United States
Environmental Protection
Agency
Prevention, Pesticides,
and Toxic Substances
(7506C)
EPA730R00001
May 2OO1
www.epa.gov/pesticides
oEPA
Report on Minor
Use Pesticides
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THE UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY
REPORT on MINOR USES of PESTICIDES
Mandated by Section 31 of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as Amended by
the Food Quality Protection Act (FQPA) of August 3,1996
Prepared by
EPA's Minor Use Team and Public Health Steering Committee
in cooperation with
the United States Department of Agriculture
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TABLE OF CONTENTS
Executive Summary 3
Background
The Importance of Minor Use Pesticides.. 6
Definition of Minor Use 7
EPA Minor Use Activities
Priorities for Minor Uses 9
EPA's Minor Use Team and Public Health Steering Committee 9
Registration Activities for Minor Uses 1°
FQPA Exclusive Use Provisions for Minor Use Pesticides
and Other Incentives to Register Minor Uses 11
Retaining Critically Needed Pesticide Uses 12
Relying on Sound Science and Real World Data 12
Maintaining a Level Playing Field in World Markets 13
Outreach and Communication 16
EPA/USDA Partnerships 18
EPA/DHHS Partnership 21
EPA/FDA Partnership 23
Conclusions 24
APPENDIX 1: Pesticides Registered Recently for Minor Use Crops 26
APPENDIX 2: Commonly used Acronyms 30
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EXECUTIVE SUMMARY
The Food Quality Protection Act (FQPA) of 1996 mandated a more coordinated approach
for managing minor crop pesticides. One of the first steps taken by EPA to help improve its
responsiveness to minor use concerns was the establishment of a full-time minor crop advisor
reporting directly to the Director of the Office of Pesticide Programs. Through this mechanism,
growers and others who are impacted by minor use issues are able to raise concerns and consult
with senior program officials in a timely and coordinated fashion regarding minor use registrations,
reregistrations and policy issues. To address public health minor use issues, EPA also designated a
public health coordinator. EPA also created a minor use team to focus coordination of minor crop
issues and a public health steering committee for vector pest control issues. These teams include
representatives from the U.S. Department of Agriculture (USDA), from the Department of Health
and Human Services (DHHS) and from various programs involved with pesticide issues throughout
JciJrA.
Background
Minor use pesticides are of'major' significance in agricultural production and for protecting
public health from disease vectors such as mosquitos, ticks, cockroaches, rats and disease-causing
organisms. Without these comparatively small-scale but vital pesticide uses, many of the fruits,
vegetables and ornamentals enjoyed in the U.S. and valued at billions of dollars could not be grown
successfully. Minor uses of pesticides are those for which the total U.S. acreage for a particular
crop is less than 300,000 acres or those for which the use does not provide sufficient economic
incentive to support its registration. Thus, minor uses are not always economically attractive to the
pesticide industry because the amount of pesticides sold for these uses is limited and revenues may
be low, while the costs to obtain and maintain registration are substantial. However, EPA working
cooperatively with USDA recognizes that a variety of pest management tools are needed in order
to: 1) produce and maintain a safe, dependable supply of fruits and vegetables; 2) implement
integrated pest management (IPM) programs; 3) manage pest resistance; 4) allow U.S. crop
producers to compete effectively in a global food market; and 5) minimize global spread of pest-
vectored public health diseases.
Priorities for Minor Uses
EPA priorities for minor uses include expedited registration of minor use pesticides. Nearly
84 percent of all uses approved by EPA's pesticide registration program in 1998 and 1999 were for
minor uses. And for 2000, the numbers are equally impressive with more than 80 percent of these
chemical-crop combinations in a reduced-risk category. Importantly, many of these minor use
crops are the fruits and vegetables consumed daily by children.
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In response to concerns expressed by the minor use community, EPA is addressing the
following issues:
Maintaining an Adequate Supply of Effective Pesticides: In fiscal year 1999, EPA registered
814 new pesticide uses for minor crops and 901 were registered in fiscal year 2000. In addition,
over 550 emergency or crisis exemptions were granted in 1999 in record turn-around times and the
same performance has continued in 2000. The majority of these actions were for reduced-risk
pesticides.
Retaining Critically Needed Pesticide Uses: The Agency is working with USDA and DHHS to
identify critical pesticide uses and is providing growers, public health program coordinators and
other stakeholders opportunities to identify critical uses and discuss regulatory actions before they
become final. In addition, provisions are being considered to permit selective use of critically
needed pesticides while alternatives are being developed.
Relying on Sound Science and Real World Data: FQPA raised the standard of protection
to pesticide exposure and has changed the way EPA conducts risk assessments. EPA is using real
world data, state-of-the art risk assessment methods and extensive studies for risk assessments and
relies on advice from the Scientific Advisory Panel, input from USDA and DHHS, internal and
external peer review and public notice and comment periods to help develop sound science
policies.
Maintaining a Level Playing Field in World Markets: EPA is harmonizing pesticide regulatory
activities with Canada and Mexico through the North American Free Trade Agreement's
(NAFTA's) Technical Working Group and with Europe and many other industrialized countries
through the Organization for Economic Cooperation and Development (OECD). One of the
primary goals of harmonization is to reduce barriers.
Developing Partnerships between EPA, USDA and DHHS: EPA has a long and productive
history of working with USDA's Inter-regional Project #4 (IR-4) on pesticide registration for minor
crops and is working with USDA's Office of Pest Management Policy (OPMP) on science policies,
tolerance reassessment, reregistration and other pest management issues. EPA and DHHS's Center
for Disease Control (CDC) signed a memorandum of understanding in July 2000 that outlines how
the agencies will collaborate on implementing the FQPA public health pesticide provisions.
Increasing Outreach and Communication by EPA: Greater public participation and increased
transparency are integral to the process used by EPA and USDA for tolerance reassessment. Based
on recommendations from the Tolerance Reassessment Advisory Committee (TRAC) to improve
outreach and communication for the FQPA-mandated tolerance reassessments, a pilot process was
successfully developed. In March 2000, EPA proposed a public participation process for pesticide
risk assessment that would apply to all tolerance reassessments. Building on the pilot process
developed with the TRAC, this allows for greater public participation at important stages, including
an opportunity for EPA, USDA and other agencies to meet with interested stakeholders to discuss
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pesticide use and usage and to share available information. EPA will also inform the public well in
advance about pesticides scheduled for the public participation process to allow registrants to
inform the Agency about studies that have begun and the public to anticipate upcoming activities
on pesticides of particular interest to them.
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BACKGROUND
The Importance of Minor Use Pesticides
Minor crop producers and public health program administrators typically have fewer pesticide
options for pest management due to lack of economic return to registrants to develop and register
and/or support reregistration of pesticides for minor uses. However, a variety of pest management
tools are needed to: 1) produce and maintain a safe, nutritious and dependable food supply and
effectively control public health pests in the United States; 2) implement integrated pest
management (IPM) programs; 3) manage pest resistance; 4) allow United States growers to
compete effectively in a global food market; and 5) minimize global spread of pest-vectored public
health diseases.
The Food Quality Protection Act (FQPA) called for a new, better coordinated approach to
managing issues involving minor uses of pesticides. This coordinated approach builds on existing
efforts at both the EPA and USDA and increases the role of stakeholders in providing information
crucial to sound regulatory decisions. The authors of FQPA recognized that in addition to
strengthening protection of children and other sensitive populations in the United States from
pesticide risks, that the Agency must consider other policy goals, such as maintaining a safe,
dependable, and affordable supply of fruits, vegetables and other foods along with the protection of
the public health from pest-vectored diseases. Most fruit and vegetable uses and public health uses,
such as mosquito control programs, are considered by EPA and USDA as minor uses for pesticides.
