United States
Environmental Protection
Prevention, Pesticides,
And Toxic Substances
(7506C)
EPA 735-R-99-002
December 1999
ice o
iennialr
FY 1998 and 1999
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OFFICE OF
PESTICIDE PROGRAMS
BIENNIAL REPORT
FISCAL YEAR 1998 AND 1999
&EPA
United States Environmental Protection Agency
Office of Pesticide Programs (7506C)
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FOREWORD
by MARCIA E. MULKEY, Director
Office of Pesticide Programs
...the Food Quality
Protection Act of
1996 has resulted in
fundamental changes
to the way pesticides
are regulated in our
country...
The Office of Pesticide Programs (OPP) is pleased to provide you with a summary report regard-
ing many of the important activities carried out by the Program during 1998 and 1999. Clearly,
the Food Quality Protection Act (FQPA) of 1996 has resulted in fundamental changes to the way
pesticides are regulated in our country-providing the Agency with new tools and standards for
assessing and reducing potential risks from pesticides, especially to children. This has been a
remarkable period of time in OPP's history and one in which we've made tremendous progress
not only in implementing FQPA but also in carrying out our many other important regulatory
responsibilities.
Throughout the past two years, the program has made great strides in increasing transparency
and stakeholder consultation in all of its activities, including, for example, developing and
revamping many key science policies and working with the Tolerance Reassessment Advisory
Committee (TRAC) to develop and implement the pilot process for public involvement in assess-
ing and managing risk from organophosphates. Significantly, the program met the first tolerance
reassessment deadline in FQPA by completing over 33% by August 3, 1999, with 3,430 toler-
ances reassessed.
Progress is not always about achieving higher numbers. While over the last two years, we
exceeded our historic performance by registering 53 new active ingredients, it is important to
note that we are continuing to bring to market higher numbers of "safer" or "reduced risk"
conventional products. These products will continue to replace older, more toxic chemicals and
thus help reduce potential risks from pesticides. Incorporating FQPA's new safety standard, we
also completed 1,046 emergency exemption decisions and achieved significant risk reductions
through the completion of 27 Reregistration Eligibility Decisions in 1998 and 1999. In virtually all
areas involving routine registration actions, we substantially reduced or eliminated backlogs.
Working with our regional, state and tribal partners, OPP made progress in implementing
worker protection programs, reassessing the applicator certification and training programs, and
advancing many other field programs-all described more fully in this report. We also remain
strongly committed to expanding the public's right to know through website development, com-
munication activities and stakeholder involvement.
I hope you will take a few moments to review our Biennial Report for 1998 and 1999. Let's
also look ahead with a commitment to make even more progress together in safeguarding public
health and the environment from pesticide risks.
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PAGE
CONTENTS
OPP BIENNIAL REPORT FY 1998 AND 1999
7 OPP AT A GLANCE
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
The Federal Food, Drug, and Cosmetic Act (FFDCA)
Pesticide Time Line
OPP's Structure
How to Reach the Office of Pesticide Programs on the Internet
11 REGISTRATION
Registering New Active Ingredients in Pesticide Products
Approving "Other Ingredients" in Pesticide Products
Registering Antimicrobial Pesticide Products
Focusing on Public Health Pesticides
Supporting Minor Crops and Public Health Pesticides
REREGISTRATION
Achieving Risk Reduction through Reregistration
Establishing Stakeholder Process During Pesticide Reregistration Reviews
TOLERANCE REASSESSMENT
Reassessing Tolerances
Establishing the Tolerance Reassessment Advisory Committee (TRAC)
Publishing Tolerance Processing Fees Rule Proposed
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20
24
29
33
36
SOUND SCIENCE
Developing New Science Policies
Improving Our Protection for Infants and Children
Expanding Our Understanding of Endocrine Disrupters
Protecting Human Test Subjects
Understanding and Predicting Spray Drift
Identifying and Developing Ecological Risk Assessment Methods
Improving Drinking Water Exposure Assessments
Developing an Aggregate Exposure and Risk Assessment Tool:
Hampshire Research Institute's (HRI) Lifeline Software Model
Collecting Pesticide Use Information
PARTNERSHIPS
Providing Support for Regional Initiatives
Developing Stakeholder Partnerships
Partnering with States and Other Agencies
Coordinating International Activities
FIELD PROGRAMS
Focusing on the Endangered Species Protection Program
Developing the Ground Water Pesticide Management Plan Program
Preventing Pesticides in the Environment through Container and
Containment Standards and Support of Collection Programs
Developing Tribal Initiatives and Programs
Supporting Agricultural Workers
Developing an Interagency Initiative:
Pesticides and the National Strategies for Health Care Providers
RIGHT TO KNOW
Expanding Pesticide Education and Outreach Materials
to the Public
Providing Toil-Free Access to Pesticides Information
APPENDICES
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The mission of the
Office of Pesticide
Programs (OPP) is to
protect human
health and the
environment from
unreasonable
adverse effects
resulting from the
use of pesticides
and to assure
that there is a
reasonable certainty
of no harm from
pesticides in the diet
of all Americans,
especially children.
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OPP AT A GLANCE
THE MISSION OF THE OFFICE OF PESTICIDE PROGRAMS (OPP) IS TO PROTECT
human health and the environment from unreasonable adverse effects resulting from the
use of pesticides and to assure that there is a reasonable certainty of no harm from pesti-
cides in the diet of all Americans, especially children. OPP regulates pesticides under two major
federal statutes: the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (FFDCA), both significantly amended by the Food Quality
Protection Act of 1996 (FQPA).
The Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA)
FIFRA is a product licensing statute. Many provi-
sions of FIFRA provide regulatory tools for OPP to use
to fulfill the intent of the law:
Registration pesticide products for use in the U.S.
generally must be registered or licensed by EPA
based on a scientific evaluation prior to manufac-
ture, transport, and sale.
Labeling all pesticide products must have a label
that describes, among other things, the content,
directions for use, safety precautions, and disposal
requirements.
Data-Call-in - since 1978, FIFRA has provided
strong authority to require data (results from pesti-
cide testing) enabling OPP to evaluate the safety of
pesticide products.
Restrictions certain high risk pesticides are
restricted for use only by trained and state-certified
applicators.
Enforcement FIFRA contains enforceable provi-
sions on the manufacture, sale, distribution, and
use of pesticides (Section 18's).
Emergency exemption authority in certain emer-
gency cases, FIFRA permits approval of unregis-
tered uses of registered products on a time-and
geographically-limited basis.
Reregistration all pesticides registered before
November 1,1984, must be reevaluated to ensure
that they meet today's more stringent safety
standards.
Registration review after EPA completes the
reregistration process, FIFRA requires the Agency
to establish a registration review program through
which all pesticide registrations will be reviewed
periodically in light of new standards and
information.
Suspension or cancellation through the appeals
and adjudicatory processes, some or all of a pesti-
cide product's uses can be suspended or canceled to
prevent unreasonable adverse effects.
Antimicrobials program FIFRA requires OPP to
review antimicrobial actions within prescribed
time-frames. Antimicrobial products are used to
control germs such as bacteria and fungi (molds
and mildews) that can cause infections, food
spoilage and odors.
Minor use program FIFRA requires EPA to estab-
lish a program that gives special consideration and
support to minor uses of pesticides, which may be
of low value to pesticide producers but high value
to farmers. Most fruits and vegetables are grown
with "minor use" pesticides.
v
Our regulatory
decisions affect
approximately:
V
30 major pesticide
producers plus
another 100 small
L producers
T
2,500 pesticide
formulators
29,000
distributors
40,000
commercial pest
control firms
V
1 million farms
V
3.5 million
farm users
,
several million
industry and
government users
'
90 million
households
FY 98-99 OPP BIENNIAL REPORT
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V
1906
the Pure Food Law
(FFDCA) set labeling
standards for
truthful labeling
1910
the Insecticide Act
(early FIFRA) was a
consumer protection
I law intended to
prevent the
manufacture, sale,
or transportation
of products that do
not work
V
1947
FIFRA enacted
V
1954
FDA gained
the authority to
establish pesticide
tolerances
V
1958
Delaney clause
added to FFDCA
V
1964
FIFRA amended
to give USDA
authority to refuse
registration for
unsafe as well as
ineffective
pesticides
The Federal Food, Drug, and
Cosmetic Act (FFDCA)
FFDCA provides the Office of Pesticide Programs
with the authority to set tolerances (maximum allow-
able residue levels) for pesticides in or on foods and
animal feed. Key elements of FFDCA include:
Tolerance reassessment all tolerances that were in
place as of August 1996 must be reassessed 33%
by August 1999; 66% are due by August 2002; and
all must be completed by August 2006.
Reasonable certainty of no harm safety standard
FFDCA now includes a health-based safety standard
for pesticide residues in both raw and processed
foods. "Reasonable certainty of no harm" is now
the general safety standard, both for tolerances
under FFDCA and registration of pesticides with
food uses under FIFRA.
Special protection of children EPA must make an
explicit determination that tolerances are safe for
children. EPA must apply an additional ten-fold
safety factor, unless there is sufficient reliable infor-
mation to support application of a different safety
factor.
Aggregate risk pesticide risk assessments must
consider all sources of non-occupational exposures
(i.e., dietary, drinking water, and residential expo-
sures).
Cumulative risk and common mechanisms of toxic-
ity- EPA must consider the cumulative effects of
related pesticides that share common mechanisms
of toxidty.
Benefit-based tolerances under very limited con-
ditions, EPA may retain a tolerance for a pesticide
that does not meet the new safety standard if it is
deemed to be in the public interest.
Right To Know the Agency must develop infor-
mation to educate the public about the risks and
benefits inherent in using pesticides on foods. EPA
must also list any tolerances that are set based on
benefits considerations, and explain ways con-
sumers may reduce their exposure to pesticides in
or on food.
Endocrine disrupters - because of concern from
human exposure to chemicals that may disrupt the
endocrine hormone system, EPA must develop an
endocrine disrupter screening and testing program
to evaluate potential adverse effects.
FY 98-99 OPP BIENNIAL REPORT
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OPP's STRUCTURE
The Office of Pesticide Programs (OPP) is divided into nine divisions and a resource manage-
ment staff, employing nearly 900 scientists, administrative and regulatory personnel. For more
information on OPP's structure, please refer to List 4 in the Appendix and visit our website at
http://www.epa.gov/pesticides.
Antimicrobial
Division (AD)
Risk Assessment
and Management
Biological and
Economic
Analysis
Division (BEAD)
Usage Data
Benefits Analysis
Chemistry Labs
Office of the
Director (OD)
Senior Science Advisor
Minor Use Officer
Deputy Director for
Pesticide Programs
Deputy Director for Pesticide
Program Management
Resource
Management
Staff (RMS)
Budget and
Personnel
Special Review
and
Reregistration
Division (SRRD)
Risk Management
Health Effects
Division (HED)
Risk Assessment
Field and
i
Registration
Division (RD)
Risk Management
Environmental
Fate and Effects
Division (EFED)
Risk Assessment
Information
Field and
External Affairs
Division (FEAD)
Field Programs
Policy and
Regulation Support
Communications
Information
Resources and
Services
Division (IRSD)
Information
Management and
Systems Support
Biopesticides
and Pollution
Prevention
Division (BPPD)
Risk Assessment
and Management
V
1970
pesticide regulation
transferred from
USDA to the newly
established EPA
V
1972
FIFRA amended to
consider risks and
benefits of pesticides
rather than efficacy
V
1974
EPA sets the first
standard for worker
reentry into treated
fields
V
1978
FIFRA amended;
allowed for
conditional
registration; gave
manufacturers
ten year rights
to data
V
1984
EPA publishes
extensive data
testing requirements
in 40 CFR Part
158-pesticide
companies now
have to perform
numerous hazard
and exposure testing
studies prior to
Lipplying for a
registration
FY 98-99 OPP BIENNIAL REPORT
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V
1988
FIFRA amended
and required
re-registration
program be
established to
review chemicals
registered prior
to 11/84
V
1996
FQPA established a
single, health-based
standard for
pesticides used on
food crops; added
protection for
I infants and children
V
1998
Pilot process for
organophosphate
risk assessments
I initiated
V
1999
Met first tolerance
reassessment
deadline and
canceled significant
food uses of two
organophosphate
pesticides
How to Reach the Office of Pesticide Programs on the Internet
http://www.epa.gov/pesticides
Office of Pesticide Programs new Websites developed in 1998 and 1999:
Sign up for Electronic Updates from the Office of Pesticide Programs at:
http://www.epa. gov/oppfead1/cb/csb_page/form/form. html
Learn about OPP's fiscal year 1999 (FY99) work plan registering
new conventional pesticides in the registration pipeline at:
http://www.epa.gov/opprd001/workplan/
Explore conventional chemical specific fact sheets at:
http://www.epa.gov/opprd1/factsheets/
Explore OPP's Ecological Risk Assessment Page at:
http://www.epa.gov/oppefed1/ecorisk/
Check on the status of FQPA Science Policy Issues
& Guidance Documents at:
http://www.epa.gov/oppfead1/trac/science/
Review EPA's data (crop by crop) organophosphate use
being used in assessments at:
http://www.epa.gov/oppbead1/matrices/
Learn how health care providers can become more aware
and of pesticide health issues at:
http://www.epa.gov/pesticides/safety/healthcare/healthcare.htm
Visit our Pesticide Program Dialogue Committee (PPDC) website at:
http://www.epa.gov/pesticides/ppdc
Visit our Tolerance Reassessment Advisory Committee (TRAC) website at:
http://www.epa.gov/oppfead1/trac/
Learn more about EPA's program to register biopesticides at:
http://www.epa.gov/pesticides/biopesticides/
Review OPP's 3-year Progress Report on FQPA implementation at:
http://www.epa.gov/oppfead1/fqpa/fqpareport.pdf
Examine the official docket for chemicals under
review in the organophosphate tolerance
reassessment process at:
http://www.epa.gov/pesticides/op/
Exercise your right to know about
pesticides and your food at:
http://www.epa.gov/pesticides/food/
The Office of Pesticide Programs
may also be reached by
writing to:
401 M St., S.W. Mailcode 7506c
Washington, D.C. 20460
Or you can visit our offices at:
1921 Jefferson Davis Hwy., CM#2
Arlington, VA
(703) 305-5017
FY 98-99 OPP BIENNIAL REPORT
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REGISTRATION
APPROXIMATELY 20,000 PESTICIDE PRODUCTS ARE CURRENTLY REGISTERED
or licensed for use in the U.S. Pesticide products are used in or on food, around homes,
businesses, schools, hospitals, and in parks. Before EPA will register a pesticide prod-
uct for sale and use, we evaluate test data on all of its ingredients. The test data, which include
studies on the effects the product will have on humans, wildlife, fish, and plants (including
endangered species), are provided by the registration applicant (known as the registrant).
Depending on the type of pesticide, a registrant may be required to generate data from as many
as 100 different tests in order for us to determine the product's safety. Pesticides which are cru-
cial to public health, such as hospital disinfectants and tuberculocides, are tested in EPA's Office
of Pesticide Program's Microbiology Laboratory to ensure that they work as claimed.
Registering New Active
Ingredients in Pesticide Products
During the last two years, OPP made significant progress in
registering new pesticides. In 1998, the Agency registered 27
newpestidde active ingredients and in 1999, we registered 26
newpesticide active ingredients. More than half of these new
pesticide registrations were for biopestiddes and "reduced
risk" conventional pesticides which pose less risk than the
more toxic conventional pesticides registered years ago.
Biopestiddes include "microbial pesticides" (bacte-
ria, viruses, or other microorganisms used to control
pests); "biochemical pesticides," such as pheromones
(compounds that disrupt the mating behavior of
insects); and plant pesticides, substances that plants
produce from genetic material that has been added to
the plant. New conventional pesticides are considered
for "reduced-risk" status if they have at
least one or more of the following charac-
teristics:
low risk to human health;
low toxicity to non-target organisms;
low ground water contamination
potential to contaminate ground water,
surface water, or other valued environ-
mental resources;
broaden the adoption and effectiveness
of integrated pest management
strategies.
To move these less risky pesticides into
the market-place more quickly, we placed
high priority on reviewing these applica-
tions. Registration decisions for conven-
tional "reduced risk" pesticides and
To move less risky
pesticides into the
marketplace quickly,
we placed high
priority on reviewing
these applications.
PROPORTION OF NEW
ACTIVE INGREDIENTS
CONSIDERED SAFER
IN FY 1998-1999
SAFER
PESTICIDES-
33
EPA Sought Public
and Scientific
Comments on New
Pesticide-
Chlorfenapyr
(Pirate)
OPP took ground-
breaking steps in
1999 in order to
inform OPP's registra-
tion decision-making
process for the new
chemical compound,
chlorfenapyr. The
Agency sought public
comment and input
on our risk and bene-
fits assessments prior
to making any regula-
tory decision through
a Federal Register
Notice and the
Internet. Chlorfenapyr
is a member of a new
class of chemical
compounds known as
'pyrroles'-a class
which has a unique
mode of action, clear
economic benefits to
the cotton industry,
and data indicating
avian reproductive
effects. Chlorfenapyr
is the first pyrrole sub-
mitted for U.S. regis-
tration. Chlorfenapyr
has clear economic
benefits to the cotton
industry because it
can play an important
role in controlling sev-
eral important cotton
pests. However,
chlorfenapyr appears
to be persistent in the
environment, and
studies show a poten-
tial adverse impact to
wildlife, particularly
birds. For these rea-
sons-and our limited
experience with
pyrroles-we believe
this chemical presents
special issues for pes-
ticide regulation.
