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Office of Pesticide Programs Annual Report for 1995
 |
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 Although the information provided here was accurate and current when first created, it is now outdated. |
Date: December 1995
ABSTRACT: This Annual Report describes many of the efforts
and accomplishments of EPA's Office of Pesticide
Programs (OPP) during fiscal year 1995 (October 1,
1994 to September 30, 1995).
NOTE: The following electronic version does not contain
the full graphics of the original version.
Information on obtaining a paper version
containing full graphics is provided in
the "Availability" section below.
ORIGINATOR: Environmental Protection Agency
Office of Pesticide Programs (7506C)
401 M Street, SW
Washington, DC 20460
AVAILABILITY: A limited number of paper copies are available
free of charge from the Communications Branch,
Office of Pesticide Programs, telephone 703-305-
5017 or fax 703-305-5558.
FOR FURTHER INFORMATION:
For more information about this and other
pesticide publications, please contact:
Communications Branch (7506C)
Office of Pesticide Programs
Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Ph: 703-305-5017
Fax: 703-305-5558
---------------------------------------------------------------
U.S. Environmental Protection Agency
Prevention, Pesticides and Toxic Substances (7506C)
Publication Number: EPA 730-R-95-002
December 1995
Office of Pesticide Programs Annual Report for 1995
Foreword
EPA's Office of Pesticide Programs (OPP) is making
significant progress in carrying out its important
responsibilities -- safeguarding public health and the
environment from pesticide risks, and ensuring that pesticides
are regulated fairly and efficiently. OPP's Fiscal Year 1995
achievements are especially noteworthy as they were accomplished
while the program was engaged in extensive reinvention
initiatives, planning for a major realignment, and responding to
pressures and concerns about impending budget actions.
This was a banner year for both the registration and
reregistration programs, with 40 new active ingredients
registered and 40 Reregistration Eligibility Decisions (REDs)
issued. To put these numbers in perspective, consider that
historically, only about a dozen new active ingredients were
registered annually. Dramatic improvements began to show in FY
1994, when 30 new active ingredients were registered. The upward
trend continued in FY 1995, with a record-breaking 40 new
registrations accomplished. Impressively, well over half of the
new registrations during the past two years are for "safer" or
reduced risk products, many with lower use rates than
conventional pesticides, and 35 are biopesticides.
During FY 95, the timeliness of EPA registration decisions
improved substantially. Historically, it has taken on average
four to six years to register a new pesticide. During the past
year, average processing times were reduced as follows: reduced
risk pesticides (8-16 months); biopesticides (3-16 months); and
all other new active ingredients (3-52 months).
OPP also accelerated its reregistration program for older
pesticides, reaching its planned annual goal of 40 REDs in FY 95,
for a grand total of 121 REDs. Combined with last year's total of
34 REDs, this means an impressive 74 reregistration decisions --
two-thirds of all REDs issued -- were accomplished in the last
two years. These decisions were made following OPP's
comprehensive review of literally thousands of scientific studies
on the potential effects of pesticides and their fate in the
environment. Based on this review, EPA took action to reduce
pesticide risks by imposing many new requirements and
restrictions as conditions of reregistration. While much work
remains to be done, including REDs for many major pesticides with
food-related uses, less than half of the original universe of
older pesticides remain in the pipeline for review.
Beyond the registration and reregistration programs, EPA
implemented a number of other initiatives to protect public
health and the environment. OPP worked to serve all of its
customers by responding to requests for information and managing
the distribution of hundreds of thousands of EPA-produced
documents that help ensure safer pesticide practices in the home,
in schools, in agriculture, and in industrial settings. Notably,
the Worker Protection Standard became fully effective in 1995.
This standard ensures that over three million agricultural
workers have the training and equipment they need to protect
themselves from pesticide risks on the job. At the same time, EPA
continues to work to refine its rules to ensure appropriate
flexibility in implementation, and to focus resources on true
public health and environmental problems, by streamlining and
"deregulating" wherever possible and establishing new alliances,
such as the Pesticide Environmental Stewardship Program.
A talented team of dedicated employees from across all OPP
divisions made these accomplishments possible. In addition, EPA's
partners in the regional offices and state and tribal pesticide
regulatory agencies continue to play a key role in implementing
and enforcing pesticide programs and policies. This Foreword
highlights only a few of OPP's positive achievements over the
past year. Others are described more fully in the following
pages. The goal of the Annual Report is to provide a public
accounting of our work for all of our constituencies. I hope that
it will serve an important function in communicating the depth
and breadth of OPP's responsibilities and accomplishments.
/signed/
Daniel M. Barolo, Director
Office of Pesticide Programs
Introduction
Protecting public health and the environment from the risks
posed by pesticides is a challenging and complex undertaking. By
their very nature, pesticides create some risk of harm to humans,
animals or the environment because they are designed to be
biologically active and have a negative effect on living
organisms. At the same time, pesticides are useful to society
because of their ability to kill potential disease-causing
organisms and to control insects, weeds, and other pests.
Over the past twenty years, EPA's Office of Pesticide
Programs (OPP) has developed a number of programs structured to
meet the challenge of evaluating and reducing pesticide risks and
promoting safe pesticide use. These programs govern a wide
variety of pesticide products and uses that are likely to be
found in virtually every home and business in the United States -
- from insect repellents to weed killers to hospital
disinfectants to swimming pool chemicals -- to name a few. The
health and environmental issues raised by pesticides in these
many settings are varied and complex. In carrying out its
responsibilities, OPP must consider both the need to minimize
risks and the benefits that pesticides offer to society. State
and tribal agencies and many other organizations, both public and
private, are vital partners in this effort.
While it would take many more pages to fully depict the
extensive efforts and achievements of this program, this report
attempts to describe many of the accomplishments of the Office of
Pesticide Programs during the 1995 fiscal year (October 1, 1994
to September 30, 1995).
Annual Report Structure
While OPP staff are formally organized into eight divisions
and a policy staff, this report is organized around the six major
activity areas used in the resource planning process. In
addition, the seventh chapter discusses some other special
initiatives.
1 - Registration
Making decisions about the registration (licensing) of
individual pesticide products, and assuring that decisions are
consistent and up-to-date.
2 - Reregistration
Bringing the scientific data base for older pesticide active
ingredients up to current standards, reassessing their regulatory
status, mitigating risks, and documenting new decisions. Assuring
that products containing eligible active ingredients are
supported by valid data, are labeled correctly, and are
reregistered.
3 - Special Review
Conducting in-depth assessments of pesticides suspected of
posing unacceptable risks to public health or the environment.
4 - Field Implementation and Communications
Working with EPA regional offices, states, and tribal
organizations to implement pesticide programs, communicating with
the public about pesticide issues, and supporting compliance
efforts.
5 - Policy, Regulations, and Guidance
Developing pesticide policies and regulations, including
improvement of the quality of scientific information used to make
decisions.
6 - Information and Program Management
Managing pesticide information (including automated
information systems, computers and computer networks, and paper
and microfiche collections) and administering programs (including
human resources, facilities, finances, and budget planning).
7 - Biopesticide, Risk Reduction, and Reinvention
Initiatives
Though integrated into the other six areas for budget
purposes, these initiatives are given special attention in this
report. They involve encouraging the introduction of a new
generation of biological pesticides, reducing pesticide risks
through environmental stewardship, and reinventing OPP
organizations.
Contents
Foreword
Introduction
Chapter 1: Registration
Overview Of Registration
New Registrations In 1995
Other 1995 Registration Achievements
Reinvention/Risk Reduction Activities
Implementing Acetochlor Registration Conditions
Ensuring The Effectiveness Of Antimicrobial Pesticides
Efforts To Improve Pesticide Labels
Pesticide Chemistry Laboratory Support For Registration
Chapter 2: Reregistration
Steps In Reregistering Pesticides
1995 Reregistration Progress
Assessing Exposure To Turf Pesticides
Pesticide Chemistry Laboratory Support For Reregistration
Reducing Pesticide Spray Drift
Chapter 3: Special Review
1995 Formal Special Reviews And Follow-up Activities
Limited Reintroduction Of Aldicarb Use On Potatoes
Chapter 4: Field Implementation and Communications
A. Field Programs
Implementing The Worker Protection Standard
Endangered Species Protection Program
Protecting Ground Water
Certification And Training Of Pesticide Applicators
B. Communications, Public Response, and Coordination
Outreach And Communications Strategies
Responding To The Public
Congressional Relations And Coordination With Other
Federal Agencies
National Agricultural Pesticide Impact
Assessment Program (NAPIAP)
International Coordination And Integration
Regional, State, And Tribal Liaison
Laboratory Tools
Chapter 5: Policy, Regulations, and Guidance
Improving Protection For Infants And Children
Acute Dietary Risk Assessment Activities
Activities Related To Implementation Of The "Delaney Clause"
Revised Food And Livestock Feed Table
"Reinvention" and Regulatory Reform: Ongoing Efforts to
Clarify and Update Regulatory Policies and Requirements
Ecological Risk Assessment and Ground-Water Study Guidance
Community-Based Environmental Protection
Improving Methods, Modeling, And Information Systems
for Environmental Assessments
Legislative Proposals
International Harmonization And Regulatory Coordination
Technical Cooperation With Developing Countries
International Trade And Environment Policy
Chapter 6: Information and Program Management
Operations, Maintenance And Integration Of The Primary
OPP Information Systems
Electronic Dissemination Of Information
Other Information Systems
Pesticide Adverse Effects Information
Reporting/6(a)(2) Activities
Ecological Incident Monitoring And Reporting
Information And Records Management Activities
Human Resources Management
Resource Allocation And Financial Management
Chapter 7: Biopesticide, Risk Reduction, and Reinvention
Initiatives
Creation Of The New Division
Promoting Integrated Pest Management (IPM)
Pesticide Environmental Stewardship Program (PESP)
Biological Pesticide Regulatory Relief
Reinventing And Streamlining OPP's Organization
How To Obtain More Information
Pesticide Program Contacts
Chapter 1: Registration
This chapter describes the pesticide registration program,
which provides the foundation for nearly all OPP activities. In
addition to allowing the use of new pesticides, the registration
program includes many activities related to the ongoing
registration of existing pesticides, such as label changes in
where and how they may be used in order to reduce risks or in
response to requests by registrants. This chapter also describes
several reinvention activities aimed at improving regulatory
decisions, processes, and team structures. Also contained in this
chapter are summaries of special programs ensuring the
effectiveness of antimicrobial pesticides, improving pesticide
labels, and the role of OPP's laboratories in pesticide
registration.
Overview Of Registration
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) requires that before anyone can sell or distribute any
pesticide in the United States, they must obtain a registration,
or license, from EPA. The term pesticide means any substance or
mixture of substances intended for preventing, destroying,
repelling, or mitigating any pest, and any substance or mixture
intended for use as a plant regulator, defoliant, or desiccant.
