: EPA's Rpje in Regulating    >.'!•'•'•'^/.C'
 Pesticides^  ; : '•'•.•-. '•:. •.'.':'; .';.-'''•'•:?'••'

 New Pesticides Registered    ;  :  ..'.-•
: and other Registration-     '.'••.-...'•', • -I
 Related Actions      ,    V  ;   :.:   .2

 Pesticides Reregistered and:. '  :
 Tolerances Reassessed     '    ".4

 Advancerrients itiScience    .,   :,    ,
 and.Techhqfogy  ;        v: ;:     6 •
Dear Readers:                               .   .

EPA's Office of Pesticide Programs (OPP) is pleased to provide you with a
•summary of the many important accomplishments carried out during fiscal
year 2001.

OPP is entrusted with responsibility for safeguarding public health  and the
environment from pesticide risks.  We also work hard to ensure that pesti-
cides are regulated fairly so that new technology can enter the market while
also meeting the tough requirements of the Food Quality Protection Act.  I
am pleased to note that the accomplishments described in this report were
possible because of the dedication and hard work by OPP's diverse and
talented employees as well as many contributions by our regulatory partners
and stakeholders.

During FY 2001, we adopted a more concise format for our annual report.
While shorter in length than previous reports, it is rich in detail describing
our accomplishments and progress. The first seven pages summarize
registration, reregistration, and tolerance reassessment activities as well as
our advancements in the area of science policy development and technology.
The remaining six pages provide a snapshot of many other pesticide regula-
tory and program implementation activities with our regional, state, and tribal
partners and many other stakeholders. To complement this report and
provide you with further details about our many other important program
activities, we encourage you to visit our Web site at www.epa.gov/pesticides. .

Finally, September 11 abruptly changed the lives of all Americans.  Our
national concern for security at home and abroad is in  the forefront. While
EPA's broad mission has become more complex, our goals remain basic, as
described by our Administrator, Christine Todd Whitman, "to make-our air
cleaner, our water purer, and our land better protected,"  To that end, I call
upon your continued cooperation and support to help us bring about greater
protection of public health and to safeguard the natural environment from
pesticide risks.                               •

' Partiters and Stakeholders   .   •'.'•:'-.
; Working Together';   <:   •'     : •.   ;8. ;i
Marcia E. Mulkey, Director
Office of Pesticide Programs

    The mission of EPA's Office of Pesticide Programs (OPP) is to protect human
    health and the environment from unreasonable adverse effects resulting from the
 use of pesticides. OPP's mission also assures a reasonable certainty of no harm from
 pesticides in the diet of all Americans, especially children. OPP regulates the use of
 pesticides under the authority of two major federal statutes: the Federal Insecticide,
 Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic
 Act (FFDCA), both significantly amended by the Food Quality Protection Act of 1996
 (FQPA). Under FIFRA, EPA has the authority to register (license) the use(s) of a
 pesticide and suspend or cancel the use(s) of a pesticide if its use would pose
 unreasonable risks.  Under FFDCA, the Agency is responsible for setting tolerances
 (maximum permissible residue levels) for any pesticide used on food or animal feed.
 With the passage of FQPA, the Agency is required to establish a single, health-based
 standard for pesticides used on food crops and to determine if tolerances are safe for

 The process by which OPP examines the ingredients of a pesticide to determine if they
 are safe is called the registration process. The program evaluates the pesticide to
 ensure that it will not have any adverse effects on humans, the environment, and
 nontarget species. Applicants seeking pesticide registration are required to submit a
 wide range of data on health and ecological effects, environmental fate, and product
 and residue chemistry.  A pesticide product cannot be legally used in the United States
 if it has not been registered by EPA unless it is specifically exempted from regulation
 under FIFRA. If emergency conditions exist, EPA may allow use of an unregistered
 pesticide under an emergency exemption or a state may declare a crisis exemption,
 which allows the unregistered use for 15 days. EPA confers with the state and
 performs a cursory review of the use at this time.