Accordingly, in 1999
we took this extra
step of seeking public
comment, of a specif-
ic nature, on this
chemical's human
health and ecological
risk and benefit
assessments before
any regulatory deci-
sion-making. The
Agency also consulted
with the U.S. Fish and
Wildlife Service,
solicited external
scientific peer review
on our ecological risk
assessment, and will
consider the alterna-
tives and their effec-
tiveness as part of the
decision-making
process.
FY 98-99 OPP BIENNIAL REPORT
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EPA's Review of
"Other Ingredients"
in Pesticide
Products
EPA announced its
policy on toxic
"other ingredients"
in pesticide products
in the Federal Register
of April 22, 1987 (52
FR 13305). Through
this policy, EPA
encourages the use
of the least toxic
FY1999
Registration Work
Plan Made Public
In keeping with the
Agency's efforts to
improve transparency
in the pesticide regis-
biopestiddes were generally made in half the time that
it takes for other conventional pesticides. We also
expedited the introduction of organophosphate alter-
natives into the marketplace.
Approving "Other Ingredients" in
Pesticide Products
Pesticide products contain "active" ingredients to
prevent, destroy, repel or mitigate a pest. By law, the
active ingredient must be identified by name on the
label together with its percentage by weight. "Other
ingredients" in pesticide products are not intended to
affect a target pest, but are used to help, among other
things, formulate, stabilize, or disperse the product.
Before 1997, these other ingredients were known as
"inert ingredients." The law does not require other
ingredients in pesticides to be identified by name and
percentage on the label unless they are of toxicological
concern.
Over the past two years, OPP approved 210 of these
kinds of "other ingredients" in pesticide products.
These ingredients are safer than many of the older
ingredients of this type. At the same time, the Agency
continues to review existing "other ingredients." In the
summer of 1998, EPA removed 249 chemicals which
"other ingredients"
available and requires
the development of
data necessary to
determine the condi-
tions of safe use of
products that contain
other ingredients
which are toxic. In
developing this policy
EPA placed "other
ingredients" in the
following four lists
according to toxicity:
Listl: "Other
ingredients" of tox-
tration process, OPP
published its fiscal
year 1999 registration
work plan in the
Federal Register and
posted it on the
Internet. This work
plan announced the
quarter by which the
icological concern.
List 2: Potentially
toxic "other ingre-
dients," with high
priority for testing.
List3: "Other
ingredients" of
unknown toxicity.
List 4: "Other
ingredients" of
minimal concern.
The list of other
pesticide product
ingredients is revised
as new data become
available.
Agency committed to
make decisions on
new active ingredi-
ents, new uses of
previously-registered
active ingredients,
and food use "other
ingredients." During
1999, OPP periodical-
were no longer in use from the list of "other ingredi-
ents" permitted for use in pesticide products which
were no longer in use. In June 1999, EPA removed 12
additional chemicals, all considered toxic and listed on
the OPPT Toxics Release Inventory. As a result, regis-
trants wishing to include these chemicals as "other
ingredients" in pesticide formulations need to satisfy
the data requirements for new other ingredients, as if
the chemicals had never been used before.
EPA also took action to remove formaldehyde as an
approved "other ingredient" in pesticide products. In
response to this initiative, manufacturers of pesticide
products that contained formaldehyde as an "other
ingredient" agreed to cancel or reformulate their prod-
ucts, thereby eliminating this chemical as an "other
ingredient."
Registering Antimicrobial Pesticide
Products
In 1998 and 1999, we continued to improve our
Antimicrobials Program. Antimicrobial pesticides are
used to control harmful microorganisms including
bacteria, viruses, or fungi in or on inanimate objects
and hard surfaces. Antimicrobial products include
sterilants, disinfectants, and sanitizers, as well as
swimming pool chemicals, wood preservatives, and
antifoulant paints. Approximately 1,000 antimicrobial
pesticide products are registered for use on food and
food contact surfaces as disinfectants, sanitizers, and
preservatives.
The Agency has made substantial progress in fulfill-
ing the antimicrobial provisions of FQPA. A backlog of
pending actions has been reduced from a high of 388
in December 1996, to only 24 outstanding actions as of
September 1999.
In September 1999, as required by FQPA, we pub-
lished in the Federal Register a proposed rule detailing
procedures and policies for reviewing antimicrobial
applications for registration, including review time
frames, a sunset provision for continued efficacy of
public health products, and labeling standards for pub-
lic health products, along with assorted definitions and
exemptions. A number of other provisions were also
proposed, including: a policy on nitrogen stabilizers;
ly published registra-
tion work plan
updates via the
Internet, including
dates when decisions
had been made.
Many external cus-
tomers encouraged
the Agency to contin-
ue to provide this
type of information
to the public. The
Agency is making
annual registration
work plans a routine
part of its operations.
FY 98-99 OPP BIENNIAL REPORT
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EPA Registers
Alternative to
Tributylin (TBT)
Antifouling Paints
On March 20,
1998, OPP regis-
tered five new
antifouling paint
products containing
the new active ingre-
dient Irgarol, in com-
bination with copper,
to enhance efficacy.
Antifoulant paints are
used on marine ves-
sels and structures to
inhibit growth of
fouling organisms,
e.g., barnacles and
algae. The new
antifouling products
are approved for ves-
sels of any size, and
appear to present
minimal risks to the
environment. After
two years, the condi-
tional registration of
Irgarol and its prod-
ucts will expire unless
the company provides
additional ecological
effects data. EPA
issued the time-limit-
ed registration
because the benefits
of introducing Irgarol
products quickly were
deemed to outweigh
any potential ecologi-
cal risks.
Since 1988, the
United States and
other industrialized
countries have pro-
hibited the use of
antifoulants contain-
ing tributyltin (TBT)
on non-aluminum-
hulled vessels shorter
than 25 meters.
Despite noticeable
improvement, ten
years after this and
related restrictions
took effect, TBT is still
present in the aquatic
environment at levels
that harm organisms
such as snails and
oysters. The TBT
phase-out target year
is 2006. EPA is work-
ing with international
organizations to
address issues associ-
ated with the
planned phase-out of
TBT antifoulants and
is reviewing data on
additional new
antifouling active
ingredients and prod-
ucts. Having alterna-
tives available is criti-
cal to meeting the
phase-out date.
permission for single applications for identical non-
data labeling changes affecting multiple products; and
labeling revisions affecting the signal word, the "Keep
Out of the Reach of Children" statement, use dilution
and first aid statements. EPA expects to publish a final
rule in 2 000.
Focusing on Public Health
Pesticides
During 1998 and 1999, EPA continued its efforts to
coordinate with USDA and the Department of Health
and Human Services (HHS) regarding the regulation of
pesticides with public health uses, such as mosquito
and cockroach control. For pesticides which have both
food and public health uses, FQPA requires that the
Agency consider exposure from the public health use
when conducting an aggregate exposure assessment.
FQPA defines public health pesticides as any minor
use pesticide product used predominantly in public
health programs for vector control or other recognized
public health protection uses. Public health pesticides
are afforded the same considerations as other minor
use pesticides, such as priority review and the waiving
of some of the fees associated with registration. As
with pesticide registrations in general, EPA is seeking
low risk alternatives to traditional public health pesti-
cides.
Supporting Minor Crops and Public
Health Pesticides
The Food Quality Protection Act (FQPA) called for
EPA to develop a new approach to managing minor
crop and public health pesticides. In response, during
1998 OPP appointed a full-time Minor Use Crop
Coordinator and an OPP Public Health coordinator,
supported by a Minor Use Team and a Public Health
Steering Committee. The teams share common mem-
bers and coordinate activities with USDA and the
Department of Health and Human Services (HHS).
The primary goals of the Minor Use Team and Public
"Minor Uses" are
pesticide uses for
which the total
United States treat-
ed acreage is less
than 300,000 acres
(minor crops) or
uses for which the
market does not
provide sufficient
economic incentive
to support the initial
or continuing regis-
tration. Minor uses
of pesticides are
often critical
because they sup-
port many fruit and
vegetable crops and
public health pesti-
cides.
Proposed Rule
Published Outlining
Procedures for
Establishing
Tolerances for
Emergency
Exemption
Requests
On June 3, 1999,
EPA published a
proposed regulation
outlining the suggest-
ed criteria for estab-
lishing tolerances
under the emergency
exemption require-
ments of FIFRA
Section 18. The pro-
posed regulation dis-
cusses the Agency's
plan to use available
data to determine the
Agency's ability to
establish time-limited
tolerances for Section
18 uses on a case-by-
case basis. These
time-limited toler-
ances will cover both
domestic commodi-
ties and those import-
ed into the U.S. dur-
ing the duration of
the emergency
exemption. The pro-
posed rule also details
provisions which
ensure that food
legally treated under
the Section 18 may
continue through the
channels of trade
after the tolerance
expires, provided the
levels are within
acceptable limits.
In addition to EPA's
proposed process, the
proposal lists recom-
mendations for
changes to the
Section 18 process
developed by the
National Association
of State Departments
of Agriculture and the
Association of
American Pesticide
Control Officials. EPA
will evaluate the com-
ments on these rec-
ommendations sepa-
rately from the com-
ments on the rule.
We expect to publish
a final rule in 2000.
FY 98-99 OPP BIENNIAL REPORT
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EPA Takes Action
Against Illegally
Pesticide-Treated
Articles
In recent years, the
marketplace has
seen a proliferation of
new types of unregis-
tered consumer prod-
ucts that are treated
with pesticides.
Among other things,
these products have
claimed to protect
consumers against
diseases caused by
bacteria, fungi, and
other microorgan-
isms. Types of pesti-
cide-impregnated
products include food
cutting boards, toys,
kitchen sponges, cat
litter, articles of cloth-
ing, and even writing
pens. Their packag-
ing often contains
words and phrases
such as "antibacteri-
al," "germ-free," or
"kills harmful E.coli."
Any pesticidal prod-
uct making public
health claims must
work as claimed and
be registered with
EPA as a pesticide.
These products are
unlawful if they make
public health claims
Health Steering Committee are to:
provide growers and public health program admin-
istrators an opportunity to discuss their needs and
concerns with the Agency before the Agency final-
izes regulatory actions;
work with USDA, industry, growers, public health
agencies and other stakeholders to promote registra-
tion and use of reduced-risk pesticides for minor uses;
encourage development and submission of "real
world" pesticide use, usage and residue data by
growers, public health agencies, USDA and other
stakeholders for use in refined risk assessments.
This increased focus has strengthened EPA's com-
munication with the minor use community and has
helped bring registrants and minor use stakeholders
together early in the regulatory process.
Cooperative Efforts with USDA's IR-4
EPA's Office of Pesticide Programs and USDA's
Interregional Research Project 4 (IR-4) have a long his-
tory of working together to register pesticides for
minor crops. With input from affected grower groups,
IR-4 and EPA are working together to accelerate regis-
tration of alternatives to organophosphates, carba-
and are not registered
with EPA.
EPA has taken
major steps to
address the prolifera-
tion of unregistered
"treated articles,"
such as cutting
boards and kitchen-
ware, that make
unlawful pesticidal
health claims. Over
20 enforcement
actions had been
taken against non-
complying companies
as of September 30,
1999, and more than
$1,000,000 in fines
were collected to fur-
ther assure compli-
ance with the law.
EPA expects to issue
guidance in 2000
that will clarify
acceptable claims.
mates and B2 carcinogens, with special emphasis on
reduced-risk products. Beginning three years ago, IR-4
has focused heavily on reduced-risk products. Over
60% of their fiscal year 1999 projects are for reduced-
risk products, and current projections are that this fig-
ure will exceed 70% for fiscal year 2000. Several current
EPA/IR-4 partnership projects are worthy of note:
developing blanket tolerances for selected reduced-
risk chemicals, reducing review time potentially by
years;
improving the tolerance petition format and creat-
ing new crop groupings;
streamlining the reduced risk justification format
for minor uses;
harmonizing registration data development with
other countries.
These efforts are already providing benefits.
Whereas the Agency established only one IR-4 spon-
sored tolerance in 1997, in 1999 the Agency established
32 tolerances for minor crops or minor crop groupings.
Based on its review of the IR-4 work plan, EPA plans to
review over 100 petitions on 40 active ingredients in FY
2000, which could result in 300 new registrations for
minor crops.
Biopesticide Profile:
Bacillus thuringiensis
subspecies
israelensisi (Bti)
In October 1998, the
I Agency registered
Bacillus thuringiensis
subspecies israelen-
sisi, part of a large
group of bacteria that
occur naturally in soil.
These bacteria are
toxic to certain
species of insects and
can be used as insec-
ticides. Called a
microbial pesticide,
Bti contains a bacteri-
um as its active ingre-
dient. Bti differs from
plant-pesticides which
are pesticides that
plants produce from
genetic material that
has been added to
the plant. Once
ingested by insects,
Bti bacteria release a
toxic protein into the
digestive system,
which results in
death. Primarily used
to control mosquito
larvae in aquatic habi-
tats, other public
health pests includ-
ing, black flies, gnats,
and filter flies are
controlled that can
transmit diseases such
as malaria, dengue
fever and encephali-
tis. Bti is a natural
bacteria that kills
insects by releasing
toxins which bind to
specific receptors in
their digestive sys-
tems. It poses no risk
to humans or other
non-target organisms.
An effective, low-risk,
low-toxicity pesticide,
Bti can be used
instead of conven-
tional public health
pesticides, many of
which are
organophosphates
which are toxic to
humans and other
non-target species.
FY 98-99 OPP BIENNIAL REPORT
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REREGISTRATION
THE OBJECTIVE OF EPA'S REREGISTRATION PROGRAM IS TO ENSURE THAT OLDER
pesticides meet contemporary standards of health, safety and product labeling and that
their risks are adequately mitigated. As directed by amendments to FIFRA in 1988, EPA
has been conducting a comprehensive review of pesticides initially registered before November
1,1984. In 1996, FQPA added new dimensions to the pesticide reregistration program. It set a
new, stricter safety standard for pesticide residues in or on food, and requires EPA to reassess all
existing tolerances within 10 years to ensure that they meet the new standard. FQPA's require-
ments - to consider the special sensitivities of infants and children, aggregate exposure and
cumulative effects of pesticides with a common mechanism of toxicity, and their possible
endocrine disrupter effects - apply to reregistration decisions for all food use pesticides.
Achieving Risk Reduction through
Reregistration
Through the reregistration program, significant
improvements in pesticide safety and use are being
made. EPA reviews and reregisters products, reassess-
es their tolerances and requires labeling changes to
achieve risk reduction. These reassessed products can
then be used more safely in the future, enhancing pro-
tection of users, the general public, and the environ-
ment. Some examples of risk reduction measures
include:
limits on amount, frequency or timing of applica-
tions;
improved use directions and precautions;
ground water and surface water safeguards;
requirements for personal protective equipment to
be worn when applying the pesticide;
Through the
reregistration
program, significant
improvements in
pesticide safety and
use are being made.
Profile of
Reregistration
Eligibility Decision
(RED): Captan
In 1999, EPAcomplet-
led a Reregistration
Eligibility Decision
(RED) for captan.
Because this fungicide
has a wide array of
agricultural and non-
agricultural uses, our
reevaluation included
all of the major new
FQPA factors and occu-
pational and ecological
risk assessments as
well. We found it does
not pose acute, chronic
or cancer risks of con-
cern through food or
drinking water.
Cancellation of lawn
uses eliminates residen-
tial exposure. Worker
risk is acceptable for
most occupational sce-
narios. New require-
ments for water solu-
ble bags, reductions in
application rates, use
of personal protective
equipment (PPE), and
revised reentry intervals
will mitigate remaining
occupational concerns.
Revised labeling will
reduce risks to non-tar-
get aquatic concerns.
Captan is used to
control diseases in
orchard crops, berries,
seeds, turf, and orna-
mentals, and is also
incorporated into
paints and adhesives as
an in-can preservative.
The Agency has classi-
fied captan as a B2
(probable human) car-
cinogen; however, all
dietary risk estimates
are below 1 X 10-6,
and worker risks are
below the level of con-
cern. There is no evi-
dence of special sensi-
tivity to infants and
children so the safety
factor was removed.
A potential common
mechanism of toxicity
exists for captan and
another fungicide,
folpet, because they
have a common
metabolite, thiophos-
gene. EPA conducted
a conservative aggre-
gate assessment for
thiophosgene, assum-
ing people may be
exposed through use
of both captan and
folpet, and concluded
that thiophosgene
does not pose risks of
concern. Because of
toddlers' exposure to
treated lawns, the
technical registrants
have agreed to volun-
tarily cancel captan's
residential lawn uses
and all other turf uses
except sod farms and
golf courses. Risks to
mixers and loaders of
wettable powder for-
mulations for aerial
applications will be
mitigated by requiring
the use of water solu-
ble bags or a suitable
reduction in application
rate. Captan is also
severely irritating to the
eyes. Thus, the
enhanced PPE required
includes eye protection
as well as chemical-
resistant gloves,
aprons/coveralls, and
dust/mist respirators in
various scenarios. Eye
wash stations are
required for occupa-
tional field workers
entering treated fields
as is repeated notifica-
tion for workers enter-
ing treated fields.
Updated reentry inter-
vals, ranging from 12
hours for seed treat-
ments to 4 days for
ornamentals, also are
required to protect
reentry workers.
FY 98-99 OPP BIENNIAL REPORT
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Insect Repellent
DEET:
Reregistration
Review and
Outreach Materials
In 1998, OPPcom-
I pleted its review of
DEET, a common
insect repellent and
an important public
health pesticide.
DEET repels biting
pests such as mosqui-
toes and ticks, includ-
ing ticks that may
carry Lyme disease.
Every year, approxi-
mately one-third of
the U.S.population is
expected to use DEET.