When making a pesticide registration decision, EPA must ensure
that the pesticide, when used according to label directions, will
not cause unreasonable adverse effects to human health or the
environment.
Registration decisions are based primarily on EPA's
evaluation of the test data provided by applicants. EPA has
established a number of requirements, such as the Good Laboratory
Practice Standards, that apply to both registrants and testing
facilities to ensure the quality and integrity of pesticide data.
Depending on the type of pesticide, OPP can require more
than 100 different tests. Testing is needed to determine whether
a pesticide has the potential to cause adverse effects to humans,
wildlife, fish, and plants, including endangered species.
Potential human risks, which are identified using laboratory
tests in animals, include acute toxic reactions (such as
poisoning and skin and eye irritation) as well as possible long-
term effects (such as cancer, birth defects, and reproductive
disorders). Data on the fate of pesticides in the environment are
also required so that OPP can assess threats to ground and
surface water or other risks.
OPP processes a variety of registration applications,
including: new pesticide active ingredients, new uses
(applications for new uses of an already registered pesticide),
"me-too's" (applications for registrations of pesticide products
that are substantially similar or identical in their uses and
formulation to currently registered products), and experimental
use permits (which set specific terms under which prospective
registrants may test pesticides outside of the laboratory prior
to registration).
Under section 18 of FIFRA, states may apply to EPA for an
exemption or declare a crisis exemption for emergency use of a
pesticide not registered for that use. Four types of emergency
exemptions may be authorized. A specific exemption may be
authorized in an emergency situation to avert significant
economic loss, or significant risks to endangered species,
beneficial organisms, or the environment. A quarantine exemption
may be authorized in an emergency to control the spread of any
pest new to or not known to be widely prevalent within the United
States or its territories. An emergency public health exemption
may be authorized to control a pest that will cause a significant
risk to human health. In an emergency where there is not time to
allow for EPA authorization of the applicable specific,
quarantine, or public health exemption, a state may invoke a
crisis exemption.
Under section 24(c) of FIFRA, states may issue registrations
for additional uses of currently registered pesticides to meet
special local needs.
New Registrations In 1995
1995 was a banner year for OPP with the registration of 40
new pesticide active ingredients, more than half of which are
considered reduced risk pesticides, including biopesticides.
Biopesticides include "microbial pesticides" (bacteria, viruses,
or other microorganisms used to control pests) and "biochemical
pesticides," such as pheromones (insect mating attractants),
insect or plant growth regulators, and hormones used as
pesticides. Biopesticides generally pose less risk to human
health and the environment than conventional chemical pesticides.
Many of these reduced risk pesticides were submitted under the
voluntary Reduced Risk Pesticides Initiative. The following table
describes the pesticide active ingredients registered for the
first time in fiscal year 1995.
New Pesticide Active Ingredients Registered in FY 1995
-----------------------------------------------------------------
Pesticide Registrant Pesticide Use(s) Biopest.
Name Type or Other
Reduced
Risk
Pesticide?
-----------------------------------------------------------------
AO-159 DuPont Insecticide Pets, No
livestock
------------- ------------- ------------- -------- ----------
Bt Corn Ciba Seeds Plant- Field Yes
and Mycogen Pesticide corn (biopest.)
------------- ------------- ------------- -------- ----------
Bt Potatoes Monsanto Plant- Potatoes Yes
Pesticide (biopest.)
------------- ------------- ------------- -------- ----------
Bacillus EcoGen Inc. Microbial Potatoes, Yes
thuringiensis insecticide tomatoes, (biopest.)
subsp. eggplants
kurstaki
------------- ------------- ------------- -------- ----------
Beauveria Mycotech Microbial Various Yes
bassiana Corp. Insecticide crops, (biopest.)
Strain GHA rangeland,
pastures
------------- ------------- ------------- -------- ----------
Beauveria Troy Microbial Ornamental Yes
bassiana Biosciences Insecticide plants, (biopest.)
ATCC 74040 turf
------------- ------------- ------------- -------- ----------
Candida EcoGen Inc. Microbial Citrus Yes
oleophila fungicide and pome (biopest.)
fruits
------------- ------------- ------------- -------- ----------
Celery BIOSYS Microbial Vegets. Yes
Looper insecticide (biopest.)
Virus
------------- ------------- ------------- -------- ----------
Chloreth- DuPont Insecticide Corn No
oxyfos
------------- ------------- ------------- -------- ----------
Cydia Louis Falcon Microbial Fruits Yes
pomonella Insecticide (biopest.)
------------- ------------- ------------- -------- ----------
(E)-5-Decenol Consep Inc. Insect Fruits, Yes
pheromone nuts (biopest.)
------------- ------------- ------------- -------- ----------
(E)-5-Decenyl Consep Inc. Insect Fruits, Yes
Acetate pheromone nuts (biopest.)
------------- ------------- ------------- -------- ----------
Diethyl Bear Country Deterrent Bears No
Sulfide Products
------------- ------------- ------------- -------- ----------
Difethialone LiphaTech, Rodenticide Resid- No
Inc. ential use
------------- ------------- ------------- -------- ----------
1,4 Dimethyl- D-I-1-4 Inc. Plant Growth Potatoes Yes
napthalene Regulator
------------- ------------- ------------- -------- ----------
Dioctyl Safe and Sure Insecticide Pets No
Sodium Products
Sulfosuccinate
------------- ------------- ------------- -------- ----------
Fenbuconazole Rohm and Fungicide Pecans No
Haas Co.
------------- ------------- ------------- -------- ----------
Flumiclorac Valent Herbicide Corn Yes
Pentyl Ester
(Resource)
------------- ------------- ------------- -------- ----------
Halosulfuron Monsanto Herbicide Corn, No
ornamental
plants
------------- ------------- ------------- -------- ----------
Hymexazol Sumitomo Fungicide Seed Yes
Chemical treatment
------------- ------------- ------------- -------- ----------
Isobardac Lonza, Inc. Antimicrobial Water No
treatment
------------- ------------- ------------- -------- ----------
Mattch Bt K Mycogen Microbial Fruits Yes
insecticide (biopest.)
------------- ------------- ------------- -------- ----------
Maxim Ciba-Geigy Fungicide Seed Yes
treatment
------------- ------------- ------------- -------- ----------
Methyl Dolphin Trust Bird Small fruits, Yes
Anthranilate Repellent ornamental
plants
------------- ------------- ------------- -------- ----------
Neem Oil W.R. Grace Fungicide Ornamental Yes
and Co. plants (biopest.)
------------- ------------- ------------- -------- ----------
Poly (N,N- Calgon Antimicrobial Water No
dimethyl systems
diallyl
ammonium
chloride)
------------- ------------- ------------- -------- ----------
Potassium Church & Fungicide (Retail Yes
Bicarbonate Dwight Co. pesticide
(baking soda) products not
yet approved)
------------- ------------- ------------- -------- ----------
Prallethrin Sumitomo Insecticide Pets, No
resid. uses
------------- ------------- ------------- -------- ----------
Primisulfuron Ciba-Geigy Herbicide Corn No
Methyl
------------- ------------- ------------- -------- ----------
P. syringae EcoScience Microbial Fruits Yes
ESC 10 Corp. fungicide (post- (biopest.)
harvest)
------------- ------------- ------------- -------- ----------
P. syringae EcoScience Microbial Fruits Yes
ESC 11 Corp. fungicide (post- (biopest.)
harvest)
------------- ------------- ------------- -------- ----------
Pyridaben Nissan Insecticide Ornamental No
Chemical plants
------------- ------------- ------------- -------- ----------
Pyriproxyfen Mclaughlin Insecticide Pets No
Gormley King
Company
------------- ------------- ------------- -------- ----------
Pyrithiobac- DuPont Herbicide Ornamental No
sodium plants
------------- ------------- ------------- -------- ----------
Rimsulfuron DuPont Herbicide Corn No
------------- ------------- ------------- -------- ----------
Sodium Church & Fungicide (Retail Yes
Bicarbonate Dwight Co. pesticide
(baking soda) products not
yet approved)
------------- ------------- ------------- -------- ----------
Sodium Creative Insecticide Ornamental Yes
Carboxy- Services Inc. plants
methyl-
cellulose
------------- ------------- ------------- -------- ----------
Sodium Asahi Plant Growth Cotton, Yes
5-Nitro- Chemical Regulator rice,
guaiacolate Manufacturing soybeans
------------- ------------- ------------- -------- ----------
Tebufenozide Rohm and Insecticide Walnuts Yes
Haas Co.
------------- ------------- ------------- -------- ----------
Undecylenic Safe and Sure Insecticide Pets No
Acid Products
----------------------------------------------------------------
Other 1995 Registration Achievements
Registering new pesticides for the first time is only one of
an enormous number of pesticide registration actions that OPP
carries out each year. Decisions made in 1995 are summarized in
the following table. Both approvals and denials of the requests
received by OPP are included in the number of decisions.
1995 Registration Activities
---------------------------------------------------------------
Registration Description of Activity Number of
Activity Decisions
------------------ -------------------------------- ---------
Registrations of First approval for use of 40
new pesticides pesticides not currently
registered in the United States.
Additional Registrations for new products 832
registrations containing pesticide ingredients
for previously already approved for proposed
registered uses.
pesticides
Amendments to Amendments, for example, to 3,614
existing reflect revised labels and
registrations changed formulations for
products already registered.
New uses for Approvals for uses of a 124
previously pesticide (such as on particular
registered food crops) for which it has
pesticides never been registered.
Emergency Decisions on granting emergency 400
exemptions exemptions to states or other
("Section 18s") federal agencies to allow use
for a limited period of
pesticides not registered for
those particular uses.
Experimental Use Decisions on permits that allow 100
Permits (EUPs) pesticide producers to test new
pesticide uses outside of the
laboratory; generally required
if more than 10 acres are to be
tested.
Tolerances Decisions on approving 122
tolerances, or maximum allowable
levels of a pesticide residues
in food or animal feed. Tolerances
(or exemptions from tolerances) are
required whenever a pesticide is
registered for use on a food or
feed crop.
Temporary Decision on tolerances 34
tolerances for experimental purposes
for an unregistered pesticide.
Special Local Registrations of pesticide 475
Need products by state agencies for
Registrations specific uses not federally
("Section registered. (The pesticides must
24(c)s") be federally registered for
other uses.)
---------------------------------------------------------------
Reinvention/Risk Reduction Activities
Over the past several years, OPP has undertaken a major
effort to overhaul its registration program, which in 1995 began
to pay substantial dividends. The reinvention effort aims to
accelerate the pace of decision-making and redirect staff
activities to those most important in protecting health and the
environment. This section describes the highlights of these
initiatives.
