapter 19 of Agenda 21
covers the environmentally sound management of toxic chemicals.
In May 1994, governments and international organizations
meeting in Stockholm, Sweden agreed to continue the
Intergovernmental Forum on Chemical Safety (IFCS) to improve the
management of international chemical safety activities. The
United States is working to implement the many Agenda 21 and IFCS
recommendations, including the assessment of several hundred
priority chemicals by the year 2000. These new assessments are
intended primarily to meet the needs of developing countries.
The IFCS is also moving to implement Agenda 21 recommendations
for improvements in harmonization of classification and labeling,
information exchange and prior informed consent, risk reduction,
and strengthening national capabilities.
Canada/U.S. Technical Working Group on Pesticides
The Canada-U.S. Trade Agreement (CUSTA) directs the
countries to work toward equivalence of pesticide standards. To
assist in this effort, CUSTA established a Technical Working
Group on Pesticides, currently co-chaired by OPP and the Chemical
Evaluation Division of Health Canada's Food Directorate. Pilot
projects in progress in 1994 included: 1) parallel registration
review of tebufenozide, an insect growth regulator, in Canada and
the United States; 2) harmonization of maximum residue limits
(tolerances) for four chemical/crop combinations; and 3)
cooperative reevaluation of heavy-duty wood preservatives.
Subgroups of the Technical Working Group have also been formed to
address specific environmental, toxicological, and occupational
exposure issues.
Technical Assistance: AID/EPA Central American Project
The AID/EPA Central American Project is a pilot technical
project involving EPA, the U.S. Agency for International
Development (AID), FDA, and USDA. It is designed to enhance
Central American efforts to improve pesticide safety and pest
management practices. During 1994, EPA participated in regional
technical workshops in Central America to provide information
about integrated pest management, safe pesticide use practices,
and U.S. pesticide/food safety import requirements. EPA
implemented a short-term assistance program in El Salvador to
identify and manage old pesticide storage sites. EPA also
provided technical assistance to the Government of Ecuador to
assist them in dealing with the "Taura Syndrome," a condition
causing high shrimp mortality in shrimp farms in the Gulf of
Guayaquil.
Biological Pesticide Policy Highlights
EPA believes that many biological pesticides are less
hazardous than traditional chemical methods of pest control, and
in 1994 the Agency continued to take steps to encourage their
development and use. This section summarizes those efforts. EPA
expects that as biological and other safer pesticides are brought
to market, they will displace an older generation of more toxic
chemical pesticides.
Pheromone Regulatory Relief Policy
Insect pheromones are a class of biochemical pesticides and
are considered to be reduced risk pesticides. They are used to
disrupt the mating of insect pests that infest agricultural
crops. As part of its efforts to provide regulatory relief for
pheromones, OPP published a final rule expanding the allowable
acreage from 10 acres to 250 acres for testing without obtaining
an Experimental Use Permit (EUP) from OPP. OPP also published an
exemption from the requirement of a tolerance for certain
formulations of pheromones and their inert ingredients based on
low risks to people. These rules applied to solid matrix
dispensers (such as those made of plastic) that can be retrieved
from fields. OPP is considering further expanding the exemption
for testing of certain groups of pheromones to include all
broadcast formulations for experimental testing on up to 250
acres.
Final Rule on the Testing of Microbial Pesticides
EPA published a final rule on September 1, 1994, that amends
the Agency's experimental use permit regulations and modifies
prior policy regarding small scale testing of microbial
pesticides. Microbial pesticides consist of microorganisms such
as bacteria, fungi, viruses, or protozoans used to control pests.
The rule will codify existing policy that requires notification
to OPP prior to initiating small-scale field tests with certain
genetically modified microbial pesticides. This rule reduces the
regulatory burden of testing microbial pesticides compared to
existing policy, while preserving sufficient federal oversight to
prevent unreasonable adverse effects from testing of microbial
pesticides.
Proposed Regulation of Plant-Pesticides
The Agency has proposed a number of actions to regulate
certain novel pesticidal substances genetically introduced into
plants for the purpose of protecting them against pests and
disease. These substances have been designated plant-pesticides.
The proposed regulations, issued in November 1994, address plant-
pesticides and not the plants themselves.
EPA is proposing to exempt three types of low risk plant-
pesticides from registration requirements:
(1) Plant-pesticides derived from a closely related plant (e.g.,
those taken from one corn plant and engineered into another
corn plant).
(2) Plant-pesticides that act primarily by affecting the plant
(e.g., plants that have been engineered to produce a
thicker, more protective outer layer of wax) rather than by
having a direct toxic effect.
(3) Plant-pesticides consisting of certain components of viruses
called "viral coat proteins," and the genetic material
needed to create the coat proteins. Scientists are now able
to transfer genes from a virus into the plant so that the
plant can produce viral coat proteins. These proteins
provide the plant with resistance to infection by disease-
causing plant-viruses.