In a 1998 reevalua-
tion, OPP concluded
insect repellents con-
taining DEET do not
present significant
special programs to enhance protection of young
children; and
cancelling pesticide uses.
Establishing Stakeholder Process
During Pesticide Reregistration
Reviews
Aluminum and Magnesium Phosphide
Stakeholder Process
In December 1998, EPA initiated an extensive public
and stakeholder process to obtain input and ideas
about ways to reduce the risks associated with alu-
minum and magnesium phosphide, two fumigants
used to control insects and rodents where agricultural
commodities are stored. Our reevaluation had identi-
fied risks to bystanders and pesticide applicators from
exposure to phosphine, a highly toxic gas created when
these fumigants are used.
The Agency originally proposed 15 risk reduction
measures to increase the level of protection to
bystanders and pesticide applicators from exposure to
phosphine. The Agency received extensive comments
on the risk reduction measures and decided to extend
the schedule to allow more time for stakeholder
involvement, public input and complete consideration
health risks when
they are used correct-
ly, but it is important
for consumers to fol-
low label directions
and take proper pre-
cautions. OPP
required several
changes to current
product labels to
ensure that DEET is
applied safely, partic-
ularly on children.
DEET products can no
longer claim that
their products are
"child safe," and new
labels will instruct
parents not to allow
children to handle
these products.
Labeling for insect
repellency must be
displayed prominently
on any DEET products
that also have cos-
metic uses.
In partnership with
the American
Mosquito Control
Association, OPP
developed two fact
sheets for consumers:
How to Use Insect
Repellents Safely,
and Mosquitoes:
How to Control
Them. This consumer
information was
available for the sum-
mer use season in
1998 and 1999.
During the late sum-
mer and fall of 1999,
the fact sheet
Mosquitoes: How to
Control Them was in
high demand on the
East Coast due to
mosquito-borne ill-
nesses in the New
York City metropoli-
tan area.
of the alternative ways to reduce risks. The Agency
plans to issue a revised set of proposed risk mitigation
measures in late 1999 and final risk mitigation mea-
sures in 2000.
To identify feasible risk mitigation measures before
releasing a new proposal, we have been working with
the National Institute of Occupational Safety and
Health, the Occupational Safety and Health
Administration, and a coalition of industry groups and
user organizations. In addition, we are consulting with
the Phosphine Task Force, a group of experts from
Land Grant Universities and USDA Agricultural
Research Service scientists with expertise in commodi-
ty storage pest management systems who are investi-
gating possible alternative risk mitigation measures.
EPA recognizes the importance of phosphine to agri-
culture, the lack of viable alternatives, and the poten-
tial impacts from the initial set of risk mitigation mea-
sures. Final decisions will be based on sound science
and a full understanding of agricultural needs. With
full participation from stakeholders, EPA will be able to
develop improved risk mitigation measures that are
both protective and practical.
Rodenticide Cluster Stakeholder Process
In March 1998, EPA assembled a stakeholder work
group to explore and recommend ways to reduce the
risk of exposure to rodent control products, especially
accidental exposures experienced by young children.
The Rodenticide Stakeholder Workgroup was estab-
lished under OPP's advisory committee, the Pesticide
Program Dialogue Committee. Members of the work
group represent public health and environmental orga-
nizations, industry groups, government agencies, and
the general public. Through an ongoing series of pub-
lic meetings in the spring and summer of 1999, the
work group has developed an initial recommendation
for improved product labeling. EPA will use all the
workgroup's recommendations in developing a strate-
gy to reduce the risks of exposure to rodentiddes while
preserving their public health benefits. Meanwhile,
EPA is requiring rodenticide registrants to incorporate
an indicator dye and a bittering agent into their prod-
uct formulations.
FY 98-99 OPP BIENNIAL REPORT
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TOLERANCE
REASSESSMENT
EPA SETS TOLERANCES (MAXIMUM RESIDUE LEVELS) FOR PESTICIDES USED TO
grow food. By 2006, EPA must review the safety of all tolerances that were in effect when
FQPA was passed in 1996. Each of these reassessments must ensure that the resulting
tolerance level is safe for all consumers, particularly infants and children, and represents an affir-
mation of public health protection and the safety of the U.S. food supply. The law requires EPA
to place the highest priority for tolerance reassessment on pesticides that appear to pose the
greatest risk.
Reassessing Tolerances
Tolerance reassessment is being
accomplished through the pesticide
reregistration program. Through the
tolerance reassessment process, we can
make decisions to raise, lower, or main-
tain existing tolerance levels, or to
revoke existing tolerances entirely to
protect consumers from unsafe pesticides residues in
or on food.
Tolerance reassessment is a large task:
more than 450 pesticides and other ingredients
have tolerances or exemptions from the require-
ment for a tolerance;
there can be many tolerances associated with a
given chemical, which contributes to the complexi-
ty of the review;
9,721 tolerances were in effect when
FQPA was passed;
EPA met (and surpassed) the first
FQPA goal as we completed the
reassessment of over 33% of all
tolerances subject to reassessment by
August 3,1999.
By the end of 1999, EPA reassessed
3430 tolerances. Each of these toler-
ances are in conformity with the stringent new safety
standard of FQPA and are based on the latest sound
scientific methods, data, and policies. EPA placed all
pesticides with tolerances that must be reassessed into
one of three priority groups. Most (two-thirds) of the
tolerances reassessed are for pesticides in our highest
priority group-those that appear to pose the greatest
risk to public health, including the organophosphates,
carbamates, organochlorines, and carcinogens.
Many of these tolerances were for pesticides used
on the top 20 raw agricultural commodities frequent-
ly eaten by kids. Almost 40% of "kids'" food toler-
ances have been reassessed. Many decisions were also
for 'minor' uses, or pesticide uses on crops with less
EPA Reduces
Pesticides Risks to
Children
The U.S. Environ-
mental Protection
Agency announced
on August 2, 1999,
cancellation agree-
ments and risk reduc-
tion strategies to
increase protections
for American families
and their children
from risks posed by
two of the oldest,
most widely used
chemical compounds
in use as pesticides
today. Based on its
concerns, EPA is elim-
inating the use of
methyl parathion-
one of the more
potent organophos-
phates-on apples,
peaches, pears,
grapes, nectarines,
cherries, plums, car-
rots, certain peas,
certain beans, and
tomatoes, among
other fruits and veg-
etables. For azinphos
methyl, also consid-
ered to be a pesticide
of concern, the
Agency is reducing
application rates and
requiring practices
that will result in sig-
nificant reductions in
allowable residues on
apples, pears and
peaches. By the end
of next year, EPA is
scheduled to com-
plete its reassessment
of the organophos-
phates and several
other older, more
commonly used pes-
ticides, and to meet
the Food Quality
Protection Act's food
safety goals.
Priority Groups for
Tolerance Reassessment
EPA placed all pesticides with
tolerances that must be
reassessed into three priority
groups. FQPA requires EPA
to give highest priority to
pesticides that appear to
pose the greatest risk.
Group 1 (228 pesticides/
5546 tolerances) includes:
Organophosphates
Carbamates
Organochlorines
Probable carcinogens
Reference dose exceeders*
High-hazard
"other ingredients"
Group 2 (93 pesti-
cides/1928 tolerances)
Possible carcinogens
All remaining reregistration
chemicals (those that were
first registered before 1984)
Group 3 (148 pesticides/
2247 tolerances)
Remaining pre-FQPA
pesticides with reregistration
eligibility decisions
Remaining post-1984
pesticides
Biological pesticides
Remaining
"other ingredients"
* Dietary exposure at levels
above the amount that is
believed to be safe for life-long,
daily consumption
FY 98-99 OPP BIENNIAL REPORT
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V
The law requires
EPA to place the
highest priority
for tolerance
reassessment on
pesticides that
appear to pose the
greatest risk.
than 300,000 acres of total U.S. production, which
include many fruits and vegetables. (See Appendix,
Figure 2)
Establishing the Tolerance
Reassessment Advisory Committee
(TRAC)
On April 30, 1998, in a response to a request from
Vice President Gore to enhance stakeholder input on
FQPA implementation, EPA and USDA established the
Tolerance Reassessment Advisory Committee (TRAC)
as a subcommittee under the auspices of EPA's
National Advisory Council for Environmental Policy
and Technology. TRAC was established to consult
with, and make recommendations to, the
Administrator of EPA and the Secretary of Agriculture
on how best to reassess tolerances, including those for
organophosphate pesticides, as required by FQPA.
TRAC Accomplishments
TRAC has met seven times and followed the four
implementation principles outlined by the Vice
President: use of sound science in decision-making,
establishing a transparent regulatory process, ensuring
a reasonable transition for agriculture to new methods
and alternatives, and fostering the involvement of
stakeholders. The group helped the EPA and USDA
make significant progress in several areas critical to the
successful implementation of FQPA. For example,
TRAC:
fostered a broader understanding of the complexity
of pesticide regulation, the special considerations
that each sector brings to the table, and the ratio-
nale that EPA uses in making decisions;
identified key science policy issues related to toler-
ance reassessment and defined an approach to
refining these policies that includes substantial
public and expert input;
initiated a pilot approach for obtaining public com-
ment on preliminary risk assessments for the
organophosphate class of pesticides as part of
OPP's effort to improve transparency of decision
making;
increased focus on transition issues to prepare grow-
ers for possible changes in pesticide use patterns.
In July 1998, in consultation with TRAC, EPA and
USDA implemented a process that allows all stake-
holders to review preliminary risk assessments and
contribute to their improvement, as well as to provide
risk management ideas later in the process. This pilot
process was designed to increase transparency and
improve opportunities for stakeholder involvement. It
helps ensure that risk assessments are based on the
best available and most realistic data. By October 1,
1999, EPA had released 31 preliminary risk assess-
ments and 15 revised risk assessments through the
pilot process.
TRAC Profile
TRAC was com-
posed of approxi-
mately 50 members
approved by the
Deputy Administrator
of EPA and the
Deputy Secretary of
the U.S. Department
of Agriculture.
Members were
selected based on
their relevant experi-
ence and diversity of
perspectives on
organophosphate
pesticide/food safety
issues from the
following sectors:
environmental and
public interest
groups; pesticide
industry and trade
associations; user,
grower and com-
modity organizations;
pediatric and public
health organizations;
federal agencies,
tribal, state, and local
governments; acade-
mia; and consumer
groups. The Deputy
Administrator of EPA
and the Deputy
Secretary of
Agriculture served as
Co-Chairs of TRAC.
FY 98-99 OPP BIENNIAL REPORT
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Visits to the field help
OPP officials identify
the components of
an effective federal
program.
The final meeting of TRAC was held October 2 0 and
21, 1999. At the meeting, the Committee reviewed
lessons learned from the pilot process. EPA and USDA
received valuable feedback on how the process could be
modified for reassessment of other chemicals in the
future. This discussion included the role and involve-
ment of growers and other pesticide users. The input
from TRAC and other informal sources will be used to
develop a proposed new process, which will be pub-
lished for public comment by the end of 1999. This
proposed process would be used for all pesticides sub-
ject to reregistration or tolerance reassessment.
Publishing Tolerance Processing
Fees Rule Proposed
FQPA requires industry to cover the costs of setting
tolerances for pesticide residues on food. EPA is revis-
ing the current fee structure to bring it in line with the
new responsibilities mandated by FQPA, the increased
complexities of science reviews, and more sophisticat-
ed data management systems. Estimates show that, to
sufficiently recover costs, tolerance fees need to
increase.
The Agency's proposed rule on Pesticide Tolerance
Processing Fees was published in the Federal Register
on June 9, 1999 for comment. We will be assessing
these comments and working with our various stake-
holders during 2000 to refine our approach.
FY 98-99 OPP BIENNIAL REPORT
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WHAT ARE
THE NINE SCIENCE
POLICIES?
V
Applying the FQPA
10-Fold Factor
Dietary Exposure
Assessment-Whether
and How to Use
'Monte Carlo' Analysis
Exposure Assessment
-Interpreting
'No Residues Detected'
Findings
V
Dietary (Food)
Exposure Estimates
V
Drinking Water Exposures
V
Assessing Residential
Exposure
Aggregating
Exposures from All Non-
Occupational Sources
T
How to Conduct a
Cumulative Risk
Assessment for
Organophosphate
Insecticides or Other
Pesticides with a Common
Mechanism of Toxicity
V
Use of Data on
Cholinesterase Inhibition
for Risk Assessments of
Organophosphates and
Carbamates
SOUND SCIENCE
SOUND SCIENCE IS A NECESSARY FOUNDATION FOR THE TOUGH DECISIONS OPP
must make every day. Whether establishing new science policies to support FQPA imple-
mentation or improving our understanding of how pesticides interact with humans and
the environment, OPP tackled a number of important issues in 1998 and 1999.
Developing New Science Policies
Shortly after passage of FQPA, EPA began using a set
of guidance (developed with input from the Food
Safety Advisory Committee) in making various pesti-
cide-related decisions. In response to subsequent
advice from the Tolerance Reassessment Advisory
Committee (TRAC), EPA identified nine science policy
issue areas important to the implementation of FQPA.
On October 29,1998, EPA published a framework to
describe these issues and a preliminary schedule for
the release of the policy and guidance documents asso-
ciated with each issue. By the end of fiscal year 1999,
EPA had released for comment 14 of the original 19
planned science policy papers and issued one science
policy paper that had been revised in light of public
comments. In addition to the nine policy areas initial-
ly identified, EPA issued four additional draft papers
on related science issues for public comment. In late
fall 1999, EPA released two additional draft science pol-
icy papers and two revised papers. The remaining sci-
ence policy papers are scheduled for final publication
New Partnerships
with the Office of
Science
Coordination and
Policy
During 1999, OPP
collaborated with the
Office of Science
Coordination and Policy
(OSCP), a new organiza-
tion within the Office of
Prevention, Pesticides,
and Toxic Substances
(OPPTS). Established in
January 1999, the pur-
pose of the new office is
to coordinate the devel-
opment and implementa-
tion of cross-cutting sci-
ence policies and pro-
grams that underpin
EPA's toxic chemical and
pesticide programs.
OSCP is helping OPP to
identify and incorporate
the latest scientific and
technological information
into its risk assessment
and regulatory decisions.
Through its management
of the FIFRA Scientific
during FY 2000. The documents are posted on the
Internet when they are completed.
(http://www.epa.gov/pesticides/trac/science/)
Improving Our Protection for
Infants and Children
In 1998, we published updated testing guidelines for
use by registrants in conducting studies to evaluate the
prenatal, developmental and reproductive effects pesti-
cides may have on infants and children. New guide-
lines on conducting studies to evaluate the effects of
pesticides to their immune system were also published.
In May 1999, we submitted to the FIFRA Scientific
Advisory Panel (SAP) for review our draft policy and
operational practices for making decisions on the 10-
fold safety factor required by FQPA to protect infants
and children. The policy was released in July 1999 for
public review and comment based on the process
established in conjunction with the TRAC. FQPA
requires that each pesticide tolerance be protective of
infants and children, and that we use an appropriate
safety factor during risk assessment to account for
their special sensitivities.
Advisory Panel and
Science Review Board,
OSCP gives OPP access
to top scientific and
technical experts and
peer reviewers. OSCP is
coordinating the devel-
opment of EPA's
Endocrine Disrupter
Screening Program, a
program that will have
an important impact on
OPP-regulated chemicals.
Working with the nation-
al and international
scientific communities,
OSCP coordinates OPPTS
activities related to the
updating and harmoniza-
tion of national and
international testing
guidelines, standard sci-
entific operating proce-
dures, and Agency
research objectives.
Most importantly, OSCP
will work to ensure that
OPPTS's science-based
methods and policies set
the standard by which
sound science isjudged.
FY 98-99 OPP BIENNIAL REPORT
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X
Specifically, EPA is required to apply an additional
safety factor of 10 during its risk assessments to
account for the potential pre-and post-natal toxicity, as
well as for the completeness of the toxicology and
exposure database, unless the Agency determines that
another factor is adequately protective. Many of
FQPA's provisions to protect children are based on rec-
ommendations in the 1993 National Academy of
Sciences (NAS) report, Pesticides in the Diets of
Infants and Children. In keeping with FQPA, each
tolerance decision issued in 1998 and 1999 contained a
specific finding that the tolerance levels are appropri-
ately protective of children. EPA used available, reli-
able data when considering the need to retain or
replace the 10-fold additional safety factor.
Expanding Our Understanding of
Endocrine Disrupters
In recent years, evidence has arisen to suggest that
chemicals may disrupt the hormone (endocrine) sys-
tem of humans and wildlife and cause reproductive
disorders, birth defects, immune dysfunction and
other harmful effects. Because of the potential concern
from human exposure to endocrine-disrupting chemi-
cals, Congress included a mandate to EPA in the FQPA
and the 1996 amendments to the Safe Drinking Water
Act (SDWA) to develop an endocrine disrupter screen-
ing program.
Since receiving the statutory authority, EPA has
moved quickly to set up a screening program that can
be used to gather data on the endocrine-disrupting
potential of pesticides and other chemicals. On
December 28, 1998, we published in the Federal
Register a proposal for an Endocrine Disrupter
Screening Program (EDSP). EPA's proposed screening
program has the following characteristics:
a two-tiered screening program for chemicals, pesti-
cides, and environmental contaminants to detect
effects on the estrogen, androgen, and thyroid hor-
mone systems;
inclusion of evaluation of potential for effects on
human health and wildlife;
potential use of high-volume, automated technolo-
gy to screen large numbers of chemicals to help set
priorities (under research and development);
development of a relational database to help set
priorities and track data; and
standardization and validation of all assays before
regulatory use.