Agreement with California to Harmonize Pesticide Regulation
OPP and the Department of Pesticide Regulation (DPR) of the
California Environmental Protection Agency began an initiative in
1994 to harmonize and simplify pesticide registration, and to
exchange work products to reduce duplication of effort and
expense. The first major milestone of this initiative was the
signing of a Memorandum of Understanding (MOU) in May 1994.
During 1995, significant progress was made in achieving the
objectives of the MOU. For example, OPP and DPR began sharing the
workload of reviewing acute toxicology studies, thereby reducing
review cost and time. This should help OPP continue to reduce its
current backlog of pending acute toxicity submissions. OPP also
identified products intended for registration under FIFRA as well
as in California. Other ongoing cooperative activities include
harmonization of risk assessment methods, international
standards, and registration of new active ingredients.
Voluntary Reduced Risk Pesticide Initiative
Since the inception of this initiative in 1993, OPP has
received 20 reduced risk pesticide applications. OPP has accepted
nine candidates (registering six so far), denied seven
candidates, and is considering four. OPP is committed to
expedited review of reduced risk applications and to making a
registration decision within one year after a candidate has been
granted reduced risk status. OPP issued a draft Pesticide
Regulation (PR) Notice expanding the initiative to include new
uses of pesticides that have been granted reduced risk status,
and expects to finalize the notice by December 1995.
Faster Approval of Minor Registration Changes
In May 1995, OPP took a major step in reducing its workload
in reviewing minor registration changes by issuing PR Notice
95-2. The notice significantly expands the categories of minor
changes, such as changes to labeling and packaging, that
registrants can make without waiting for OPP approval. Under this
program, OPP expects that as many as 500 amendments each year, or
10% of the total, will be made by notifying OPP rather than
requesting approval. For certain cases of minor changes not
expected to change the potential risks of the products,
registrants are not even required to notify OPP of the changes.
In addition, the notice creates an accelerated process for
reviewing minor formulation changes in 45 days instead of 90
days. Besides reducing OPP's workload, this action will allow
registrants to make changes much more quickly.
Exemption of Effluent Discharge Statements for Small
Container Products
On May 1, 1995, OPP issued PR Notice 95-1 exempting small
containers (less than five gallons liquid or 50 pounds dry
weight) from previously-required effluent discharge labeling.
This reduces the burden on small container products with labels
that lack space for these statements. Effluent discharge
statements continue to be required for larger containers used in
the industrial/commercial sector.
Encouraging Water Soluble Packaging (WSP)
Water soluble packaging allows a pesticide product to be
transferred from its original container to the tank from which it
will be applied with a minimal risk of spills or splashes. It
also eliminates the need for rinsing the original container.
Because of these benefits to pesticide handlers and the
environment, OPP began to implement a streamlined process for
registering WSP products in 1995. Registrants who wish to market
a registered product in water soluble packaging can do so using
the same registration number and by notifying OPP rather than
waiting for OPP approval.
Other Reinvention Initiatives in Progress
Other efforts to improve the registration process in 1995
included:
o Exploring the possibility of allowing registrants to self-
certify the results of product-specific acute toxicity tests
rather than requiring OPP review.
o Working to finalize a rule proposed in 1994 under section
25(b) of FIFRA that would exempt a number of pesticides from
regulation because they do not pose risks warranting
regulation.
o Developing guidance to standardize and simplify procedures
for certain registration applications.
o Preparing a proposal to streamline the registration of
different sizes of rodent control pesticide products.
o Developing a proposal to allow self-certification by
registrants of certain "me-too" products.
Implementing Acetochlor Registration Conditions
In registering the pesticide acetochlor in 1994, OPP
embarked on a new approach by setting strong standards to protect
ground and surface water. The approach establishes clear criteria
that trigger voluntary suspension or cancellation of the
registration if water quality is adversely affected. In
particular, the Acetochlor Registration Partnership (ARP) is
required to conduct extensive monitoring programs to ensure that
use of this herbicide will not adversely affect ground or surface
water.
During the past year, OPP worked with the partnership and
State Lead Pesticide Agencies to implement the registration
agreement. The ARP established 175 monitoring wells, 25 in each
of the seven major use states (Illinois, Indiana, Iowa, Kansas,
Minnesota, Nebraska, and Wisconsin). The ARP also established 175
surface water monitoring sites at drinking water supply
facilities in 12 states, and began biweekly monitoring in March.
Detections of acetochlor in ground water were reported in eight
wells, which the ARP is investigating. Acetochlor was found in
approximately 20% of the surface-water samples collected,
generally well below the 2 ppb annual trigger. Also, the ARP
began work on a second monitoring program, initiating two of
eight prospective ground-water studies in Wisconsin and in Ohio.
Four additional studies will begin in 1996, and the last two in
1997.
The Agreement between the ARP and OPP has already produced
results. In the first year of use, the ARP has restricted the use
of acetochlor on sandy soils to reduce the risk of ground-water
contamination. OPP has validated the ARP's multi-residue method
for detecting acetochlor and is reviewing the ARP's acetochlor-
specific detection method. Finally, an ARP evaluation found that
commercially available, low-cost methods may be useful in
screening for the presence of acetochlor and similar compounds in
water.
Recently, OPP made available to the public a map indicating
areas throughout the country where acetochlor has been sold
between March 1994 and January 1995. This county level usage
information will be made available to the public annually by OPP
and can be used to target monitoring by states and others.
Ensuring The Effectiveness Of Antimicrobial Pesticides
Antimicrobial products are used to control "germs" such as
bacteria and fungi (molds and mildews) that can cause odors, food
spoilage, or infections. They are used in homes, hospitals,
cafeterias, restaurants, and many other institutions. Over the
past several years, OPP has implemented a comprehensive strategy
to ensure the efficacy of antimicrobial pesticides, placing
highest priority on those that have significant public health
uses. During 1995, OPP accomplished many of its research goals
under a comprehensive Antimicrobial Program Strategy. Highlights
include:
Test Methodology Research Cooperative Agreements
Substantial progress was made in each of the five research
cooperatives. Three cooperatives finalized most of the research
to improve the existing test methods used to determine
antimicrobial product efficacy. New sporicidal, virucidal and
tuberculocidal test methods have been developed and are in the
process of being validated through collaborative studies. Another
agreement focused on bacterial cell injury and proposed a
protocol for determining the level of injury sustained during
typical efficacy test conditions.
Antimicrobial Complaint System Cooperative Agreement
Through the National Pesticide Telecommunications Network
(NPTN), the Antimicrobial Complaint System (ACS) handles phone
inquiries and complaints regarding EPA-registered antimicrobials.
The ACS responded to over a thousand calls in 1995.
Antimicrobial Product Testing Program
In 1995, the Antimicrobial Product Testing Program was
converted from a contract to an OPP-managed program. Product
efficacy testing of tuberculocides and hospital disinfectants is
now being conducted at OPP's new Microbiology Laboratory in
Cincinnati. The laboratory will continue to evaluate selected
hospital disinfectant and tuberculocidal product claims in
support of OPP's Testing Program to ensure the efficacy of
antimicrobial pesticides. The laboratory will also assist in
enforcement actions where efficacy claims cannot be confirmed.
Efforts To Improve Pesticide Labels
Labeling is one of OPP's most important tools for achieving
its mission of protecting human health and the environment. No
other pesticide document or publication has a more direct impact
on risk reduction or the potential to prevent pollution. Over
time, however, some labels have become cluttered and confusing.
OPP has taken several steps to address labeling concerns and has
accomplished the following:
Computer Software to Standardize Precautionary Labeling.
Precautionary statements are those portions of a pesticide label
that summarize a product's hazards, provide first aid
instructions, and list storage and disposal instructions. In
1995, OPP began developing a computer program which displays the
correct precautionary labeling statements for a product based on
acute toxicity studies. This system could be used by both OPP and
registrants to assure accurate and appropriate precautionary
labeling. This could help reduce review time and rejection of
applications with incorrect labeling. OPP expects to distribute
the software in early 1996.
Label Review Manual. In December 1994, OPP completed and
made available its first comprehensive Label Review Manual, a
document to be used by OPP staff in reviewing and determining the
acceptability of pesticide labeling. The manual is available to
the public.
Label Policy Directory. In October 1994, OPP launched an
electronic "on-line" Labeling Policy Directory that allows OPP
staff to quickly search and access labeling policy information
via computer. Portions of the directory will soon be made
available to the public.
Labeling Coordination. OPP issued a draft PR Notice
establishing an annual compliance date for implementing most EPA-
mandated labeling changes, and describing current approaches to
coordinating labeling issues and related streamlining efforts.
After review of public comments, OPP plans to issue a final
notice in 1996.
Total Release Fogger Labels. OPP continued to work to
improve the labels of total release foggers, sometimes called
"bug bombs." The aerosol propellants found in these indoor
fumigants can cause fires or explosions if the products are not
used properly. OPP expects to issue final labeling requirements
in 1996.
Pesticide Chemistry Laboratory Support For Registration
OPP's pesticide registration program is supported by two
pesticide chemistry labs: the Analytical Chemistry Laboratory
(ACL) in Beltsville, Maryland, and the Environmental Chemistry
Laboratory (ECL) in Bay St. Louis, Mississippi. The labs support
registration through the food tolerance and environmental
chemistry methods validation programs, which ensure that
pesticide residues can be accurately measured in food and the
environment.
The ACL has the lead responsibility for the food tolerance
methods validation program. In fiscal year 95, ACL validated a
record 65 food tolerance methods out of a total of 102 submitted
or carried-over from 1994 (see table below). In addition, the ACL
developed a new method for detecting residues of multiple
sulfonylurea pesticides in water using capillary zone
electrophoresis. Scientists are enthusiastic about the method and
additional work is underway at both EPA and industry labs to
determine the suitability of the method for monitoring pesticide
residues.
The ECL has lead responsibility for the environmental
chemistry methods validation program. The demand for
environmental chemistry methods testing increased dramatically in
1995 (see second table below). The primary emphasis of this
program is to evaluate those methods associated with studies for
environmental fate, exposure, and ecological effects. The ECL
completed 35 validations in 1995, including three expedited
methods for acetochlor. ECL continued to evaluate new, low-cost
technology for detecting pesticide residues using immunoassay
tests, completing review of eight tests in 1995.
--------------------------------------------------------------
Tolerance Method Validations
--------------------------------------------------------------
FY 91 FY 92 FY 93 FY 94 FY 95
----- ----- ----- ----- -----
Carried- 7 6 7 9 23
over
Requests
New 26 18 31 63 79
Requests
Completed 27 17 29 49 65
--------------------------------------------------------------
--------------------------------------------------------------
Environmental Chemistry Method Validations
--------------------------------------------------------------
FY 91 FY 92 FY 93 FY 94 FY 95
----- ----- ----- ----- -----
Carried- 0 3 9 17 23
over
Requests
New 6 10 16 17 54
Requests
Completed 3 4 8 11 35
--------------------------------------------------------------
Chapter 2: Reregistration
Pesticide reregistration is one of OPP's most vital
programs. OPP is required by 1988 amendments to federal pesticide
law to review and, as warranted, reregister all existing
pesticide products that contain active ingredients initially
registered before November 1, 1984. The goal is to update
labeling and use requirements and reduce potential risks
associated with older pesticide active ingredients -- those first
registered when the standards for government approval were less
stringent than they are today. This comprehensive reevaluation of
pesticide safety in light of current standards is critical to
protecting human health and the environment.
