United Stales
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7506C)
735-R-01-OOZ
September 200]
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The North American Initiative
A Report of the North American
Free Trade Agreement Technical
Working Group on Pesticides
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CICOPLAFEST
xvEPA
This report was produced cooperatively by the following agencies:
Pest Management Regulatory Agency, Canada
Comisi6n Intersecretarial para el Control del Proceso y Uso de Plaguicidas y Sustancias
T6xicas, Mexico
Environmental Protection Agency, United States of America
Cover photo: "Greeness" map derived from advanced very high resolution radiometer satellite
data, United States Geological Survey.
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Contents
Perspectives List of Acronyms ii
Throughout this report
you will see boxes like
this one, which contain
the perspectives of vari-
ous key stakeholders who
have been involved with
the TWO. These per-
spectives were provided
during interviews, and do
not necessarily represent
the views or opinions of
the TWO Executive
Board, the editors of this
report, or any agency
engaged in the work of
the TWO. We would
like to thank the follow-
ing people for providing
their perspectives for this
report:
Jo-Ann Buth, Canola
Council, Canada
Julia Langer, World
Wildlife Fund, Canada
Karen Either, Bayer
Corporation, United
States
Amada Velez, Secretariat
for Agriculture, Mexico
Letter from the Executive Board iii
Introduction: Looking Beyond Borders 1
Working with Neighbors to Protect Human Health
and the Environment 5
Increasing Regulatory Efficiency 7
Ensuring North American Growers Have the
Tools They Need 8
Partnership Solutions 10
Looking Ahead 12
Appendix I: Accomplishments and Next Steps Al
Appendix II: Ongoing Projects A3
Appendix III: Contacts A4
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List of Acronyms
AMIFAC
CEC
CEC SMOC
CICOPLAFEST
CUSTA
DDT
EPA
EPA OPP
IPM
IWG
MRLs
NAFTA
NAFTA TWG
OECD
PCBs
PESP
PMRA
USDA
USDA IR-4
USMPIE
Asociacion Mexicana de la Industria Fitosanitaria, A.C.
Commission for Environmental Cooperation
CEC Sound Management of Chemicals
Comision Intersecretarial para el Control del Proceso y
Uso de Plaguicidas y Sustancias Toxicas (Mexico)
Canada-United States Trade Agreement
Dichlorodiphenyltrichloroethane
Environmental Protection Agency (U.S.)
EPA Office of Pesticide Programs (U.S.)
Integrated Pest Management
Industry Working Group
Maximum Residue Limits
North American Free Trade Agreement
NAFTA Technical Working Group on Pesticides
Organization for Economic Cooperation and Development
Polychlorinated Biphenyls
Pesticide Environmental Stewardship Program
Pest Management Regulatory Agency (Canada)
U.S. Department of Agriculture
USDA Interregional Research Project Number 4
U.S./Mexico Pesticide Information Exchange Program
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Letter from the Executive Board
We are pleased to present to you the Milestone Report for the NAFTA
Technical Working Group on Pesticides. For the last few years, this
workgroup has been involved in activities that are really a step outside
of the normal day-to-day business of a federal government, namely attaining the
goals of the North American Initiative.
Through this initiative, the early signs of a North American market for pesticides
are emerging: North American governments have made a concerted effort to,
reach over their common borders to make pest control tools more consistently
available across Canada, Mexico, and the United States; companies are
submitting pesticide applications to Canada and the United States
simultaneously, with some joint submissions including Mexico; and many
maximum residue limits (MRLs, or U.S. tolerances) have been harmonized,,
thereby removing trade barriers. The Technical Working Group has succeeded
in laying the foundation for a North American framework for regulating
pesticides.
This work ensures a stringent regional standard for protecting human health and
the environment, while making pest control tools available to growers across
North America. In broadening the dialogue on pesticides, we have succeeded in
making pesticide risk assessments more openly understood and scientifically
sound. As such standards continue to evolve, this initiative can increase
agricultural prosperity and the security of our region's food supply.
This report serves two purposes: first, it highlights the numerous
accomplishments the TWG has made over the last several years; second, it
provides a valuable perspective for setting our agenda for the future of the TWG.
Please join us in congratulating all those involved in making the first years of the
TWG a success. We hope that you, the reader, will join us in making the
upcoming years even more successful.
Sincerely,
Claire Franklin, Ph.D.
Executive Director
Pest Management
Regulatory Agency
Canada
Carlos Santos Burgoa, Ph.D.