EPA is beginning to implement the Endocrine
Disrupter Screening Program using a tiered approach.
The tiered approach uses a priority setting process
for selecting the initial chemicals for the screening pro-
gram, developing methods for endocrine disrupter
screening and testing, and standardizing and validat-
ing the screening and testing methods for regulatory
programs.
Protecting Human Test Subjects
EPA is concerned about the welfare of people who
participate as test subjects in scientific research on
human health or the environment, regardless of who
conducts the research or how it comes to the Agency's
attention.
EPA neither requires nor encourages human toxicity
testing with pesticides, and will not rely on these data
to make final decisions under FQPA until a policy is in
place which can ensure that any such testing meets the
highest ethical and scientific standards.
In December 1998, EPA convened a special joint sub-
committee of its Science Advisory Board and the
FIFRA Scientific Advisory Panel to discuss ethical and
scientific issues surrounding human testing. The sub-
committee met again in November 1999. EPA will
develop its policy after the subcommittee submits their
recommendations.
Understanding and Predicting
Pesticide Spray Drift
OPP made significant progress during the last two
years towards gaining a more comprehensive under-
standing of the science of pesticide spray drift and
improving our ability to predict spray drift and the
associated potential risks under a wide array of agri-
cultural applications and weather conditions. We com-
pleted our assessment of the results of spray drift stud-
ies submitted by the registrants' Spray Drift Task Force
and cooperated with EPA's Office of Research and
FIFRA Scientific
Advisory Panel (SAP)
To help make decisions
and policies based on
sound scientific principles,
OPP frequently consulted
with the FIFRA Scientific
Advisory Panel (SAP) on
key issues. Managed by
EPA's Office of Science
Coordination and Policy
(OSCP), the FIFRA
Scientific Advisory Panel
consists of independent
outside scientific experts
who provide scientific
advice on health and envi-
ronmental impacts of pes-
ticides and pesticide relat-
ed issues. The panel was
created in 1975 through
amendments to the
Federal Insecticide,
Fungicide, and Rodenticide
Act, and modified by
FQPA.
The SAP's role extends
to peer-reviewing current
scientific issues which may
influence the direction of
OPP's regulatory decisions.
During 12 scheduled
meetings in FY1998 and
1999, OPP consulted with
the SAP on over 20 issues,
including:
human testing ethics,
determination of the
appropriate risk assess-
ment safety factor for
children,
methods to estimate
basin-scale pesticide
concentrations in drink-
ing reservoirs,
residential exposure
assessment procedures,
assessment of risk from
opportunistic human
pathogens,
assessment of cumula-
tive risk from pesticides
with a common mecha-
nism of toxicity,
the Endocrine Disruptor
Screening Program.
FY 98-99 OPP BIENNIAL REPORT
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Acute Dietary Risk
Assessments
Using Monitoring
Data:
In 1999, the Office of
I Pesticide Programs
(OPP) continued the
process of developing
new and refined tools
for estimating acute
dietary exposure and
risk to pesticides.
Significant accomplish-
ments include: devel-
opment of proposed
guidelines for conduct-
ing probabilistic, aggre-
gate and cumulative
risk assessments; devel-
opment of proposed
guidelines on regulating
acute dietary risk at the
99.9thpercentileofthe
exposed population;
and the development of
statistical models to
expand the applicability
of monitoring data to
assess acute dietary
exposure and risk by
"decompositing"
composited pesticide
residue samples to
better reflect pesticide
residues on single-
serving sized samples.
Development and the Task Force to develop predictive
modeling for our risk assessment and management
responsibilities for pesticides.
OPP sought outside expert opinions of these studies
and the modeling by consulting with the SAP and
other independent experts. Overall, these experts sup-
ported our conclusions of the studies and utility of the
spray drift model. Data from these studies are superi-
or to using the standard assumptions OPP previously
used to assess drift from aerial and ground applications
of agricultural pesticide sprays. These new data will
enable OPP to better understand the risks from spray
drift and will result in better informed decisions on
how applicators can control spray drift. OPP plans to
begin using these conclusions and the predictive model
for its risk assessments and, where necessary, risk
reduction strategies for applications of agricultural
pesticide sprays will be implemented.
Identifying and Developing
Ecological Risk Assessment
Methods
In May 1996, the FIFRA Scientific Advisory Panel
advised the Office of Pesticide Programs (OPP) to
improve the ecological risk assessment process by mov-
ing from the currently used methods which are useful
for screening purposes to more sophisticated, scientifi-
cally rigorous methods which could better support reg-
ulatory decisions. These new methods must be able to
predict the magnitude of the expected impact of pesti-
cide use on non-target organisms as well as the uncer-
tainty and variability involved in these estimates. In
response to this recommendation, OPP began a new
initiative in 1997 to strengthen the core elements of
the ecological assessment process by identifying, devel-
oping, and validating tools and methods to conduct
probabilistic assessments and to improve the charac-
terization of the risk by describing all attendant uncer-
tainties in the assessment. EPA formed the Ecological
Committee on FIFRA Risk Assessment Methods
(ECOFRAM) to review current assessment methods
and to develop new tools and approaches for terrestri-
al and aquatic assessments. This committee was com-
posed of scientific experts drawn from government
agencies, academia, industry, environmental advocacy
groups and contract laboratories. Members represent-
ed the appropriate disciplines and represented a cross-
section of affiliations.
In May 1999, the terrestrial and aquatic reports were
issued. They contained detailed and thorough recom-
mendations on risk assessment methodologies and
data requirements needed to perform probabilistic risk
assessments in these two areas. The reports received
peer review and comments in June and an implemen-
tation team was organized in August. The team's goal
is to prioritize the recommendations made by the com-
mittee, to set short term, intermediate and long term
goals for the program, and to identify data and
research needs that will provide the Agency with the
ability to perform refined probabilistic risk assess-
ments on those pesticides which most adversely affect
ecosystems and the environment.
The program is enthusiastically moving forward and
working with other offices within EPA, including the
Office of Water and the Office of Research and
Development, to develop new risk assessment tools,
exposure models and appropriate test guidelines need-
ed for probabilistic ecological risk assessment. By
improving methods and the ability to refine ecological
risk assessments for those chemicals which have the
greatest potential to adversely impact the environ-
ment, the risk managers in OPP will possess the infor-
mation required to make more informed regulatory
decisions that are based on sound, defensible science
and good public policy.
Improving Drinking Water
Exposure Assessments
FQPA mandates EPA to add the contribution of pes-
ticide residues in drinking water to the total dietary
exposure to pesticide residues. In order to improve its
methods of estimating pesticide concentrations in
drinking water and to obtain actual occurrence data on
these residues, OPP began working closely with the
Office of Water, the U.S. Geological Survey (USGS) and
industry to obtain occurrence data of pesticides in sur-
face and ground waters which supply drinking water to
the public. The ideal situation is to obtain monitoring
data on finished water taken during high pesticide use
seasons in agricultural areas throughout the United
States, or to be able to reliably approximate concentra-
tions using validated, predictive models. In additio
USGS and OPP have launched a reservoir pilot pn>
gram which will monitor surface water and fmi
water in 12 reservoirs throughout the United States;
The Office of Water (OW) and OPP have set up a
:oordination workgroup for the purpose of sharing
data on occurrence of pesticides in drinking water
monitored under the requirements of the Safe
Drinking Water Act. OPP now has access to occur-
rence levels of regulated pesticide contaminants,
pesticides considered as priorities for regulation
and others that are unregulated but are being moni-
tored due to production, release and physical prop-
erties. In addition, OPP and OW are working
together on cross-cutting science policy issues and
recommending research priorities to ORD for the
development and validation of exposure models
I
V
FY 98-99 OPP BIENNIAL REPORT
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which can estimate pesticides in drinking water
human health risk assessments and for use in prob-
abilistic ecological risk assessments;
OPP has improved the screening level model by
developing an index reservoir scenario to replace
the small pond model which also considers the per-
centage of the acreage treated with the pesticide (s);
OPP is working with the American Crop Protection
Association (ACPA) to design a national survey
with emphasis on surface water sources for drink-
ing water;
OPP is also developing a predictive model for and is
studying the effects of water treatment methods on
pesticide concentrations in drinking water.
Developing an Aggregate
Exposure and Risk Assessment
Tool: Hampshire Research
Institute's (HRI) Lifeline Software
Model
In June 1998, OPP entered into a co-operative agree-
ment with the Hampshire Research Institute (HRI) to
support the development of an aggregate and cumula-
tive risk modeling tool to be made available to the gen-
eral public. The computer-based modeling tool will
allow professional and non-professional persons inter-
ested in risk assessment to better engage in a discus-
sion of exposure and risks from pesticides in the envi-
ronment. This effort is geared toward more effective
protection of public health and the environment
through fostering the dissemination of reliable infor-
mation on risk, and by increasing the public's ability
to analyze, understand and make decisions about envi-
ronmental problems.
There are three main goals to this software modeling
project. The first is to stimulate investigation and dis-
semination of aggregate risk assessment concepts. The
project will develop literature and tools to help the
public understand the concept and role of risk assess-
ment in environmental decision making to allow for
greater public involvement. This is especially relevant
in light the new requirements of FQPA to investigate
aggregate exposure (exposure to a pesticide from mul-
tiple sources and by multiple routes) and, in the future,
cumulative risk (risk associated with concurrent expo-
sure to multiple pesticides that act via a common
mechanism of toxicity). The second goal is to support
development of a flexible computer model which per-
forms aggregate risk assessment by combining expo-
sures to chemicals used as pesticides from the dietary,
drinking water and residential routes of exposure
through utilization of a flexible computer model. The
tool uses new approaches to risk assessment evaluating
multiple exposures (aggregate) in a computer-based
platform that allows for input of currently available
information (the U.S. Census) and user-specified infor-
mation.
An additional goal of the project is to facilitate the
availability of the aggregate risk modeling tool to the
public at a cost that is not prohibitive. OPP believes it
is important to encourage the distribution of aggregate
risk assessment concepts and models to all interested
members of the general public in an understandable
format and at a cost that is affordable. OPP believes
that support of this software development, addressing
both aggregate exposure and cumulative risk, will help
to make scientific advancements compatible with more
effective public involvement in environmental deci-
sion making.
Collecting Pesticide Use
Information
In 1998, EPA began collecting available information
about current pesticide use (starting with the
organophosphates) and organizing it into tables or
crop matrices to improve accessibility and ease of use
by analysts, decision-makers, and stakeholders. Crop
matrices present, on a crop basis, the best available
information on actual use of organophosphates. The
information, largely quantitative, describes the percent
of each crop treated, average and maximum rates of
pesticide use, and number of applications. They also
identify target pests, alternatives to the organophos-
phates (OPs), and their constraints. OPP uses data
from the matrices to assess risks and to make decisions
about regulatory actions. Draft OP matrices for ten
crops are posted on the Internet at
http://www.epa.gov/oppbeadl/matrices. Matrices
for other crops will be posted as they are completed.
EPA Region III
Administrator,
Mike McCabe,
speaks during
the dedication
ceremony of the
new Environmental
Science Center in
Fort Meade, MD.
Opening of EPA's
Environmental
Science Center
In January 1999, labo-
I ratory staff from the
Office of Pesticide
Programs (OPP) and
Region 3 moved into
their new laboratory at
Fort Meade, Maryland.
The new lab replaces
outdated laboratory
facilities with state-of-
the-art technology and
consolidates six EPA
facilities formerly located
in Annapolis and
Beltsville, Maryland;
Cincinnati, Ohio; and
Research Triangle Park,
North Carolina; and is
the first non-Department
of Defense federal facili-
ty at Fort Meade. The
new Environmental
Science Center supports
enforcement & monitor-
ing for Region III and
analytical chemistry and
microbiology for the
Office of Pesticide
Programs. Its analytical
capabilities include
chemistry (organic, inor-
ganic, and metals)
analysis, biology, micro-
biology, and other scien-
tific activities that fur-
ther the mission and
goals of the Agency.
FY 98-99 OPP BIENNIAL REPORT
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PARTNERSHIPS
V
OPP works with
these partners, as
well as the diverse
stakeholder
community, in
developing and
applying better,
more consistent
pesticide program
policies and
decisions.
BY MAINTAINING STRONG COMMUNICATIONS WITH EPA REGIONS, OTHER
government agencies, states, and tribes, OPP promotes the Agency's mission of pro-
tecting public health and the environment from the risks pesticides may pose and pro-
moting safer means of pest control. OPP works with these partners, as well as the diverse stake-
holder community, in developing and applying better, more consistent pesticide program poli-
cies and decisions.
Providing Support for Regional
Initiatives
Pesticide Urban Initiative
Misuse of pesticides in residential settings has been
a recurring problem for many years, with a series of
highly dangerous incidents sharply increasing OPP's
level of concern. In several separate incidents a highly
toxic agricultural pesticide, methyl parathion, was ille-
gally used indoors to control cockroaches. EPA took
action on two fronts: our Superfund program led a
lengthy and expensive cleanup efforts in private
homes; enforcement actions focused on stopping this
extremely dangerous practice and developing ways to
prevent future misuse incidents. Our enforcement
partnership included pesticide and enforcement pro-
grams-espedally in our EPA regional offices and our
state lead agencies.
In response to our increased concern, EPA devel-
oped a strategy in 1999 called the Pesticide Urban
Initiative, to help stop pesticide misuse. Key compo-
nents of the strategy include increased regulatory and
enforcement presence in urban communities to detect
diversion of agricultural pesticides to urban areas, and
enhanced outreach effort to educate the public on the
dangers of misuse of pesticides. EPA is providing
training and compliance assistance to states in imple-
menting this program, such as workshops with state
agriculture departments and cooperative extension
services.
EPA issued a public service announcement providing
information on how to hire an appropriate pest control
service and about the dangers of pesticide misuse.
Articles describing the consequences of pesticide mis-
use and pest control methods were published in various
medical and consumer publications. EPA regional
offices have developed a wide variety of outreach mate-
rials, often in cooperation with extension service and
state agencies, and are actively conducting seminars
and training sessions for state and local health depart-
ment staff, homeowners and apartment residents.
Developing Stakeholder
Partnerships
Pesticide Environmental Stewardship
Program
The Pesticide Environmental Stewardship Program
(PESP) is a voluntary partnership between EPA and the
pesticide user community to reduce pesticide risk in
agricultural and nonagricultural settings. Organi-
zations with a commitment to reducing pesticide risk
Regional
Agricultural
Initiatives
To increase communi-
cations between EPA
and stakeholders on
issues relating to FQPA,
four pilot projects were
initiated. Highlights of
the four pilots include:
Region 4 (Atlanta)
enrollment of more than
163 thousand acres of
farmland in the Delta
F.A.R.M. project
(Mississippi), designed
to increase the accep-
tance of best environ-
mental practices, and
development of crop
profiles in Florida, which
will provide better data
on current pesticide use.
Region 5 (Chicago)
a pesticide residue study
conducted by Michigan
State University and the
Michigan Department of
Agriculture, which will
result in more accurate
risk assessments for
minor use crops.
Region 9 (San
Francisco)
ajoint project between
the California grape
industry, the University
of California, USDA, and
others to develop a
comprehensive overview
and analysis of the
problems faced by grape
growers, current pesti-
cide use, and available
alternatives.
Region 10 (Seattle)
a cooperative agree-
ment with Washington
State University to study
biological controls, alter-
native crop systems,
precision pesticide
application, and other
mechanical and cultural
practices which might
mitigate pesticide risk.
FY 98-99 OPP BIENNIAL REPORT
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OPP staff and pineapple farmers discuss
integrated pest management (IPM) strategies
under the PESP program
are eligible to join PESP either as Partners or
Supporters. Partners are organizations that either use
pesticides or represent pesticide users. Supporters are
organizations that have an interest in pesticide issues.
PESP's membership now includes over 100 Partners
and 25 Supporters who have agreed to develop and
implement strategies to reduce pesticide risk and to
report regularly on their progress. OPP provides each
Partner and Supporter with a liaison to help them
obtain information not only about the partnership, but
about other EPA programs, policies, and procedures.
PESP also works to reduce pesticide risk in non-agri-
cultural settings. A PESP Supporter, the Bay Area
Stormwater Management Agencies Association (BAS-
MAA) reported that diazinon and chlorpyrifos, pesti-
cides widely used in urban landscapes, were exceeding
acceptable levels in the surface water runoff in the San
'randsco Bay area. In this urban area (population of
million), homeowner use was identified as a major
mirce of diazinon and chlopyrifos reaching the creeks.
Using funds from OPP and the State of California,
BASMAA developed a program to educate sales per-
sons and the general public in pesticide retail outlets
(landscape nurseries, hardware stores) about the use of
less toxic pesticides and integrated pest management.
In one hardware store, diazinon sales decreased 20%
while the sales of less toxic pesticides increased 20%.
The store personnel attributed these results to the edu-
cational program. BASMAA plans to expand this pro-
gram from four pilot stores to more than 100 in the Bay
area. Detailed information on PESP, its members and
their activities, and funded projects is available on the
Internet at www.pesp.org.
EPA Partnerships with Potato Grower
Stakeholders
In October 1998, in a cooperative effort with the
Wisconsin potato growers, University extension spe-
cialists, and Zeneca Ag Products, EPA issued an
Experimental Use Permit (EUP) to test azoxystrobin, a
"reduced risk" pesticide for use on potatoes in
Wisconsin to control early and late blight. The
Experimental Use Permit generated information that
was useful for the preparation of the risk assessment for
the registration of the use on potatoes. The latest
health risk assessment including potatoes reinforced
the benign nature of azoxystrobin, as determined dur-
ing previous registration activities on this chemical.
The tolerance on potatoes was established later in 1999.