This chapter discusses OPP's progress in reregistering
pesticides, as well as some related initiatives. These include
efforts to develop additional information on pesticide exposure
to people who enter treated lawn and turf areas and to reduce the
risks posed by pesticide spray drift.
Steps In Reregistering Pesticides
Through the pesticide reregistration program, now in its
final phase, OPP is reviewing studies submitted to support each
reregistration case (or group of related pesticide active
ingredients). After examining the health and environmental
effects, OPP employs measures to mitigate risks most effectively.
This evaluation and risk mitigation process is complete when OPP
is satisfied that the pesticide, used in accordance with approved
labeling, will not pose unreasonable risks to human health or the
environment.
OPP's regulatory conclusions about each case are presented
in a Reregistration Eligibility Decision document, or RED. Later,
once product-specific data and revised labeling are submitted and
approved, OPP reregisters products containing the eligible
pesticide(s). A product is not reregistered, however, until all
of its active ingredients are eligible for reregistration.
1995 Reregistration Progress
OPP is making significant progress in reregistering
pesticides. During fiscal year 1995, OPP completed 40
Reregistration Eligibility Decisions, or REDs, a record in terms
of both the number and magnitude of the decisions. Working with
the Special Review program (described in chapter 3), the
reregistration program is employing a variety of measures to
reduce the most serious pesticide risks. These include use
phaseouts, voluntary cancellations, restricted use
classifications, ground-water label advisories, and strengthened
requirements to better protect pesticide handlers and other
workers. New label guidance for aerial applications, requirements
for vegetative buffer strips bordering areas treated with
pesticides, and reduced application rates are reducing risks to
wildlife.
For example, the Picloram RED Team worked with state
representatives and the registrant to reduce use rates in order
to decrease risks to nontarget plants. The Ethalfluralin RED Team
strengthened personal protective equipment and restricted entry
intervals to reduce risks of cancer and developmental effects to
workers, and required buffer strips to mitigate threats to
aquatic wildlife.
With this year's accomplishments, OPP has completed a total
of 121 REDs covering 30 percent of the cases to be reregistered,
including glyphosate, metolachlor, picloram, and other major
pesticides. About 1,000 tolerances (maximum legally permissible
levels of pesticide residues in foods) have been reassessed, and
many are being revised to better ensure food safety. About 750
products have completed the process and have been reregistered.
Looking to the future, more pesticides with food uses and
other significant human exposures are scheduled for
reregistration eligibility decisions during fiscal year 1996. For
the first time, OPP expects that the number of candidates ready
for decisions in FY 1996 will exceed the resources available to
complete those decisions.
Some of the principal accomplishments of the reregistration
program during fiscal year 1995 and cumulatively are summarized
below.
Annual and Cumulative Completion of REDs
The number of REDs completed per fiscal year has been
increasing steadily since the accelerated reregistration program
began. This number reached 40 in fiscal year 1995 for a
cumulative total of 121 completed REDs. A target of 40 more REDs
has been set for 1996.
Number of REDs Completed:
FY91: 13
FY92: 15
FY93: 19
FY94: 34
FY95: 40
--
Cumulative through FY95: 121
FY96 Goal: 40
FY96 Cumulative Goal: 161
Status of Reregistration Cases
OPP has completed a total of 121 REDs, representing nearly
one third of the 382 chemical cases currently supported for
reregistration. Meanwhile, 230 of the original 612 cases are
unsupported (meaning that the registrants have decided not to
complete and submit the studies required for reregistration).
Cases that remain unsupported have been or will be cancelled. OPP
therefore has 261 more REDs to complete, less than half of the
original cases from 1988.
Anatomy of the 121 REDs Completed
...Or, What "121 REDs Completed" Means...
The 121 REDs completed cover 170 pesticide active
ingredients, 4,633 products, and 957 tolerances. They represent
about 30% of all supported reregistration cases (a case consists
of one or more related pesticide active ingredients); 30% of all
food use pesticides (supported List A cases); and 17% of original
List A tolerances reassessed.
As described in the table below, the completed REDs
represent about two-thirds of the total quantity of pesticides
used (by volume) in the United States. They include over two-
thirds of all homeowner-applied pesticides, about one third of
all pesticides used in agriculture, and two-thirds of all
pesticides used commercially, by industry and government.
Amount of Pesticide Usage (by Volume)
Covered By REDs Completed*
---------------------------------------------------------------
Homeowner Agriculture Commercial/ TOTAL
Applied Industrial
and
Government
------------- ----------- ----------- ----------- ---------
Fungicides 50% to 55% 60% to 65% 4% to 7% 40 to 48%
Herbicides 20% to 25% 30% to 35% 16% to 30% 28 to 32%
Insecticides 10% to 15% 1% to 2% 3% to 5% 8 to 10%
Anti- 99% + 99% + 99% + 99%
microbials
TOTAL 68% 32% 65% 65%
---------------------------------------------------------------
* Please note that the REDs completed for two antimicrobial
cases -- bleach (sodium and calcium hypochlorite) and
chlorine -- account for a large proportion of the usage of
antimicrobials and the overall usage of pesticides covered
by the REDs completed so far. Note, too, that the pounds
used may not indicate the relative percent of market share
or number of applications.
REDs Completed in 1995
The following table summarizes the 40 REDs completed in FY
1995:
----------------------------------------------------------------
Pesticide Case Pesticide Use(s) Eligible
Type for Rereg-
istration?
----------------------------------------------------------------
Agrobacterium Fungicide Fruit, nut, and All uses
radiobacter Insecticide ornamental trees
(nursery stock)
------------------ ------------- ------------------ ---------
Aliphatic Antimicrobial Indoors All uses
Alcohols Fungicide (including
(ethanol and Insecticide homes),
isopropanol) Plant Growth agriculture
Regulator
------------------ ------------- ------------------ ---------
Alkyl Antimicrobial Fuel oil All uses
Imidazolines
------------------ ------------- ------------------ ---------
Amitraz Insecticide Cotton, pears All uses
livestock, dogs
------------------ ------------- ------------------ ---------
Ancymidol Plant Growth Ornamental plants All uses
Regulator
------------------ ------------- ------------------ ---------
Asulam Herbicide Sugarcane, turf, Some uses
ornamental plants,
and other non-
cropland uses
------------------ ------------- ------------------ ---------
Benzocaine No longer Medicine (regu- (Not
considered lated by Food appli-
a pesticide and Drug Admini- cable)
stration, not EPA)
------------------ ------------- ------------------ ---------
O-Benzyl- Antimicrobial Various indoor All uses
Chlorophenol uses, including
agricultural,
food, and medical
facilities
------------------ ------------- ------------------ ---------
Bis(trichloro- Antimicrobial Water systems, Some uses;
methyl)sulfone industrial uses, one use
chemical products awaiting
additional
info.
------------------ ------------- ------------------ ---------
Bromohydroxy- Antimicrobial Paints, adhesives, All uses
acetophenone and other
(BHAP) chemicals
------------------ ------------- ------------------ ---------
Bronopol Antimicrobial Water systems, All uses
industrial uses,
chemical products
------------------ ------------- ------------------ ---------
Chlorhexidine Antimicrobial Livestock All uses
Diacetate facilities
------------------ ------------- ------------------ ---------
Chlorpropham Herbicide Potatoes, spinach, Some uses;
Plant Growth ornamental plants others
Regulator awaiting
additional
info.
------------------ ------------- ------------------ ---------
4-Chlorophenoxy- Plant Growth Food industry All uses
acetic Acid Regulator (bean sprouts)
(4-CPA)
------------------ ------------- ------------------ ---------
Cyanazine Herbicide Corn, cotton, No: use
sorghum are being
phased out
------------------ ------------- ------------------ ---------
Cytokinin Plant Growth Various crops, Some uses;
Regulator ornamental plants, others
forestry awaiting
additional
info.
------------------ ------------- ------------------ ---------
DCPA Herbicide Various crops, All uses
ornamental plants,
lawns
------------------ ------------- ------------------ ---------
Dimethoxane Antimicrobial Industrial uses, All uses
chemical products
------------------ ------------- ------------------ ---------
Diquat Dibromide Herbicide Potatoes, seed All uses
crops, non-crop
areas
------------------ ------------- ------------------ ---------
Dowicil 100 Antimicrobial Industrial uses, All uses
paints, textiles
------------------ ------------- ------------------ ---------
Ethalfluralin Herbicide Various vegetable Some uses;
and grain crops others
awaiting
additional
info.
------------------ ------------- ------------------ ---------
Ethephon Plant Growth Cotton, various All uses
other crops,
ornamental plants
------------------ ------------- ------------------ ---------
Fenitrothion Insecticide Ornamental plants, Some uses
greenhouses,
indoors (including
homes)
------------------ ------------- ------------------ ---------
Fosamine Ammonium Herbicide Rights-of-way, Some uses
industrial sites,
fencerows
------------------ ------------- ------------------ ---------
Linuron Herbicide Soybeans, other Some uses
crops, ornamental
plants
------------------ ------------- ------------------ ---------
Methyl Nonyl Animal and Residences, All uses
Ketone Insect ornamental plants
Repellent
------------------ ------------- ------------------ ---------
Metolachlor Herbicide Various crops, Some uses
lawns, ornamental
plants, rights-of-
way, forestry
------------------ ------------- ------------------ ---------
Nabam Antimicrobial Water systems, All uses
other industrial
uses
------------------ ------------- ------------------ ---------
Nuranone Insect Agricultural and All uses
(Japanese ornamental plants
beetle)
Pheromone
------------------ ------------- ------------------ ---------
Picloram Herbicide Rights-of-way, All uses
forestry,
rangelands,
pastures, small
grain crops
------------------ ------------- ------------------ ---------
Polybutene Bird and Roosting sites, All uses
Squirrel other indoor and
Repellent outdoor locations
------------------ ------------- ------------------ ---------
Prometryn Herbicide Celery, cotton, All uses
dill
------------------ ------------- ------------------ ---------
Propamocarb Fungicide Ornamental plants, Some uses
lawns, turf, golf
courses
------------------ ------------- ------------------ ---------
Sodium Predator Sheep, goats All uses
Fluoroacetate (coyote)
(1080) Poison
------------------ ------------- ------------------ ---------
Sodium Omadine Antimicrobial Industrial uses, All uses
chemical products
------------------ ------------- ------------------ ---------
Starlicide Bird Poison Bird feeding and All uses
roosting areas
------------------ ------------- ------------------ ---------
Terbuthylazine Algicide Water systems, All uses
Antimicrobial fountains,
aquaria
------------------ ------------- ------------------ ---------
Tetrachlorvinphos Insecticide Livestock, pets, Some uses
various other sites
------------------ ------------- ------------------ ---------
Trichlorfon Insecticide Various crops, Some uses
other indoor and
outdoor sites
------------------ ------------- ------------------ ---------
Trifluralin Herbicide Various crops, Some uses
ornamental plants
----------------------------------------------------------------
Risk Reductions Achieved Through FY 1995 REDs
The 1995 REDs include many changes intended to reduce risks
to people and the environment. Some of the risk reduction
measures achieved in the 40 REDs completed this fiscal year are
summarized in the following table:
----------------------------------------------------------------
Number of REDs Risk Reduction Measures Required By RED
---------------- ----------------------------------------------
2 Voluntary cancellation of all or many uses.
(Cyanazine voluntary cancellation of all
production for domestic use effective 12/31/99;
use of existing stocks will be phased out in
stages, and entirely by 1/1/03. Fenitrothion
voluntary cancellation of all uses except ant &
roach bait treatments.)