Director of Environmental
Health
Ministry of Health
Mexico
Marcia E. Mulkey
Director
Office of Pesticide
Programs
United States
111
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[I IMl
Introduction: Looking Beyond
Borders
Political boundaries can cut across mountains, run through bodies of water,
and separate two farms growing the same crop. Just as a political
boundary will not curtail the wind or rain, it cannot thwart pests, filter out
pollutants, or stop the dispersion of pollen. These borders, however, can affect
the free flow of trade and have an impact on food and pesticide markets.
When the U.S. and Canadian governments entered into a free trade agreement in
1988 (the Canada-United States Trade Agreement, or CUSTA), they realized that
differences in their regulatory structures and requirements could inhibit trade.
For example, differing tolerances (maximum pesticide residue limits on food
products) could prevent farmers growing the same crops in the same geographic
region from using the same pesticides. This led to the establishment of a
pesticide working group, whose task it was to find ways of alleviating trade
barriers posed by such regulatory differences without compromising public
health and environmental standards.
By the time the North American Free Trade Agreement (NAFTA) was
completed in 1994, it was clear that tolerances were not the only trade barriers.
If agricultural goods were to pass freely through the channels of trade among the
United States, Canada, and Mexico, North American governments needed to
address a number of issues, such as differing data requirements for pesticide
registration, dissimilar formats for data submissions, and disparate scientific
assessments of pesticide data. Thus, the NAFTA Technical Working Group
(TWO) on pesticides was created in 1996 to build on the work of the CUSTA
TWG and to move forward on the full range of issues with all three governments
of NAFTA.
The North American Initiative
In June 1997, the NAFTA TWG on pesticides restructured its operational
framework by establishing four technical subcommittees (see below), and by
articulating a clear vision for the future. This vision included two goals:
1) By 2002, make work sharing the way of doing business among Canada,
Mexico, and the United States.
2) Develop a North American market for pesticides, while maintaining
current high levels of protection of public health and the environment and
supporting the principles of sustainable pest management.
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The NAFTA TWG outlined this vision, and a proposal for reaching these goals, in
a document entitled "The North American Initiative," or NAI. In this document,
the TWG established the following objectives to achieve the above goals:
. A pesticide product designed with the North American market in mind;
. A common data submission and format for country data reviews;
. A coordinated review process, utilizing each country's reviews to the
fullest; and
. A minimization of trade problems resulting from different Maximum
Residue Limits (MRLs) on agricultural commodities traded among the
three countries.
Achieving these objectives would allow the North American countries to
maximize their efficiency by sharing the work of pesticide registration, while
minimizing trade barriers. To meet these objectives, the NAFTA TWG
identified specific areas that needed to be addressed:
data requirements
relevant test protocols
data submissions (dossiers) and study report formats (monographs)
data review and risk assessment practices
. regulatory decision making
administrative processes and procedures
The NAFTA TWG began addressing these issues on a project-by-project basis.
Each project is categorized under one of four subject areas: regulatory capacity
building, risk reduction, joint review of chemical pesticides, and food residues.
For each category, the NAFTA TWG established a subcommittee to coordinate
work on the respective projects.
In addition to progressing towards the goal of establishing a North American
market for pesticides, the work of the NAFTA TWG accomplishes a variety of
benefits for North American governments, stakeholders, the pesticide industry,
and the general public. These benefits include the following: using existing
resources of both governments and industry more effectively; increasing overall
availability of resources needed to manage issues unique to national interests;
facilitating access to a wider range of safe and effective pest management tools;
minimizing barriers to the trade in food resulting from differences in pesticide
residue levels; and ensuring greater consistency between regulatory decisions
and the broader environmental and sustainable development goals of NAFTA.
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NAFTA TWG Partners
The NAFTA TWG subcommittees are not the only ones working towards the
goals of the North American Initiative. Grower groups and the pesticide indus-
try have played an important role in the process of harmonization, by identifying
trade barriers, supporting harmonization projects, contributing scientific expert-
ise, and providing resources for reviewing pesticides. Public interest groups also
participate by commenting on proposed policies relevant to human health and
environmental risks. The following organizations have actively worked with the
NAFTA TWG on a regular basis:
The NAFTA TWG works closely with the Commission for
Environmental Cooperation (CEC), which was created to implement
the environmental side agreement to NAFTA. Canada, Mexico, and the
United States, working with CEC's Working Group on the Sound
Management of Chemicals (SMOC), have taken action on a regional
basis to reduce the use of and reliance on two pesticides: DDT and
chlordane. These were identified as priority persistent and toxic
substances for joint attention due to their potential risks. Another
pesticide, lindane, is under consideration for regional action.