The Consumer Labeling Initiative
The Consumer Labeling Initiative (CLI) is a volun-
tary, cooperative effort among OPP, the Office of
Pollution Prevention and Toxics (OPPT), other federal
and state agencies, industry, and the public, to foster
pollution prevention and to improve consumer under-
standing of safe pesticide use and information on
household consumer product labels. The CLI has been
focusing on indoor insecticides, household hard sur-
face cleaners, and outdoor pesticides.
In 1999, EPA approved most of the CLI Partner/Task
Force recommendations, including label changes,
ingredient information, and disposal instructions.
OPP will issue Pesticide Registration Notices and/or
Federal Register Notices, as appropriate, to implement
the label changes. OPP continues to work with state
and local and industry representatives to develop
revised disposal label instructions; a draft proposal is
planned for late in 1999. Outreach efforts included
presentations to EPA staff and other interested organi-
zations around the country, a CLI web site, and other
program status updates. The CLI team, at manage-
ment's direction, continued to develop educational
materials, a logo, and an implementation strategy for
the consumer education campaign. All of the research
and work done under Phase II was included in the CLI
Phase II Report. This report was peer reviewed and the
CLI plans to publish the report in late 1999.
Coordination with Infection Control
Specialists in Medical Facilities
One of OPP's successful outreach activities involved
the Association for Professionals in Infection Control
and Epidemiology (APIC). Members are infection con-
trol specialists who work primarily in health care set-
tings. APIC has the formidable task of trying to reduce
the number of hospital-acquired infections occurring
in the United States, currently estimated at more than
2 million annually. Because approximately 1,000 out
of 5,000 registered antimicrobials products are hospi-
tal disinfectants, OPP has opened a dialogue with APIC
members to explore areas of mutual interest.
APIC members indicated a need to know which
agency to call with specific questions about infection
V
Profile on
PESP
As funds allow, OPP
provides PESP with
money to support pest
management projects
that reduce pesticide
risk. The Texas
Association of
Nurserymen, with assis-
tance from Texas A&M
University and EPA,
have succeeded in get-
ting IPM information
about horticultural
crops into the hands of
growers over the Inter-
net. Their website at,
http://www.hortipm.tam
u.edu averages 1.5 mil-
lion hits per month,
36% from growers, and
32% from extension
agents who advise
growers. The site pro-
vides detailed informa-
tion on, and pictures of
pest identification,
scouting methods, and
cultural, biological and
chemical pest control
methods. The site's
users highly rate the
advice they get from
the site: 47% of users
think the pest solutions
provided are good or
outstanding: and 100%
say they will continue
using the site. Quick,
reliable access to this
information will allow
growers to make pest
control decisions using
the latest reduced-risk
technologies.
FY 98-99 OPP BIENNIAL REPORT
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Working Closely
with State and
Federal
Laboratories
OPP operates three
laboratories
which work closely
with State FIFRA labo-
ratories providing
technical support for
compliance monitor-
ing and enforcement
activities, as well as
assistance with quality
assurance and train-
ing. In 1998 and
1999, OPP and states
cooperated to help
develop critically
needed methods for
analyzing herbicides
which require newer
analytical and instru-
mental technologies.
More and better
residue monitoring
data for organophos-
phates (with emphasis
on children's foods)
will be the result of a
new agreement
between OPP and
FDA. Our Analytical
Chemistry Laboratory
is working with FDA
to develop multi-
residue methods at
least ten times as sen-
sitive as the old meth-
ods. Using those
methods, FDA
through its existing
network of field labo-
ratories and compli-
ance monitoring pro-
gram, will analyze a
thousand imported
and domestic food
samples in the com-
ing year.
OPP's Microbiology
Laboratory has begun
a collaborative
research project with
the FDA's Engineering
and Analytical Center
to evaluate new pro-
cedures and equip-
ment to improve the
tuberculocidal test.
OPP laboratories
include:
a microbiology lab,
which conducts
efficacy testing of
antimicrobial pesti-
cide products of
public health signif-
icance, such as
hospital disinfec-
tants;
an analytical chem-
istry lab, which
evaluates analytical
methods to detect
pesticides in foods
and fibers to
ensure that the
methods are suit-
able for enforce-
ment monitoring;
and
an environmental
chemistry lab spe-
cializing in evaluat-
ing test methods
for pesticides in soil
and water to deter-
mine if they are
suitable for gener-
ating reliable data
to support pesti-
cide registration
and reregistration
decisions.
control practices and products. OPP, with input from
other agencies, prepared a document to answer APIC s
most immediate questions. The document explains
that EPA generally is responsible for products that con-
trol germs on inanimate surfaces and objects; such as
walls and bedpans, and for some products that treat
medical waste before disposal. (Liquid chemical steri-
lant products used on critical and semi-critical medical
devices are FDA's responsibility.) APIC and OPP have
exchanged drafts of various manuscripts to help
ensure their accuracy and usefulness. Future activities
may include: arranging site visits between OPP staff
and APIC members, making APIC training courses
available to OPP staff, working together to make label-
ing more user friendly; and discussing ways of treating
medical waste before disposal.
Partnering with States and Other
Agencies
EPA and Texas Aquatic Herbicide
Workgroup
OPP and our Region 6 office in Dallas, Texas estab-
lished an Aquatic Herbicide Workgroup to work with
the Texas Department of Agriculture to negotiate risk
mitigation measures that would allow Texas to use
endothall and diquat dibromide. These efforts provid-
ed the necessary tools to the state to control of aquatic
weeds, while ensuring that the use of these pesticides
would not cause unreasonable adverse effects to
humans and/or the environment.
OPP and the Association of American
Pesticide Control Officials (AAPCO)
Celebrate 20 Years of Partnership
In an effort to fulfill the need for information
exchange between OPP and state regulatory officials
regarding the implementation of the amended Federal
Insecticide, Fungicide and Rodenticide Act, a coopera-
tive agreement was entered into in 1978 by OPP and
AAPCO. It created the State FIFRA Issues Research and
Evaluation Group (SFIREG), which consists primarily of
state pesticide regulatory officials. Reports that contain
valuable information and recommendations on matters
relating to pesticide registration, enforcement, training
and certification, water quality, disposal, and other areas
of environment concern are received from co-sponsored
meetings with SFIREG. Both parties continue to work
together to ensure the development, guidance and
approval of state pesticide programs and policies.
Working with USDA to Bring
Conventional Reduced Risk Pesticides
to the Marketplace
As a result of a January 1999 meeting between the
Environmental Protection Agency and the U.S.
Department of Agriculture, the Interregional Research
Project 4 (IR-4) has accelerated data development
efforts to support tolerances for the pesticide spinosad
for all crop groups. The expanded use of this pesticide
is expected to provide alternatives to many
organophosphates (OPs) used on a wide variety of
fruits and vegetables. The IR-4 expects to complete all
spinosad residue data requirements and submit toler-
ance petitions, covering major and minor crops, to the
Agency early in the year 2000.
FY 98-99 OPP BIENNIAL REPORT
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In 1999, the Agency approved an emergency exemp-
tion (Section 18) for the use of spinosad for the 1999
season's Medfly program of the Florida Department of
Agriculture. The Agency is hopeful that with its
approval, spinosad will become the principal pesticide
used in Florida to address Medfly outbreaks. The avail-
ability of this lower risk pesticide will allow Florida to
phase-down and/or phase-out the use of malathion in
their Medfly programs.
Joint EPA/USDA Seminars on
Pesticide Use
In a joint venture with USDA, OPP provides staff
with in-service education by hosting approximately 22
seminars a year. Speakers come from universities and
industries throughout the U.S. to discuss a variety of
subjects, ranging from minor crops to non-agricultural
uses of pesticides. Topics cover field experience in pest
management in a variety of crops, such as sweet pota-
toes, apples, cotton, wheat, stored grains, corn and
sorghum, canola, and wild rice, as well as regional
crops in the northeast, mid-Atlantic, southeast and
New Mexico. Seminars in the past year outlined pro-
duction of California pistachios, northwest small
berries, California carrots, wine grapes, and processed
tomatoes in California. Alternative pesticides were dis-
cussed in various seminars, most notably for atrazine
in corn and sorghum weed management and for syn-
thetic fungicides. Even pesticide tracking and report-
ing systems were described in seminars on The
California Pesticide Use Reporting System and An
Overview of Non-agricultural Uses of Insecticides in
the U.S. All seminars were well attended and provided
excellent opportunities for meaningful dialogue.
Coordinating International
Activities
The overall goals of OPP's international efforts are
to promote improved health and environmental pro-
tection world-wide, and to ensure that international
trade initiatives and other agreements are consistent
with the high level of protection afforded by U.S. laws.
With the expansion of international trade in agricul-
tural and chemical products, it is no longer possible to
separate domestic and international issues, and a glob-
al approach is often required. In 1998, we worked with
a number of partners at the bilateral, regional, and
global levels. These cooperative activities will result in
reducing risks more quickly, promoting food safety,
helping save resources by avoiding redundant efforts,
and leading to better and more consistent program
decisions grounded in sound science.
International Agreements
Regional Treaty on Persistent Organic
Pollutants-ln June 1998, the U.S., Canada, and
European countries (including the Russian Federation
and Newly Independent States), signed a legally bind-
ing protocol on persistent organic pollutants.
Persistent organic pollutants are toxic chemicals that
do not readily break down in the environment and that
bioaccumulate through the food chain. Initially, the
chemicals covered by the agreement include aldrin,
chlordane, DDT, dieldrin, endrin, heptachlor, mirex,
toxaphene, hexachlorobenzene, PCBs, dioxins and
furans. Other chemicals may be added as scientific evi-
dence warrants. The protocol establishes obligations
aimed at restricting or eliminating persistent organic
pollutants and will inform ongoing efforts to develop a
global persistent organic pollutant agreement.
Prior Informed Consent-In September 1998,
the United States signed the Convention on the Prior
Informed Consent Procedure for Certain Hazardous
Chemicals and Pesticides in International Trade. This
agreement governs trade in pesticides and other haz-
ardous chemicals that have been banned or severely
restricted in the U.S. or other countries based on health
or environmental risk concerns, or which pose special
risks in developing countries. Participating countries
are obligated to provide information about regulatory
actions and to prohibit the export of PIC chemicals
when importing countries indicate that they do not
want to receive shipments.
Working with the Organization for
Economic Cooperation and
Development
Harmonization and Work Sharing-The
Organization for Economic Cooperation and
Development's (OECD) Pesticide Working Group pro-
vides a forum where governments can express their points
of view, share their experiences, and search for common
answers on pesticide regulatory issues. One of the main
objectives of the OECD Program is to make registration
and re-registration evaluations more efficient by harmo-
nizing the structure and content of pesticide review
reports and sharing the work of reviews. In 1998-1999,
OECD Member countries reached agreement on harmo-
nized formats for dossiers (industry data submissions)
and monographs (country review reports). Common for-
mats are critical to sharing the work of pesticide registra-
tion successfully. Guidance documents on dossier and
monograph formats were adopted in February 1998 and
made available on the Internet. An expanded version of
these documents will be published in 2000.
In 1998-1999, progress was made on harmonizing
data requirements, including a workshop on common
core data requirements for pheromones and an initial
FY 98-99 OPP BIENNIAL REPORT
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proposal for common core requirements for microbial
pesticides. The outcome of a series of workshops held
in 1999 to develop a proposal for common data require-
ments to establish Maximum Residue Limits (MRL) will
be presented to the OECD Pesticide Working Group in
2000. Agreement on data requirements for MRLs is
important not only to OECD Member countries, but
also to the work of the Codex Alimentarius
Commission, which sets international MRLs.
Classification, Labeling and Test
Guidelines-The 1992 United Nations Conference
on The Environment and Development endorsed the
development of a globally harmonized system of
chemical hazard classification and labeling, with a goal
for completion by the end of the year 2000. Through
OECD, international consensus was achieved in late
September 1998 on classification criteria for eight
health and environmental endpoints: acute toxicity;
aquatic toxicity; cardnogenicity; eye and skin irrita-
tion/corrosivity; germ cell mutagenicity; reproductive
and developmental toxicity; and sensitization. Criteria
for physical hazards, such as flammability and explo-
sivity, are also substantially complete. Efforts are
ongoing to harmonize hazard labeling and approaches
for dealing with chemical mixtures.
EPA completed work on a number of test guidelines,
harmonizing EPA's requirements internationally
through OECD. Among the guidelines published in
1998 were those governing testing for key reproductive
and developmental endpoints.
Codex
OPP continued to support the Codex Alimentarius
Commission, a joint program of the United Nations
Food and Agriculture Organization (FAO) and World
Health Organization (WHO) that sets international stan-
dards for pesticide residues in foods. The United States is
working to improve the scientific basis and timeliness of
Codex decisions, and to boost public participation.
North American Free Trade Agreement
(NAFTA) Activities
Cooperative work with Canada and Mexico under the
NAFTA Technical Working Group on Pesticides contin-
ued to grow in 1998 and 1999. The first joint review of
the conventional "reduced risk" pesticide was successful-
ly completed in 1998, with coordinated registrations
issued in Canada and the United States. In 1999, the
United States and Canada completed the joint reviews of
two additional conventional "reduced risk" pesticides
and one pheromone. NAFTA countries developed a pro-
cedure and priority scheme for handling agricultural
impediments to trade (e.g., different registrations or tol-
erances) and are continuing to work with growers and
pesticide producers to resolve them, particularly with
respect to canola production and pesticide seed treat-
ments. In 1999, OPP worked with the Office of
Enforcement and Compliance Assurance to complete a
United States-Canada Memorandum of Understanding
(MOU) on Good Laboratory Practices, aimed at pro-
moting reciprocal acceptance of high quality data to
support pesticide registrations in both countries.
Under NAFTA, a cooperative project between OPP
and its Canadian counterpart, the Pesticide
Management Regulatory Agency (PMRA) was initiated
to determine the distribution of landscapes in the
northern tier states of the United States which are sim-
ilar to the soil landscapes in the southern regions of
several Canadian provinces.
Assuming pesticide dissipation is comparable
among similar soil landscapes and climatic regions
with corresponding management practices and crop-
ping patterns, the identified landscapes could be used
for conducting terrestrial field dissipation studies in
support of pesticide registration in both countries.
Field studies conducted in similar landscapes would
reduce the costs associated with field dissipation stud-
ies and increase knowledge of pesticide dissipation
under field conditions. Comparable soil landscapes
will be identified using a customized Geographic
Information System (GIS) application with crop distri-
butions, ecological regions of North America, rainfall
distribution, soil temperature regimes, and various soil
attributes in the Canadian Soil Landscapes System and
the U.S. State Soil Geographic Database (STATSGO).
OPP will further benefit from the project through
increased access to geo-spatial data (e.g., crop distribu-
tions, soils information) to refine risk characterizations
and improve guidance for evaluating terrestrial field
dissipation studies.
Cooperating with Developing Countries
To enhance environmental protection world-wide,
OPP and its Regional offices work with developing
countries to improve pesticide regulation and promote
the sound management of chemical production, distri-
bution, use and disposal. Activities in 1998 included:
training and consulting with the Pesticide
Secretariat of the Indonesian Ministry of
Agriculture as part of a capacity-building project
funded by the World Bank;
developing a Central American regional pesticide
laboratory training seminar, in collaboration with
international development agencies;
working with the Choluteca community in
Honduras on a community-based pesticide risk
reduction plan which could serve as a model for
other Central American communities; and
initiating new pest/pesticide management project
with Ukraine, under the leadership of Region 5 and
in cooperation with the Agency for International
Development and Virginia Tech.
FY 98-99 OPP BIENNIAL REPORT
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FIELD PROGRAMS
THE EPA'S OFFICE OF PESTICIDE PROGRAMS (OPP) RELIES HEAVILY ON
cooperative relationships with EPA regional offices, state pesticide regulatory agencies,
and tribes, in addition to public and private organizations and other stakeholders to
carry out its regulatory programs in the field.
tations with the FWS to include specific pesticides and
species. Finally, the Endangered Species Protection
Program continues to work with the pesticide indus-
try's FIFRA Endangered Species Task Force, which was
formed to address certain endangered species protec-
tion conditions on new registrations.
Highlighting a Success: The Peregrine
Falcon and the American Bald Eagle
On August 20,1999, the Department of the Interior
announced final action removing the peregrine falcon
from the Endangered Species List. A proposal to
remove the American bald eagle from the list was
announced in July 1999.
The removal of these birds from the Endangered
Species list is the culmination of the good work of
many people and agencies through the years. It is a
reminder that laws, such as FIFRA and the Endangered
Species Act, in combination with the will and skill to
administer them, can make a profound difference in
our environment.
Recovery of these birds began with, and would not
have been possible without, the cancellation of DDT in
the 1970's. The decision to cancel DDT was difficult
and controversial, but the results have paid off many-
fold for protecting human health and the environment.
Developing the Ground Water
Pesticide Management Plan
Program
The ground water Pesticide Management Plan
(PMP) program continued to move forward in 1998-
99. When final, the PMP program will provide states
and tribes the opportunity to manage use of pesticides
known to be found in ground water. The PMP pro-
gram employs management measures that can be tai-
lored by states or tribes to reflect their philosophy on
ground water protection, pesticide use in their area,
and the use, value, and vulnerability of ground water.
The regulatory review team continued efforts to
address public comments on the proposed regulation
and to develop the final regulation, which is anticipat-
ed to be promulgated in the Spring of 2000.
The woodstork is protected by the
Endangered Species Protection Program
Focusing on the Endangered
Species Protection Program
The Endangered Species Protection Program relies
on cooperation between the U.S. Fish and Wildlife
Service (FWS), EPA Regions, states, and pesticide users.