14 Some uses deleted or not currently eligible
for registration.
5 Restricted Use Pesticide classification added
or maintained, so that the pesticide may be
used only by or under the direct supervision
of a certified applicator.
27 Personal Protective Equipment (PPE)
requirements for pesticide applicators
strengthened or confirmed.
21 Restrictions that limit entry of workers into
treated areas (including Restricted Entry
Intervals/REIs) strengthened or confirmed.
19 Amount, frequency, or rate of application is
reduced, limited, or specified.
40 Use Directions on labeling strengthened or
made more specific, or Additional Restrictions
imposed.
25 User safety measures required.
10 Label Advisory or other measures to protect
ground or surface water required.
18 Environmental Hazard statements to reduce
ecological risks strengthened.
12 Tolerances revised (reduced, revoked, or newly
approved).
----------------------------------------------------------------
Tolerances Reassessed
As part of reregistration, OPP is reassessing pesticide
tolerances, or maximum residue limits in food and feed. A
pesticide must have a tolerance (or be granted an exemption from
the tolerance requirement) for each different type of food or
animal feed on which it may be used. The number of tolerances for
the List A pesticides (which represent the most significant food
use pesticides) was about 5,600 in November 1988, when the
accelerated reregistration program began. Since then, almost
1,000 (or 18%) of the List A pesticide tolerances have been
reassessed as part of the reregistration process.
Several hundred more tolerances are associated with List A
active ingredients no longer supported for reregistration. These
active ingredients ultimately will be cancelled and their
tolerances revoked. Meanwhile, OPP is actively revoking
tolerances as warranted by the tolerance reassessment decisions
reflected in the REDs.
Status Of Studies Received
Registrants have responded to Data Call-Ins and other
requirements by submitting over 20,000 studies in support of
reregistration. Reviews of these studies provide the basis for
OPP's reregistration decisions. By end of fiscal year 1995, OPP
had reviewed almost 13,000 of these studies, including over 7,000
of the 9,500 studies received for List A pesticides. The
cumulative numbers of studies received, reviewed, and awaiting
review by scientific discipline are shown in the following tables
for the List A pesticides and for all pesticides undergoing
reregistration.
Status Review Status For List A Pesticides
--------------------------------------------------------------
Study Type Received Reviewed Awaiting
Review
----------------------------- ---------- --------- --------
Residue Chemistry 2,962 2,309 653
Environmental Fate 2,242 1,440 802
Reentry Non-Dietary 214 59 155
Toxicology, Non-CORT** 1,580 1,278 302
Toxicology, CORT* 766 684 82
Ecological Effects 1,822 1,483 339
ALL DISCIPLINES 9,586 7,253 2,333
--------------------------------------------------------------
Status Review Status For All Pesticides
Undergoing Reregistration (Lists A, B, C, and D)
--------------------------------------------------------------
Study Type Received Reviewed Awaiting
Review
----------------------------- ---------- --------- --------
Residue Chemistry 4,760 3,102 1,658
Environmental Fate 3,916 2,194 1,722
Reentry Non-Dietary 283 67 216
Toxicology, Non-CORT** 5,292 3,061 2,231
Toxicology, CORT* 1,913 1,238 675
Ecological Effects 4,529 3,249 1,280
ALL DISCIPLINES 20,693 12,911 7,782
--------------------------------------------------------------
* Tox., CORT - Chronic feeding, carcinogenicity
(oncogenicity), reproduction, and
developmental toxicity (teratology) studies.
** Tox., Non-CORT - Studies other than CORT studies that measure
the toxicity of pesticides.
Product Reregistration
While REDs are OPP's major reregistration output, much of
the real world impact of eligibility decisions and risk reduction
measures occurs after the RED is issued, once products are
reregistered. As of October 1995, about 2,200 products have
completed this concluding phase. OPP has reregistered about 750
of these products, granted 1,175 voluntary cancellations, amended
20 existing registrations, and suspended 300. An additional 600
products have just entered this phase, and decisions are pending
on another 1,750. Activity in this important area is increasing
rapidly and will accelerate during the next several years.
Process Improvements
Some innovations that have helped improve OPP's
reregistration and Special Review processes and products during
FY 1995 include the following:
SRRD Peer Review Committee -- The Special Review and
Reregistration Division (SRRD) Peer Review Committee, comprised
of both staff and managers, is reviewing draft RED documents and
Special Review Position Documents (PDs) to ensure clarity and
consistency in addressing risk and regulatory issues.
Policy Capture Workgroup -- This workgroup is developing a
means of capturing electronically the issues addressed, policies
established, and risk mitigation measures required by key
regulatory decisions, primarily REDs and Special Review Position
Documents.
RED Process Improvement Committee -- This committee
developed "A þHow toþ Guide for REDs" providing guidance on RED
schedules, team responsibilities, and meetings.
RED Document Improvement Workgroup -- This workgroup is
considering new, more comprehensible ways to present and
disseminate the large body of information currently contained in
a complete RED document package.
Pesticide Use and Usage Data Outputs -- OPP is improving the
compilation of pesticide use and usage information by
consolidating information into a single database. While still in
the developmental stage, it has already provided efficiencies by
allowing quick access to a preliminary overview of pesticide use
parameters. In a related effort, OPP is piloting a new matrix
format to provide key pesticide usage parameters to be used in
the development of REDs. These efforts will continue to be
refined.
Assessing Exposure to Turf Pesticides
OPP began a cooperative effort in 1995 with 35 pesticide
manufacturers (the Outdoor Residential Exposure Task Force),
California EPA, and Health Canada to obtain information on
exposure to applicators and residents from pesticides used on
home lawns. In March, OPP issued a Data Call-In for data which
will be used to evaluate exposure to pesticides undergoing
reregistration, as well as new pesticides being registered for
the first time. The goal of the effort is to develop generic
exposure data for different types of pesticide formulations so
that exposure to lawn-care pesticides can be predicted without
requiring data on specific compounds. This effort will save
industry and OPP time and resources. Since the project is a joint
effort with California and Canada, the findings from the required
studies will be used to support pesticide registrations by their
respective regulatory agencies as well. OPP expects the task
force to begin submitting its initial findings in 1997 and to
complete the effort in 1999.
Pesticide Chemistry Laboratory Support For Reregistration
In addition to supporting the pesticide registration
program, as described in chapter 1, OPP's pesticide chemistry
labs provide reregistration support. The labs work to confirm
that the methods described by registrants for detecting pesticide
residues in food and in the environment are effective. The
Analytical Chemistry Laboratory (ACL) received 23 requests to
validate food tolerance methods for reregistration in 1995, a
marked increase from the seven requested in 1994, and validated
nine methods. The Environmental Chemistry Laboratory (ECL)
completed 20 analytical method validations for pesticides in soil
and water under the reregistration program in 1995.
Reducing Pesticide Spray Drift
Aerial or ground application of pesticides may lead to off-
target drift and result in exposure to workers, nearby residents,
nontarget plants, and other ecological resources. During 1995 OPP
continued its work with the Spray Drift Task Force (SDTF), an
industry consortium conducting research into the factors which
contribute to and can control spray drift. During 1995, the task
force submitted its research results to OPP. OPP began a
comprehensive scientific review of the data in 1995 and the
review will continue during 1996.
In 1995, OPP continued its work with EPA's Office of Re-
search and Development to develop computer models which will
estimate the potential for off-target pesticide drift and suggest
methods for reducing drift. Also, in conjunction with the SDTF
and following input from some state and pesticide applicator
groups, OPP developed a set of Best Management Practices (BMPs)
for aerial pesticide application. During 1995, the BMPs were
added to REDs, new chemical registrations, and other OPP actions
involving aerial pesticide applications.
Chapter 3: Special Review
Special Review is EPA's formal process for determining
whether the use of a pesticide poses unreasonable risks to people
or the environment. In making this determination, EPA must
consider the pesticide's risks and benefits. Special Review is
designed to allow formal public input to the decision-making
process. A Special Review can result in a decision to cancel,
restrict, or continue the pesticide uses in question.
The Special Review process is set in motion when EPA has
reason to believe that the use of a registered pesticide poses
significant risks to people or the environment. Over 100
pesticides or groups of closely related pesticides have been
evaluated through Special Review. While reregistration applies to
all older pesticides, Special Reviews apply to those pesticides
of particularly serious concern.
1995 Formal Special Reviews And Follow-up Activities
Triazines and the Cyanazine Phaseout
OPP initiated a Special Review for these related herbicides
in November 1994. Up to 121 million pounds of atrazine,
cyanazine, and simazine are used yearly on food crops including
corn, and on cotton and turf. Atrazine currently is one of the
two most widely used agricultural pesticides in the U.S. (based
on pounds of active ingredient applied per year) and cyanazine
ranks among the top five agricultural pesticides. In initiating
the Special Review, the Agency determined that the triazines may
pose significant risks of cancer due to exposure to residues in
food and drinking water and through exposure when mixing,
loading, and applying these pesticides. Growers, professional
agricultural and lawn care applicators, and some homeowners
appear to be at risk from using one or more of these products.
OPP is also concerned about the risks to the environment from the
large amount of triazines used.
Because each of the three pesticides appear to have similar
potential to cause adverse effects, and because they can be used
to some degree interchangeably, OPP decided to address their
risks simultaneously. The announcement of the Special Review
prompted over 87,000 public comments, all of which have been
screened. The substantive comments are now being evaluated. The
Agency's risk and benefit analyses, including responses to the
comments, should be published by the end of 1996.