EPA is proposing to exempt three categories of low risk
plant-pesticides (including associated genetic material) from the
requirement to obtain a tolerance:
(1) Plant-pesticides derived from closely related plants.
(2) Plant-pesticides not derived from closely related plants, as
long as the plant-pesticide would not result in
substantially different exposure through food (e.g., those
taken from a highly consumed crop such as corn and
engineered into another crop such as eggplant).
(3) Coat proteins from plant viruses.
Activities Related To Implementation Of The "Delaney Clause"
In 1992, the Ninth Circuit Court of Appeals issued a
decision in the Les v Reilly case mandating a strict
interpretation of the Delaney clause of the Federal Food, Drug
and Cosmetic Act (FFDCA). According to the court, the Delaney
clause forbids EPA approval of food additive regulations if the
pesticide has been found to induce cancer, regardless of the
degree of risk to the public. (Food additive regulations are
maximum residue limits, or tolerances, for processed food and are
required if a pesticide is used or becomes concentrated in
processed food.) The Delaney clause does not apply to tolerances
for raw agricultural commodities. EPA has taken a number of
actions to achieve full and continuing compliance with the
Delaney clause, and in fiscal year 1994:
o Proposed to revoke food additive regulations for a number of
pesticides found to cause cancer. OPP proposed the
revocation of 26 tolerances of 7 pesticides on July 1, 1994.
OPP expects to propose the revocation a number of other
tolerances in 1995.
o Revoked tolerances for dichlorvos (DDVP) on bagged
commodities, for dicofol on tea, and mancozeb on washed
raisins. A temporary stay of the revocation is in effect
for DDVP and dicofol.
o Issued a notice to registrants (PR Notice 93-12) explaining
the revised policy that dried hops are a raw agricultural
commodity (RAC), and therefore no longer subject to the
Delaney clause. Two tolerances were subsequently
established for dried hops as a RAC.
o Published in the Federal Register an updated list of
pesticides potentially affected by the Delaney clause.
o Issued a Federal Register Notice explaining OPP's policy to
delay action on pending petitions and registration actions
subject to the Delaney clause until Delaney policy issues
are resolved.
Standards For Pesticide Containers And Containment
In February 1994, OPP proposed the "Standards for Pesticide
Containers and Containment." These measures are intended to
protect human health and the environment by reducing exposure to
pesticides and reducing production of wastes when pesticide
containers are stored, handled, and refilled. The standards are
a result of Congressional amendments to FIFRA in 1988, which
authorized EPA to issue regulations in two areas of concern:
pesticide container design standards and residue removal
standards. The proposed rule would establish standards for the
removal of pesticides from the containers and the rinsing of the
containers and would facilitate safe use, refill, and disposal of
containers. The rule also would establish requirements for the
containment of stationary bulk containers and pesticide
dispensing areas.
OPP reviewed and summarized approximately 200 public
comments and entered them into an issue-oriented data base. A
workgroup is being re-established to finalize the rule, which is
expected to take 18 months.
Other Regulations Under Development
In 1994, OPP continued to develop a number of regulations
designed to increase protection of human health and the
environment.
Tolerances and Food Safety
OPP is reinventing its processes for establishing tolerances
and estimating risks to consumers (including children) from
exposure to pesticide residues in food. Thus far, eight
potential procedural changes have been identified. OPP is
considering taking into account factors such as those known to
reduce pesticide residues in foods between the time crops are
harvested and eaten (e.g., storage, processing, washing, peeling,
and cooking) when setting tolerances. The resulting tolerances
would more closely reflect real exposure to pesticide residues in
food. OPP expects to issue an Advance Notice of Proposed
Rulemaking (ANPRM) in the spring of 1995.
Revised Pesticide Registration Data Requirements (Part 158)
In 1994, OPP provided draft comprehensive revisions to data
requirements for registering pesticides (Part 158 of the Code of
Federal Regulations) to the EPA Scientific Advisory Panel (SAP)
for review in preparation for proposed rulemaking in early 1995.
Much of this proposed rule would implement changes already
adopted in OPP in the course of registration and reregistration.
The revisions would ensure that comprehensive data packages are
supplied to OPP so that each pesticide can be evaluated using
current health and environmental standards.
Reporting of Pesticide Incidents (6(a)(2) Rule)
Section 6(a)(2) of federal pesticide law requires
registrants to report to OPP incidents related to pesticide use
or other information related to potential adverse effects of
pesticides. This information is important in helping OPP decide
if action should be taken to reduce the risks posed by a
particular pesticide. In 1994, OPP worked to finalize the
proposed 6(a)(2) rule, which would clarify the incident reporting
obligations of registrants. OPP expects to publish the final
rule in mid-1995. (Chapter 6 provides further discussion of
6(a)(2) activities during 1994.)
Protecting Endangered Species and Ground Water
As described in more detail in chapter 4, OPP continued to
work on a final regulation to protect federally listed threatened
and endangered species from the impacts of pesticide use and to
draft several regulations to further protect ground water
resources.