In 1998, the American Crop Protection Association, Asociacidn
Mexicana de la Industria Fitosanitaria, A.C., and the Canadian Crop
Protection Institute formed a NAFTA Industry Working Group (IWG) to
enhance communication between the NAFTA TWG and the pesticide
industry. The NAFTA IWG is dedicated to providing expertise and
assistance on projects, presenting the industry's needs and concerns, and
helping to resolve NAFTA issues.
ป Mexico and the United States have also established an important forum
for promoting an ongoing exchange of technical information on pesticide
statutes, regulations, policies, procedures, and enforcement practices
between Mexican and U.S. Federal and border State pesticide agencies.
Called the U.S./Mexico Pesticide Information Exchange Program, or
USMPIE, the program functions by hosting conferences, seminars,
training sessions, and work exchanges.
. Another important partner working with the NAFTA TWG is the
Interregional Research Project, Number 4 (IR-4). IR-4 is a government-
and university-sponsored program that develops the data necessary to
support registration of pesticides for use on minor crops, which EPA
policy has defined as pesticides used on crops grown on fewer than
300,000 acres. Examples of minor use pesticide registrations include
many pesticide uses on fruit and vegetable crops and uses on
commercially grown flowers, ornamentals, trees, and turf grass. IR-4 is
beginning to play a major role in helping North American minor-use
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growers access effective pest control tools.
Additionally, in 1999 growers in all three countries established a
trinational group, the NAFTA Grower Network, to ensure grower input
and representation in the NAFTA process and to facilitate collaboration
among growers on certain issues, such as potential trade barriers or
alternative pest control products. The group represents people growing
various commodities, such as barley, corn, soybean, canola,
horticulturals, pulse crops, rye, and oats.
Velez works in Mexico's Secretariat of Agriculture, one of four agencies
involved in regulating pesticides in Mexico. For Velez, the prospect of harmo-
nization promised relief from the difficulties that Mexican growers frequently encountered when
trying to export commodities that had pesticide residues not in accord with U.S. pesticide regula-
tions.
Working with the TWO has been a very positive experience for Velez, but quite frustrating as .
well. That four separate agencies in Mexico are responsible for regulating pesticides makes coor-
dinating work and establishing a uniform regulatory framework for pesticides difficult. She indi-
cated that Mexico may establish one agency dedicated to regulating pesticides in the near future, a
development that would truly help Mexico participate in the work of the NAFTA TWG.
Nevertheless, over the years she has seen more growers in Mexico become interested in the work
of harmonization. Harmonization will allow growers to sell their commodities on a larger market,
access the same low-risk pesticides available to U.S. and Canadian growers, and gain important
training on how to minimize the risks of working with pesticides.
The pesticide industry, too, stands to benefit from the work of the NAFTA TWG. The residue
zone maps currently being developed will allow the companies to obtain MRLs for the United
States and Canada, while conducting field trials in Mexico and vice versa.
Over the next few years, Velez would like to see Mexico become more active in the TWG- Velez
would also like the TWG to continue harmonizing tolerances with Mexico and establishing IPM
programs for Mexican growers. Velez has very high expectations for the TWG, and she looks
forward to working with the TWG to produce tangible results.
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Working with Neighbors to Protect
Human Health and the Environment
The Technical Working Group on Pesticides provides an important forum in
which the North American governments have the opportunity to work
together to establish a solid framework for protecting public health and
the environment on a regional and global scale. The TWO has used the
pportunity to strengthen working relationships and scientific exchanges
O among the three countries, as well as to collaborate in other international
fora. Through this process, regulators, growers, and the pesticide industry
in each country have gained a clearer understanding of the needs of their
ounterparts in the other NAFTA countries. Moreover, as the activities
C described below demonstrate, protecting human health and the environment
is an integral part of the NAFTA TWG's work.
The NAFTA TWO, in coordination with the USMPIE, held a week-long
training workshop for Mexican pesticide officials in March 2000 in the
United States. During the workshop, U.S. scientists provided training on
risk assessment methodologies and registration processes used to assess
pesticides to help officials in Mexico manage potential risks from
pesticides.
. Members of the TWG have met on various occasions to share data,
leam from one another, and engage in open dialogue. Annual meeting
places rotate throughout North America, giving participants an
opportunity
to visit new places and gain a better understanding of their neighbors.
Additionally, participants have had the opportunity to visit farms and
laboratories in neighboring countries, giving them important real-world
perspectives.
. In June 2000, Mexico and the United States initiated a new bilateral
project on agricultural worker protection. The goal of this project is to
coordinate activities and integrate programs that promote the safe and
proper use of pesticides, reduce human exposure to pesticides, and
strengthen coverage of pesticide risk education efforts. The target
population includes occupational users of pesticides (i.e., farmworkers
and their families, farm owners, ranchers, and agricultural pesticide
applicators). Mexico and the United States are working to establish
national Train-the-Trainer networks for pesticide safety educators, and
both countries will pilot harmonized programs in early 2002.