In August 1995, the primary registrant, DuPont, agreed to
completely phase out production of cyanazine for domestic use and
to voluntarily cancel its registration effective December 31,
1999. (The other formulator of cyanazine is now compelled to
follow suit). Use of remaining stocks will be allowed through
2002, but maximum use rates will drop incrementally in 1997,
1998, and 1999. OPP believes that a significant reduction in
potential risks from exposure to cyanazine will result from these
reductions in cyanazine production and use. Additionally,
beginning in 1998, all applications must be made from within a
closed cab (meaning that the driver of the vehicle applying the
pesticide is enclosed in a cab designed to significantly reduce
the exposure to pesticides being applied). The Agency expects to
terminate the Special Review of cyanazine in 1996.
Lindane
In March 1994, the Agency proposed not to initiate a Special
Review of lindane. The proposal was prompted by a review of
studies in which laboratory animals were exposed to this
organochlorine insecticide. Initially, OPP was concerned about
risks to humans based on an effect on kidney function in male
rats; the kidney effect is a serious and uncommon one that is
usually associated with exposure to petroleum products. Further
research showed that the lindane effect was particular to male
rats, not female rats or any other species tested, and unlikely
to occur in humans. OPP formally closed the Special Review for
kidney effects in July 1995. Comments on the 1994 proposal,
however, identified lindane as a potential disrupter of the
endocrine system, so the Agency is now developing a strategy for
evaluating that effect in lindane and three other organochlorine
pesticides that are candidates for reregistration.
Propoxur
In January, the Agency proposed not to initiate a Special
Review of propoxur, an insecticide once suspected of posing an
unreasonable cancer risk to residents and pest control
professionals. Propoxur is used to control indoor pests such as
ants and cockroaches and also to control fleas on pets. In its
proposal, OPP reported that the cancer risk has diminished since
the Special Review was first suggested in 1988 because the
registrants voluntarily dropped the uses which caused the
greatest concern. OPP also reported that a reevaluation of
exposure data and the cancer potency of propoxur indicated that
the remaining uses are likely to present only negligible risks.
OPP expects to complete its review of comments and issue a final
decision in FY 1996.
Carbofuran
The uses of granular carbofuran on corn, sorghum, and rice
were marked for phaseout by 1994 because of risks to wildlife,
which were substantiated by large and widespread bird kills in
and around treated fields. Birds of prey (such as eagles),
waterfowl, game birds, and songbirds were all affected. The
registrant appealed the decision, and in March 1995, the Agency
rejected the reinstatement of uses on corn and sorghum while
extending the use on rice for two years. The rice decision was
based on a continued lack of alternatives to control the rice
water weevil, a serious rice pest, and on the vigorous approach
rice growers took to adopt environmental stewardship practices to
protect wildlife at risk. These practices included working with
the State of California and other agencies to identify and avoid
times and sites where carbofuran application poses the greatest
risk to threatened species, such as the bald eagle and the giant
garter snake. The rice growers organization also supported a user
education program and the development of publications for the
program. The Agency is currently negotiating with the registrants
of liquid carbofuran formulations to mitigate wildlife risks.
Dichlorvos
OPP issued a proposal to minimize the cancer and
neurological risks of the insecticide dichlorvos (DDVP) in
September 1995. Dichlorvos is used to control pests in the home,
on livestock and manure, and in warehouses. The Agency is
proposing to cancel some uses of dichlorvos, including all
residential uses and use on stored food. Additional uses could be
cancelled unless certain changes, such as restrictions on reentry
into treated areas and prohibition of use except by licensed
applicators wearing protective clothing, are incorporated into
product labels. Public comment on the proposal will be accepted
for 90 days.
Limited Reintroduction Of Aldicarb Use On Potatoes
When excessive residues of aldicarb appeared on potatoes in
1990, the Agency halted its sale and use in potato production. In
September 1995, the Agency reapproved this use for farmers using
positive displacement equipment -- a new technology designed to
control application rates more precisely and prevent spills and
leaks. Use on potatoes is permitted only in Oregon, Idaho,
Washington, Montana, northern Florida, and parts of Utah and
Nevada, where the risk of ground-water contamination is believed
to be low. Several other measures to reduce risks have also been
imposed: furrow irrigation is prohibited; use after planting is
prohibited; and the minimum interval between aldicarb application
and potato harvest has been extended from 90 days to 100 days in
Florida and 150 days elsewhere. Additionally, anyone wishing to
apply aldicarb must receive special training in product
stewardship. The reinstatement of use on potatoes is supported by
data from the registrant showing that residue levels under the
new application technology are within safe limits. Federal
agencies will continue to monitor potatoes for aldicarb residues.
The Special Review of aldicarb on the issue of ground-water
contamination is still proceeding.
Chapter 4: Field Implementation and Communication
The first three chapters of this report have focused largely
on OPP's work to ensure that individual pesticides are
appropriately licensed, that decisions are made in a timely
manner, and that the conditions of registration reflect up-to-
date scientific standards. This chapter turns to the important
area of field implementation and communication: OPP's work with
pesticide users and others to ensure safe pesticide use practices
are implemented in the field and to provide organizations and
individual citizens with the information they need to make
environmentally sound pesticide decisions. These efforts
complement the pesticide regulatory programs described in the
first three chapters and are critical to achieving our nation's
health and environmental protection goals.
A. Field Programs
OPP managed four major field programs in FY 1995. These
programs are aimed at protecting agricultural workers, endangered
species and ground water from pesticide risks, and ensuring that
applicators of potentially more hazardous pesticides are
appropriately trained and certified in their use. In all of these
programs, OPP relies heavily on cooperative relationships with
regional offices, state and tribal pesticide regulatory agencies,
other public and private organizations, and individuals. Only
through the combined efforts of all of these groups can EPA's
field programs be successfully implemented.
Implementing The Worker Protection Standard
OPP's Worker Protection Standard (WPS) for agricultural
pesticides became fully effective on January 1, 1995. The
Standard represents a major strengthening of national efforts to
safeguard agricultural workers. It requires agricultural
employers to ensure that employees receive basic training in
pesticide safety and to notify workers when pesticides are
applied. Employers also must provide washing facilities and
supplies if workers are likely to come into contact with
pesticides, and provide and maintain protective equipment to
reduce potential health risks due to pesticide exposure in
agriculture. OPP believes that effective implementation of the
WPS will substantially reduce the risk of pesticide poisonings
among agricultural workers and pesticide handlers.
In 1995, OPP carried out a number of WPS activities in
collaboration with EPA's ten regional offices. In addition, OPP
continued to refine requirements to maximize effective protection
for workers in a wide variety of agricultural settings, while
ensuring appropriate flexibility in implementation. Highlights of
OPP's 1995 efforts include:
o Ongoing work with pesticide registrants to ensure that the
labeling of all agricultural pesticides was revised to
convey stronger worker protection requirements, such as
restrictions on entry into treated areas and use of personal
protective equipment. The goal of ensuring that all end-
users received the required WPS labeling by October 1995 was
achieved, without creating undue burdens on the pesticide
industry.
o Work with the states, USDA's Cooperative Extension Service,
and the agricultural community to help employers obtain the
information and assistance they need. OPP created or funded
1,100,000 grower compliance manuals, 2,700,000 safety
training manuals, 685,000 safety posters, 11,500 safety
training videos, and 6,000 grower compliance video/slide
sets that were made available free or at low cost to farmers
and farmworkers.
o Implementation of a voluntary program to issue training
verification cards to agricultural workers and pesticide
handlers upon completion of WPS training. This will promote
safety training and help agricultural employers fulfill
their responsibilities by making it easier for them to
verify that their workers have been trained. To date,
2,500,000 training verification cards have been distributed
to the 42 states, Puerto Rico, and two tribes participating
in the program.
o Workshops, periodic meetings, and ongoing discussions with
agricultural groups and farmworker organizations affected by
the WPS. These discussions enabled OPP to identify key
concerns, resolve problems and improve implementation.
o Implementation of a process for considering requests for
exceptions to WPS requirements. Under the WPS, OPP may
approve exceptions if the benefits outweigh the costs
(including any health risks attributable to the exception).
In 1995, OPP denied an exception to the WPS early entry
restrictions for uses of chlorothalonil in certain states,
because the information supplied to OPP did not justify the
exception.
o Issuing several final rules that strengthened WPS safety
training requirements, but reduced certain requirements in
situations where the restrictions were not necessary to
achieve WPS objectives. For example, OPP reduced
requirements for crop advisors who have already been through
comprehensive training, for irrigation activities and other
work that results in only limited contact with pesticides,
and for situations involving use of relatively low risk
pesticides.
Endangered Species Protection Program
The primary goal of OPP's Endangered Species Protection
Program (ESPP) is to protect federally listed threatened and
endangered species from the direct and indirect impacts of
pesticide use, while minimizing regulatory burdens on pesticide
users. OPP's current ESPP is an interim non-regulatory program. A
final program will be established that reflects any necessary
changes once Congress enacts legislation reauthorizing the
Endangered Species Act.
During this interim period, the ESPP relies primarily on the
development and dissemination of county-specific pamphlets that
describe voluntary measures pesticide users can take to avoid
affecting endangered species. In 1995, OPP began developing the
pamphlets internally, ending dependence on contractors. A total
of 277 pamphlets have been completed and are being distributed
with state assistance in 25 states and Puerto Rico. OPP also
developed additional fact sheets on endangered species in FY
1995, bringing the total to 59, and continued to operate a toll-
free endangered species hotline.
In implementing the ESPP, OPP works closely with EPA
regions, states, and other federal agencies. The ESPP allows
states to develop plans to protect species in their states in a
manner suited to local conditions. At present, 20 states have
developed plans, which may include detailed assessments and site-
specific protection measures as well as provisions for agreements
with landowners to protect species on their property. During
1995, OPP completed a status review of the plans, and (working
with the U.S. Fish and Wildlife Service) approved the first two,
prepared by North Dakota and Kansas. Several other states are
close to approval.
Other FY 1995 highlights include:
o Continuing cooperative efforts with the Wyoming Department
of Agriculture, U.S. Fish and Wildlife Service (FWS), and
EPA's Region 8 to locate and protect the Wyoming toad. Local
landowners again agreed to delay pesticide applications
until their lands were searched for the presence of toads.
Although reintroductions of this endangered species are
being made in wildlife refuges, it appears that the toad no
longer exists elsewhere in the wild, and all of the searched
lands were cleared for pesticide use.
o Initiation of efforts to clarify the roles of OPP and
federal land management agencies to protect species.
Procedures have been worked out with the National Park
Service and are being developed with the Department of
Defense and the U.S. Forest Service.
o Cooperation with pesticide manufacturers, who have formed a
task force to provide extensive and valuable information
about where endangered species are located, relative to
pesticide use sites on private lands.
o Verification with the FWS of the accuracy of OPP's
comprehensive national database of the county-by-county
location of endangered species. This database is available
to other EPA offices and federal agencies, and to the public
upon request.