Legislative Proposals
OPP played a lead role in working with USDA, FDA and the
White House domestic policy staff to draft comprehensive
pesticide and food safety legislative reforms advanced by the
Administration, preparing for Congressional hearings on the
proposals, and conducting numerous communications and outreach
activities. OPP also performed a preliminary cost analysis and
analyzed other bills advanced in the 103rd Congress. The
Administration proposals aim to provide authorities under both
the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) to enable
regulatory agencies to take prompt action to reduce risks to
health and the environment, and to promote development of safer
methods of pest control.
Notably, the Administration's legislation would replace the
"Delaney clause" of the FFDCA with a consistent, health-based
standard for setting tolerances for pesticide residues in all
types of food. Other FFDCA proposals respond to the
recommendations of the National Academy of Sciences report
"Pesticides in the Diets of Infants and Children"; call for a
review of all existing tolerances against the new, health-based
standard; and enhance FDA's enforcement powers. FIFRA proposals
include registration "sunset" provisions; incentives for
development and registration of reduced risk and minor use
pesticides; support for risk and use reduction and IPM
activities; streamlined cancellation and suspension procedures;
export restrictions; record-keeping for all agricultural
pesticide use; additional fees to support FIFRA '88
reregistration; enhanced enforcement for FIFRA violations; and a
number of other regulatory tools.
The Administration's proposals were introduced into the
103rd Congress, but no final action was taken before the close of
the session. OPP expects a number of these issues to resurface
in the next Congress, either as independent legislation or in the
context of the 1995 Farm Bill.
Maintaining And Improving OPP's Science Base
OPP's critical decisions rely upon the scientific
information and judgment about those pesticides. OPP invests
considerable effort in obtaining the best scientific information
available and working with other experts within and outside of
government to make sure its standards reflect the latest
scientific thinking. This section describes some of OPP's
efforts in 1994 to build upon its scientific base.
Ecological Effects Pesticide Toxicity Database
Over the past two years, OPP has developed a database to
provide a rapidly accessible source of ecotoxicity data for all
pesticides in use nationwide. Ecotoxicity data consist of
information about the toxicity of pesticides to birds, mammals,
fish, plants, and other organisms. The database will track,
record, and summarize OPP's vast library of toxicological data,
which until now has been available only in paper format, and
should prove to be an extremely valuable tool for assessing the
risks associated with various alternative pesticide uses. OPP
has already provided database information to EPA regions and
other offices, USDA, the U.S. Fish and Wildlife Service, a number
of state agencies, and others. The database will also allow OPP
to more efficiently complete registration and reregistration
actions. The database currently contains over 7,000 toxicity
records for 300 major use pesticides and is about halfway
completed. OPP plans to incorporate this database into the
Pesticide Information Network (described in chapter 4) and other
publicly available data sources.
National Water-Quality Assessment Program
OPP scientists have worked closely with the U.S. Geological
Survey's National Water-Quality Assessment (NAWQA) Program over
the past several years. NAWQA is describing the status and
trends in a representative part of the nation's ground and
surface waters. One product from the joint efforts is the
publication entitled "Summary of National Standards and
Guidelines For Pesticides in Water, Bed Sediment and Aquatic
Organisms and Their Application to Water-Quality Assessments."
This publication summarizes current national standards and
guidelines, and provides definitions, originating agencies,
statutory authorities, regulatory status, applicable sampling
media, beneficial use and resource protected, and full citations
of published documentation. An entire issue of Reviews of
Environmental Contamination and Toxicology has been dedicated to
the publication.
EPA's Contaminated Sediment Management Strategy
OPP has actively participated in the Agency's Contaminated
Sediment Management Strategy, published August 1994. OPP
scientists have served on various Agency committees covering a
wide range of topics from toxicity testing to use of sediment
water quality criteria. They have also worked closely with EPA's
Office of Pollution Prevention and Toxics to provide a
Prevention, Pesticides and Toxic Substances policy, as well as a
scientific position on the Strategy.
Health Effects Research and Guidelines
OPP participated in a number of projects in 1994 to advance
scientific knowledge and understanding of the health effects of
pesticides. Some of these projects included:
o Drafting and sharing publicly the test guidelines for
reproduction and developmental toxicity studies. OPP is
finalizing the guidelines based on public comment. OPP has
also developed Standard Evaluation Procedures (SEPs) for
reproduction and developmental toxicity studies and is
gathering public comment. These procedures should
standardize how the studies are evaluated both by industry
and EPA.
o Holding an Ocular Toxicity Workshop to explore testing
options for the adverse eye effects associated with
organophosphate pesticides. OPP and pesticide registrants
discussed the protocols and feasibility of several proposed
tests.
o Convening a workshop with leading researchers to obtain
comment on draft revisions to the guidelines (known as the
Subdivision K guidelines) for assessing pesticide exposure
to people in both work and residential settings.
o Working with the International Life Sciences Institute
(ILSI) to explore a number of contentious scientific issues.