The FQPA directs EPA, working together with USDA and DHHS, to give special consideration to
minor uses for pesticides.
FQPA raises the standard of protection for children and other sensitive populations from
pesticide risks and prescribes a time-line for reassessing all pre-existing pesticide residue
tolerances. Minor use stakeholders are concerned that minor uses will be lost as EPA implements
the tolerance reassessment/reregistration requirements of the FQPA. Prior to enactment of the
FQPA in August 1996 and in response to reregistration changes in the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA) mandated in 1988, approximately 1,000 minor uses were
voluntarily canceled by registrants during the reregistration process. Minor uses do not offer
economic returns to registrants comparable to major crop uses, and have historically been the first
uses dropped by registrants negotiating risk reductions for reregistration with EPA. In addition,
many of these pesticides have outstanding data requirements that must be met before reregistration
can be completed. Sometimes the cost of providing these data can be too high for the registrants,
particularly in cases where the chemicals have a small or declining market share and profit margin.
In these cases, the registrants may seek to voluntarily cancel part or all the uses of the pesticide.
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Definition of'Minor Use'
FIFRA section 2(11), as amended by FQPA, defines 'minor use' as follows: "The term
'minor use' means the use of a pesticide on an animal, on a commercial agricultural crop or site, or
for the protection of public health where--
1) The total United States acreage for the crop is less than 300,000 acres, as determined by the
Secretary of Agriculture; or
2) The Administrator, in consultation with the Secretary of Agriculture, determines that, based
on information provided by an applicant for registration or a registrant, the use does not
provide sufficient economic incentive to support the initial registration or continuing
registration of a pesticide for use and
A) There are insufficient efficacious alternative registered pesticides available for
the use; or
B) The alternatives to the pesticide use pose greater risks to the environment or
human health; or
C) The minor use pesticide plays or will play a significant part in managing pest
resistance; or
D) The minor use pesticide plays or will play a significant part in an integrated
pest management program."
Several hundred'crops, including most fruits and vegetables, meet the acreage criterion in
this definition. The easiest way to identify them is by listing what is not a minor crop under the
acreage portion of the definition. The following crops are grown on more than 300,000 acres, and
thus do not meet the acreage definition of a minor crop: almonds, apples, barley, beans (snap and
dry), canola, corn (field, sweet and pop), cotton, grapes, hay (alfalfa and other), oats, oranges,
peanuts, pecans, potatoes, rice, rye, sorghum, soybeans, sugar beets, sugarcane, sunflower, tobacco,
tomatoes, turf and wheat.
These 'major crops', however, can have minor protection needs, for certain pests or in
certain regions. In such cases, a crop meeting the economic definition is eligible for treatment as a
minor use. The Agency and IR-4 routinely undertake regional/pest specific requests for apples,
grapes, snap and dry beans, pecans, potatoes, sugar beets and tomatoes that meet the economic
definition of a minor crop.
FQPA defines public health pesticides as a sub-category of minor use pesticides.
Specifically, section 2(nn) of FIFRA defines a "public health pesticide" as:
[A]ny minor use pesticide product registered for use and used predominantly in public
health programs for vector control or for other recognized health protection uses, including
the mitigation of viruses, bacteria or other microorganisms (other than viruses, bacteria, or
other microorganisms on or in living man or other living animal) that pose a threat to public
health.
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FIFRA section 2(oo) defines the term "vector" as~
"any organism capable of transmitting the causative agent of human disease or capable of
producing human discomfort or injury, including mosquitoes, flies, fleas, cockroaches, or
other insects and ticks, mites, or rats".
These definitions taken together contain the three mandatory conditions for a pesticide
product to qualify as a "public health pesticide":
1) The public health use of the pesticide product must be a minor use, meeting the economic
criterion under section 2(11) of FIFRA.
2) The pesticide must be registered for use and used predominantly in public health programs.
3) The use of the pesticide in the public health program must be for vector control or for other
recognized health protection purposes.
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EPA MINOR USE ACTIVITIES
Priorities for Minor Uses
Priorities for minor uses include expediting minor use pesticide registrations. EPA gives high
priority to minor use registrations that: replace uses canceled during tolerance reassessment and
reregistration; avoid reissuance of FIFRA section 18 emergency exemptions; offer alternatives to
methyl bromide, organophosphates, carbamates and class B2 carcinogens; fill critical use needs;
will play a significant part in managing pest resistance; or will play a significant part in integrated
pest management programs.
Minor use priorities for reregistration and tolerance reassessment are guided by
recommendations from the Tolerance Reassessment Advisory Committee (TRAC) and the recently
formed Committee to Advise on Reassessment and Transition (CARAT). In a response to a request
to enhance stakeholder input on FQPA implementation, EPA and USDA established the TRAC 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. The four implementation principles that direct EPA's priorities for
reassessment of minor uses of pesticides are:
Use of sound science in decision-making.
Establishing a transparent regulatory process.
Ensuring a reasonable transition for agriculture to new methods and alternatives.
Fostering the involvement of stakeholders.
EPA and USDA have made considerable headway towards these goals with the development
of key science policies for decision-making, use of the internet to post risk assessments and policies
that increase transparency in real time, use of interactive processes for increasing stakeholder
involvement, expedited registration of reduced-risk minor use pesticides, and implementation of
grant programs for pest management strategies that reduce risk.
Obtaining real world pesticide use and residue data for refined risk assessments is a priority
for EPA. These data are more readily available for major uses of pesticides than minor uses. EPA
is working with USDA, minor crop growers, public health program administrators and other
stakeholders to obtain real world data for minor uses.
EPA's Minor Use Team and Public Health Steering Committee
FQPA calls for coordinated action on minor use issues by EPA, USDA and DHHS and an increase
in stakeholder involvement in actions affecting minor uses. As a focus for coordination, EPA
created the multi-disciplinary Minor Use Team and the Public Health Steering Committee to
facilitate minor use activities. These groups include members from USDA and DHHS. The goals
of the Minor Use Team and Public Health Steering Committee are:
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Ensure that growers and public health program administrators have an opportunity to
discuss their needs and concerns with EPA before EPA finalizes regulatory actions;
Work with USDA, IR-4, DHHS, industry, growers, public health agencies and other
stakeholders to promote registration and use of reduced-risk pesticides for minor uses;
Encourage development of real world pesticide use and residue data by growers, public
health agencies, USDA, DHHS and other stakeholders for use in refined risk assessments.
Registration Activities for Minor Uses
EPA's efforts to respond to minor crop growers' needs are evidenced by progress made on
new registration decisions for minor crops. In fiscal year 1999, EPA registered new pesticides and
approved new uses of existing pesticides, which provided growers with 814 additional new uses for
minor crops. In fiscal year 2000, 901 new minor crop pesticide uses were registered. Of these,
over three quarters involved biopesticides or reduced-risk pesticides. Examples of some of the
recently registered minor uses are listed in Appendix 1.