Protecting Ground Water
Protection of ground water from pesticide contamination is
the focus of OPP's third major field program. Ground water is a
priority concern for both human health and environmental
protection reasons. It is the source of drinking water for about
half of the U.S. population, and because it flows into lakes and
rivers it helps supports fish and wildlife habitats and
commercial activity.
The centerpiece of OPP's ground-water strategy is a
cooperative effort with the states and EPA regions to develop
State Management Plans (SMPs) to prevent ground-water pollution
from pesticides. Forty-eight states have submitted draft
"generic" SMPs, designed to create capacity for protecting ground
water regardless of the particular pesticides used. The other two
states are developing pesticide-specific plans in lieu of a
generic plan. In 1995, EPA regions concurred (with comments) on
three of the state plans, and are expected to concur on the
remaining plans by the end of 1996. In 1995, OPP completed much
of the work on the next major step, a proposed rule requiring
SMPs for five widely-used herbicides frequently detected in
ground water. OPP consulted extensively with state officials
during 1995, so the proposed rule is expected to have broad
support among the states when published for comment in 1996.
Another important feature of OPP's strategy has been to
evaluate a pesticide's potential to contaminate ground water
whenever OPP makes registration and reregistration decisions,
with an emphasis on early mitigation of ground-water risks, as
first implemented in 1994. The Agency is also continuing to track
evidence of ground-water contamination through its Pesticides in
Ground Water Database. In 1992, the Agency proposed a rule to
establish specific criteria for classifying a pesticide as
"restricted use" if any of its ingredients has the potential for
contaminating ground water on a widespread basis. Restricted use
pesticide products may be purchased and used only by certified
pesticide applicators or individuals under their supervision. OPP
believes that these specialized requirements will reduce the
potential for ground-water contamination. In 1995, OPP completed
much of the work on the final rule, which will be published in
1996.
Certification And Training Of Pesticide Applicators
When OPP designates some or all uses of a pesticide as
"restricted use," then the pesticide may only be used by or under
the direct supervision of specially trained and certified
applicators. Certification programs are conducted by states,
territories, and tribes in accordance with national standards set
by OPP. All states require commercial applicators to be
recertified, generally every three to five years, to maintain
their certification. States also sometimes require
recertification or other training for private applicators.
Over one million applicators are currently certified
nationwide, including over 900,000 private applicators and about
350,000 commercial applicators. In 1994, the most recent year for
which figures are available, more than 80,000 private and 60,000
commercial applicators were certified. More than 120,000 private
and 120,000 commercial applicators were recertified in the same
year. In addition, several hundred thousand applicators attended
training sessions to learn or review appropriate methods for
applying pesticides, in some cases as part of receiving or
maintaining certifications.
In FY 1995, OPP continued work to revise national standards
to better ensure continued competency of certified applicators.
To assist state, territorial and tribal governments in conducting
certification programs, OPP also funded 64 cooperative agreements
and provided support to state extension coordinators through the
U.S. Department of Agriculture. Other activities included support
for train-the-trainer and pesticide applicator workshops;
development of training materials on improving pesticide drift
management and application technology; and methods for evaluating
behavioral and attitudinal changes in applicators as a result of
certification and training programs.
B. Communications, Public Response, and Coordination
Few organizations serve a wider "public" than OPP.
Communications efforts must be tailored to the needs of a broad
spectrum of constituents who are affected by or interested in OPP
actions and policies: other EPA offices and regions, state and
tribal agencies, individual citizens, environmental and public
interest groups, industry and trade associations, pesticide
users, health professionals, academia, foreign governments and
international organizations, Congress and other federal agencies,
and the media.
Appropriate outreach activities are vital to OPP's efforts
to ensure that groups and individuals have the information they
need to make responsible decisions about pesticides and promote
public health and environmental protection goals. The challenge
is to make information widely available, easily accessible, and
suited to the needs of OPP's many "publics." To accomplish this,
OPP issues announcements and publications for both general and
scientific audiences, provides information by telephone and
electronic network, responds to written requests for information,
maintains a public docket for walk-in visitors, holds public
meetings, and presents speeches and Congressional testimony. This
section describes some of the ways OPP provides information and
obtains valuable public input. Additional information on
electronic information dissemination is found in chapter 6.
Outreach And Communications Strategies
In 1995, OPP issued approximately 65 announcements informing
the public of major regulatory and policy decisions, continuing
an upward trend from 1994. Each announcement is planned using a
communications strategy, which often entails a press notice and
additional outreach materials, such as fact sheets or questions
and answers. In addition, OPP issued background materials to
respond to inquiries arising out of media reports on pesticide-
related issues.
Public demand for pesticides information increased
dramatically in FY 1995. Directly and through the National Center
for Environmental Publications and Information, OPP managed
distribution of over 700,000 copies of publications, a four-fold
increase over FY 1994.
OPP is working with others inside and outside EPA to
increase public awareness of available information resources on
pesticides and ensure the most cost-effective, timely
distribution of educational materials. One key accomplishment in
FY 1995 was the production of an updated catalogue of pesticide
publications. The catalogue was distributed in "hard copy" in
1995; it will be posted electronically and updated annually in
the future.
Significant new publications developed in FY 1995 include
joint publication with the Occupational Safety and Health
Administration of a Guide to Heat Stress for Agricultural Workers
and a major update and expansion of OPP's core consumer
publication, Citizen's Guide to Pest Control and Pesticide
Safety, to be printed and distributed in FY 1996.
Protecting children from pesticide poisoning continues to be
an important focus of outreach efforts. In collaboration with the
Poison Prevention Council and the Consumer Product Safety
Commission, OPP participated in Poison Prevention Week and other
activities, distributing thousands of copies of fact sheets to
medical establishments and the general public. Fact sheet topics
included child safety and using insect repellents safely (both in
English and Spanish).
Responding To The Public
Freedom of Information Act (FOIA) Requests
OPP responds to technical or complicated requests for
information from the public under the Freedom of Information Act
(FOIA). OPP continues to receive the highest number of FOIA
requests of any program within EPA, and in fiscal year 1995
received 1,537 requests and completed 1,235 responses. The
majority of requestors receive all of the records requested, with
the most common requests being for science reviews of
registration data, administrative files for pesticide products,
and reregistration information.
OPP Public Docket
OPP has established four dockets to house the regulatory
notices, background documents, and public comments on OPP
activities. These consist of the Federal Register, Special
Review, Registration Standard, and Special Program Dockets. The
docket now has the capability to accept the electronic submission
of public comments. The most active docket action was the
Triazines Special Review, which received over 87,000 public
comments. Over 2,000 requests for docket information received by
letter, telephone, and in person were filled in fiscal year 1995.
National Pesticides Telecommunications Network (NPTN)
NPTN is a national service accessible by a toll-free
telephone number that provides objective information about
pesticides upon request to anyone in the United States, Puerto
Rico, and the Virgin Islands. The service operates Monday through
Friday from 6:30 a.m. to 4:30 p.m. (Pacific Time). NPTN provided
services to more than 17,000 callers during fiscal year 1995,
including approximately 1,700 calls concerning pesticide
incidents. The remaining calls were requests for general
information on pesticide products and issues concerning health,
safety, and use.
National Pesticide Medical Monitoring Program (NPMMP)
The NPMMP, located at Oregon State University, provides
information and referrals on clinical toxicology questions and
analytical services for biological and environmental samples.
Health care professionals and possible victims of pesticide
poisonings are major users of the service. NPMMP handled 452
incidents in FY 1995.
Other Letters and Inquiries
Rising public interest in pesticides and their effects on
people and the environment is reflected in the hundreds of
letters and telephone inquiries that OPP receives annually. In
1995, OPP prepared responses for senior EPA officials to over
1,600 letters, ranging from highly complex Congressional
inquiries to postcard write-in campaigns. In addition to the
docket letters described above, OPP received over 30,000 cards
and letters supporting alternatives to animal testing and nearly
1,000 letters on biotechnology issues. The triazines Special
Review (involving ground-water issues) was the next most popular
topic, with over 70 letters. Other frequent subjects included the
Worker Protection Standard, pesticides and children, the Delaney
clause and other food safety issues. Over the past year, OPP laid
the groundwork to be one of the first EPA offices to adopt a new
automated correspondence control and information storage and
retrieval system. This will enhance efficiency and allow improved
responsiveness to OPP's many customers.
Congressional Relations And Coordination With Other Federal
Agencies
Congressional interest and oversight of pesticide and food
safety issues continues at a high level. Over 450 of the letters
described above were responses to Congressional inquiries. In
addition, OPP prepared testimony and briefing materials for four
Congressional hearings on pesticide issues and activities,
including implementation of the Worker Protection Standard and
proposals for major changes in legislation governing pesticide
regulation and food safety.
OPP continued to assist the General Accounting Office and
EPA's Inspector General with several ongoing evaluations of
pesticide program activities, including implementation of the
Worker Protection Standard, activities to address alternatives to
the pesticide methyl bromide (scheduled for phaseout under the
Clean Air Act), management of the fees paid by pesticide
registrants, incident monitoring and follow-up, the progress of
reregistration of older pesticides, and a review of the effect of
environmental laws and regulations on U.S. agriculture and other
industry.
Pesticide and pest control issues often involve the
jurisdiction of several federal agencies. To promote efficiency
and consistency of federal effort, OPP coordinates many of its
activities with those agencies through Memoranda of Understanding
and less formal working groups. Some of the areas of common
activity are: FDA -- food safety and antimicrobial pesticides
(such as hospital disinfectants); USDA -- food safety and farm-
related regulations (such as worker protection and pesticide
storage and disposal); Consumer Product Safety Commission --
labeling issues; Department of Interior -- endangered species;
Occupational Safety and Health Administration -- worker
protection; Customs and Coast Guard -- import and export issues;
Department of Defense -- pest control on military installations;
and Department of Transportation -- harmonization of safety
standards for hazardous chemicals.
One example of OPP federal coordination in 1995 was its
interagency agreement with the U.S. Geological Survey (USGS).
This agreement will allow OPP to access USGS monitoring data and
information on water quality trends, thereby enhancing OPP's
ability to assess ground and surface water vulnerability to
pesticide contamination and to make sound regulatory decisions to
protect water resources.
National Agricultural Pesticide Impact Assessment Program
(NAPIAP)
OPP played a significant role in the independent panel
review of NAPIAP, a USDA program. Recognizing significant changes
in the demands for information and in regulatory priorities,
tight budgets, and government reinvention, the panel was charged
with evaluating NAPIAP in the context of USDA's overall pesticide
and pest management information function. The panel's report
highlighted 13 key findings and recommendations. The report
reaffirmed NAPIAP's primary mission to provide science-based
benefits information that contributes to EPA's pesticide
regulatory decisions. The report recommended improving benefits
information by establishing formal procedures and assessment-
specific protocols, and continuing to improve communications and
cooperation between USDA and EPA. OPP is continuing to work with
USDA to address these recommendations.