Among the most important ones are the significance of
mammary and bladder tumors in laboratory animals and how to
interpret certain effects in laboratory animals found at
extremely high doses of pesticides (the Maximum Tolerated
Dose, or MTD, issue).
o Drafting and distributing for preliminary comment revised
guidelines for performing toxicology metabolism studies.
The new guidelines will have a tiered system of testing.
OPP plans to hold a workshop on the guidelines in May 1995.
Chapter 6: Information and Program Management
OPP's information and program management efforts are not as
publicly visible as some of its other programs, but without them
none of the other programs could operate. The buildings that OPP
occupies, the supplies and equipment it uses, the funds it
administers, the systems for processing and storing the vast
amounts of information that OPP uses, and the staff itself -- all
of these critical program components are managed under this
program area. This section describes some of the information and
program management achievements during 1994.
Operations, Maintenance And Integration Of The Primary OPP
Information Systems
In 1994, OPP finished major parts of its automated
information management infrastructure. All OPP employees are now
equipped with personal computers linked via a high-speed local
area network (LAN). Detailed and summary information about
pesticide chemicals, products and their uses, registrants,
registration action requests, tolerances, reregistration status,
and other information is available through the LAN. Electronic
mail (email), scheduling, word processing, spreadsheet, and other
software packages are also available. This infrastructure is
reliable and has greatly improved internal communication and
data-sharing in OPP.
Additionally, OPP completed the integration of several
computer systems used to manage the pesticide reregistration
process into an improved system called the Chemical Review
Management System (CRMS). OPP used CRMS in preparing the
Reregistration Report Cards sent to each registrant involved in
reregistering a pesticide. Major improvements were also added to
the Pesticide Regulatory Action Tracking System (PRATS), which
OPP uses to help manage the flow of registration actions through
the program. The improvements added capabilities for priority
planning, scheduling, and performance analysis.
Other major improvements to the automated information
management infrastructure in 1994 included upgrading the staff
personal computers, completing the major preparatory steps for
integrating all the OPP-wide computer systems into one umbrella
system, aggressively pursuing electronic submission of detailed
data critical to science studies, and adding more software to the
network.
Pesticide Incident Reporting/6(a)(2) Activities
Section 6(a)(2) of federal pesticide law requires
registrants to report to EPA incidents, studies, or other
information indicating new potential adverse effects of
registered pesticides. This information is important in helping
EPA decide if action should be taken to reduce the risks posed by
a particular pesticide.
The number of 6(a)(2) submissions to OPP increased in 1994
to approximately 700 covering 4,500 individual incident reports.
OPP's 6(a)(2) Team screened 755 adverse effects submissions,
which were primarily studies and preliminary reports of possible
adverse effects from studies not yet completed. As a result of
screening, 20% of the submissions were determined to warrant
expedited review. Of those, about 20% resulted in label changes
to reduce risks, mostly in cases of new findings of acute
toxicology studies, and 8% showed a new adverse effect that is
being addressed by Special Review, an imminent reregistration
decision, or risk mitigation measures. The remainder are in
various stages of review or required no further action.
Ecological Incident Monitoring And Reporting
In 1994, OPP completed the development of the Ecological
Incident Information System (EIIS). OPP expects that this system
will play an essential role in understanding how poisoning
incidents involving nontarget species (unintentionally affected
animals and plants) occur and will help OPP to reduce
environmental risks. This database is a compilation of the
information currently used for completing risk assessments. A
total of 630 incidents have been entered into the database,
including the most recently reviewed pesticide, carbofuran.
Based on the data entered to date, over 101 active ingredients
have caused adverse effects to 1,300 species of nontarget
organisms.
In response to substantial interest in the EIIS, OPP has
distributed the software to 175 state and federal agencies as
well as to private industry. OPP contacted over 75% of the state
agencies who are responsible for collecting the data. OPP has
presented its efforts at professional meetings and to other
federal agencies such as the National Biological Survey (NBS).
OPP has also initiated cooperative agreement efforts between EPA,
NBS, and the Fish and Wildlife Service and is developing a
standardized protocol for ecological incident monitoring and
reporting.
Information And Records Management Activities
OPP receives and generates an enormous number of documents
each year, such as studies submitted regarding the effects of
pesticides and OPP's review of these studies. These records must
be properly managed to ensure timely, appropriate decisions and
for future reference. Significant accomplishments were made in
OPP's records management program in 1994. OPP conducted regular
training for its network of records management liaison offices
and drafted major changes to the records retention schedule for
review by the National Archives.