EPA's Registration Division (RD) uses a priority planning system to manage conventional
pesticide registration actions and gives high priority to minor use and reduced-risk pesticide
registrations. IR-4 shares EPA's commitment to prioritizing registration of reduced-risk pesticides,
and as a result over 80 percent of IR-4 projects for fiscal year 2000 supported registration of
reduced-risk pesticides. RD has increased its efficiency in registering minor uses with IR-4 and
industry registrants through developing new crop groupings for tropical fruits and other minor
crops, discussing needs with grower groups and registrants and consolidating reviews. In addition,
at the request of IR-4, RD has streamlined the requirements needed to support reduced-risk
classification for minor use pesticide applications. Through hard work by both partners,
productivity has increased and many new reduced-risk pesticides are being made available to minor
crop producers. EPA and IR-4 are exploring additional ways to increase productivity.
The Fiscal year's FIFRA section 18 emergency response program granted over 550
emergency use or crisis exemptions in fiscal year 1999 with record turn-around times that have
continued. Quick response to FIFRA section 18 emergency and crisis requests are a priority for
EPA's Office of Pesticide Programs (OPP), and the majority of emergency exemption and crisis
requests are for minor uses of pesticides. Prior to FQPA, EPA did not establish pesticide tolerances
for crops in conjunction with Section 18 exemptions or crises, but advised the Food and Drug
Administration (FDA) of acceptable pesticide levels for residues resulting from use under an
exemption or crisis. FDA used the action levels for enforcement when monitoring foods for
pesticide residues. FQPA specifically requires EPA to establish tolerances for FIFRA section 18
emergency exemptions. Obtaining required tolerances quickly has been a major concern for minor
crop producers. EPA is evaluating these tolerance actions quickly, often relying on residue data
provided by IR-4, and is also working with state lead agencies and grower groups to mitigate risks
or find effective alternatives for requested pesticides that do not meet FQPA safety standards.
Prescriptive-use programs have been developed for some section 18 requests, requiring growers,
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state lead agencies and university extension specialists to work together to mitigate risks from
pesticides and reduce the development of pest resistance to pesticides.
Biopesticides are registered by EPA's Biopesticides and Pollution Prevention Division
(BPPD). Biopesticides are generally reduced-risk materials that have fewer human health and
ecological toxicity concerns than most conventional pesticides. BPPD works together with IR-4,
USDA-Agricultural Research Service (ARS) and USDA-Forest Service (FS) to facilitate
registration of biological pesticides. USD A IR-4, ARS and FS have biopesticide research and/or
development programs and have detailed some of their scientists to BPPD to learn about data
requirements and the registration process. Biopesticides generally are not as broad spectrum or as
quick acting as conventional pesticides and therefore require more field development and testing to
determine how to use them most effectively. IR-4 is working with the biopesticide industry to
develop the field testing and grower demonstrations vital to successful use of these products.
EPA and USDA are working together with stakeholders to find alternatives for
organophosphate, carbamate, and class B2 carcinogen pesticides. Both EPA and USDA recognize
that pest management products must be field tested, economically feasible and compatible with
other integrated crop management practices in order to be accepted as viable alternatives. EPA is
determining how to streamline experimental testing of reduced-risk pesticides, and USDA is
gearing up to support new research and development proposals through IR-4 and with their
competitive grants programs: 'Pesticide Management Alternatives Program' (PMAP), 'Crops at
Risk' (CAR), and 'Risk Mitigation Program for Major Crops System' (RAMP). EPA relies on
USDA to help minor crop producers develop viable alternatives.
FQPA Exclusive Use Provisions for Minor Use Pesticides and Other Incentives to Register
Minor Uses
FQPA provides for extension of exclusive use rights to rely on supporting data when a
registrant applies for new minor uses. This was intended to be an incentive for registering more
minor uses. FQPA directs EPA to give priority to registration submissions that request three or
more 'significant minor uses' for every major use. Significant minor use is defined by FQPA as a
minor use that would, in the judgment of the Administrator, serve as a replacement for any use that
has been canceled in the five years preceding the receipt of the application, or a minor use that, in
the opinion of the Administrator, would avoid the reissuance of an emergency exemption under
FIFRA section 18 for that minor use. There have only been several specific requests by registrants
to use this incentive. The American Crop Protection Association (ACPA) suggested, however, that
an even greater incentive is EPA giving priority to any submission, which combines minor use
applications with major uses.
RD has incorporated ACPA's suggestion into their priority system and also gives priority to
submissions for minor and major uses, which are organophosphate pesticide alternatives. EPA is
responsive to minor use concerns and routinely meets with IR-4, industry and minor use groups to
prioritize needs and seek registration efficiencies.
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Retaining Critically Needed Pesticide Uses
There is concern that critical uses of old pesticides, such as the organophosphates,
carbamates and B2 carcinogens, will be lost as EPA reassesses tolerances under the new
requirements of FQPA. Critical uses of pesticides are those that have few or no alternatives to
pesticide uses undergoing tolerance reassessment or reregistration review. The transparent, highly
interactive pilot process for reassessing organophosphate pesticide tolerances, developed by EPA
and USDA with recommendations from TRAC, provides opportunities for stakeholders to identify
critical uses and supply practical information for mitigating risks before regulatory actions become
final.
As an illustrative example, the TRAC pilot process was used to assess the risks associated
with the use of formetanate hydrochloride (Trade name Carzol), a carbamate insecticide/miticide.
Acute dietary risk assessments for Carzol indicated that currently registered use patterns of the
pesticide exceeded the allowable dietary intake by children. Risk mitigation would be required to
achieve acceptable dietary levels. As part of the risk assessment process, EPA called on USD As
Office of Pest Management Policy (OPMP) to help identify critical uses and practical risk
mitigation methods. USDA-OPMP arranged conference calls with growers, the registrant of
Carzol, IR-4, state lead agricultural agencies, university extension specialists and others to discuss
the risk assessment and identify critical uses. The calls helped identify practical risk mitigation
practices for critical uses, and surfaced information crucial to the registrant's decision to support or
abandon specific uses. In this case, based on input from affected grower groups, the registrant
decided to support several critical minor uses that it had intended to drop. Other, non-critical uses
were dropped to reduce risks from dietary exposure. In addition, prescriptive-use programs, similar
to those used to mitigate risks for FIFRA section 18 emergency exemptions, are being developed to
mitigate risks to acceptable levels and preserve critical uses until effective alternatives are
developed.
Relying on Sound Science and Real World Data
Requirements of FQPA are changing the way EPA does risk assessments and new methods
and policies have been developed to implement the law. EPA worked with TRAC to identify nine
science policy issues that are key to the implementation of the FQPA and tolerance reassessment.
Although EPA has sought independent review and public participation on a wide variety of issues,
EPA agreed that the implementation process would benefit from a more thorough process of public
notice and comment. In October 1998, EPA published a framework to describe these issues and a
preliminary schedule for the release of the policy and guidance documents associated with each
issue. In addition to the nine policy areas initially identified, EPA is seeking public comment on
several related issues, such as policy on early assessments. To date, 19 science policy papers have
been released for comment. EPA relies on the advice of the Scientific Advisory Panel, input from
USDA and DHHS, public notice and comment and internal and external peer review to help
develop sound science policies.
EPA is using real world data and state-of-the art risk assessment methods to develop
quantitative risk assessments that meet the new requirements of FQPA. EPA works with USDA-
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OPMP on science policies and relies on real world data generated by various USDA programs.
The statistically valid, nationally representative residue data generated by USDA's Pesticide Data
Program (PDP), crop-specific pesticide use data collected by the National Agricultural Statistics
Service (NASS) and USDA food consumption surveys have played vital roles in EPA's FQPA risk
assessments, and their importance cannot be overemphasized.