 Through a process called reregistration, OPP is reviewing older pesticides—registered
 before 1984-to ensure that they meet current, more stringent health and environmental
 standards. After reviewing a pesticide for reregistration, OPP issues a Reregistration
Eligibility Decision (RED) document or an Interim Reregistration Eligibility Decision
 (IRED)  document detailing whether the pesticide can remain on the market or if
 changes in label instructions  must be made hi order to reduce risks to consumers.
During reregistration, OPP also reassesses tolerances as required by FQPA to ensure
that they meet current safety  standards and issues Reports on FQPA Tolerance
Reassessment Progress and Interim Risk Management Decisions (Tolerance Reassess-
ment Eligibility Documents [TREDs]). To date, OPP has reassessed almost 4,000 of
the 9,721 tolerances requiring reassessment.


Pesticide products contain both "active" and "inert"
ingredients. An active ingredient is one that prevents,
destroys, repels, or mitigates a pest, or is a plant regula-
tor, defoliant, desiccant, or nitrogen stabilizer. By law,
the active ingredient must be identified by name on the
label, together with its percentage by weight.  An inert
ingredient is simply any ingredient in the product that is
not intended to affect a target pest (e.g., a solvent).
Highlights of pesticide products registered in FY 2001

Methyl Bromide Alternatifes
•Two new products (InLine® and Telone EC®) contain-
ing the active ingredient 1,3-dichloropropene (Telone®)
as a pre-plant soil fumigant allow drip application to
tarped soil, primarily for use on strawberries and toma-

•Terramaster®, a terrazole-containing product for use as
a soil sterilant for tobacco crops, allows tobacco trans-
plants to be grown in a float-bed system.

Foot and Mouth Disease Antimicrobial
• Oxonia Active to disinfect hard, nonporous inanimate
surfaces in livestock facilities and animal quarters,  and
on equipment against the potential spread of the Foot and
Mouth Disease (FMD) virus.

Organopliospfiale (OP) Alternate
•Thiamethoxam as an insecticide on seeds of barley,
canola, cotton, sorghum, and wheat.

Hew Reduced-Risk Pesticides
•Huazinam as a fungicide on potatoes and peanuts.
•Mesotrione as an herbicide on field corn.
•Zoxamide as a fungicide on grapes.
•Novaluron as an insecticide on ornamentals (indoor,
  Insecticide Products Padapjng Reexamined to Protect Children
  In FY 2001, OPP began reviewing conventional
  insecticide products labeled for residential use to
  determine whether the containers meet today's Child
  Resistant Packaging (CRP) requirements. The Agency
  identified and required registrants of more than 160
  products to make the necessary changes (e.g., changing
  container size, adding a child resistant cap, or deleting
  residential uses) to protect children.
'6248rNew Uses; of Conventional-Pesticides .(includes 77 •  :'•..'
Reduced-risk pesticide uses, 69 OP alternative uses, 3 methyl
 bromide'alternative uses, 99 IR-4 minor uses)

 »9 New Uses of.Antimicrobials
 «72 Nonfood-Use Inert Ingredients

 «8 Mew Food-Use Inerts (with tolerance exemptions
                                                               (In addition, 33 tolerances were established for emergency

                                                               OPP met the FQPA-mandated deadlines for reviewing
                                                               antimicrobials for public health use:

                                                               "180 Old Chemicals (89 fast-track and 91 nonfast-track) .  .

                                                               •1,013 Amendments (890'fast-track-and 123 nonfast-track) ;.

                                                              • °533 Notifications         '..'•-
OPP's FY 2002 workplcm for reviewing applications and making
decisions on conventional pesticides can be accessed online at:
www.epa.gov/opprdOO 1 /workplan

                                                                Status of Pesticide Reregistration
                                                                                     REDs Completed
Pesticide Registration
•Completed Reregistration Eligibility Decision (REDs)
documents for 3 pesticide active ingredients:  benomyl,
propargite, and ethion (an OP).

•Issued Interim Reregistration Eligibility Decisions
(IREDs) for 6 organophosphate pesticides: acephate,
chlorpyrifos, ethoprop, methidathion, pirimiphos-methyl,
and terbufos.  Organophosphates (OPs) are potentially the
most toxic pesticides and are in FQPA Priority Group 1-
the first group of pesticides to be reviewed.