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The United States and Canada are developing a joint pesticide applicator
core examination to measure the competency of a pesticide applicator.
The pesticide applicator certification and training program aims to reduce
risks to human health and the environment by providing pesticide users
with the knowledge needed to use products safely and effectively.
In Canada and the United States, the TWO has facilitated the
development of low-risk alternative pesticides, such as pheromones and
microbials, by agreeing to similar data requirements for their registration.
OECD countries have used this work to help guide their own
harmonization efforts.
On numerous occasions, scientists in Canada, Mexico, and the United
States have come together to compare approaches, share data, and
understand the pivotal studies for assessing the risks from specific
pesticides in each country. These discussions help ensure regulators are
basing their decisions on the most current and relevant data. In addition,
there have been scientific personnel exchanges in corresponding
regulatory offices, thereby giving scientists valuable, first-hand
experience with their peers.
In collaboration with the California EPA, the TWG has developed
harmonized guidelines for the measurement of post-application exposure
in agricultural and residential settings. These studies can help ensure a
consistent, stringent standard for protecting the health and safety of
farmworkers.
Under the Joint Review Program, efficacy data reviews determine the
lowest rates of use at which a pesticide is still effective. These reviews,
along with reviews of human health and environmental data, help
regulators ensure that pesticides do not pose unreasonable risks to human
health and the environment
^anSer t>eSan following the work of the TWG actively under the CUSTA. Representing the
World Wildlife Fund Canada, Langer has participated in many TWG meetings.
Langer sees in the TWG the potential to reduce the use of pesticides, increase the accessibility of information across
North America, and adopt the highest human health and environmental protection standards. Unfortunately, this poten-
tial has not been realized, said Langer, because the TWG has disproportionately devoted its resources to harmonization
of regulations and residue limits at what she fears is the lowest common denominator and not on pesticide reduction.
"Environmental protection must go hand-in-hand with liberalized trade, something that Canada, the U.S., and Mexico
reaffirmed in signing the NAFTA side agreement on environmental protection," said Langer. Rather than focusing on
facilitating trade, Langer believes that the TWG needs to work on raising environmental standards and reducing reliance
on pesticides in all three countries.
For the future, Langer would like to see the TWG work more closely with the Commission for Environmental
Cooperation, devote more time to addressing the sustainable development goals of NAFTA, and work on minimizing,
not just harmonizing, pesticide residues. To achieve these goals, Langer said, the TWG needs to include more voices
and perspectives than those of the pesticide regulators currently represented.
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Increasing Regulatory Efficiency
The process of harmonization has not only provided an opportunity for the
North American governments to work together, but it has also allowed
them to streamline their regulatory processes. Efficient harmonization of
pesticide regulatory procedures and requirements is an ultimate goal of the North
American Initiative. The TWO has been working on a number of projects to
realize this goal. Through joint review and worksharing, countries have shared
the work of reviewing pesticides; many registration requirements have been
harmonized, facilitating the submission of simultaneous pesticide applications;
and North American countries have started accepting electronic pesticide
applications.
. Canada and the United States have completed joint and workshare
reviews of numerous pesticides, such as zoxamide for use on potatoes
and grapes; fenhexamid for use on grapes, strawberries, and ornamentals;
Virosoft CP4 for coddling moths; and flucarbazone-sodium for use on
wheat. Numerous other pesticides are currently undergoing the
joint/workshare review process. (See appendix II for more detailed
information.)
Canada, Mexico, and the United States have completed residue zone
maps that are based on scientifically defined common crop zones not
affected by political borders. These zones will facilitate the
development of residue data for major and minor use crops, as well as
prevent the duplication of trials in each of the three countries, thereby
reducing the cost for industry to develop data and the unnecessary release
of pesticides into the environment.
. Canada and the United States have developed guidance and protocols for
submitting pesticide applications electronically. One of the NAFTA
projects ensures coordination of electronic submission and review
initiatives. Several companies have already submitted electronic
submissions to Canada and the United States. Initial experience has been
that electronic submission expedites government review.
* OECD countries have agreed on common submission format, or
"dossier," and a common review format, or "monograph." Both Canada
and the United States accept submissions in this format (which is
available at www.oecd.org/ehs/PestGD03.htm).
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Ensuring North American Growers
Have the Tools they Need
Many growers use pesticides to help control devastating pests and pro-
duce a bountiful harvest. Certain barriers, however, can prevent or
hinder farmers from accessing the pest control tools they need. The
NAFTA TWO has worked closely with the pesticide industry and grower groups
to ensure that growers have access to effective pest control products. The TWG
has organized workshops and meetings wherein growers identified difficulties
and discussed possible solutions; supported the development of low-risk alterna-
tive pesticides; and provided guidance for safeguarding the efficacy of existing
pest control tools.