Human Resources Management
OPP's human resources efforts included hiring, training, and
promoting staff. More than half of OPP employees received some
form of technical, career, or management development training in
1994. Another human resource effort was that of the Cultural
Diversity Task Force. The Task Force is committed to valuing OPP
employees regardless of physical attributes, ethnicity, or sexual
orientation. Three subcommittees have been formed:
Communications, Planning, and Outreach. In 1994, the
Communications Committee educated OPP staff on the mission of the
task force. The Planning Committee determined that the task
force should focus on recruiting and retaining minorities,
developing careers for minorities, and ensuring unbiased reviews
for minorities eligible for promotion. In 1994, the committee
participated in drafting a Diversity Plan that should be
finalized in early 1995. The Outreach Committee developed a
database of potential applicants that will be made accessible to
all managers to help them find qualified applicants.
Resource Allocation And Financial Management
OPP resources are allocated in three distinct phases: budget
formulation, planning, and execution. During any given year, OPP
is formulating a budget two years in advance, planning a budget
for the upcoming year, and executing a budget for the current
year.
Budget Formulation
Budget formulation is the process of developing the budget
submitted by the President to Congress each year. During fiscal
year (FY) 1994, OPP prepared the submission of the FY 1996
budget. OPP worked with the Administrator's office to develop
the budget, investing in some areas and disinvesting from others,
based on Agency priorities and objectives. OPP's major proposed
areas of investment are ecological protection (including reducing
pesticide use/risk and building tribal capacity), food safety,
and implementation of the Worker Protection Standard. These
investments are to be accompanied by disinvestments from
registration and reregistration, by completion of some efforts,
and by streamlining efficiencies. The budget will then be
reviewed by OMB and ultimately become part of the President's
Budget. After Congressional review and ratification, it becomes
the Congressional Budget. Ideally, the final budget is approved
with the signing of the Appropriations Bill by the President
prior to October 1 (the beginning of the new fiscal year).
Budget Planning
The planning process starts about nine to 12 months before
funds are actually appropriated by Congress; OPP began FY 1995
planning in January 1994. The participants include a Senior
Management Board, a Steering Committee, six Program Area
Workgroups (PAWs), and coordinators from each of OPP's divisions.
The PAWs identify resources needed to fund Program Area
activities and prioritize those activities. The Steering
Committee then makes recommendations based on the PAW efforts to
the Senior Management Board, which integrates the area plans into
the OPP Resource Management Plan. This plan describes the
projects to be performed and their level of funding for the
upcoming fiscal year.
For FY 1995, the OPP planning process allocated $18.2
million for headquarters contracts and grants, $3.3 million in
expenses, and $52 million in salaries for approximately 785
employees. The planning process incorporated reductions
requested by Congress, the conversion of some contractor
functions to OPP staff, "buy-outs" to facilitate staff
reductions, and implementation of the new pilot division.
Nondiscretionary state grants and assistance, which are allocated
outside of the OPP planning process, totalled $15 million.
Budget Execution
After the Appropriations Bill is signed by the President,
the EPA Comptroller issues a new Operating Plan, which is
executed by each Agency office. In executing the budget, OPP
must carefully monitor expenditure of all funds, track compliance
with budget plans, and coordinate appropriate Agency financial
reports. During 1994, OPP obligated (spent) $93 million dollars.
These funds consisted of $52 million in travel expenses and
salaries for approximately 785 employees; $26 million for
contracts, interagency agreements, grants, and expenses; and $15
million for grants and support to regions and states. In 1994,
OPP continued to collect several types of funds from pesticide
registrants, which supplement Congressional appropriations. The
collected funds consisted of $2.1 million in tolerance fees,
$14.1 million in annual registration maintenance fees, and
$800,000 in reregistration fees. The collected fees are placed
in revolving funds that may be used over multiple years, whereas
most Congressional appropriations must be used within two years.
In 1994, OPP improved its systems for using the revolving
funds and helped carry out financial management responsibilities,
such as those under the Chief Financial Officer's Act and the
Government Performance and Results Act. OPP also continued to
fully use available resources to meet mission goals.
1994 Staff Effort Per Program Area
----------------------------------------------------------
Program Area FTEs
--------------------------------------------------- -----
Registration 189
Reregistration 241
Special Review 70
Field Implementation and Communications 78
Policy, Regulations, and Guidance 69
Information and Program Management 120
TOTAL 767
----------------------------------------------------------
This table indicates the approximate distribution of OPP
staff effort to the six program areas. The table is presented in
terms of "Full-time Equivalents" (FTEs). One FTE represents the
number of hours spent by one employee working full-time for one
year. Because some employees work part-time, or are hired or
leave part-way through the year, the actual number of employees
in any given year exceeds the number of FTEs. Many employees
divide their time among different program areas.
Funds Expended in 1994 By the Six Program Areas
----------------------------------------------------------
Program Area Funds
--------------------------------------------------- -----
Registration 11 %
Reregistration 33 %
Special Review 3 %
Field Implementation and Communications 13 %
Policy, Regulations, and Guidance 16 %
Information and Program Management 24 %
TOTAL 100 %
----------------------------------------------------------
In 1994, OPP expended approximately $14.2 million allocated
through the program area budget process. These "discretionary"
funds were used for external contracts. This table shows how
these funds were distributed among the different program areas.