•Made reregistration decisions on 856 pesticide products,
exceeding goal of 750 decisions:  63 product labels were
amended,  613 products were canceled (includes 387
chlorpyrifos products), and other types of reregistration
actions were taken for 180 additional products.  (One
pesticide active ingredient may be used in 10 or more
pesticide products, thus requiring reregistraton decisions
for all products after a RED has been completed for the
active ingredient.)

Tolerance Reassessment
•Issued 5 Reports on FQPA Tolerance Reassessment
Progress and Interim Risk Management Decisions
(TREDs):  butylate (thiocarbamate), chlorpyrifos-methyl
(OP), oxadixyl, phosalone (OP), and trichlorfon (OP).
Pesticides Canceled
                                    REDs to be Completed
              Tolerance Reassessment
            As of September 2001 By August 2006

       By August 2006, EPA must complete the review of all tolerances that were in
       effect in August 1996 when FQPA was passed.

  •Completed tolerance reassessment decisions for 5
 pesticides, bringing the total of tolerances reassessed up to
.3,832.  This represents 39 percent of the 9,721 tolerances
 that require reassessment by 2006. Over 63 percent of
 these decisions were for pesticides in FQPA Priority Group
 Review of Organophosphate (OP) Pesticides
 •Completed individual decisions for 25 OPs.

 •Continued to develop scientific methods and the compo-
 nents of a cumulative risk assessment for the OPs. Cumu-
 lative risk assessment combines exposure (the amount of a
 pesticide to which an individual is exposed) and hazard
 (the potential health effects of a pesticide) from all
 substances that share a common pathway of toxicity.

 •Issued the science policy on Cumulative Hazard and
 Dose-Response Assessment for Organophosphorus
 Pesticides in August 2001 .

•Completed comprehensive reassessment of conditionally
registered, genetically engineered Bt corn, cotton, and
potato products.  Solicited scientific peer review and
public comment on the draft reassessment.

•Held a public briefing to present the final reassessment
and potential regulatory options for conditionally regis-
tered Bt products.

•Sought and made available to the public data on the
potential effects of Bt corn on monarch butterflies. The
data that were analyzed showed "no significant risk" to
monarch butterflies from the use of Bt corn.
•Made provisions to strengthen insect resistance
management, increase grower awareness and compli-
ance, and continue Bt research.

•Required registrants to conduct monitoring of
potential impacts from the continued use of the

•Required registrants to educate growers about their
responsibilities in planting and harvesting plant-
incorporated protectants.


Advancements in            and
Test Methods for Public Health Pesticides

•Developed guidance for Agency scientists to use
while reviewing new protocols for testing the efficacy
of pesticides.

•Eliminated phenol-resistance tests for disinfectants
and pesticides used as sanitizers because it was
difficult to maintain and propagate test cultures to
obtain consistent results.

Mew Tools for  Estimating Ecological Bisks

•Developed preliminary terrestrial and aquatic
probabilistic models which estimate the magnitude,
probability,  and certainty of ecological risk. These
models were strongly supported by the Scientific
Advisory Panel (SAP) and well received by the
international community. They are currently  being
revised based on internal and peer review comments.

•Developed a case study for refining risk assessments
which was peer reviewed and strongly supported by
the SAP.

•Sponsored a workshop on refining the risk assess-
ment of the pesticide atrazine,  where the registrant's
risk assessment was analyzed.

•Provided training on refining risk assessments to
scientists and risk managers making decisions.
       Enhancements to OPP's Web Site

j  •   .Searchable database for FIFRA Section 13
i      Emergency Exemptions:

'  •   Searchable database for Food and Feed
      Commodity Vocabulary:
•      www.epa.gov/pesticides/foodfeed
"  •   'Test Your Knowledge" on the kids'Web site:

  •   Tolerance Reassessment page that tracks actions
      and offers reports.
*      www.epa.gov/pesticides/tolerance

  •   Pesticide Product Label System (PPLS) database

  •   Pesticide Analytical Methods and Procedures:

•.': ••  ...Pesticide PrpducUnfoVmatioh System (PPIS)'
'•.:' •:  (updated):  ... •  .  ".....''  '       .  '   •     : v"
      www.epa.gov/opppmsd1/PPlSdata/index.htmr  ;