. Over the last few years, IR-4 has held annual workshops to facilitate the
development of pesticide data for minor use crops. During the
workshops, representatives of PMRA, EPA, U.S. and Canadian minor use
growers, CICLOPLAFEST, and AMIFAC identified minor uses for
which data can be developed jointly among NAFTA countries. For
example, certain minor crop-such as papaya and broccoli-data that
would otherwise be too expensive to develop have been supported by
IR-4. Such data are critical for evaluating the safety of pesticides and to
bringing new, low-risk alternatives to the market.
In April 2001, the NAFTA IWG hosted a workshop in Missouri. The
workshop allowed representatives of the Canadian, Mexican, and United
States governments, grower groups, and registrants to discuss and
recommend strategies for achieving common goals in harmonizing
NAFTA registrations for pesticides. The workshop also addressed a
number of issues, including support for minor-use pesticides, equal
access to pest control products, and the need to enhance education and
communication among all parties involved in the TWG.
. Pesticides can gradually lose their effectiveness due to the
development of resistance by pests. In an attempt to maintain
effectiveness of the products, users may increase rates and frequency of
application. This approach can further limit the effectiveness of the
pesticide, while increasing exposure risks. Canada and the United States
have worked collaboratively to provide voluntary labeling guidelines that
will help pesticide applicators prevent the onset of pest resistance.
. Canada and the United States have produced crop matrices showing the
registration status and MRLs of products that are registered for use on
either side of the border. Using these matrices and other resources, U.S.
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I
and Canadian growers are identifying their critical needs, on national
and bilateral bases, and providing the regulatory agencies and registrants
with clear grower priorities.
The TWG has eliminated a number of trade barriers by establishing
common MRLs for 12 pesticide/crop combinations that had been
identified by commodity groups as causing trade disruptions (i.e.,
compliance violations at the border). Growers are working together with
registrants to identify and prioritize work on pesticide/crop combinations
that have the potential to disrupt trade.
V / W r Jo-Ann Buth is the Vice President for Crop Production for the Canola Council,
based in Canada. Buth began working on harmonization efforts early in the life
of the TWG. She has found her experience working with the TWG quite positive, finding that
members on all sides have been very open.
She noted that the TWG has succeeded in registering additional pesticides in the United States to
be used on canola, which allows Canadian growers continued access to pest control tools for crops
that will be exported to the United States. This reduces the threat of trade action from the United
States. Additionally, Buth has been impressed by the TWG's progress in harmonizing registration
requirements for biologicals. One source of frustration, however, has been the lack of resources
available to agencies involved with the TWG.
Looking ahead, Buth would like to see more resources allocated to agencies involved in harmoniz-
ing standards to help expedite the review of NAFTA registration and MRL applications. In addi-
tion, she would like the TWG to work on mechanisms for addressing older pesticides, especially
on a larger international scale; that is, she would like to see the TWG work more with OECD and
the European Union.
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Partnership Solutions
By working in partnerships, growers, industry, and government are able to
coordinate solutions to agricultural challenges more quickly and effec-
tively. For example, growers are generally the first to encounter difficul-
ties posed by trade barriers, which can cause economic hardship for those unable
to access effective and affordable pest-control tools. The pesticide industry is
well situated to respond to the needs of growers. Thus, both groups can provide
a valuable perspective on the TWG's priorities and workload.
. The IWG and the TWG cooperatively hosted an international seminar on
preparing OECD-formatted dossiers and electronic submissions to help
lay the groundwork for a NAFTA-wide submission.
The TWG, with support from PESP, has begun implementing a North
American integrated pest management production system for canola.
Representatives of major canola growers in Canada and the United
States, as well as the World Wildlife Fund Canada, academia, and
extension services, have participated in this project.
. The IWG has convened country-specific industry/grower meetings in
which growers have presented their concerns and priorities to industry.
Through these meetings, the pesticide industry has seen the level of
interest and participation on behalf of the grower community increase.
The pesticide industry has actively supported the development of low-
risk alternative pesticides by making the development of such products a
priority. As part of this process, they have played a key role in
identifying the older, riskier pesticides that can be replaced by the new
alternatives.
. The TWG has fashioned a common and sustainable approach to
managing cranberry production in the United States and Canada. The
TWG worked with numerous organizations, such as the Cranberry
Institute (which is supported by PESP), representatives of the crop
protection industry, grower groups, and academic researchers from
Canada and the United States to create an IPM strategy. While this
strategy helps to protect crops, it also minimizes environmental impact.