In addition, efforts by the Minor Crop Farmer Alliance and the American Mosquito Control
Association to collect and submit real world pesticide use data for validation by EPA's Biological
and Economic Analysis Division (BEAD) have provided critically important data for refined risk
assessments and well-informed risk management decisions. Some grower and food processor
groups have also voluntarily provided real world residue data, which EPA has validated and used
for tolerance reassessments.
BEAD is taking a new approach to providing real world use and usage data for risk
assessments, benefiting EPA's understanding of minor crop pest management issues and risk
management possibilities. Instead of evaluating use and usage from a single-chemical perspective,
BEAD is providing crop-based evaluations, which include validated use and usage information
from stakeholders. These evaluations report regional variations and comparative efficacy of the
various pest management tools available for the crop. To complement and supplement BEAD'S
crop evaluations, USDA is developing over 500 crop profiles and is piloting projects with USDA-
NASS and USDA-PDP to provide EPA with data representing pesticide levels in foods resulting
from growers' prevailing pesticide use practices. The EPA's Health Effects Division (HED) and
BEAD have developed statistical models to translate USDA's PDP composite residue sampling data
to single serving residue data, a form of data much more useful and more refined than currently
available data for use in EPA's probabilistic acute dietary risk assessment model. HED also worked
with USDA to develop a protocol for pesticide residue sampling for single servings, and PDP is
using this method for its monitoring program.
Maintaining a Level Playing Field in World Markets
The North American Free Trade Agreement (NAFTA) and the General Agreement on Trade
and Tariffs (GATT) have increased trade opportunities and challenges for U.S. growers and level
playing field issues are becoming more critical than ever in an increasingly global food market.
Minor crop producers want assurances that pesticides, which are severely restricted or banned from
use in the United States, are similarly restricted or banned for use on imported food. They suggest
that analytical methods that can detect pesticides banned or restricted in the U.S. at very low levels
are required, and enforcement surveillance must be increased.
EPA has entered into an interagency agreement to begin purchasing analytical instruments
for some FDA laboratories. The new instruments will allow for detection of pesticides at levels far
below what is currently possible. EPA is developing methodologies for laboratory use and will
provide FDA with a list of pesticides and crops for priority monitoring. The pesticides will be
mainly organophosphates and the crops will consist of many domestically grown and imported
children's foods. This improved monitoring will serve two purposes. First, it will allow detection
of low levels of pesticides for which there are no tolerances. Second, where tolerances already
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exist, it will provide better information on actual organophosphate residue levels for use in EPA's
risk assessments.
EPA-OPP is active in a number of scientific harmonization and regulatory coordination
efforts through international and regional organizations and directly with other countries. One of
the primary goals of harmonization is to reduce trade problems and level the playing field in the
world marketplace. In addition to reducing trade problems, harmonization also improves food
safety, reduces regulatory burden on national governments and strengthens scientific procedures.
OPP is involved in cooperative work on pesticide issues with the Organization for
Economic Cooperation and Development (OECD), an intergovernmental organization consisting of
29 industrialized countries in Europe, North America, Asia and the Pacific. OPP works with
OECD through the OECD Working Group on Pesticides to explore ways to harmonize pesticide
data requirements, focus test guidelines on pesticide regulatory needs, and harmonize industry data
submissions and government data review formats and content. The Working Group on Pesticides
is the only established international forum for OECD member countries to meet regularly to discuss
pesticide regulatory issues of common interest. This group meets approximately every nine months
in conjunction with OECD Joint Meetings to discuss and make decisions about the program of
work agreed to by the member countries.
Common data requirements are an important building block for harmonizing countries'
regulatory reviews. OECD member countries have developed proposals for similar core data
requirements for biological pesticides, pheromones and microbials. OECD has built a database
containing information on national pesticide registration evaluations and encourages the ad hoc
exchange of data reviews. OPP keeps the Unites States' entries current and uses the database to
determine which countries have pesticide reviews that could be of use in the United States. As a
result, EPA has been able to use some of these reviews to support regulatory decisions. OECD
member countries would like a common approach to testing pesticides and are working on
achieving this by developing standardized test guidelines. Some testing guidelines have been
harmonized and OECD is revising their test guideline program next year to increase responsiveness
to member country's needs. OECD developed harmonized formats for industry data submissions
and regulatory reviews. Standardizing the content and structure of submissions and reviews makes
them more easily understood and potentially interchangeable between country's regulatory
agencies.
Cooperative U.S./Canada bilateral efforts on pesticide regulatory harmonization were
expanded in 1996 to include Mexico through the NAFTA Technical Working Group (TWO). The
TWG is developing a coordinated pesticides regulatory framework among NAFTA partners to
address trade irritants, build national regulatory/scientific capacity, share review burden and
coordinate scientific and regulatory decisions on pesticides. This work has already begun to pay
dividends by addressing specific trade irritants, developing a better understanding of each
regulatory agency's risk assessment practices, working to harmonize each country's procedures and
requirements and encouraging pesticide registrants to make coordinated data submissions to the
three NAFTA countries to facilitate joint reviews.
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The NAFTA TWO started doing joint reviews in 1998 and has completed reviews for
cyprodonil fungicide on fruit, diflufenzopyr herbicide on field corn, fenhexamid fungicide on
grapes, strawberries and ornamentals, Virosoft CP4 bio-insecticide for codling moth control in
apples and Eastern Pine Shoot Borer pheromone. Eleven other joint reviews are in progress for an
assortment of conventional and biological pesticides.
In an effort to support pesticide registration in all three NAFTA countries and to facilitate
data development in support of minor crops, the NAFTA Food Residues Subcommittee completed
the North America Crop Field Trial Zone Maps for Canada and the United States. Zones for
Mexico have been provided to stakeholders for comment. Ten pesticide/crop combinations
between Canada and the U.S. and one combination between Mexico and the U.S. were identified
for field trials for minor use pesticide registrations in 2000 through the IR-4 program. The Food
Residues Subcommittee will be working on residue zone validation and coordinating data waiver
policy in the coming year.
The NAFTA TWO finalized a Geographic Information System (GlS)-based decision
support system that registrants can use to select field dissipation study sites to address requirements
of both Canadian and U.S. regulators. A new project will address harmonization of dissipation
field study protocols including the number of sites that need to be tested for specific uses. In
addition, the groundwork to allow full work sharing for occupational and residential exposure
assessments is complete. Guidelines have been developed to use the EPA Pesticide Handlers
Exposure Data Base for these reviews. Estimates of exposure conducted according to these
guidelines can be used to address the requirements of Canada's Pest Management Regulatory
Agency (PMRA), EPA and the California Department of Pesticide Regulation.
EPA supports the Codex Alimentarius Commission, a joint program of the United Nations
Food and Agriculture Organization (FAO) and the World Health Organization (WHO) whose goal
is to protect the health of consumers and to ensure fair trade practices in food trade. It develops
international food safety standards, including pesticide Maximum Residue Limit (MRL)
recommendations. National governments can decide whether or not to accept and use the Codex
MRL recommendations as national standards. Many developing countries depend upon Codex
MRLs to set acceptable pesticide residue levels in their own countries. Industrialized countries
with long-established programs review the Codex MRL recommendations and usually accept them
when they are consistent with their national standards. In addition to governmental representation
from 165 member countries, other international organizations and consumer, environmental and
industry non-governmental groups participate as observers in Codex activities. EPA contributes
technical expertise to the development of these international standards and tries to ensure that they
are compatible with the U.S. levels. The FQPA placed increased emphasis on using Codex MRLs
in setting U.S. tolerances for pesticide residues, to the extent feasible.