 •• •"  Public-Private Partnerships for Reducing
  :.   ' Pesticide Risk Web site:.;    :    '       •  ••    \_
      www.epa.gov/oppbppdi/partnerships     '

 '••?'  .Integrated Pest Management Web site:
     ] www.epa.gov/oppbppd1/ipm/index.htm

  . •  •;•• Models for estimating pesticides in. ground and
     ..surface, waters, with spray drift scenarios:



 Pesticide Environmental Stewardship Program (PESP)
 •Under PESP partnership, provided funding for the
 National Council of Farmer Cooperatives to explore how
 farmer cooperatives can play a greater role in developing,
 promoting, and marketing biopesticides and other "re-
 duced-risk" pesticide alternatives in the best interest of
 their members. For example, the National Grape Coop-
 erative and a registrant held field trials and a grower field
 day to demonstrate how to use the harpin protein product,
 Messenger®, and how to increase crop yields. This
 product uses natural defense mechanisms against a broad
 spectrum of viral, fungal, and bacterial diseases,

 •With the American Farmland Trust, provided funding  to
 pear growers in Washington's Yakima Valley who
 experimented with pheromones to disrupt the mating and
 reproduction of codling moths. Between 1997 and 2001,
 the growers' use of pheromones reduced their organo-
 phosphate use by over 30(percent (an average savings of
 $22/acre) and increased the effectiveness of pest control
 as well as the quality and quantity .of their pears.

 •Provided funding to PESP partner Lodi-Wbodbridge
 Wine Grape Commission, which developed and is
-implementing the Lodi Wine Growers Workbook: A self-
' assessment ofintegrated farming practices (IFF). The
 workbook addresses pest management practices, includ-
 ing, monitoring and using economic thresholds, selecting
 pesticides, determining alternatives to pesticide use,
 calibrating sprayers, ensuring worker safety, and properly
 storing pesticides.
 The Commission is distributing the workbook in small
 workshops of 5-10 growers at a time.  Growers can use the
. workbook as a tool to develop their own action plan, and
 the workbook also provides a baseline measure of the
 integrated farming practices adopted for measuring future

 • A partnership funded by EPA, IR-4, and the California
 Department of Pesticide Regulation (Cal-DPR) resulted in
 establishing tolerances for 51 new uses of pesticides for
 minor use crops.  With crop-group tolerances, this will
 allow for the registration of approximately 200 crop uses.
 In this workshare project, Cal-DPR reviews IR-4 residue
 data, and EPA ultimately establishes tolerances measuring
 future progress.

Partners to Divert StarIM Corn from the Food Supply
 Partners in Assessing Pesticide Use
•Worked with food industry and federal partners (USDA,
FDA, and CDC) to identify and divert from the food
supply trace amounts of StarLink corn, the Bacillus
thuringiensis (Bt) corn product that was registered for
animal feed and industrial uses but not for human con-
sumption (a limited registration). Efforts coordinated to  •
address the StarLink issue included the following:

-Canceled StarLink registration at the registrant's request.

-Announced that the Agency would no longer grant limited
registrations for plant-incorporated protectants as was done
for StarLink.

-Determined that there was not enough scientific evidence
to justify granting a limited tolerance for the remaining
traces of StarLink corn in the food supply.

-Required extensive testing of corn grain for the presence
of StarLink.

-Held two Scientific Advisory Panel meetings to review
the scientific assessments on exposure and allergenic
potential of the protein Cry9C.

-Investigated reports of allergic reactions to corn products.
The Centers for Disease Control and Prevention was able
to determine that food containing StarLink corn did not
cause any allergic reaction in people who reported having
reactions after consuming corn products. The Agency
believes the risks of allergenicity, if any, are extremely low.

•Conducted a thorough analysis of the wet milling process
of StarLink corn, enabling the Agency to conclude that
there is virtually no detectable presence of any protein in
corn products produced by wet milling.

 •Engaged stakeholders in assessing actual use and potential
 benefits of more than 40 uses.of two important organo-
 phosphate (OP) pesticides undergoing reregistration.

 •Communicated regularly with crop experts and groups
 concerned about pesticide use to gain more understanding
 of crop practices, pests, and pest control options.  Stake-
 holders were encouraged to review and comment on the
 draft benefits assessments which were posted on OPP's
 Web site at www.epa.gov/pesticides/cumulative.