In a coordinated effort, Canada, the United States, canola growers, and
the pesticide industry have facilitated the registration of alternatives to
10
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lindane through the joint review process. Lindane was registered for
canola seed treatment in Canada but not in the United States, thereby
inhibiting trade. The pesticide industry voluntarily phased out the use of
lindane on canola seed in Canada while developing alternatives. This
allowed Canadian canola growers to sell seeds to the United States.
Through worksharing, Canada and the United States have made
alternative products for use on canola available in both countries.
Representatives of government, grower groups, pesticide manufacturers,
and research scientists from Canada and the United States developed an
IPM strategy to control new strains of potato late blight fungus that were
becoming resistant to fungicides. The IPM strategy helped farmers
avoid fostering resistance among the new strains of the fungus and
provided effective control of the pest.
Karen Pimer' Manager of NAFTA and International Regulatory Affairs for Bayer
Corporation, United States, co-chaired the IWG until April 2001.
Although the process of harmonization can be difficult at times, overall Either said that she has been
impressed with the progress the TWO has made, especially in regard to the harmonization of study
protocols.
Pither sees a number of benefits to the process of harmonization: it will make markets that had been
cost prohibitive more accessible; it will make alternative pest control tools more affordable to grow-
ers; and it will streamline the process of developing new products-all of which helps to make the
lives of growers a little easier.
Looking ahead, Pither would like to see the TWO work on harmonizing environmental guidelines
and protocols, continue working with Mexico to make it a true North American system, refine the
electronic submission process, and harmonize submission formats to eliminate country-specific
requirements. She is committed to harmonization and looks forward to continuing an open dialogue
with the TWO and grower groups.
|iI?iPiI||siiili
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Looking Ahead
The Technical Working Group on Pesticides has gained significant
momentum in achieving the goals of the North American Initiative. There
remains more work to be done, however, to ensure equitable access to the
safest and most effective pesticide products within the North American market
for pesticides.
The horizon for the TWG has always been the continent of North America.
Many of the projects, however, have primarily involved Canada and the United
States. Thus, harmonization with Mexico will be a significant priority over the
next few years. Additionally, the horizon for harmonization continues to expand
as the TWG works with OECD and the European Union.
The TWG will continue to work with growers, the pesticide industry, and other
key stakeholders to identify and avoid trade barriers and develop low-risk
alternative pest control products and solutions. Central to this process is the
development of IPM programs and new low-risk products such as microbials and
semiochemicals.
The TWG is working to make electronic submissions a fundamental part of
registering pesticides. Electronic submissions have the potential to dramatically
reduce the amount of paper generated for pesticide applications, as well as
facilitate the sharing of information among regulatory agencies.
The TWG has also begun to explore the concept of a NAFTA label and has
piloted this idea with a Joint Review biopesticide. The TWG is now expanding
the pilot NAFTA label project to include chemical pesticides and is actively
soliciting registrants to work with us to further develop a NAFTA label.
A true North American market for pesticides will allow growers in all three
countries to access the same pest control tools. Working toward this goal,
Canada, Mexico, and the United States will continue to harmonize pesticide
regulations, strengthen public health and environmental standards, and build a
sustainable agricultural system across North America. The TWG will continue
to rely on growers, academia, extension specialists, public interest groups, the
pesticide industry, and the general public to help ensure all decisions are
appropriate and scientifically sound.
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Appendices
Appendix I
Appendix II
Appendix III
Accomplishments and Next Steps
Ongoing Projects
Contacts
A
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Appendix I-Accomplishments and Next Steps
Area
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B Residue chemistry data requkements harmo-
nized-06/98. 1*1 ป
B Data requkements forresidue field trials harmo-
nized-06/99. 1*1 K
3 Data requkements for seed treatment and terrestri-
al food uses harmonized-06/00. 1*11*1
3 Residue Zone Maps defining common crop zones
completed-08/01.1*1 ' ^
3 Data Requkements for pheromones (semio-
chemicals) and microbials
harmonized-04/00. 1*1 S
Complete project, "Definition of
Acceptable Protocols for Residue Trials."
Harmonize non-target plant testing and
terrestrial field dissipation study protocols.
3 Envkonmental fate and toxicology protocols har-
monized-03/00.1*1 H!
3 Canada accepts all U.S. protocols for pheromones
and microbials-04/00. 1*1
3 Food residues and product chemistry study proto-
cols are harmonized in the field of mammalian toxi-
cology. 1*118
3 Guidelines for residue chemistry studies are har-
monized-06/98. *
ซ&
8
O
H OECD-formatted registration submissions for
chemical pesticides now accepted-03/01. 1*1
13 Data Evaluation Record templates for each scien-
tific discipline harmonized12/00.1*1
Develop an OECD format for microbial
and pheromone submissions and reviews.