U.S. minor crop stakeholders indicate that they are having trouble exporting commodities
treated with newly registered pesticides because MRLs have not been established for the new
pesticides and importing countries will not accept the treated food commodities without an
established MRL. Many of the newly registered pesticides are reduced-risk pesticides that U.S.
producers would like to use, but may not be able to use on food commodities for export until MRLs
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are established. It takes four to eight years to establish Codex MRLs under current MRL
procedures. U.S. Codex Alimentarius Commission members are attempting to alleviate this
concern by developing a process to quickly establish time-limited, temporary MRLs for newly
registered reduced-risk pesticides.
Level playing field issues also affect public health programs. Global travel increases the
potential for spread of pest-vectored diseases. Travelers carrying vector-borne pathogens and
accidental introduction of pest vectors can result in epidemics of previously unseen diseases. The
Agency tracks pest-vectored disease outbreaks in the United States and works with affected states
and public health pesticide program administrators to ensure that effective pesticides are available
and are used with minimal impact to the surrounding environment.
Outreach and Communication
Increased outreach, communication and transparency to all stakeholders guided
development of the pilot process for reassessing the organophosphate pesticide tolerances by EPA
and USDA with recommendations from TRAC. The pilot process has provided the public the
opportunity to review and comment on risk assessments before they are finalized. The public
process has encouraged sharing of information reflecting actual field practices for refining risk
assessments and working with EPA and USDA on risk mitigation strategies. The pilot process
includes the following activities: 1) risk assessments are posted on EPA's internet site and public
docket, and comment periods are provided to obtain stakeholder input; 2) for many chemicals,
EPA's Special Review and Reregistration Division (SRRD) provides technical briefings to the
public on how risk assessments were done and on the calculated risks; 3) USDA arranges meetings
and/or conference calls for EPA with grower groups, registrants, extension specialists, independent
crop consultants and others to identify critical pest uses and provide a better understanding of
actual use patterns; and 4) stakeholders, including environmental groups, industry, public interest
groups, grower groups, regional EPA and state regulatory agencies, are contacted by EPA and
USDA before the end of the tolerance reassessment or reregistration process to ensure that sound
final regulatory decisions are made.
The EPA Minor Use Team and Public Health Steering Committee work with USDA and
DHHS to ensure that the best available data are obtained and used in risk assessments. USDA is
meeting with growers to develop Pest Management Strategy Programs and to identify critical pest
control needs. EPA and IR-4 are using the critical pest needs identified at these meetings to
channel and prioritize development and registration of alternatives for critical uses. This
information also helps USDA to prioritize needs for their pest management competitive grants
programs. These programs are discussed in more detail below under 'EPA/USDA Partnerships'.
EPA's Pesticide Environmental Stewardship Program (PESP) facilitates communications
with grower and other pesticide user groups. The PESP program has over 30 minor use crop and
public health partners. PESP works with their partners to develop practical, cost effective reduced-
risk pesticide strategies and facilitates education and information sharing between pesticide user
groups. PESP has provided seed money to support education about reduced-risk and IPM
programs for both minor and major uses. In addition, PESP coordinates and catalyzes activity
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between regional EPA, USDA and private enterprise IPM programs, which is resulting in real
world pesticide risk reductions.
Other EPA outreach efforts include publication and Internet posting of RD's annual work
plan to better inform all stakeholders of registration actions planned for the year and to increase
predictability and timeliness of registration actions. EPA meets regularly with grower groups to
discuss their priority needs and to provide information about the registration process. EPA's Minor
Use Team and IR-4 are working with registrants and grower groups to facilitate development and
testing of new biopesticides and reduced-risk pesticides for minor crops.
OPP initiated four pilot Agricultural Initiative projects in four of its ten regions in 1998.
The four regions represent the areas of the country where the largest percentage of minor crops are
produced including California (EPA Region 9), Florida and the southeast (EPA Region 4),
Michigan and portions of the mid-west (EPA Region 5), and the Pacific Northwest (EPA Region
10). Each of the four regions hired an agricultural initiative specialist to facilitate communication
and implement pollution prevention programs with the pesticide user community. The agricultural
initiative programs are promoting understanding of FQPA and cultivating partnerships that draw
affected regulatory agencies, industry and agricultural communities together to develop a clear
understanding of regional pest management concerns and priorities and to develop pest
management strategies that address these concerns. Agricultural initiative projects range from on-
farm testing and demonstrations of reduced-risk pest control practices to collecting pesticide use
information on minor crops. The regional agricultural initiative specialists are also working with
USDA-OPMP on crop and region specific Pest Management Strategy Plans (PMSP).
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EPA/USDA PARTNERSHIPS
Cooperative Efforts with IR-4
EPA's Office of Pesticide Programs and IR-4 have a long history of working together to
register pesticides for minor crops. IR-4 shares EPA's commitment to prioritizing registration of
reduced-risk pesticides, and as a result, over 80 percent of IR-4 projects for fiscal year 2001 support
registration of reduced-risk pesticides. EPA gives high priority to minor use and reduced-risk
pesticide registration submissions and expedites reviews for these submissions. EPA and IR-4 are
working together to streamline processes and procedures for minor use pesticide registrations. The
effectiveness of this streamlining was apparent in EPAs quick registration of IR-4's bifenthrin
insecticide/miticide submission for snap beans and sweet corn; this product is-proving to be an
effective alternative to organophosphates on over 50,000 acres of beans and sweet corn. EPA and
IR-4 are also working with USDA's Agricultural Research Service (ARS) to seek and register
methyl bromide alternatives for minor crops. As a result, EPA expedited registration of
halosulfuron-methyl, an herbicide alternative to methyl bromide, for control of nutsedge in
cucumbers and squash.
Several EPA/IR-4 partnership projects are worthy of note:
Streamlining the reduced-risk justification format for minor uses, making it less resource
intensive for IR-4 to request reduced-risk classification.
Developing 'blanket1 tolerances for selected reduced-risk chemicals, reducing EPA review
time.
Improving the tolerance petition format, reducing EPA review time by two to three months.
IR-4 assigning one of its minor crop experts to the Director's office in OPP to aid the
program with minor crop issues.
Sharing work plans, allowing EPA to predict arrival of IR-4 petitions and IR-4 to group
submissions for the same pesticide, contributing further to a streamlined review.
Harmonizing generation and review of data to support simultaneous registration of both
conventional and biological pesticides with Canada's Pest Management Regulatory Agency
(PMRA). Efforts are underway to do the same with Mexico and Europe.
Creating new crop groupings resulting in fewer data requirements and substantial savings
to both IR-4 and registrants. Crop groups combine similar commodities that are closely
related botanically and have similar cultural practices and pest problems. By developing
residue data on the representative crops within a crop group, a crop group tolerance
applicable to all crops within that group can be obtained. This results in fewer field trials
and less laboratory work than would be necessary to obtain tolerances on a crop-by-crop
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basis. The use of crop groupings has had significant positive impact on both IR-4's and the
industry's efficiency in obtaining tolerances. Five new commodity definitions for tropical
fruits have been approved recently. In this example, residue data developed for papaya will
be used to support the registration of pesticides for black sapote, canistel, mamey sapote,
mango, and star apple. The potential research savings from reducing duplicate testing for
all the tropical fruits could amount to $2.5 million on a yearly basis.