(Other major pesticide expenditures not reflected in this table
are travel expenses; salaries; grants and other assistance to
states, regions, and other organizations; and set-asides for
special projects, such as pesticide disposal.)
Chapter 7: Opportunities and Initiatives For 1995
In addition to continuing the work previously described
throughout this report, OPP expects to pursue several important
opportunities and initiatives during 1995. This section
highlights some of those opportunities.
Biological Pesticides And Promoting Risk Reduction
OPP is taking several measures to promote biological and
other potentially safer pesticides, such as waiving data
requirements, where possible, and placing a high priority on
completing needed scientific reviews. OPP is also encouraging
alternatives to pesticides and other ways of reducing pesticide
use and risks. Two important new opportunities for continuing
progress in these areas are the creation of a pilot division and
the Memorandum of Understanding between EPA and the U.S.
Department of Agriculture.
Creation of the Pilot Division
EPA has established a pilot, multi-disciplinary division of
33 employees within OPP to promote reduced pesticide use,
encourage development and use of safer pesticides, and accelerate
registration of new biological pesticides. The Biopesticides and
Pollution Prevention Division (BPPD) is responsible for: (1) all
registration and reregistration actions for biological
pesticides; (2) Integrated Pest Management (IPM) programs and
strategies; and (3) continued development of pesticide pollution
prevention activities, including the Pesticide Environmental
Stewardship Partnership.
In accordance with the Administration's National Performance
Review (highlighted in the Vice-President's report on reinventing
government), the pilot division will have a streamlined structure
which exceeds the goal of 11:1 staff to management ratio. Small,
self-directed and empowered teams are being formed as an
alternative management structure. The approach is designed to
promote staff development and OPP productivity for all science
reviews and administrative processes for registration and
reregistration actions, providing team leadership opportunities
and allowing OPP to test and evaluate new methods of operation to
assist with the overall streamlining of OPP scheduled for 1996.
EPA/USDA Memorandum of Understanding (MOU)
Under this MOU, signed in August 1994 by EPA Administrator
Carol Browner and Department of Agriculture Secretary Mike Espy,
the two agencies agree to work in collaboration to provide the
agricultural community with pest management practices to reduce
the risks associated with pesticides. The agreement will
increase USDA research for alternative methods for pest control
and establish practical means for transferring these tools to the
farmer. Each year, USDA will identify those crop/pest/control
combinations which are potentially vulnerable for the producer
(i.e., situations where growers have few effective alternatives
or where pest resistance limits effective pest management).
Similarly, EPA will identify agricultural pesticides for which it
is considering regulatory action that would affect their
availability or use. Together, USDA and EPA will expedite
research, development, education and registration, if necessary,
to meet these priority needs.
Opening Up OPP
OPP has several projects underway to "open up OPP" -- that
is, to allow everyone to obtain information from OPP more easily,
and to participate in and understand OPP's decision-making
process. OPP strongly believes that a well-informed public will
make wiser choices involving pesticides and will help improve the
quality of federal pesticide actions.
Electronic Dissemination of Information
OPP continues to experiment with innovative ways of making
information available to affected organizations and the general
public. The Agency's Email (electronic mail) Integration Pilot
this year extended OPP's realm of communications to include EPA
regional offices and made possible the exchange of Internet
messages. Internet is a telecommunications system that connects
thousands of computer networks and literally millions of computer
users. Early in calendar year 1995, OPP expects to complete the
process enabling all OPP personnel to easily communicate with
anyone on the worldwide Internet. OPP has also begun to make
some of its publications available on the Internet.
During fiscal year 1994, OPP also piloted the new Pesticide
Special Review and Reregistration Information System, an
electronic bulletin board system (BBS) available free of charge
to any member of the public who has access to a PC with a modem.
This BBS contains recent Reregistration Eligibility Decision
(RED) documents and all the RED fact sheets. Other files
available for downloading include basic information explaining
reregistration and Special Review, lists of pesticides under
review and the appropriate Chemical Review Managers' names and
telephone numbers, the Rainbow Report (or "Status of Pesticides
in Reregistration and Special Review"), and "OPP Selected Terms
and Acronyms." Additional documents to be added soon include this
Annual Report, the Rejection Rate Analysis chapters, and the
quarterly "Pesticide Reregistration Progress Report." To reach
this BBS from a PC with modem, dial 1-703-308-7224. The BBS also
can be reached on the Internet via FEDWORLD.GOV. EPA's "gopher
server," EARTH1.EPA.GOV, is another source of these electronic
files. The Sysop, or system operator, welcomes comments,
questions and feedback.