 Consumer Labels Initiative (CLD
 •Continued to implement the CLI's "Read the Label First"
 consumer education campaign with regional, tribal, state,
 and local pesticide regulators and educators:

 -Distributed over 55,000 promotional items with the EPA
 logo and phone number for the National Pesticide Informa-
 tion Center (NPIC), formerly the National Pesticides
 Telecommunications Network (NPTN), to consumers and
 pesticide applicators  across the country.

 -Displayed CLI exhibit at eight national level events.

 -Included the "Read  the Label First" logo in a truck ad

 -Published the poster, "Use These Products Safely."

 -Provided a grant to the National Safety Council for
 further outreach efforts.

Pesticide Regulatory Education Program
•Sponsored, with OECA, five training programs for state
regulatory officials to promote better understanding of
pesticide issues.

 Pesticide Handlers and Worker Protection
 •Began a national assessment to evaluate and suggest
 improvements to pesticide worker protection activities by
 conducting workshops attended by stakeholders including
 states, EPA regions, and worker advocates.

 •Held a national Pesticide Applicators Training and
 Certification Workshop with Texas extension agents and
 representatives from Canada and Mexico to discuss greater
. coordination of agricultural workers protection efforts and
 the development of a core examination for pesticide
 applicators in Canada and the United States.

               www.epa.gov/oppfead 1 /safety

 Tribal Partners
 • Provided funding, for the sixth year, to eligible tribal
 governments or inter-tribal consortia that are working on or
 plan to carry out projects in support of the development of
 a pesticide program on tribal lands.

 •Piloted a project on Native American reservations in
 Arizona, Washington, and Idaho, to educate healthcare
 providers in identifying, treating, and preventing acute
 pesticide poisonings.

 Partners to Protect the Food Siipplf from Pesticide Misuse
 •EPA reinforced partnerships with other federal, state, and
 local government agencies, and pesticide manufacturers to
 protect the U.S. food  supply' from the improper use of the
 restricted-use pesticide zeta-cypermethrin.  Sold under
 trade names Fury® and Mustang®, zeta-cypermethrin was
 illegally applied to .wheat in Mississippi and Arkansas.
 EPA and FDA led negotiations with the registrant that
 resulted in an unprecedented multimillion-dollar wheat
 buy-back agreement.
Mealed Wood
•Reached an agreement with the American Wood Preserv-
ers Institute (AWPI) to increase safety for individuals who
handle CCA-treated wood:

-Wood preservers volunteered to label CCA-treated wood.

—Retailers volunteered to display signs over storage bins
containing such wood and to distribute consumer safety
information sheets to buyers of CCA-treated wood.

-EPA and AWPI made available CCA information on Web
sites and publicized toll-free numbers to AWPI and NPIC.


Pilot Drinking Water Monitoring Program with U. S. Geological Sur?ej
•Designed a pilot drinking water program to collect surface
water monitoring data at five sites in the United States.
Information from the program will help the Agency better  .
understand how frequently pesticides should be monitored
in drinking water.

•Obtained results from OPP-USGS study measuring
concentrations of 197 pesticides and their breakdown
compounds in drinking water.  The results will be applied
to mathematical models used to estimate exposure in
pesticide registration and reregistration.

•Worked with USDA to develop 45 standard crop sce-
narios for use in assessing pesticide exposures in surface
water.  These scenarios will make OPP's water assessments
for different pesticides consistent with respect to the
specific crop and the soil in which it is grown.

•Working with USGS, OPP completed the pilot reservoir
program which monitored raw and finished water in 12
reservoirs across the United States. The results of this
monitoring study were analyzed and made public in 2001.
The index reservoir scenario was also incorporated into the
Agency's aquatic exposure models to refine drinking water

OSGS and EPA Partner to Protect Endangered Species
•Initiated work under an Interagency Agreement for
cartographic services to develop county-level maps aimed
at protecting endangered species.  Geographic Information
System (GIS) county-level maps depict species, habitat
where pesticide use may be limited to protect listed
endangered species.