EPA processing of IR-4 minor crop tolerance petitions was delayed the year immediately
following the passage of FQPA (August, 1996 - August, 1997) like all other tolerance setting
while EPA developed new methods of risk assessment required by FQPA. EPA has now developed
many of the needed science policies and procedures to evaluate risk under FQPA's stricter safety
standards, and the tolerance setting process is improved. IR-4 actions, on average, are processed by
EPA in 18 months compared with 31 months for all new use actions submitted. Through hard work
by both partners, productivity has increased and many new reduced-risk pesticides are being made
available to minor crop producers. EPA and IR-4 are exploring additional ways to increase
productivity and are building partnerships with California Department of Pesticide Regulation
Canada's PMRA and OECD for work sharing.
Cooperative Efforts with USDA-Offlce of Pest Management Policy (OPMP)
USDA's OPMP consolidates pest management issues in USDA and includes members from
all sectors of USDA with pesticide or pest management missions. EPA works closely with USDA-
OPMP to obtain statistically valid, real world data for risk assessments and to identify critical pest
management needs for tolerance reassessments and pest management strategies. This allows both
EPA and USDA to focus efforts on working with those growers who need effective, viable
alternatives to organophosphate, carbamate and class B2 carcinogen pesticides. OPMP is
facilitating development of crop profiles for minor and major crops and has more than 300 such
profiles to date, and expects to develop over 200 more. The crop profiles are state- and region-
specific, and provide useful information for EPA risk management decisions. OPMP also
facilitates development of Pest Management Strategy Programs (PMSP) by growers to address
critical pest control needs. In addition, newly created USDA regional centers will be designated to
further streamline and focus efforts on PMSP plans and regional pesticide issues.
EPA's Minor Use Team and Public Health Steering Committee keep the pesticide
registration divisions and IR-4 informed on critical pesticide use needs identified during the
tolerance reassessment process in order to focus registration efforts on those pesticide uses that
need alternatives most. The EPA Minor Use Team Leader is a member of the USDA-OPMP core
management team. Examples of the benefits of EPA and USDA coordination include:
USDA Pesticide Data Program (PDF): EPA relies on POP for statistically valid, reliable, real
world residue data on children's foods. This is the best source of refined residue data available to
EPA and covers both United States and foreign produced crops consumed in the United States.
PDP data have been essential for refining the risk assessments for the organophosphates and for
npn-organophosphate reregistration eligibility decisions. EPA meets regularly with USDA-PDP to
discuss data needed by EPA for risk assessments. EPA and PDP developed a protocol for pesticide
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residue sampling for single servings statistical models, a form of data needed for EPA's
probabilistic acute dietary risk assessment model.
USDA National Agricultural Statistics Service (NASS): USDA-NASS provides statistically
reliable, real world nationwide data on pesticide use for major and selected minor crops. EPA
relies on these data to refine risk assessments. USDA-NASS also meets routinely with EPA and
will custom design data collection for use by EPA.
USDA Cooperative State Research, Education and Extension Service (CSREES): CSREES is
home to many programs that can provide alternative pest management practices for those growers
who may lose pesticide uses through FQPA implementation. The IR-4 program is primarily funded
by CSREES and the national Integrated Pest Management (IPM) and Pesticide Applicator Training
(PAT) programs reside in CSREES. USDA has several competitive grant programs, administered
by CSREES designed to develop alternatives for critical uses of pesticides as follows: the Test
Management Alternatives Program1 (PMAP), and recently funded 'Crops at Risk1 (CAR), and 'Risk
Management for Major Crop Systems' (RAMP). Lists of critical pest/pesticide uses that need
alternatives are co-developed by EPA and USDA and USDA has given EPA voting rights on
awarding the grants. Grower participation in programs like these is essential for changing real
world pest management practices.
USDA Agricultural Research Service (ARS): USDA-ARS research is responsible for many
insect pheromone and microbial pesticide discoveries and innovative ways to use parasites and
predators for effective pest control. Many of the currently registered biopesticides owe their
origins to USDA-ARS work. ARS has successfully transferred some of its technology to growers
using area wide pest control programs. The USDA-ARS Pacific Northwest area wide codling moth
pheromone control program for apples and pears is a good example of this. This program has
allowed growers and researchers to develop effective and practical applications of pheromone
technology for western apple and pear production areas. It has good potential to provide these
apple and pear producers with sustainable, affordable alternatives to season-long conventional
chemical controls. This technology has also been adopted by California pear growers who are
developing novel application techniques for their growing areas. EPA supports these and similar
programs through their PESP and regional grant programs. USDA-ARS also partially funds the
IR-4 program and has detailed scientists to EPA's BPPD to facilitate development and registration
of biopesticides.
USDA Forest Service (FS): USDA-FS has a productive biopesticide development program and
has also detailed scientists to EPA's BPPD to facilitate development and registration of
biopesticides. The USDA-FS is developing pesticide use profiles for forest uses, similar to crop
profiles and has provided useful information for risk mitigation and identification of critical uses.
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EPA/DHHS PARTNERSHIP
In July 2000, EPA and DHHS's CDC signed a Memorandum of Understanding (MOU) that
provides a framework for joint efforts and coordination of FQPA implementation between EPA and
CDC. EPA/DHHS coordinated efforts required for FQPA implementation include:
EPA, in coordination with DHHS and USD A, shall identify pests of significant public
health importance.
EPA shall consult with DHHS, upon a timely request to do so, prior to taking final action to
suspend registration under Section 3(c)(2)(B), or cancel a registration under Sections 4, 6(e)
or 6(f).
EPA, in coordination with DHHS, shall implement programs to improve and facilitate the
safe and necessary use of chemical, biological and other methods to combat and control
such pests of public health importance.
EPA shall exempt any public health pesticide from the payment of a reregistration fee or
registration maintenance fee if EPA determines, in consultation with DHHS, that the
economic return to the registrant from sales of the pesticide does not support the registration
or reregistration of the pesticide.
EPA shall assure the expedited processing review of any application that proposes the initial
or amended registration of an end use pesticide that, if registered as proposed, would be
used as a public health pesticide.
If necessary and appropriate DHHS shall make arrangements for the conduct of studies if
EPA, in consultation with DHHS, determines that the benefits of continued use warrant a
commitment by DHHS to conduct the studies for reregistration or continued registration.
EPA shall amend the 3(c)(2)(B) notice to allow for reasonable time periods for submission
of data by DHHS before taking final action.
EPA's Public Health Steering Committee worked with DHHS and USDA to identify
significant public health pests and published the FQPA mandated public health pest list in April
2000 for review and comment. The Public Health Steering Committee works with stakeholders,
such as the American Mosquito Control Association, to obtain real world pesticide use information,
and has actively solicited input from DHHS on organophosphates used in mosquito control and
other important public health programs.
EPA facilitates the safe and necessary use of pesticides to control pests of public health
importance with CDC through PESP and Public Health Steering Committee membership on CDC's
Federal West Nile Virus Coordinating Committee. EPA's PESP promotes IPM and reduced-risk
pest management programs and both CDC and the American Mosquito Control Association are
PESP partners.
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EPA has not received any reregistration fee exemption requests to date and has had two
requests for registration maintenance fee waivers: one that was granted and one that was denied.
There have been no requests for registration of end use products for public health pest control to
date.
EPA has provided DHHS with potential data gap information and estimated costs for
conducting studies. EPA has not yet been faced with a case warranting a commitment by DHHS to
conduct studies, but an EPA/CDC consultative process has been developed in case of need. EPA
also arranged for discussions between DHHS and USDAIR-4, who has a well-established program
in place to generate data for minor crops.