International Coordination And Integration
This section describes OPP's efforts to inform foreign
governments about changes in the status of pesticides in the U.S.
and major OPP programs. The purpose of these efforts is to help
foreign governments, especially those that have not yet developed
extensive pesticide regulatory and information-gathering
programs, make informed choices about the use of pesticides in
their countries. Not only do these efforts benefit citizens of
foreign nations, but they also benefit Americans by helping to
ensure the safety of imported food and other commodities treated
with pesticides. In addition, these efforts help to protect
wildlife, like migratory birds, that cross international borders.
Export Notification for Unregistered Pesticides
For all exports of pesticides not registered in the United
States, section 17(a) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) requires the U.S. exporter to obtain a
statement from the buyer acknowledging that the product is not
registered. The exporter must submit this statement to OPP, and
OPP forwards a copy to the importing government. In 1995, OPP
transmitted approximately 2,000 export notifications for about
260 pesticide active ingredients to the governments of more than
125 importing countries. Since 1992, reporting has increased by
more than 150% for exports containing active ingredients approved
in other U.S. products, but where the particular export
formulation is not registered by OPP. In 1994, such pesticides
comprised more than half of the unregistered pesticide exports.
Reinventing EPA's Pesticide Export Notification Program
In September 1995, as part of the effort to reinvent
government, OPP made options for revising its pesticide export
notification policies available for public comment. The key
option would take a risk-based approach in determining when
export notices would be required, significantly reducing the
number of exports subject to notification. After consideration of
comments, OPP will revise its current requirements. In addition,
the European Union (EU) has recently announced plans to revise
its pesticide export regulations. This announcement presents an
opportunity for the United States to work with the EU in
developing complementary export notification programs.
Information Exchange with Foreign Countries
Another provision of FIFRA, section 17(b), requires OPP to
share information with health and environmental agencies in other
countries. Under this requirement, OPP sends notices to other
governments on important regulatory decisions made in the United
States related to pesticides, food safety, and pest management.
In 1995, OPP transmitted 31 notices covering a range of
regulatory actions, such as initiation of the triazine Special
Review and the new agricultural Worker Protection Standard.
Notifications are distributed directly to pesticide regulatory
authorities in approximately 140 countries.
Prior Informed Consent (PIC)
OPP continues to actively participate in this joint program
developed by the United Nations Environment Programme (UNEP) and
the U.N. Food and Agriculture Organization (FAO) to promote the
safe management of chemicals in international trade. PIC
establishes a mechanism whereby importing countries can receive
information about pesticides and industrial chemicals and then
make informed decisions on whether to allow, restrict, or
prohibit future imports. In 1995, OPP prepared a discussion paper
for FAO/UNEP on determining which pesticides pose particular
concerns under conditions of use in developing countries,
reviewed draft FAO/UNEP Decision Guidance Documents prepared to
assist importing countries, and responded to requests from other
countries for additional information.
Work progressed internationally toward making PIC a legally
binding instrument. Formal negotiations toward an international
treaty are expected in FY 1996.
International Visitors
OPP arranges briefings with key U.S. officials for foreign
visitors interested in U.S. pesticide policies and scientific
evaluation procedures. During the past fiscal year, OPP hosted 85
visitors, including representatives from Australia, Brazil,
Canada, Chile, Denmark, France, Hong Kong, Indonesia, Japan,
Latvia, Malaysia, South Korea, Moldova, New Zealand, Russia,
Taiwan, the United Kingdom, and Venezuela.
Regional, State, And Tribal Liaison
Regional Coordination
EPA's 10 regional offices are OPP's primary connection to
state, territorial, and tribal governments. They negotiate
cooperative agreements for OPP's field programs, assist in
developing and implementing programs, and oversee accomplishments
and commitments made by the states, territories and tribes.
Regional staff communicate OPP's programs and policies to the
public and in turn provide OPP with public input.
State and Territorial Programs
States and territories are true partners with EPA in
protecting human health and the environment from pesticide risks.
They assist in developing and implementing field programs, and
they enforce OPP's regulations and pesticide labeling and use
requirements. To further these common goals, OPP supports a
cooperative agreement with the Association of American Pesticide
Control Officials for the State FIFRA Issues Research and
Evaluation Group (SFIREG). In 1995, SFIREG continued to meet
periodically with OPP to develop pesticide programs and discuss
implementation and enforcement issues of concern to the states
and territories.
Tribes
Native American tribal governments have sovereign rights and
certain specific assurances from the federal government under
treaties. The capacity of tribal governments to carry out
environmental regulatory programs varies significantly from tribe
to tribe, and the challenge for OPP is to accommodate tribal
differences while ensuring that basic health and environmental
protections are achieved for all Native Americans.
OPP is working with tribes to assist them in building
capacity to conduct regulatory and field programs for pesticides.
In 1995, OPP helped fund an environmental scholarship program to
assist college students studying environmental sciences and
interested in addressing Native American issues. OPP also
sponsored a Native American intern to work on these issues and
learn more about how EPA works, supported efforts by the Native
American Higher Education Consortium to develop college-level
courses related to pesticide safety, and developed and piloted a
seminar on Native American culture and history for OPP staff.
OPP is also addressing specific issues uniquely affecting
Native Americans. In 1995, OPP continued work with other state
and federal authorities to address potential pesticide exposure
by members of the California Indian Basketweavers Association
(CIBA). CIBA members are concerned about potential exposure to
pesticides from contact with native plant materials used in
traditional basketweaving.
Laboratory Tools
Pesticide Chemistry Laboratories (PCLs) in Beltsville,
Maryland, and Bay St. Louis, Mississippi, support EPA regions and
states with technical reference standards, technical assistance,
and laboratory services. (Technical reference standards are
pesticide samples of known concentration that can be used, for
example, in verifying the formulations of pesticides being
offered for sale.) In FY 1995, OPP distributed 735 technical
reference standards to the regions and states, and PCLs responded
to 76 requests for assistance. Most of the requests came from
chemists in other federal, state or private labs. OPP's PCLs are
the primary repository for all food tolerance, product, and
environmental chemistry methods, as described in chapters 1 and
2.
In 1995, OPP also drafted an Environmental Chemistry Methods
Manual describing how to detect pesticides in soil and water.
When finalized, it will include introductory chapters, formatted
methods developed by EPA or pesticide registrants, and technical
appendices. OPP is planning wide distribution and will make the
manual available to public and private labs for a fee.
Chapter 5: Policy, Regulations, and Guidelines
OPP makes many individual decisions in its registration,
reregistration, and special review programs. To guide these
decisions and inform its many stakeholders, OPP develops
regulations, policy documents, guidelines and analyses covering
scientific, legal, and international matters. Active public
participation and feedback is critical to the development of
practical pesticide policies. Regulations are published for
notice and comment in the Federal Register. When final, they are
incorporated in the Code of Federal Regulations. OPP makes other
policy and guidance documents available through a variety of
mechanisms, such as the Government Printing Office, direct
mailings, and increasingly, through electronic dissemination.
This chapter highlights some key areas of progress over the last
fiscal year.
Improving Protection For Infants And Children
OPP has made substantial progress implementing
recommendations in the 1993 report of the National Academy of
Sciences (NAS), Pesticides in the Diets of Infants and Children.
The report made recommendations to improve protection of infants
and children in four areas: toxicology, risk assessment, residue
chemistry, and food consumption.
Toxicology
o To better assess newborn and pre-adolescent toxicity, EPA's
Scientific Advisory Panel (SAP) peer reviewed in 1995 a
number of data requirements developed by OPP. The
requirements are for assessing the potential effects of
pesticides on immune function, the nervous system,
reproduction and development, and the visual system. The
requirements will be proposed in 1996 as part of
comprehensive revisions to OPP's data requirement
regulations (40 CFR Part 158).
o Test guidelines for each of these areas have been developed
(neurodevelopmental, neurotoxicity) or will be completed in
1996 (reproductive/developmental, visual system).
o The National Toxicology Program at the Department of Health
and Human Services (HHS) completed a pilot study on the use
of an additional thyroid test which is now being evaluated
by OPP.
Risk Assessment
o EPA is revising its guidelines for assessing the cancer
risks posed by chemicals to take into account all available
biologically-based information.
o OPP is phasing in the evaluation of multiple routes of
pesticide exposure (such as from food, drinking water, and
household use) and combined exposures to multiple pesticides
which have the same mechanism of action (that is, they cause
the same toxic effect in the same way). For example, in the
Special Review of the triazine family of pesticides, the
potential combined risks from consumption of these chemicals
in food and drinking water is being considered along with
application exposure via agricultural and residential use.
In addition, OPP now routinely addresses the potential for
additive risks from drinking water and food in making
reregistration decisions. Evaluation of exposure to children
and other potentially sensitive subpopulations is a routine
aspect of dietary risk assessments in both the registration
and reregistration programs.
Food Consumption
o To provide more reliable information regarding exposure to
pesticides in foods, OPP will be using USDA's Food Grouping
System in standardizing the "recipes" used to convert foods
"as eaten" (for example, pizza) to raw agricultural
commodities (for example, wheat, and tomatoes). In addition,
OPP is revising its commodity list which, upon completion,
will be transmitted to USDA so all recipes can be
standardized based on the new commodity list by the end of
1996.
o USDA requested additional funds to carry out a supplemental
food consumption survey, but monies were not appropriated.
OPP is working with USDA and HHS, as part of the Food
Consumption Working Group, to design future surveys.
Residue Chemistry
o A design for a National Pesticide Residue Monitoring
Database is complete and could be implemented in FY 1997, if
funds were available.
o OPP completed a market basket feasibility study for
monitoring pesticides in the top 20 foods eaten by children.
o OPP routinely uses actual field trial data to estimate
potential residues in treated food. Guidance specifying
number of field trials per crop was peer reviewed by the SAP
and completed in 1995.
Acute Dietary Risk Assessment Policies
Acutely toxic pesticides are those which could cause illness
or injury based on short term exposure to excessive residues. For
example, high residues of such a pesticide in food could cause
illness to some people after a single serving of the food. Unlike
potential chronic effects, which are evaluated based on likely
consumption of foods containing varied residue levels over many
years, acute effects must be evaluated based on the possibility
of excessive exposure to "high residue" foods within a relatively
short period. Using average residue values in evaluating health
risks would not provide an adequate margin of safety for
consumers in the case of acutely toxic pesticides.
In FY 1995, OPP developed new, refined guidance for
determining potential risks posed by acutely toxic pesticide
residues in food. The policy optimizes the use of available
residue data and takes a tiered approach, proceeding from worst
case assumptions to more realistic assumptions. The new approach
incorporates recommendations from the National Academy of
Sciences report on Pesticides in the Diets of Infants and
Children and was presented to the OPP's Science Advisory Panel
for expert peer review in October 1994. The new policy
standardizes OPP risk assessment for acutely toxic pest