Public Involvement in Risk Decisions
Achieving risk reduction through negotiations with pesticide
registrants can lead to quicker action than formal Special Review
procedures; however, it has been criticized for not always
providing an adequate opportunity for public involvement. OPP
published a notice in the Federal Register in 1994 that described
a number of ways OPP would be making the process more open,
including a process for public comment on proposed agreements
with registrants. OPP will continue this process in the coming
year. OPP is also exploring avenues for expanding its efforts to
include the public in pesticide registration decision-making.
The Aquatic Risk Assessment and Mitigation Dialogue Group
To help implement the "New Paradigm" for pesticide
regulatory decisions (described in chapter 2), OPP organized a
workgroup known as the Aquatic Risk Assessment and Mitigation
Dialogue Group with the joint sponsorship of the American Crop
Protection Association (formerly NACA). The group consisted of
representatives from the pesticide industry, academia,
environmental groups, OPP, and EPA's Office of Research and
Development (ORD). The group met seven times in 1993 and 1994 to
promote an open scientific dialogue about the assessment and
mitigation of risks to aquatic organisms posed by pesticides.
The primary topics discussed by the Dialogue Group were
ecological effects and exposure characterization, integrated risk
characterization, and mitigation practices to reduce the risk of
pesticides to aquatic resources. Subgroups researched a variety
of topics, such as how to better employ existing data in risk
assessments, how to improve pesticide risk assessment
methodology, and cataloguing pragmatic short-term mitigation
practices. Long-term needs for mitigation and monitoring were
also discussed. The Group reached a number of conclusions and
recommendations in a final report issued in November 1994.
Reinventing And Streamlining OPP's Organization
As part of the efforts to "reinvent" and flatten the federal
government structure and to increase responsiveness, OPP has
undertaken twenty major streamlining projects in four main areas.
Progress through fiscal year 1994 is summarized for each project
in the table below. This broad range of activities is overseen
by an OPP Streamlining Council, composed of the senior program
managers, and an Employee Advisory Group, representing the staff.
OPP Streamlining Projects
===============================================================
Streamlining Project Current Status
========================== ===================================
Review and Evaluate OPP Program
---------------------------------------------------------------
Survey Customer Preliminary test complete. Full
Satisfaction surveys of regulated community and
general public to begin in FY 95.
Surveys of states/regions completed
in FY 94.
Perform Outside Pre-test complete. Interviews of 160
Management Review OPP staff began mid-October 1994.
Final report submitted in January
1995.
Upgrade Monitoring of Performance to be measured against
Performance vs. Plan fiscal year 1995 resource allocation
plans.
---------------------------------------------------------------
Revise Core Production Processes in OPP
---------------------------------------------------------------
Drop Activities Identification of candidate
Contributing Little processes complete. Winnowing
to Risk Reduction process underway.
Increase Delegations Many redelegations completed; others
and Empowerment in progress. Allows quicker decision-
making and fewer layers of review.
Streamline Correspond- Project getting underway.
ence Management in OPP
Pilot a "Living RED" Test effort to maintain a continually
updated, automated OPP regulatory and
scientific position about a specific
pesticide. Pilot pesticide selected,
and prototype system under
development.
Standardize Science Pilot efforts completed in 1994. Two
Review Documentation subgroups now focusing on review
content and on technology for
storing,indexing,and retrieving
reviews.
Automate Product Electronic letterhead and
Manager Team concurrence copies now used to
Operations simplify correspondence. Work to
further automate correspondence
underway.
Use Quality Circles Pilot under development for non-
in Health Effects supervisory quality management in
Division science review division.
---------------------------------------------------------------
Implement Human Resources Initiatives
---------------------------------------------------------------
Implement Diversity Draft OPP Diversity Plan completed
Initiatives and circulated for comment throughout
OPP. Revisions in response to
comments underway. Final plan
implementation in 1995.
Develop New Perfor- OPP working jointly with Office of
mance Appraisal Pollution Prevention and Toxics.
System Staff survey planned for early 1995;
full pilot to be in place for 1996
standards.
Appraise Supervisory Full OPP-wide implementation began
Performance by Staff in September 1994.
Establish Multiple OPP effort, which depends upon
Career Tracks Agency-wide progress, is in beginning
stages.
Implement Administra- System approved and implementation
tive Support Career underway.
Management System
Redefine Leadership OPP effort is in beginning stages.
Needs in Streamlined
Organization
Develop Staff OPP effort is in beginning stages.
Rotation Program
Develop Comprehensive OPP-wide survey of training needs
Training Strategy has begun.
---------------------------------------------------------------
Streamline OPP Organization
---------------------------------------------------------------
Establish Pilot operations began in October
Biopesticides and 1994.
Pollution Prevention
Division
Realign Organization Divisional reorganization plans
to Meet Streamlining completed 3/94. Overall OPP
Mandates streamlining plan to be developed by
2/95 by Streamlining Council.