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EPA/FDA PARTNERSHIP
EPA and FDA are working on ways to assure safe harbor through channels of trade for
food commodities containing legal residues of a pesticide whose pesticide tolerance has been
revoked after legal treatment. Certain processed commodities have long shelf lives and can remain
in channels of trade for four years or more. It is not illegal to have residues of pesticides whose
tolerances have been revoked in food commodities if the pesticide was applied before revocation
and use was lawful at the time under FIFRA. However, it is difficult for FDA to know which
commodities that have residues of pesticides with revoked tolerances were legally treated. It is also
difficult for food processors to gather the documentation required to prove that the foods were
legally treated years after the foods were introduced into channels of trade. EPA and FDA have
recently published proposals for review and comment on EPA tolerance revocation and FDA
enforcement processes that provide for safe harbor and minimize burden on food processors.
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CONCLUSIONS
What is Working Well
EPA and IR-4 have an effective, productive relationship. This partnership is solid and
continues to yield new efficiencies and better ways to do business. It is a fine example of a
successful strategic collaboration between EPA and USD A.
Harmonization of pesticide issues and data requirements between NAFTA and OECD
pesticide working groups has provided workload efficiencies and avenues to pursue level playing
field policies. EPA partnerships have been expanding to include harmonization and work sharing
with the California Department of Pesticide Regulation and IR-4 is facilitating even greater work
sharing for minor crops with all of these organizations.
Minor use stakeholders indicate that they like the pilot process for the FQPA
organophosphate pesticide tolerance reassessments. It provides them with an opportunity to
comment on the risk assessments before they become final. As part of the pilot process, EPA has
been providing clearly articulated, highly refined risk assessments in public technical briefings.
These briefings help stakeholders to understand EPA's concerns and allow time for further
refinements, comments and risk mitigation discussions. Adequate time to develop the refined risk
assessment and consider risk management options is a critical issue for minor use stakeholders.
Other Issues
Real world pesticide use and residue data are necessary to refine risk assessments to reflect
actual exposure scenarios for tolerance reassessment, reregistration and registration actions. EPA is
encouraging generation and submission of these types of data. However, potential submitters
should ask EPA to review their protocols for generating these data before they start data generation.
EPA can help potential submitters determine how to provide data, which can be used to refine
exposure assessments.
It is common practice to rotate short season vegetable crops like cucumbers, tomatoes, snap
beans and cole crops (cabbage, broccoli, cauliflower). Rotational crop residue data are required by
EPA to determine if residues from pesticides applied to one crop will occur in a different crop
planted after the first crop is harvested. If these data are not available, restrictions on rotation are
necessary and may preclude the use of the product. Registrants often do not find it cost effective to
generate these data for minor crops, which can severely limit the applicability of the pesticide in
areas where crop rotations are used. EPA is working on practical ways to work through this issue,
including consideration of establishing tolerances on rotational crops by bridging data from other
crops if the additional rotational crop uses do not exceed EPA's levels of concern and the registrant
supports the additional uses.
A number of new insecticides and fungicides show real promise for minor crop uses.
Many of these products are biopesticides and reduced-risk pesticides and represent new classes of
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chemistry or biology, which makes them potentially effective new tools to manage pesticide
resistance. However, most of these new compounds are not drop-in, one-for-one replacements for
widely used older chemicals, and field efficacy testing and experimentation will be essential before
growers will be prepared to risk relying on them. Efficacy testing is rarely performed anymore on
minor crops that registrants do not actively seek registration. Most USD A and university
researchers cannot justify the time and effort to do field research with minor crops, and there is
little incentive or support for others to do this work. Registrants will not support registration of
new products without efficacy and crop safety data due to liability concerns. In addition, the lack
of field research showing efficacy is a major barrier to grower adoption of alternatives. Supporting
programs or grants that lead to grower testing of promising alternative pest management practices
is crucial for successful adoption of new technologies for pest management.
Efficacy testing and field demonstrations are just the first hurdle to be overcome for these
products to be successfully adopted by growers. The second and probably more critical hurdle is
the availability of trained professionals (consultants, extension agents, scouts, pest control advisors)
to provide the education, monitoring and damage threshold evaluations required to use these
products effectively and economically. Biopesticides and many of the reduced-risk pesticides tend
to be very pest specific and most do not have the quick knock-down features that older,
conventional pesticides have. In addition, they may be more expensive and labor intensive to use
initially. Their long term benefits to cropping systems, such as increased populations of beneficial
parasites and predators and pesticide resistance management, are difficult, at best, to convince
growers about if trained professionals are not available to carefully monitor fields for optimal
application timings and to develop economically feasible, integrated approaches for their use.
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APPENDIX 1: Pesticides Registered Recently for
Minor Use Crops
In fiscal year 1998, EPA registered new pesticides and new uses, which provided growers
with over 750 additional pesticide uses for minor crops. In 1999, 814 additional minor crop
pesticide uses were registered and 901 more were registered in fiscal year 2000. Some highlights
of minor use registration actions on reduced-risk pesticides include:
Acibenzolar-s-methyl (Trade name Actigard)
Acibenzolar is a selective, systemic compound, which induces host plant resistance. This
mode of action mimics the natural defense system in plants, referred to as systemic acquired
resistance (SAR). It has no direct effect on the target pest. Actigard was registered in
August 2000 for control of downy mildew on leafy vegetables, including Brassica leafy
vegetables, bacterial spot and spec on tomatoes, blue mold on tobacco and diseases of
banana. These are particularly difficult diseases to control and have few alternatives for
control. The SAR-enhancing types of pesticides like Actigard are expected to revolutionize
pest management disease control and reduce risks from pesticides.
Azoxystrobin Fungicide (Trade names Heritage, Abound, Quadris)
In March 1999, EPA approved the registration of the reduced-risk fungicide azoxystrobin
for use on almonds, grain, bananas, canola, cucurbits (examples include cucumbers, melons,
squash), peanuts, pistachios, potatoes, rice, stone fruits (examples include peaches and
cherries), tree nuts (examples include walnuts and pecans) and wheat. These new, mostly
minor uses fill only a small percentage of the overall risk allowance for this chemical. The
establishment of these additional tolerances allowed the withdrawal of five Emergency
Exemption (Section 18) applications: two for cucurbits on watermelons and cantaloupes and
three for rice. Azoxystrobin has also been approved for use on a wide variety of ornamental
plants against a number of fungal pests that cause foliar and root diseases, where it offers a
low-risk alternative to some other fungicides. IR-4 has received approval from EPA to
submit a "blanket" tolerance petition for azoxystrobin, which will establish tolerances for all
crop uses of this chemical.
Bifenazate Miticide (Trade name Floramite)
In June 1999, this new reduced-risk miticide was registered for use on ornamental crops.
This selective miticide has minimal impact on beneficial insects and IR-4 is pursuing
additional registrations for minor crops.
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Bifenthrin Insecticide (Trade names Capture, Brigade, Talstar, Biflex)
EPA registered new uses for the insecticide bifenthrin on cabbage, cucurbits (examples
include cucumbers, squash and melons), edible-podded legume vegetable subgroup
(examples include sugar snap peas and snowpeas), eggplant; globe artichoke, head and stem
Brassica subgroup - except cabbage (examples include broccoli and cauliflower), rapeseed
(canola), succulent shelled pea and bean subgroup (includes green, wax, lima and snap
beans), and sweet corn. Tolerances for the last two crop groupings were jointly requested
by IR-4 and FMC Corporation, the manufacturer of bifenthrin. Reports from the field
indicate that this product is effective and is expected to replace organophosphate use on
50,000 acres of beans and sweet corn.