• la coordination with USGS, began developing for public
use information bulletins containing county maps, specific
steps pesticide users can take to protect the endangered
species, and the specific pesticide uses that may be limited.

Report on State and Local Partners' Clean Sweep Programs
•Documented state and local programs' successes across
the country in collecting unwanted agricultural pesticides.
Over the past 20 years, more than 24 million pounds of
pesticides that otherwise could wind up as pollution have
been collected and properly disposed of or recycled.

A report on these cooperative programs examines success
from national,, state, and local perspectives and will be
available by March 2002.  A description of each Clean-
Sweep program offers information on funding, operations,
costs, and successes.
Building Laboratory Capacity for Testing AntimicroMals
•Worked to develop the capacity for state laboratories to
test the efficacy of hospital-strength antimicrobial
products. Four state laboratories-Ohio, Michigan,
California, and Mississippi-received cooperative agree-
ment funds from EPA's Office of Enforcement and
Compliance Assurance (OECA) to assist in the Agency's
Antimicrobial Post-Registration Testing Program.  At
EPA's Environmental Science Center (ESC), OPP hosted
three hands-on laboratory training sessions covering
methods for testing the efficacy of these products.

                www.epa.go v/oppbead 1

Dental Unit faterline Treatments
•Coordinated efforts with industry, government, and
academia to develop protocols  for testing antimicrobial
treatments to prevent microorganism contamination of
dental unit waterlines. These units deliver coolant water
for high-speed dental handpieces, air-water syringes, and
ultrasonic sealers.

EPA's Regional Offices
       Where You Live
            EPA haslO
        Regional Offices.
      Each EPA Regional
      office is responsible
       within its states for
      the execution of the
      Agency's programs.
Integrated Pest Management (IPM) in Schools
•Funded the opening of two pilot IPM in Schools.
centers-Texas A&M and Purdue University (encompass-
ing nine states) to help promote the safe use of pesticides
in schools. Staff from the centers visited schools and
provided training in pest management, disseminated
information, created Web sites, and opened toll-free
telephone lines to answer questions from school offi-

• Partnered with EPA's Region 9 to initiate an IPM in
Tribal Schools pilot program at several  Bureau of Indian
Affairs (BIA) schools on the Navajo reservation. The
long-term goal of this project is to provide reference
materials and assistance to any tribe interested in
implementing IPM practices at a tribal school.

*» American Samoa
•» Trust Territories

•*> Puerto Rico
«•> Virgin Islands

*• Commonwealth of the Northern Mariana Islands |

Global Partners
•Helped negotiate a global convention, signed by more
than 90 countries to date, reducing and/or eliminating
production, use, and release of 12 pesticides of global
concern and establishing a mechanism by which additional
pesticides may be added in the future.

•Worked with the Mexican Government to develop a
national 'Train-the-Trainer" educational and outreach
program to promote pesticide safety in Mexico.

•Strengthened with Canada and Mexico the North
American framework for regulating pesticides, which ,
promotes a stringent standard for protecting human health
and the environment while providing equal access to pest
control tools throughout North America.

 •Worked with Canada to develop a proposal for updating
nontarget plant toxicity testing requirements. This tiered
testing scheme was peer reviewed, and comments are
being incorporated into OPP's proposal.

•Joined Canada and Mexico on the first successful
trilateral review of a pesticide application.

•Participated in an Organization for Economic Coopera-
tion and Development Workshop on Pesticide Reviews
that explored ways to increase the efficiency of agricul-
tural pesticide evaluations through improved international

•Coordinated U.S. participation in achieving final consen-
sus on the  Globally Harmonized System for Chemical
Hazard Classification  and Labeling, which promotes safer
transportation, handling, and use of chemicals, and
reduces trade barriers.

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  about pesticide regulatory activities:
For general questions on pesticides and pesticide
poisoning prevention, contact the National Pesti-
cide Information Center (NPIC), formerly the
National Pesticides Telecommunications Network:

Telephone: 1-800-858-7378

E-mail: npic @ ace. orst. edu
                                                        Web site: http://npic.orst.edu/

  Amber Waves of Grain
United States Environmental Protection Agency
Office of Prevention, Pesticides
 and Toxic Substances (H7101)
Washington, DC 20460
January 2002

Penalty for Private Use $300