===============================================================
Registration Streamlining
In September 1994, OPP released its plan for streamlining
several aspects of the registration process. Two major areas for
improvement identified are amendments to pesticide product
registrations and other process changes. In the first area, OPP
is proposing to expand the types of amendments which may be
accomplished by notification. Under a notification system, a
pesticide registrant may modify its pesticide label without prior
approval so long as it notifies OPP of its action and fulfills
OPP label requirements. This notification process will be
limited to minor changes that do not increase risks. OPP is also
proposing to simplify the notification process. Other potential
areas for improving the registration process include streamlining
the review of acute toxicity studies, self-certification by
registrants for products with low acute toxicity, strengthening
precautionary labeling statements, and expediting the review of
products similar to products already registered ("me-too"
registrations).
How To Obtain More Information
The Office of Pesticide Programs (OPP) wishes to provide
timely and consistent information to the public and offers a
variety of ways to do so. If you would like additional
information on subjects discussed in this report or other topics,
here are some sources available to you:
OPP Public Docket - OPP's docket houses the regulatory notices,
background documents and public comments on OPP activities. The
Docket is open to the public from 8:00 a.m. to 4:30 p.m., Monday
through Friday, and is located in Room 1132 of Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, Virginia (near the
Crystal City subway station), telephone 703 305-5805.
Catalog of OPP Publications and Other Information Media - This
catalog provides a listing of hundreds of pesticide publications,
including science chapters, fact sheets, etc., and is available
from EPA's Public Information Center, 401 M Street, S.W.,
Washington, D.C. 20460 (Telephone 202 260-2080); or the National
Center for Environmental Publications and Information (NCEPI),
P.O. Box 42419, Cincinnati, Ohio 45242-2419 (Telephone 513 891-
6561 or Fax 513 891-6685).
Pesticide Regulation (PR) Notice 94-3 - This document provides
general guidance for obtaining a variety of OPP records and
publications. It provides key information and contacts for many
resources available to the public (including Pesticide Dockets,
Freedom of Information Act, the pesticide hotline, and on-line
databases). Lists of OPP program contacts are included to help
direct public requests regarding specific chemicals or policy
issues. PR 94-3 can be obtained from:
Communications Branch, FOD (7506C)
Office of Pesticide Programs, U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
(703 305-5017)
Communications Branch - Recent announcements and copies of non-
technical brochures and fact sheets on pesticide issues can be
obtained from the Communications Branch, as listed above.
National Pesticides Telecommunications Network (NPTN) - NPTN is a
toll-free telephone service which provides general information
about pesticides and is available to anyone in the United States,
Puerto Rico and the Virgin Islands (Monday-Friday, 8:00 a.m. to
6:00 p.m. CST) at 1 800 858-7378.
Electronic Availability of Pesticide Reregistration Documents -
Many reregistration and Special Review documents are available
through an electronic bulletin board system, which can be reached
via modem at 1-703-308-7224. They are also available through the
Internet via FEDWORLD.GOV and via EPA's gopher server,
EARTH1.EPA.GOV. A fact sheet describing these services can be
obtained from the Public Docket, NCEPI, or the Communications
Branch.
Pesticide Information Network (PIN) - The PIN is an interactive
database containing current and historic pesticide information.
It is free and operational 24 hours per day, seven days per week.
It can be reached via modem and communications software at 703
305-5919.
Pesticide Program Contacts
The following is a listing of OPP's senior managers as of January
1995, as well as the managers of OPP's parent office, the Office
of Prevention, Pesticides and Toxic Substances (OPPTS). All OPP
telephone area codes are 703.
Office of Prevention, Pesticides and Toxic Substances
Lynn R. Goldman, M.D., Assistant Administrator (202) 260-2902
Susan H. Wayland, Deputy Assistant Administrator (202) 260-2910
James V. Aidala, Associate Assistant Administrator (202) 260-2897
Office of Pesticide Programs
Daniel M. Barolo, Director 305-7090
Penny Fenner-Crisp, Acting Deputy Director 305-7092
Policy and Special Projects Staff
Anne Lindsay, Director 305-7102
Biological and Economic Analysis Division
Allen L. Jennings, Director 305-8200
Biopesticides and Pollution Prevention Division
Janet L. Andersen, Acting Director 308-8712
Flora Chow, Acting Deputy Director 308-8712
Environmental Fate and Effects Division
Anne L. Barton, Director 305-7695
Paul F. Schuda, Deputy Director 305-7695
Field Operations Division
William Jordan, Acting Director 305-7410
Health Effects Division
Stephanie R. Irene, Acting Director 305-7351
Richard D. Schmitt, Acting Deputy Director 305-7351
Program Management and Support Division
Frank T. Sanders, Acting Director 305-5440
Norman W. Chlosta, Deputy Director 305-5440
Registration Division
Stephen L. Johnson, Director 305-5447
Lois A. Rossi, Acting Deputy Director 305-5447
Special Review and Reregistration Division
Peter P. Caulkins, Acting Director 305-8000
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