Buprofezine (Trade name Applaud)
Applaud insect growth regulator is a reduced-risk pesticide with a novel mode of action that
was registered in August 2000 for control of sweet potato whitefly and other pests on
various melons, cucumbers and lettuce. Sweet potato whitefiies have the potential to
quickly develop resistance to pesticides and are responsible for millions of dollars of
damage to susceptible crops. The registration of Applaud provides an effective tool for
resistance management for this difficult to control pest.
Codling Moth Granulosis Virus
This biological pesticide was registered in July 2000 for control of codling moths. Codling
moth is a primary pest of western apples, pears and walnuts. This product can support
biointensive IPM programs and offers an alternative for codling moth pesticide resistance.
The active ingredient is specific to control of codling moth and has minimal impact on the
environment and human health. No risk to pesticide applicators or workers is expected and
minimum levels of personal protective equipment are required.
Diflubenzuron Insect Growth Regulator Insecticide (Trade name Dimilin)
In April 1999, EPA registered the insect growth regulator, diflubenzuron, for use on rice.
This action facilitated the use of this product for control of the rice water weevil, designated
a critical crop/pest use (one that has few or no alternatives to a pesticide use undergoing
tolerance reassessment or reregistration) by EPA and USDA's Pest Management
Alternatives Program. Growers in California, Texas, Arkansas, Louisiana, Mississippi and
Missouri will now have a replacement for carbofuran (Trade name Furadan), which is being
phased out because of high avian toxicity.
Fenhexamid Fungicide (Trade name Elevate)
In May 1999, following joint U.S./Canada review, the new reduced-risk fungicide
fenhexamid was registered for use on grapes, strawberries and ornamentals to control
botrytis gray mold. Its use is expected to reduce dependency on older fungicides classed as
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B2 carcinogens, such as captan, benomyl, iprodione, ziram, thiophanate-methyl and
chlorothalonil and provide a resistance management alternative for producers. IR-4 is
generating data to support registration of this product for many minor crops.
Fludioxonil Fungicide (Trade names Maxim, Medallion)
This reduced-risk fungicide has been registered on over 200 crops (both major and minor
crops) for seed treatment use over the past several years. It is a resistance management
alternative for producers.
Halosulfuron-methyl Herbicide (Trade names Permit, Sempra)
Halosulfuron-methyl was recently identified as a methyl bromide alternative by IR-4 and
USDA's ARS for control of nutsedge in cucumbers and related crops and as a result
received expedited registration this year by EPA.
Harpin Protein
Harpin protein is a biopesticide that works by activating natural defense mechanisms in host
plants, referred to as systemic acquired resistance (SAR). Harpin elicits a protective action
in plants that make them resistant to a wide range of fungal, bacterial, and virus diseases. In
addition, it can also reduce infestation of selected insect pests. This product has a tolerance
exemption and can be used on all food commodities as well as trees, turf and ornamentals.
Harpin is not expected to cause any harm to the environment and also has minimal human
health risks. Risks to pesticide applicators and workers are not expected and the minimum
level of personal protective equipment is required. Harpin has been used effectively in
tomato IPM programs, decreasing usage of conventional fungicides and insecticides by an
average of 70%, while controlling diseases as well as or better than conventional fungicides.
The SAR-enhancing types of pesticides like Harpin are expected to revolutionize pest
management control and reduce risks from pesticides.
Methoxyfenozide (Trade name Intrepid)
Intrepid insect growth regulator was registered for use on pears, apples and other pome
fruits in July 2000. Field testing indicates that it is effective for control of various leaf
rollers and other lepidopterous pests and potentially fits well into orchard IPM systems.
The product has reduced-risk characteristics and is an organophosphate alternative.
Naval Orangeworm Pheromone
Navel orangeworm pheromone is a biopesticide that works by disrupting the mating
patterns of the navel orangeworm, a serious pest of almonds in California. A tolerance
exemption has been established for this pheromone and minimal environmental or human
health effects are expected. Mating disruption pheromones have been useful in IPM
programs, reducing pesticide resistance development and risks to agricultural workers.
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Prohexadione Calcium (Trade name Apogee plant growth regulator)
Apogee plant growth regulator was registered in May 2000 for use on apples and peaches.
This reduced-risk active ingredient is used on apples to aid in control of fireblight, a
devastating bacterial disease of apples with few alternatives for control. Apogee does not
directly affect the pest. Instead, it limits the amount of succulent apple growth that is
particularly susceptible to the disease. This product will be used in conjunction with
cultural practices and conventional and biopesticides to control the disease.
Pyriproxyfen Insect Growth Regulator Insecticide (Trade names Knack, Esteem and Distance)
In April 1999, the reduced-risk insecticide, pyriproxyfen, was registered for use on pome
fruits (apples, pears) and walnuts. Pyriproxyfen is a potential organophosphate and
carbamate insecticide alternative. In 1998, it was registered for use on cotton, providing a
much-needed alternative for control of sweet potato whitefly, a relatively new pest that has
developed resistance to most older pesticides. IR-4 is generating data to support the
registration of this product on several minor use crops.
Spinosad Insecticide (Trade names Spintor, Tracer, Success, and Conserve)
In May 1999, the reduced-risk insecticide spinosad was registered for use on sweet corn,
potatoes and other tuberous and corm vegetables (includes sweet potatoes and ginger).
IR-4 has received approval from EPA to submit a "blanket" tolerance petition for spinosad,
which will establish tolerances for all crop uses of this chemical.
Tebufenozide Insect Growth Regulator Insecticide (Trade names Confirm and Mimic)
In April 1999, the reduced-risk insecticide tebufenozide was registered for use on 70 new
crops including: the berry crop group (examples include strawberry, blueberry and
raspberry), cranberries, peppermint, spearmint, fruiting vegetables - except cucurbits
(examples of this crop group include tomato, peppers and eggplant), head and stem brassica
subgroup (examples include cabbage, broccoli and cauliflower), leafy brassica subgroup
(examples include collards and kale), leafy greens subgroup (examples include spinach and
lettuce) and leafy petioles subgroup (examples include celery and chard). These
registrations were supported by IR-4 generated data. This product is also registered for use
on walnuts, pome fruits (examples include apples and pears) and cotton. Tebufenozide is a
highly specific insecticide, which controls lepidopterous pests (such as army worms and
cabbage worms). It tends to fit well into IPM and resistance management programs and
may be an alternative for some organophosphate and carbamate insecticides.
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APPENDIX 2: Commonly Used Acronyms
EPA Environmental Protection Agency
OPP Office of Pesticide Programs
USD A United States Department of Agriculture
DHHS Department of Health and Human Services
FQPA Food Quality Protection Act
TRAC Tolerance Reassessment Advisory Committee
IR-4 Interregional Research Project 4
OPMP Office of Pest Management Policy
PMRA Pest Management Regulatory Agency
OECD Organization for Economic Cooperation and Development
NAFTA North American Free Trade Agreement
FAO United Nations Food and Agricultural Organization
OP Organophosphate pesticides
PESP Pesticide Environmental Stewardship Program
PDF Pesticide Data Program
NASS National Agricultural Statistics Service
CSREES Cooperative State Research Education and Extension Service
ARS Agricultural Research Service
MRL Maximum Residue Level
OPP DIVISIONS
RD Registration Division
SRRD Special Review and Reregistration Division
BEAD Biological and Economic Analysis Division
HED Health Effects Division
BPPD Biopesticides and Pollution Prevention Division
EFED Environmental Fate and Effects Division
FEAD Field and External Affairs Division
IRSD Information Resources and Services Division
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