The goal of the Endangered Species Protection Program
is to protect threatened and endangered species from
potentially harmful effects of pesticides, while mini-
mizing the impact of the program on pesticide users.
In 1998 and 1999, the Endangered Species
Protection Program focused on improving the avail-
ability of public and technical information, and con-
sultation with stakeholders. OPP upgraded its toll-free
endangered species information line to include "fax-
back" capability for county bulletins, which contain
measures pesticide users can take to prevent harm to
endangered species. OPP also upgraded the species-
by-county database to include all species listed through
June 1999, and made the database Internet-accessible.
With development of a new Geographic Information
System data for several states, OPP is overlaying crop,
rangeland and forestry information with species loca-
tions and pesticide use data for two pilot states in the
western United States. Preliminary results indicate
that this will be a powerful tool in focusing our consul-
V
The removal of
these birds from
the Endangered
Species list is the
culmination of the
good work of many
people and agencies
through the years.
FY 98-99 OPP BIENNIAL REPORT
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New Regional
Approach to
Pesticide
Education and
Enforcement
In 1998, EPA
I Region 10 initiated
a new "circuit rider"
staff position to
work with six tribes
in the region. The
new staff person
travels among the
six reservations and
enforces tribal and
federal pesticide
regulations, while
sharing information
with the tribes that
use pesticides or
are impacted by
pesticides.
The PMP program is unique in that it recognizes the
local knowledge possessed by states and tribes regard-
ing the ground water resource; the regulatory review
team is unique in that all 10 EPA Regional Offices, plus
10 states and three tribes, are represented.
Two innovative PMP outreach activities began in
1998 and 1999. OPP designed a new approach to pro-
viding information and technology transfer in Indian
Country. More than 5% of the nation's land base is
located on tribal lands and over sixty tribes have been
identified as having significant agricultural operations
affected by the proposed PMP rule. The Agency's tribal
outreach efforts were designed to improve the knowl-
edge of tribal environmental agencies and staff about
developing PMPs using training which considers Native
American land-use and cultural beliefs and practices.
In 1998 and 1999, the regulatory review team con-
ducted 22 training sessions or workshops in Indian
Country. These included outreach sessions, rule-edu-
cation workshops to guide participants through the
essentials of OPP's rulemaking and chemical-specific
management programs, and workshops for training
interested tribes in developing a model or "shell" PMP.
During the first six months of the program, more than
250 tribal officials and environmental professionals
were introduced to the PMP concept of adopting man-
agement measures based on local natural conditions
and levels of pesticide use.
Also in 1998, a team from EPA Headquarters and EPA
Region 7, joined by state agencies from Missouri,
Kansas, Iowa and Nebraska, and two grower organiza-
tions, developed, planned and executed a process to bet-
ter inform growers of the provisions of the PMP rule.
Approximately 100 people representing growers,
industry, natural resources protection agencies, public
interest groups, universities, and federal agencies,
attended a workshop that allowed participants to devel-
op parts of a "mock" PMP and put it into practice based
on several different scenarios of pesticide use and
ground water contamination detections. According to
evaluations from participants, the workshop was a suc-
cess and can be used as a model to engage the grower
community on a variety of issues in the future.
Preventing Pesticides in the
Environment Through Container
And Containment Standards and
Support of Collection Programs
OPP continued developing final regulations for pes-
ticide container standards and containment areas.
While the regulations do not specifically address dis-
posal of unwanted pesticides, OPP continues to sup-
port state efforts. States have taken the initiative to col-
lect and dispose of unwanted pesticides to prevent
these products from winding up in ditches, streams,
and ground water.
These efforts, referred to as Clean Sweep Programs,
play an important role in pollution prevention and, as
funding allows, are supported by EPA Regional Offices
through grants and technical assistance. While some
programs are fully implemented and permanent oper-
ations for regular collection and disposal of unwanted
products, many states face unpredictable funding and
operate their programs on an occasional or one-time
basis when funds are available.
During 1999, OPP began tabulating data on Clean
Sweep Programs, and developing a clearinghouse for
information on this topic. Information gathered by
OPP shows these programs are increasing and are col-
lecting greater volumes of unwanted pesticides.
Between 1989 and 1998, over 13 million pounds of
unwanted product were collected and disposed of
safely.
OPP will compile the data and individual state infor-
mation in a Clean Sweep Report during the year 2000.
The report will publicize successes of Clean Sweep pro-
grams nationwide, and provide ideas and information
for program managers wishing to initiate or improve a
program. The report will also support EPA's integrated
strategy on persistent and bioaccumulative toxic chem-
icals (PBTs), which includes both national programs,
such as the Great Lakes National Program Office, and
international treaty negotiations, such as the Persistent
Organic Pollutants (POPs) Protocol.
In 1999, OPP issued a Call for Proposals to fund pro-
jects for states, tribes, or counties to monitor and
report the amount of specific pesticides collected dur-
ing Clean Sweep Programs and to estimate the cost of
tracking this additional information. OPP is interested
in data on amounts of all pesticides, but is focusing on
those which support EPA's broad PBT Initiative and the
POPs treaty negotiations.
Developing Tribal Initiatives and
Programs
Like states, tribes have primary responsibility for
enforcing pesticide regulations under FIFRA. A num-
ber of tribes provide this function under a grant agree-
ment with EPA Regions and are in the process of devel-
oping programs for these areas as needed. OPP works
with tribes, EPA Regions, states, other EPA program
offices (e.g., the American Indian Environmental
Office, Office of General Counsel) and other federal
agencies coordinating efforts related to tribes and pes-
ticides. It is OPP's goal to help tribes resolve pesticide
issues regardless of their capacity or whether they have
an established pesticide program.
FY 98-99 OPP BIENNIAL REPORT
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Currently, OPP works with over 25 tribes that have
pesticide programs, helping them develop ground
water, certification and training, worker protection
and endangered species components of their pro-
grams. Other activities relating to Tribal Initiatives
and Programs include:
National Tribal Pesticide Council-ln
September 1999, EPA awarded a cooperative agree-
ment to Native Ecology Initiative (NEI) to organize a
national group-the Tribal Pesticide Program Council
(TPPC). Membership will initially include 30 tribes
that now have EPA pesticide programs and a number of
tribes with pesticide interests. The TPPC will promote
and enhance tribal pesticide program development,
raise pesticide issues important to tribes and their peo-
ple, and deal with policy at the national level. TPPC
issues will include pesticide registration, training,
enforcement, certification, ground water, disposal and
spray drift. The national group give tribes a mecha-
nism for communication and organization similar to
that provided by the State FIFRA Issues Research and
Evaluation Group (SFIREG) for the States.
Outreach to Tribes on Groundwater
Management-Dunng 1998 and 1999, through a
grant with the Native Ecology Initiative, EPA provided
tribes across the country with information on EPA's
proposed Pesticide Management Plan rule, as well as
technical and legal assistance for developing ground-
water management plans. EPA also entered into an
Interagency Agreement (IAG) with the U.S. Geological
Survey (USGS) to support tribes and states in the
development of PMP's. In this IAG, USGS assists
tribes and states as they collect, integrate and interpret
existing technical information and apply it to their
lands of interest as they develop a PMP.
Tribal Pesticide Projects-\n 1998, OPP solicited
tribal pesticide project proposals through the Regions
and awarded grants for the projects to tribes across the
nation. The projects addressed various pesticide issues
on tribal land. Six out of ten project proposals were
chosen.
There was a significant increase in the submission of
tribal project proposals in 1999. Eight out of 25
groundwater project proposals submitted were funded
from Regions 6, 7, 8 and 9. Six out of 19 special pesti-
cide project proposals submitted were funded from
Regions 8, 9 and 10. The types of projects selected for
funding ranged from the development of groundwater
pesticide management plans to assessing the impact of
pesticides on culturally significant plants and subsis-
tence hunting and fishing.
Supporting Agricultural Workers
Special Protection for Agricultural
Workers
EPA places strong emphasis on assuring the health
of workers whose jobs require mixing, loading, or
applying pesticides, and is committed to strengthening
national efforts to safeguard upwards of 3.5 million
farm workers and their families. EPA's Worker
Protection Standard, first implemented in 1992, has
resulted in safety education and training efforts across
the country.
During 1998 and 1999, our Worker Protection
Program devoted significant resources to producing
and distributing bilingual or multi-lingual educational
materials. Communications include a new Pesticide
Workers Website, publication of over 1 million grower
compliance manuals, over 2.7 million safety training
manuals, over 680,000 safety posters, and more than
11,000 safety training videos.
EPA began reviewing worker protection activities,
including risk assessment methods, to determine if
workers are receiving adequate protection. Last year,
EPA initiated a national assessment of implementation
and enforcement of the worker protection regulation.
We are establishing a worker protection assessment
group comprised of EPA, USDA, the Department of
Labor, the Department of Health and Human Services,
state regulators, state extension service safety educa-
tors, farm worker advocacy groups, farm worker ser-
vice/training associations, agricultural employer asso-
ciations, farm worker clinicians networks, and others.
The group's goals are to:
assess the current program's status;
generate stakeholder interest that can effect change
in the programs;
foster the partnerships essential to make the
program work; and, most importantly,
provide a continuing forum to focus on, and hope-
fully resolve, worker protection issues.
Tribes and EPA lost a true
environmental advocate
with the October 1999
death of Conner
Byestewa, Jr. of the
Colorado River Indian
Tribes in Parker, Arizona.
He contributed signifi-
cantly to the develop-
ment of the Tribal
Pesticide Program
Council. Conner was
well known for his ability
to create change through
personal involvement and
positive relationships. We
appreciated his gentle
way, his humor, and his
presence. He will be
greatly missed.
Conner Byestewa, Jr.,
Colorado River Indian
Tribes, shares news
from Indian country
with OPP staff.
FY 98-99 OPP BIENNIAL REPORT
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FIFRA Section
6(a)(2)
Submissions
Section 6(a)(2) of
FIFRA requires pesti-
cide product registrants
to submit adverse
effects information
about their products to
OPR OPP reviews these
submissions and studies
to see if there are risks
associated with the
product that were not
anticipated at the time
of registration. In late
1998, OPP's new
adverse effects report-
ing requirements took
effect. These regula-
tions clarified and in
many cases lowered the
threshold for adverse
incident reporting. As a
result, 6(a)(2) submis-
sions increased consid-
erably during FY99. For
additional information
on 6(a)(2), please refer
to the Appendix,
Figure 3.
In FY 1998, OPP
received approxi-
mately 1,800 sub-
missions containing
reports of more than
22,000 incidents.
In FY 1999, OPP
received nearly
1,500 submissions
containing reports of
more than 46,000
incidents.
The worker protection assessment group will devel-
op a strategic plan for the national worker protection
program and issue annual reports detailing accom-
plishments and progress towards achieving its goals.
Applicator Certification and Training
More than 1.2 million applicators are currently cer-
tified nationwide, including over 800,000 private appli-
cators and about 400,000 commercial applicators.
Over the past two years, approximately 160,000 private
and 170,000 commercial applicators received initial
certification and more than 400,000 private and
380,000 commercial applicators were recertified.
EPA also conducted a national assessment of the
applicator certification and training program. A certi-
fication and training assessment group, consisting of
representatives from EPA, USDA, state pesticide agen-
cies, tribes, and pesticide safety educators, was formed
to draft proposals to guide the program's future. The
proposals for review by the nation's program partners
are grouped under five program goals:
reduce risks to the public from exposure to pesti-
cides;
provide high quality pesticide use education and
safety training programs;
maintain the consistency, integrity and validity of
the certification and recertification programs and
processes;
ensure adequate and equitable funding for educa-
tion and training programs; and,
improve the efficiency of program organization and
operations.
Response from the program partners and the pro-
gram stakeholders will help frame a national strategy
for the future of the applicator certification and train-
ing program.
Pesticide Worker Website
In 1999, EPA launched a new website
(www.epa.gov/pesticides/safety) to inform farm work-
ers, certified applicators, and health care providers
about the Agency's pesticide safety programs. This
site, which provides easy access to information in both
English and Spanish, marks an important step in the
Agency's pesticide worker safety outreach efforts. It
provides specific information on applicator certifica-
tion and training requirements and EPA's Worker
Protection Standard, including pesticide safety train-
ing, notification of pesticide application, use of per-
sonal protective equipment, and emergency medical
assistance. Finally, the web site contains the 5th
Edition of Recognition and Management of Pesticide
Poisonings, a manual that assists health care providers
in diagnosing and managing pesticide poisonings,
which was published in 1999.
Developing an Interagency
Initiative: Pesticides and the
National Strategies for Health Care
Providers
In 1998, an EPA-led interagency initiative began with
the support of the U.S. Department of Agriculture, the
U.S. Department of Health and Human Services, and
the U.S. Department of Labor. The interagency group
sponsored a workshop to identify strategies to improve
the ability of health care providers to recognize, diag-
nose, manage and prevent adverse health effects due to
pesticide exposure.
Based on the proceedings of the workshop, EPA
published a report, Pesticides and National
Strategies for Health Care Providers, which outlines a
series of recommendations for improving the training
that health care providers receive on health concerns
related to pesticide exposures. Among the recommen-
dations are the need to:
specify competencies that healthcare providers
should demonstrate upon completion of their edu-
cation and other specialty training;
develop educational tools and training materials
that will motivate students and health care
providers to acquire an understanding and knowl-
edge of possible health effects resulting from pesti-
cide exposure;
raise awareness and make more information avail-
able to providers on health complaints and illnesses
that may be related to pesticide exposure through
materials and resource development, professional
meetings, marketing and outreach programs, and
other activities.
To carry forward this initiative, and further develop
these broad strategies, workgroups were created in
three core areas: Formal Education of Health Care
Providers; Health Care Provider Practice; and
Resources for Health Care Providers.
In May 1999, EPA and several other federal agencies
convened the Education and Practice workgroups to
further develop components of an implementation
plan for raising knowledge and awareness of pesticide
issues in the educational and practice settings of pri-
mary care providers. Workgroup members came from
academic faculty, professional associations for physi-
cians, nurses and physician assistants, farmworker and
community interest groups, federal and state agencies,
and pesticide experts. A third workgroup on Resources
began its deliberations in August 1999.
Once the workgroups have developed proposals, a
draft national implementation plan will be published
which will serve as a working document for the next
year of activity on this initiative, culminating in a
national forum in 2000.
98-99 OPP BIENNIAL REPORT
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RIGHT TO KNOW
PROVIDING ALL AMERICANS WITH ACCESS TO INFORMATION ABOUT PESTICIDES
and involving them in our work are essential parts of the Agency's comprehensive
approach to protecting public health and the environment. This goal is premised on the
concept that all U.S. citizens have a right to know about the pesticides in their environment, as
well as those used to grow food they consume.
Access to such information
enables Americans and the inter-
national community to make
informed decisions about their
environment. In 1998 and 1999,
the Office of Pesticide Programs
expanded its pesticide education
and outreach programs by dis-
seminating information about
pesticides to the public through
fact sheets, brochures, other writ-
ten correspondence and docu-
ments, the Internet, mass media,
public meetings, press announce-
ments, and other outreach tools.
Highlights of some these docu-
ments are provided below.
Expanding Pesticide
Education and
Outreach Materials
to the Public
Disseminating Fact
Sheets and Brochures
Over the past two years, we
developed over 30 fact sheets for
the public on topics ranging from
pesticides and mosquito control
to Integrated Pest Management and food production.
With advice from the Pesticide Program Dialogue
Committee and consumers, and in consultation with
USDA and FDA, EPA developed in English and
Spanish, the brochure, "Pesticides and Food: What You
and Your Family Need to Know." The brochure
informs consumers about pesticide use on food, gov-
ernment programs that protect them from pesticide
risks, and ways they can reduce their exposure to pesti-
cides. The brochure also explains how the Food
Quality Protection Act (FOJA) increases protection of
infants and children from exposure to pesticides. Over
Pesticides
and!
Whatynu
and your family
nred to know
six million copies have been dis-
tributed to 30,000 grocery stores,
public health officials, libraries,
and the medical community and
it is also available on our website.
Responding to Written
and Electronic Inquiries
OPP places great importance
on listening and responding in a
timely fashion to comments and
inquiries from the general public
on the various pesticide pro-
grams. In 1998 and 1999, OPP
responded to over 2,700 inquiries
from the public and their repre-
sentatives in Congress. These
inquiries came in the form of e-
mails, postcards, letters, and
phone calls and ranged from citi-
zens seeking information on pes-
ticide health issues to expressions
of opinions regarding pesticide
regulations.
Providing Pesticide
Information on the
Internet:
www.epa.gov/pesticides
OPP's use of the Internet con-
tinued to grow during the past two years, offering
information for consumers, businesses, researchers,
states, and international partners. The Website has
become an important resource to OPP's customers and
is beginning to have a fundamental effect on the way
OPP communicates.
The increase in Internet access has made it easier for
the public and stakeholders to get the information they
need and want, saving them time and natural
V
This goal is
premised on the
concept that all U.S.
citizens have a right
to know about the
pesticides in their
environment as well
as those used to
grow food they
consume.
FY 98-99 OPP BIENNIAL REPORT
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resources. Highlights of new items added to OPP's
website over the past two years include:
the activities of the Pesticide Program Dialogue
Committee and Tolerance Reassessment Advisory
Committee;
guidance for submitting pesticide registration docu-
ments electronically known as "CADDY";
EPA's scientific reviews of the class of pesticides
called organophosphates. This is the first time risk
assessments have been published on the website,
making them widely available for public comment.