EPA is currently piloting the food
residues and occupational exposure tem-
plates. Develop templates for conditional-
ly required studies.
I
ง
vj
<1>
I ซ
as ซ
ซ A
13 "Procedures for Joint Reviews of
Biopesticides"-07/97. 1*1 !
13 "Revised Procedures for Joint Reviews of
Biopesticides"-10/98. 1*1
[3 "Procedures for Joint Reviews of Microbials and
Semiochemicals"-05/99. * *
0 Methodologies for dietary risk assessment (acute
and chronic exposure) harmonized-06/99. 1*1 !
El "Procedures for Joint Review Applications for
Chemical Pesticides" revised to include products not
qualifying for EPA's Reduced-Risk Program but that
do qualify as OP alternatives or NAFTA priority
chemicals-08/99. * *
E "Post-Application Exposure Monitoring
Guidelines," released for comment
-09/98. 1*1 *
Revise procedures to reduce timelines for
pheromone joint reviews.
Develop country-specific subsets of data,
e.g., percent crop treated.
Revise procedures for Joint Review appli
cations for chemical pesticides to include
pesticides that do not qualify as reduced-
risk or OP alternatives.
Revise to incorporate comments.
*The date given is when the project was completed. Flags represent those
countries that participated in the project. There are three represented above,
Canada [1*1], Mexico [|ป|], and the United States [IB].
Al
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Appendix I-Accomplishments and Next Steps
ฃ .2
*: .3
(t CJ
E.- ซ
P 3
If
Completed Joint Reviews
S Fenhexamid, a fungicide registered by
Tomen/Bayer, for use on grapes, strawberries, and
ornamentals-05/99.
03 Eastern Pine Shoot Borer, a pheromone, registered
for use against forest insect pests-04/99.
H Cyprodinil, a fungicide registered by Syngenta,
for use on fruit-04/98.
B Virosoft CP4, a bio-insecticide, registered for use
on apples against the coddling moth-06/00.
H Diflufenzopyr, an herbicide registered by BASF,
for use on field corn and nonagricultural sites-02/99.
E Zoxamide, a fungicide registered by Rohm &
Haas, for use on grapes and
potatoes-05/011*1 03/01.
Completed Workshares
E Flucarbazone-sodium, an herbicide registered by
Bayer, for use on wheat-03/001*1 09/00.
IB Thiamethoxam (includes fludioxonil, mefenoxam,
difenoconazole), an insecticide and fungicide regis-
tered by Syngenta, for use on canola in Canada, and
canola, mustard, barley, cotton, sorghum, and wheat
seed treatment in the U.S.-12/00.
E Sulfosulfuron, an herbicide registered by
Monsanto, for use on wheat-03/991*105/99.M
E U.S. Import Tolerance Guidance document
completed-06/00.
E Procedures for the Identification and Resolution
of NAFTA Pesticide Trade Irritants, version 2,
released-12/98.
Prepare guidance document for all
NAFTA countries.
Resolved MRLs
Country of
Origin
| Canada
E Permethrin residues on spinach and lettuce.
E Acephate residues on beans, peppers, cranberries, celery, and soybeans.
i=--"United"
f. -..'-. ._.
r'States
A2
^ Clethodim residues on potatoes.
--. .
E Dimethoate residues on blueberries. 1*1
E Glyphosate residues on oats. B*l
E Prometryn residues on carrots. B*I
B Chlorothalonil residues on non-bell peppers, fel
*Flags represent countries with which the trade barrier was resolved.
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Appendix II-Ongoing Projects
Reassess wood preservatives (pentachlorphenol, creosote, chromated
copper arsenicals (CCA)) (Canada and the United States).
Coordinate work on lindane and organotin antifoulant paints (Canada and the United
States).
Coordinate work on health and safety of farmworkers (Mexico and the United States).
Refine electronic tools for the assembly and evaluation of pesticide registration
submissions (Canada and the United States).
Develop pilot NAFTA labels for biopesticides and conventional chemical pesticides
(Canada, Mexico, and the United States).
I * nr JPI w^
Harmonize evaluation of non-agricultural (antimicrobial)
pesticides (Canada and the United States).
Develop NAFTA Import Tolerance Guidance Document
(Canada, Mexico, and the United States).
Complete field testing of and finalize core examination to
assess competency of pesticide applicators (Canada and the
United States).
Assess feasibility of probabilistic tools and methods for
ecological assessments (Canada and the United States).
Develop an E?M manual for cranberry growers in the Eastern
North American Region, as was already completed for the
Western Region (Canada and the United States).