This effort to increase transparency has evolved
into a comprehensive organophosphate homepage,
providing updated schedules, risk assessments, and
other information on the organophosphate pesti-
cides as the information is placed in the Pesticides'
Docket (an information collection and dissemina-
tion service that provides public access to proposed
rules and regulations relating to pesticides);
the Pesticide Management Resource Guide;
the Label Review Manual, developed as a training
and guidance tool for reviewing pesticide product
labels;
a FIFRA Section 18 database listing actions, by
chemical name (FIFRA Section 18 allows states,
under emergency conditions, to use a pesticide for
an unregistered use for a limited time);
various forms and guidance information required
for pesticide registration;
a regional, state and tribal web page, which
includes information on OPP's field programs that
help put pesticide laws and regulations into prac-
tice;
extensive information about biopestiddes;
the "Pesticides and Food" website, which is refer-
enced in the printed brochure, provides consumers
with more detailed information on pesticide regula-
tion (www.epa.gov/pesticides/food);
"Sign up" through the Web site to a mailing list for
electronic OPP Updates.
Finally, OPP made significant changes to the web-
site's design, making it easier and quicker for people to
find information. For example, at the home page, the
browsing public now has access to enhanced search
tools, as well as a "site map" which presents major cat-
egories of information and related documents.
Providing Toil-Free Access to
Pesticide Information
iD
Sometimes people want to pick up the telephone
and communicate with a real person on a particular
issue. To answer questions the public may have about
pesticides, the Office of Pesticide Programs provided a
grant to Oregon State University in Corvallis, Oregon,
to operate two toll-free telephone services: the National
Pesticide Telecommunications Network and the
National Antimicrobial Information Network.
National Pesticide Telecommunications
Network (NPTN)
NPTN provides objective, science-based informa-
tion on a wide variety of pesticide-related subjects.
The NPTN website is an increasingly popular source
of information and can be accessed at
http://ace.orst.edu/info/nptn. In 1998 and 1999,
NPTN answered over 46,000 requests from the public,
including over 36,800 calls received between March
and October of both years. This coincides with the
FY 98-99 OPP BIENNIAL REPORT
-------
time of year when most pest pressures are the highest.
Over 20,000 calls were health-related inquiries.
Approximately 10,000 calls were for information about
pesticide usage, and nearly 5,000 calls were of a regu-
latory nature.
National Antimicrobial Information
Network (NAIN)
Another toll-free service available to the public is the
National Antimicrobial Information Network (NAIN),
which provides a wide variety of information about
antimicrobial pesticides. NAIN also has an Internet
service. Organized as a cooperative effort between
Oregon State University and EPA, NAIN maintains
information on the toxicity, health effects, and safety of
antimicrobial pesticides. It also maintains lists of
antimicrobial products registered with EPA, including
sterilants, disinfectants, tuberculoddes, and products
effective against HBV and HIV. NAIN also helps callers
interpret product labels and EPA's antimicrobial poli-
cies and regulations. The website, which receives
about 20,000 hits annually, contains regulatory and
policy documents to help keep interested parties up-to-
date about antimicrobial activities.
Within the last two years, NAIN has received an
average of 2,000 telephone calls. More than half of the
callers are from the medical community, with manu-
facturers and the general public accounting for most of
the remainder. Most callers request information about
specific products or types of products; the next largest
set of calls covers regulation, registration, and com-
plaints, including complaints about unregistered or
ineffective antimicrobial products. Common ques-
tions include:
can household bleach be used for cleaning blood
spills in medical settings?
is product X registered for use in nursing homes?
should my restaurant install "antimicrobial"
carpeting?
While continuing to respond to all inquiries, NAIN
plans to maintain, expand, and publicize its antimicro-
bial website, and develop documents and fact sheets
that answer frequently asked questions and that provide
information on common antimicrobial products. NAIN
operates toll free at 1-800-447-6349, Monday through
Friday 7:30 a.m. to 4:30 p.m. Pacific time. The fax num-
ber is 541-737-0761; e-mail: nain@ace.orst.edu;
website: http://ace.orst.edu/info/nain/
Staff from NPTN
answer an average of
2,000 inquiries per
month.
FY 98-99 OPP BIENNIAL REPORT
-------
APPENDICES
TABLES AND FIGURES OF OPP'S FISCAL YEAR 1998 AND 1999
ACCOMPLISHMENTS
TABLE 1
TABLES 2 & 3
TABLES 4 & 5
TABLES 6 & 7
FIGURE 1
FIGURE 2
FIGURE 3
LIST 1
LIST 2
LIST 3
LIST 4
Registration of Safer Chemicals
Pesticide Active Ingredients Registered
Registration Decisions versus Targets
Risk Reduction Measures Achieved through REDs
Cumulative Status of Registration:
Reregistration Eligibility Decisions (REDs)
Tolerance Reassessment Accomplishments
Outcome of 6(a)(2) Submissions
Pesticide Stewardship Program Partners and Supporters
OPP Divisions
Regional Pesticide Offices
Acronyms
PAGE
37
38
40
42
44
45
46
47
49
50
51
FY 98-99 OPP BIENNIAL REPORT
-------
TABLE
REGISTRATION OF SAFER CHEMICALS
The proportion of pesticide active ingredients that are considered to be safer (biological
chemicals and reduced-risk conventional chemicals) than conventional chemical pesticides
has steadily increased over the past several years, as the chart below indicates.
NUMBER OF PESTICIDE REGISTRATIONS BY CATEGORY
BIOLOGICALS
REDUCED-RISK
CONVENTIONAL
CHEMICALS
CONVENTIONAL
CHEMICALS
O
40
35
30
25
- 20
oo
£ 15
10
5
0
-
YEAR
CJ
a
FY 98-99 OPP BIENNIAL REPORT
-------
PESTICIDE ACTIVE INGREDIENTS
REGISTERED IN FY 1998
Of the 27 new active ingredients registered, 14 are safer pesticides. For the purpose of this
chart, safer pesticides are those that have at least one or more of the following
characteristics: they have low risk to human health; low toxicity to non-target organisms
(birds, fish and plants); low ground water contamination potential; low use rates; low pest
resistance potential; are compatible with integrated pest management (IPM); or are biopes-
ticides. Non-reduced-risk pesticides do not pose unreasonable adverse affects, but may have
the potential to cause greater harm than reduced risk pesticides if not properly used.
PESTICIDE
Bt Isrealensis Strain
Canola oil
Carfentrazone-ethyl
Cloransulam-methyl
Cry9C Protein
Cuprous Chloride
2-Cyclopenten-1-one, 2 hydroxy-
3-methyl Maple lactone
Cymoxanil
Cyprodinil
Dimethomorph
Fish oil
Flufenacet
Fluroxypyr
Gamma aminobutyric acid
Gliocladium catenulatum
strain J1446
Hypochlorous acid
Imiprothrin
Isoxaflutole
Kaolin
Kresoxim-methyl
L-Glutamic acid
Mono and di potassium salts
of phosphorous acid
Monobasic potassium
phosphate
Paccilomyces fumororoseus
Apopka Strain 97
Potassium hypochlorite
Propazine
Pyrimethamil
TYPE
insecticide
insecticide
herbicide
herbicide
insecticide
fungicide
insect attractant
fungicide
fungicide
fungicide
mammal repellent
(deer, rabbits)
herbicide
herbicide
plant regulator
fungicide
biocide
insecticide
herbicide
insecticide, fungicide
fungicide
plant regulator
fungicide
fungicide
insecticide
disinfectant
herbicide
fungicide
CLASS
microbial
biochemical
conventional
conventional
plant-pesticide
conventional
biochemical
conventional
conventional
conventional
biochemical
conventional
conventional
biochemical
microbial
antimicrobial
conventional
conventional
biochemical
conventional
biochemical
biochemical
biochemical
microbial
antimicrobial
conventional
conventional
USES
mosquito
range of fruit, vegetables, ornamentals
corn, soybeans, wheat
soybeans
field corn
non-food
roach attractant- non food
potatoes
stone fruit, pome fruit, grape, almond
potatoes
ornamentals
corn, soybeans
wheat, barley, oats
field crops, vegetables, ornamentals
range of fruit, vegetables, ornamentals
indoor, non-food use
indoor, non-food use
corn
all ag crops
non-food use
field crops, vegetables, ornamentals
turf, ornamentals, bedding plants
apples, grapes, cucurbits, stone
fruits, peppers, tomatoes, roses
greenhouses, interiorscapes
indoor, non-food use
greenhouses
imported wine grapes
SAFER
yes
yes
yes
no
yes
no
yes
no
yes
no
yes
no
no
yes
yes
no
no
no
yes
no
yes
yes
yes
yes
no
no
no
FY 98-99 OPP BIENNIAL REPORT
-------
PESTICIDE ACTIVE INGREDIENTS
REGISTERED IN FY 1999
Of the 26 new active ingredients registered, 19 are safer pesticides. For the purpose of this
chart, safer pesticides are those that have at least one or more of the following
characteristics: they have low risk to human health; low toxicity to non-target organisms
(birds, fish and plants); low ground water contamination potential; low use rates; low pest
resistance potential; are compatible with integrated pest management (IPM); or are biopes-
ticides. Non-reduced-risk pesticides do not pose unreasonable adverse affects, but may have
the potential to cause greater harm than reduced risk pesticides if not properly used.
PESTICIDE
Agrobacterium radiobacter
(strain K 1026)
Anthraquinone
Bifenazate
Diflufenzopyr
a-dod...
(E)-90dodecenyl acetate
Emamectin Benzoate
Fenhexamid
Fluthiacct-metyl (Action)
Formic Acid
IR3535
Lithium P. Sulfonate
Methylcyclopropene
3-methyl-2-cyclohex-1 -one
n-Methylneodecanamide
Nonanoyloxybenzene Sulfonate
Oxypurinol
Potato Leafroll Virus
Resistance Gene
Pseudomonas aureofaciens strain
TX-1
Pymetrozine
s-Dimethenamid
Sulfosulfuron
Tralkoxydim
Trifloxystrobin
Xanthine
Z.E-9, 12-Tetradecadien-1-yl
acetate'4'
Z-9-Tetradecen-1-ol(4)
TYPE
fungicide
repellent
insecticide
herbicide
insecticide/pheremone
insecticide
fungicide
herbicide
insecticide
repellent
insecticide
plant growth regulator
pheremone type
insecticide
antimicrobial
insecticide
fungicide
fungicide
insecticide
herbicide
herbicide
herbicide
fungicide
insecticide
insecticide
insecticide
CLASS
biopesticide
biopesticide
conventional
reduced risk
conventional
reduced risk
biopesticide
conventional
conventional
reduced-risk
conventional
biopesticide
biopesticide
conventional
biopesticide
biopesticide
conventional
conventional
biopesticide
plant-pesticide
biopesticide
conventional
reduced-risk
conventional
reduced-risk
conventional
conventional
conventional
biopesticide
biopesticide
biopesticide
USES
crown gall
geese
ornamentals
corn
shoot borers
brassica, lettuce, celery
grapes, strawberries
soybean seed
mites
mosquitoes
wasp bait station
cut flowers
beetles (forestry)
indoor use
laundry sanitizer
cockroach
potatoes
turf
tuberous and corn vegetables,
tobacco, ornamentals
dry beans, corn, popcorn, peanuts,
soybean
wheat
wheat, barley
pome fruits, grapes, cucurbits,
peanuts, bananas, turf
cockroach
beet army worm
beet army worm
SAFER
yes
yes
yes
yes
yes
no
yes
no
yes
yes
no
yes
yes
no
no
yes
yes
yes
yes
yes
no
no
yes
yes
yes
yes
FY 98-99 OPP BIENNIAL REPORT
-------
TABLE
REGISTRATION DECISIONS VERSUS
TARGETS IN FY 1998
The following table summarizes, by action, the number of decisions that were made in the
Office of Pesticide Programs versus the target, or goal, that the program anticipated could
be made. The target numbers are determined by anticipating market influences and taking
into account past trends.
REGISTRATION CATEGORY
TARGETS
DECISIONS
Old chemicals (fast track1)
364
478
Old chemicals (non-fast track2)
275
334
Amendments (fast track1
1810
2946
Amendments (non-fast track2
246
375
New uses
99
320
New active ingredients
29
27
Experimental use permits3
Tolerances
91
236
Temporary tolerances
18
Inerts (non-active ingredients)
41
110
Emergency exemption (Section 18) decisions
366
504
Emergency exemption (Section 18) tolerances
95
Special local needs4
349
Biotech notification
iFast Track An application for registration of a pesticide product that is substantially similar or identical in its uses and composi-
tion (both active and other ingredients) to a currently registered product. Typically, no significant data need to be reviewed
before the Agency can issue a registration decision.
2Non-Fast Track An application for a registration of a pesticide product that is sufficiently different in composition and/or uses
that additional product specific data must be reviewed prior to the issuance of a registration decision. Typically, these data
include acute toxicology, product chemistry, and product-specific efficacy.
Experimental Use Permits (EUP) EPA normally must first authorize field testing of unregistered pesticides through an experi-
mental use permit (EUP). The EUP establishes limited conditions for the transportation, application and disposal of unregistered
test products. The granting of an EUP limits the sale and distribution of the test product only between approved participants in
the test program, and use of the test product only under conditions specified in the EUP. Registrants typically request EUPs to
gather large-scale efficacy testing and/or crop-specific residue chemistry data.
4Special Local Needs Under Section 24(c) of FIFRA, states may register an additional use of a federally registered pesticide prod-
uct, or a new end use product to meet special local needs. "Special local need" means an existing or imminent pest problem with-
in a state for which the state lead agency, based upon satisfactory supporting information, has determined that an appropriate
federally registered pesticide product is not sufficiently available. EPA reviews these registrations, and may disapprove the state
registration if, among other things, the use is not covered by necessary tolerances, or the use has been previously denied, disap-
proved, suspended or canceled, or voluntarily canceled subsequent to a notice concerning health or environmental concerns.
5Biotech Notification A Biotech Notification is a submission of information to OPP prior to any small-scale testing of certain genet-
ically modified and nonindigenous microbial pesticides. OPP has 90 days to solicit public comment, review the submission, and
decide, among other options, whether to allow the release or not, or to require an EUP.
FY 98-99 OPP BIENNIAL REPORT
-------
TABLE
REGISTRATION DECISIONS VERSUS
TARGETS IN FY 1999
The following table summarizes, by action, the number of decisions that were made in the
Office of Pesticide Programs versus the target, or goal, that the program anticipated could
be made. The target numbers are determined by anticipating market influences and taking
into account past trends.
REGISTRATION CATEGORY
TARGETS
DECISIONS
Old chemicals (fast track1)
342
513
Old chemicals (non-fast track2)
258
509
Amendments (fast track1
1760
3141
Amendments (non-fast track2
240
445
New uses
90
681
New active ingredients
24
26
Experimental use permits3
29
Tolerances
95
351
Temporary tolerances
Inerts (non-active ingredients)
45
109
Emergency exemption (Section 18) decisions
370
542
Emergency exemption (Section 18) tolerances
62
Special local needs4
596
Biotech notification
1
iFast Track An application for registration of a pesticide product that is substantially similar or identical in its uses and composi-
tion (both active and inert (other) ingredients) to a currently registered product. Typically, no significant data need to be
reviewed before the Agency can issue a registration decision.
2Non-Fast Track An application for a registration of a pesticide product that is sufficiently different in composition and/or uses
that additional product specific data must be reviewed prior to the issuance of a registration decision. Typically, these data
include acute toxicology, product chemistry, and product-specific efficacy.
Experimental Use Permits (EUP) EPA normally must first authorize field testing of unregistered pesticides through an experi-
mental use permit (EUP). The EUP establishes limited conditions for the transportation, application and disposal of unregistered
test products. The granting of an EUP limits the sale and distribution of the test product only between approved participants in
the test program, and use of the test product only under conditions specified in the EUP. Registrants typically request EUPs to
gather large-scale efficacy testing and/or crop-specific residue chemistry data.
4Special Local Needs Under Section 24(c) of FIFRA, states may register an additional use of a federally registered pesticide prod-
uct, or a new end use product to meet special local needs. "Special local need" means an existing or imminent pest problem with-
in a state for which the state lead agency, based upon satisfactory supporting information, has determined that an appropriate
federally registered pesticide product is not sufficiently available. EPA reviews these registrations, and may disapprove the state
registration if, among other things, the use is not covered by necessary tolerances, or the use has been previously denied, disap-
proved, suspended or canceled, or voluntarily canceled subsequent to a notice concerning health or environmental concerns.
5Biotech Notification A Biotech Notification is a submission of information to OPP prior to any small-scale testing of certain genet-
ically modified and nonindigenous microbial pesticides. OPP has 90 days to solicit public comment, review the submission, and
decide, among other options, whether to allow the release or not, or to require an EUP.
FY 98-99 OPP BIENNIAL REPORT
-------
TABLE
RISK REDUCTION MEASURES ACHIEVED
THROUGH FY 1998 REDs
RED
/ V / V / 7 /
Alachlor
Aluminum phosphide
Magnesium phosphide
Bromoxynil
Chlorothalonil
DEET
1,3-Dichloropropene
Dicofol
Hydramethylnon
Iprodione
Methomyl
Propachlor
Thiodicarb
Total
/'
/1
/
/3
/5
/
/
7
/
/
/
/
/
/
/
7
/
/
/
/
/
/
/
7
/
/
/
/
/
/
/
/
/
/
/
11
/
J
/
/
/
/
/
7
/
/
/
/
/
/
/
/
/
/
10
/
/
/
/
/
/
/
/
/
/
/
11
/
/
/
/
/
/
/
/
8
/
/
/
/
/
/
/
/
8
/
/
/
/
/
/
/
/
/
9
/
/
/
/
/
/
/
/
8
/
/
/
/
/
/
6
/
J
/
/
/
5
/2
/4
/6
/6
4
/
J
/
/
/
/
/
/
/
/
/
11
/1 STAKEHOLDER PROCESS UNDERWAY WILL HELP DETERMINE ELIGIBILITY AND FINAL RISK MITIGATION MEASURES FOR
AL AND MG PHOSPHIDE.