Implement integrated pest management for canola (Canada and
the United States).
Conduct workshop on the registration of biopesticides, 13-15
November 2001, in Arlington, VA (Canada and the United
States).
Harmonize non-target plant testing requirements (Canada and
the United States).
Harmonize guidelines for conducting terrestrial field dissipation
studies (Canada and the United States).
Continue to coordinate on reregistration, Food Quality
Protection Act (FQPA) and the Re-evaluation Process (Canada
and the United States).
Pesticides Currently Under Joint
Review or Workshare
Group 1A: Reduced Risk
-Pyraclostrobin, a fungicide from BASF.
-EH-2001, a rodenticide from Exit Holdings,
LLC.
Group IB: Negotiated Reduced Risk
Acetamiprid, an insecticide from Aventis.
-BAS 510, a fungicide from BASF.
Group 2: Non-Reduced Risk Chemicals*
-Clothianidin, an OP replacement insecticide
from Bayer.
Group 3: Negotiated Joint Review
-Famoxadone, a fungicide from Dupont.
Microbials and Semiochemicals
-Virosoft BAS, a microbial from Biotepp.
-Sporodex, a biofungicide from Plant
Products.
-Chondrostereum, a biofungicide from
Mycologic.
Parallel and Workshare Reviews
-Sulfonylureas, an herbicide from Aventis.
-Import tolerance for Iprovalicarb, a fungicide
from Bayer.
Import tolerance for Tolyfluanid, a fungicide
from Bayer.
Minor Use Joint Review Pilot Project
-Fenhexamid, a fungicide from Bayer/Tomen,
for use on raspberries.
*Organophosphate (OP) alternatives and other NAFTA pri-
orities.
A3
i -8
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On the Internet
PMRA, Canada
www.hc-sc.gc.ca/pmra-
arla
CICOPLAFEST, Mexico
www.sagarpa.gob.mx
www.ssa.gob.mx
www.ine.gob.mx
www.secofi.gob.mx
EPA, U.S.
www.epa.gov/oppfeadl/
international/naftatwg/
A4
Appendix Ill-Contacts
Subcommittee Contacts:
Food Residues:
Ariff Ally (C)
Steve Funk (US)
Robert McNally (US)
Luis Suguiyama (US)
Amada Velez
Mendez (M)
613-736-3549
703-305-5430
703-308-8085
703-305-6027
525-658-2828
Regulatory Capacity Building:
Diana Somers (C)
Charalyn Kriz (C)
Carmen Krogh (C)
Kate Bouve (US)
Elizabeth Leovey (US)
Donna Davis (US)
613-736-3519
613-736-3715
613-736-3696
703-305-5032
703-305-7328
703-305-5374
Joint Review of Chemical Pesticides:
Richard Aucoin (C)
Wendy Sexsmith (C)
Terri Stowe (US)
Kathy Monk (US)
Janet Taylor (C)
Amada Velez
Mendez (M)
Risk Reduction:
Wendy Sexsmith (C)
Rocio Alatorre (M)
Janet Andersen (US)
613-736-3780
613-736-3704
703-305-6117
703-308-8071
613-736-3780
525-658-2828
613-736-3704
525-624-3671
703-308-8712
(C) = Canada (US) = United States (M) = Mexico
ariff_ally@hc-sc.gc.ca
funk.steve@epa.gov
mcnally.robert@epa.gov
suguiyama.luis @ epa.gov
amada.velez@ sagar.gob.mx
Diana_Somers @hc-sc.gc.ca
Charalyn_Kriz@hc-sc.gc.ca
Carmen_Krogh@hc-sc.gc.ca
bouve.kate @ epa.gov
leovey.elizabeth @ epa.gov
davis.donna@epa.gov
Richard_Aucoin @ hc-sc.gc.ca
Wendy_Sexsmith @ hc-sc.gc.ca
stowe.terri@epa.gov
monk.kathy @ epa.gov
Janet_Taylor@hc-sc.gc.ca
amada. velez @ sagar.gob.mx
Wendy_Sexsmith @hc-sc.gc.ca
alatorre @ ine. gob. mx
andersen.j anet @ epa.gov
NAFTA Secretariat:
Victoria Tunstall 613-736-3614
VictoriaJTunstall @ hc-sc.gc.ca
Mexico
Lucero Rodrfquez 525-255-4551
lrodriquez@mail.ssa.gob.mx
United States
Vera Soltero 703-308-9359
Soltero.veraฎ epa.gov
Keith Chanon 703-305-5306
Chanon.keith@epa.gov
Tracy Perry 703-305-7461
perry, tracy @ epa.gov
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