/2 PRODUCTION CONTROLS-MUST REDUCE LEVEL OF HCB IMPURITY TO 40 PPM BY 1/1/03.
/3 STAKEHOLDER PROCESS UNDERWAY WILL HELP DETERMINE ELIGIBILITY OF DEET-PLUS-SUNSCREEN PRODUCTS
/4 TECHNOLOGICAL CONTROLS, IMPROVED PRODUCT STEWARDSHIP MATERIALS ARE REQUIRED FOR 1,3-D.
/5 RESIDENTIAL USES OF DICOFOL VOLUNTARILY CANCELED; NEW STUDIES TO DETERMINE ELIGIBILITY OF REMAINING USES;
VOLUNTARY CANCELLATION IF RISKS DO NOT DECLINE.
/6 STATEMENT SUPPORTING USE OF AN IPM PLAN MUST BE ADDED TO METHOMYL AND THIODICARB LABELS.
98-99 OPP BIENNIAL REPORT
-------
TABLE
RISK REDUCTION MEASURES ACHIEVED
THROUGH FY 1999 REDs
RED
Bendiocarb
Captan
EPTC
Folpet
Fonfos
Isofenphos
Niclosamide
Oxythioquinox
Pebulate
Ryanodine
Sulfotepp
TFM
TPTH
Vernolate
Total
/1
/
/
/
/
/
7
/3
/4
/5
/7
4
/
/
/
/
/
/
6
/
/
/
/
4
/
/
/
/
/
/
/
/
8
/
/
/
/
4
/
/
/
/
/
/
/
/
8
/
/
/
/
/
/
/
/
8
/
/
/
/
/
5
/
1
/
/
/
/
/
5
/
/
/
/
/
/
/
/
8
/
/
/
/
/
/
/
7
/1
/6
/9
3
2R2
60 /
20 /
10/
35 R
24 R
N/A8
22 R
3/
1 R
N/A
N/A
13/
13 R
106 /
+97 R
=203 Total
/1 BENDIOCARB VOLUNTARY CANCELLATION INCLUDES PRODUCTION CAP AND PHASE OUT.
R2 NUMBER OF TOLERANCE REVOCATIONS: AS A RESULT OF THE VOLUNTARY CANCELLATION, (2) TOLERANCES ARE BEING REVOKED.
/3 CAPTAN RED INCLUDES VOLUNTARY CANCELLATION OF RESIDENTIAL TURF USES TO MITIGATE RISKS TO CHILDREN.
/4 EPTC RED PROHIBITS RESIDENTIAL USE OF EMULSIFIABLE CONCENTRATE FORMULATIONS, AND PROHIBITS USE OF BELLY GRINDER FOR HOMEOWNER
PRODUCTS.
/5 FOLPET RED INCLUDES VOLUNTARY CANCELLATION OF MOST AGRICULTURAL, ORNAMENTAL, AND GREENHOUSE USES (IMPORT TOLERANCES REMAIN)-
THE ONLY REMAINING ELIGIBLE USES INCLUDE USE ON FLORIDA AVOCADOS AND IN PAINTS, COATINGS, AND SEALANTS.
/6 ISOFENPHOS VOLUNTARY CANCELLATION INCLUDES A SALES CAP FOR THE TECHNICAL PRODUCT.
/7 MOLLUSCICIDE USES OF NICLOSAMIDE ARE BEING VOLUNTARILY CANCELED OR DECLARED INELIGIBLE.
N/A8 NOT APPLICABLE (I.E., THE PESTICIDE HAS NO FOOD USES).
/9 SULFOTEPP VOLUNTARY CANCELLATION INCLUDES A PRODUCTION CAP.
FY 98-99 OPP BIENNIAL REPORT
-------
FIGURE
CUMULATIVE STATUS OF REREGISTRATION:
REGISTRATION ELIGIBILITY DECISIONS
(REDs) COMPLETED
OPP presents the results of its reregistration reviews in Reregistration Eligibility Decision
(RED) documents. In FY1998, OPP completed 13 REDs, and in FY 1999, OPP completed 14
REDs.
At present, the pesticide reregistration program has completed 70% of the number of
reviews to be performed. OPP has issued 198 REDs, which represent 32% of the original 612
cases that were subject to reregistration when the program began in late 1988. (14 of the
198 are voluntary cancellations counted as REDs-OPP had made significant progress in
developing RED documents for these pesticides when requests for their voluntary cancella-
tion were received.) An additional 231 cases (38%) were voluntarily canceled earlier
through the reregistration process. Therefore, 183 reregistration cases (30%) remain to be
completed.
PROGRESS IN COMPLETING REDS
183 TO COMPLETE (30%)
198 COMPLETED (32%)
231 CANCELED (38%)
FY 98-99 OPP BIENNIAL REPORT
-------
FIGURE
TOLERANCE REASSESSMENT
ACCOMPLISHMENTS
STATUS OF FY 1998
TOLERANCE REASSESSMENT
TOTAL NUMBER OF
REASSESSMENT DECISIONS
IN FY 1998=1398
REGISTRATION ACTIONS-22.2%"
FR REVOCATIONS-57.9%
REGISTRATION ACTIONS
REREGISTRATION ACTIONS
FR REVOCATIONS
OTHER
REREGISTRATION ACTIONS-19.9%
(OTHER ISO FOR FY 1998)
STATUS OF FY 1999
TOLERANCE REASSESSMENT
TOTAL NUMBER OF
REASSESSMENT DECISIONS
IN FY 1999=1445
REGISTRATION ACTIONS-23.5%
FR REVOCATIONS-35.5%
REREGISTRATION ACTIONS-24.8%
OTHER-16.2%
STATUS OF TOLERANCE
REASSESSMENT
CUMULATIVE SINCE AUG. 3, 1996
TOTAL NUMBER OF
REASSESSMENT DECISIONS
AS OF OCTOBER 1, 1999 = 3430
REGISTRATION ACTIONS-25.4%
FR REVOCATIONS-38.6%
REREGISTRATION ACTIONS-29.1%
OTHER-6.8%
FY 98-99 OPP BIENNIAL REPORT
-------
FIGURE
REASSESSMENT27%
(THE RISK ISSUES PRESENTED
BY THESE DATA ARE
ADDRESSED BY PLANNED OR
COMPLETED REGISTRATION
ELIGIBILITY DECISIONS, SPE-
CIAL REVIEWS, FQPA TOLER-
ANCE REASSESSMENTS, OR
RISK MITIGATION
NEGOTIATIONS.)
OUTCOME OF 6(a)(2) SUBMISSIONS
Section 6(a)(2) of FIFRA requires pesticide product registrants to submit adverse effects
information about their products to OPP. OPP reviews these submissions and studies to
determine if there are risks associated with the product that were not anticipated at the
time of registration. In late 1998, OPP's new adverse effects reporting requirements took
effect. These regulations clarified and in many cases lowered the threshold for adverse
incident reporting. As a result, 6(a)(2) submissions increased considerably during FY99.
Incidents: In FY 1998, OPP received approximately 1,800 submissions, containing reports
of more than 22,000 incidents.
Incidents: In FY 1999, OPP received nearly 1,500 submissions, containing reports of more
than 46,000 incidents.
Studies: In FY 1998, OPP screened 411 adverse effects submissions consisting of studies
and preliminary reports of possible adverse effects. About 15 percent of these submissions
warranted expedited review and are being further tracked.
In FY 1999, OPP streamlined the 6(a)(2) study screening process by imaging key study
information and routing it electronically to subject matter experts. This reduced the time
necessary to complete the screening process. OPP screened 337 adverse effects submissions
consisting of studies and preliminary reports of possible adverse effects. About 12 percent
warranted expedited review and are being further tracked.
Outcome of submissions warranting expedited review: Since 1992, over 700 6(a)(2)
submissions werejudged to warrant expedited review. The outcomes for these submis-
sions are presented in the chart that follows.
LABEL CHANGE17%
REVIEW INITIATED11%
(THIS INCLUDES STUDY REVIEWS
AS WELL AS RELATED PEER REVIEWS.)
MORE DATA NEEDED8%
OTHER4%
(THIS INCLUDES AMENDED TOLERANCES
[PRE-FQPA], VOLUNTARY CANCELLATIONS,
AND CHANGES IN REGULATORY AUTHORITY
FOR SOME PESTICIDES TO FDA.)
NO FURTHER ACTION32%
FY 98-99 OPP BIENNIAL REPORT
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LIST
PESTICIDE STEWARDSHIP
PROGRAM PARTNERS AND
SUPPORTERS
New Partners during FY 1999
Kansas Grain Sorghum Producers Association
Kansas Corn Growers Association
Low Input Viticulture and Enology of Oregon
Central Virginia Electric Cooperative
Sarasota County Government Public Works
Massachusetts IPM Council
Ecolutions, Inc.
New Partners during FY 1998
All Service Pest Management, Inc.
American Peanut Council
Artichoke Research Association
California Floral Council
California Lettuce Research Board
California Cling Peach Growers Advisory Board
California Fresh Carrot Advisory Board
City/County of San Francisco, CA Dept. of Agriculture
Creative Technology, Inc.
Daystar Termite Control, Inc.
Enviroguard Pest Control
Florida Pest Control Association
Georgia Peach Council
Hawaii Banana Industry Association
Massey Services, Inc.
National Pest Control Association
Nature's Safeway Pest Control
New York City Board of Education
Northeast Utilities
Pest Birds, Inc.
Roses, Inc.
Sprague Pest Solutions
Steritech Group, Inc.
Texas Association of Nurserymen, Inc.
U.S. Hop Industry Plant Protection Committee
U.S. Canola Association
Walnut Marketing Board
New Supporters during FY 1999
National Council of Farmer Cooperatives
Miami Tribe of Oklahoma
New Supporters during FY 1998
Agricultural Conservation Innovation Center
Bio-Integral Resource Center
Claymont Center for Continuous Education
Northeast Research & Extension Committee-IPM
Existing Partners (prior to FY 1998)
Almond Board of California
American Pest Management, Inc.
American Mosquito Control Association
American Nursery and Landscape Association
American Electric Power Service Corporation
Arizona Public Service
California Tomato Commission
California Pear Growers
California Pear Advisory Board
California Citrus Research Board
California Pistachio Commission
California Prune Board
Carolina Power & Light
Central Maine Power Company
Chevy Chase Village, MD
City of Davis, CA
Connectiv
Cranberry Institute
Delta Pest Control
Duke Power Company
Eastern Utilities
Edison Electric Institute
Environ "Pest Elimination" Inc.
Fillmore Citrus Protective District
Florida Fruit & Vegetable Association
Global Integrated Pest Management
Golf Course Superintendents Association of America
Griggs County (ND) 319 Water Quality Project
Hawaii Agriculture Research Center
Hawaiian Electric Company
Hood River Grower-Shipper Association
Lodi-Woodbridge Wine Grape Commission
Michigan Cherry Committee
FY 98-99 OPP BIENNIAL REPORT
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(Continued)
Mint Industry Research Council
Monroe County School Corporation
National Potato Council
New Orleans Mosquito Control Board
New England Vegetable & Berry Growers Association
New York State Gas & Electric
New York Berry Growers Association
Northern Indiana Public Service Company
Northwest Alfalfa Seed Grower Association
Owen Specialty Services, Inc.
Pacific Coast Producers
Pear Pest Management Research Fund
Pebble Beach Company
Pennsylvania Power & Light
Pennsylvania Electric
Pennsylvania Rural Electric Association
Pest Police Pest Control
Pineapple Growers Association of Hawaii
Planet Pest Products Corporation
Processed Tomato Foundation
Professional Lawn Care Association of America
Redi National Pest Elimination
Reliable Pest Control
Sanitary Exterminating Company
South Dakota Cattlemen's Association
South Texas Cotton and Grain Association, Inc.
Sun-Maid Growers of California
Sunkist Growers
Tennessee Valley Authority
Texas Pest Management Association
U.S. Department of Defense
U.S. Apple Association
U.S. Public Health Service
University of Georgia
Utilicorp United
VA, MD, & DE Association of Electric Cooperatives
Vegetation Managers, Inc.
West Virginia Power
Winter Pear Control Committee
Wisconsin Public Service Corporation
Wisconsin Ginseng Growers Association
Existing Supporters (prior to FY 1998)
Aqumix, Inc.
Association of Applied Insect Ecologists
Audubon Cooperative Sanctuary System
Bay Area Stormwater Management Agencies Assoc.
Campbell Soup Company
Del Monte
Farm A Syst/Home A Syst National Office
Gempler's, Inc.
General Mills, Inc.
Gerber Products Company
Glades Crop Care, Inc.
Institute for Agriculture and Trade Policy
Rainforest Alliance-ECO o.k. Program
United States Golf Association
FY 98-99 OPP BIENNIAL REPORT
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LIST
OPP DIVISIONS
Office of the Director
703-305-7090
Responsible for overall management of the Office
of Pesticide Programs.
Antimicrobials Division
703-308-6411
Responsible for all regulatory activities
associated with antimicrobial pesticides,
including product registrations, amendments,
and reregistrations.
Biological and Economic Analysis
Division
703-308-8200
Responsible for assessing pesticide use and
benefits; and operating analytical chemistry
and antimicrobial testing laboratories.
Biopesticides and Pollution Prevention
Division
703-308-8712
Responsible for risk/benefit assessment and
risk management functions for microbial
pesticides; tolerance reassessment for
biopesticides; biochemical pesticides;
plant-pesticides and Pesticide Environmental
Stewardship Program.
Environmental Fate and Effects
Division
703-305-7695
Responsible for evaluating and validating
environmental data submitted on pesticide
properties and effects.
Field and External Affairs Division
703-305-7102
Responsible for program policies and
regulations; legislation and Congressional
interaction; regional, State, and tribal
coordination and assistance; international
and field programs; and communication
and outreach activities.
Health Effects Division
703-305-7351
Responsible for reviewing and validating data
on properties and effects of pesticides, as well
as characterizing and assessing exposure and
risks to humans and domestic animals.
Information Resources and Services
Division
703-305-5440
Responsible for information support; Public
Docket; records computer support; FIFRA
section 6(a) (2) issues; pesticide incident
monitoring; and National Pesticide
Telecommunications Network.
Registration Division
703-305-5447
Responsible for product registrations,
amendments, reregistrations, tolerances,
experimental use permits, and emergency
exemptions for all pesticides not assigned to
BPPD or AD.
Special Review and Reregistration
Division
703-308-8000
Responsible for Reregistration Eligibility
Decisions (REDs), product reregistration,
tolerance reassessment; and Special Reviews.
FY 98-99 OPP BIENNIAL REPORT
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LIST 3
REGIONAL PESTICIDE OFFICES
Region 1
617-918-1501
John F. Kennedy Federal Building
One Congress Street
Boston, MA 02203-0001
Region 2
212-637-4000
290 Broadway
New York, NY 10007-1866
Region 3
215-814-3127
1650 Arch Street
Philadelphia, PA 19103
Region 4
404-562-9077
61 Forsyth Street
Atlanta, GA 30303
Region 7
913-551-7307
901 North 5th Street
Kansas City, KS 66101
Region 8
303-312-6390
999 18th Street, Suite 500
Denver, CO 80202-2466
Region 9
415-744-1585
75 Hawthorne Street
San Francisco, CA 94105
Region 10
206-553-4181
1200 Sixth Avenue
Seattle, WA 98101
Region 5
312-886-7475
77 West Jackson Boulevard
Chicago, IL 60604-3507
Region 6
214-665-7200
Fountain Place, 12th Floor Suite 1200
1445 Ross Avenue
Dallas, TX 75202-2733
FY 98-99 OPP BIENNIAL REPORT
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LIST
LIST OF ACRONYMS
AD Antimicrobials Division
APIC Association for Professionals in Infectious Control and Epidemiology
ARS Agricultural Research Service
BBPD Biopesticide and Pollution Prevention Division
CADDY Computer Aided Dossier and Data Supply
CDPR California Department of Pesticide Regulation
CLI Consumer Labeling Initiative
DDT Dichloro diphenyl trichloroethane (DDT)
EIIS Ecological Incident Information System
FAO Food and Agricultural Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FEAD Field and External Affairs Division
FFDCA Federal Food, Drug and Cosmetic Act
FQJA Food Quality Protection Act
GLP Good Laboratory Practices
HHS Department of Health and Human Services
IFCS Intergovernmental Forum on Chemical Safety
IPM Integrated Pest Management
IR-4 Interregional Research Project No. 4
LAN Local Area Network
MOU Memorandum of Understanding
MRL Maximum Residue Limits
NAFTA North American Free Trade Agreement
NTIS National Technical Information Service
OECD Organization for Economic Cooperation and Development
OP Organophosphates
OPP Office of Pesticide Programs
PDSL Pesticide Data Submitters List
PESP Pesticide Environmental Stewardship Program
PIC Prior Informed Consent
PMRA Pesticide Management Regulatory Agency (Canada)
POPs Persistent Organic Pollutants
PPDC Pesticide Program Dialogue Committee
RED Reregistration Eligibility Decision
TRAC Tolerance Reassessment Advisory Committee
USDA United States Department of Agriculture
WHO World Health Organization
WPS Worker Protection Standard
FY 98-99 OPP BIENNIAL REPORT
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NOTES
FY 98-99 OPP BIENNIAL REPORT
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