UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
SSt-}
u
' PREVENTION, PESTICIDES
OFFICE OF
TION, PES
AND TOXIC SUBSTANCES
November 1,2004
CERTIFIED MAIL
Subj ect: Amendment to the 1 999 Captan RED
Dear Registrant:
The Reregistration Eligibility Decision (RED) document for captan was completed in
September 1999 and a public comment period for the RED followed. The Environmental Protection
Agency reviewed the public comments submitted and responded in a October 30, 2003 Captan
Response to Comments document. Further, as a result of its review of the public comments the
Agency is amending the 1999 Captan RED. To access the documents supporting this amended
decision please refer to docket number OPP-2004-0296 on the electronic docket web site at
http://www.epa.gov/edocket/. The Agency has determined that products containing captan are
eligible for reregistration provided the risk mitigation as outlined in the following items 1 through 8, the
attached label table, and the 1999 Captan RED are implemented:
1 . Based on incident data the Agency continues to have concerns for post application eye irritation
following captan applications in agricultural settings. Captan is classified in toxicity category I
for being severely irritating to the eyes; therefore the Agency is requiring double notification for
all agricultural applications of captan. All captan labels with agricultural uses must include the
following statement:
• "Double Notification: Notify workers of the application by warning them orally and by posting
warning signs at entrances to treated areas."
To further assure that worker eye irritation concerns are addressed, eye-wash stations must be
provided as outlined in the Worker Protection Standard (WPS), 40 Code of Federal
Regulations Part §170.150, and workers must be informed orally of potential eye irritation
associated with captan for 7 days following an application. All captan labels with agricultural
uses must include the following statement:
• "Eye-Protection: For at least seven days following the application of captan:
1 . at least one container designed specifically for flushing eyes must be available in
operating condition at the WPS-required decontamination site for workers entering
the area treated with captan, and
2. workers must be informed orally, in a manner they can understand:
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- that residues in the treated area may be highly irritating to their eyes,
- that they should take precautions, such as refraining from rubbing their eyes, to
keep the residues out of their eyes,
- that if they do get residues in their eyes, they should immediately flush their eyes
with the eyeflush container that is located at the decontamination site, and
- how to operate the eyeflush container."
2. The amount of active ingredient handlers could be exposed to in the support of aerial
applications for the wettable powder formulations of captan may result in concerns (MOE=41,
see calculations in the September 10, 2004 Captan HEP Revisions to the Occupational Risk
Assessment for the RED Document! Therefore the registrants have agreed to water soluble
packaging for wettable powder formulations intended for aerial applications. Water
dispersable granules and liquid formulations are acceptable formulations for aerial application of
captan with the addition of PPE as outlined in the attached table (Table A).
3. In the 1999 Captan RED the aerial application and chemigation exposure estimate for mixers
and loaders was based on treating 350 acres of strawberries in one day. Aerial applicators are
generally commercial applicators treating multiple fields, therefore they could be treating 350
acres of strawberries in one day. However, chemigation mixers and loaders are generally
treating individual farms that are on average less than 20 acres; therefore the level of exposure
is reduced since the number of acres treated through chemigation is low. Accordingly, the
water soluble package will not be required for wettable powders intended for chemigation.
4. The dichondra ornamental grass use rate is reduced from a single application rate of 43 pounds
per active ingredient per acre to 4.3 pounds per active ingredient per acre. Two applications
per year are allowed for a seasonal maximum application rate of 8.6 pounds of active ingredient
per acre.
5. All captan labels with agricultural uses must include the following statement:
"PPE required for early entry to treated areas that is permitted under the
Worker Protection Standard and that involves contact with anything that has
been treated, such as plants, soil, or water, is:
- coveralls,
- chemical-resistant gloves made of any water-proof material,
- shoes plus socks,
- protective eyewear."
6. The restricted entry interval (REI) for ornamentals will be 48 hours and will not allow hand
labor during the REI with early entry PPE. This REI was calculated based on the California
Department of Pesticide Regulation's transfer coefficient for ornamentals (see page 2 of the
September 10, 2004 Captan HEP Revisions to the Occupational Risk Assessment for the
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RED Document). The ornamental REI will be set at 48 hours and is in agreement with the 48
hour REI requirement in the WPS for Toxicity Category I products.
7. The restricted entry interval (REI) for blackberries, blueberries, raspberries, and grapes will be
48 hours. A transfer coefficient was calculated from an Agriculture Re-Entry Task Force
(ARTF) study. (See calculation on page 5 of the September 30, 2004 Captan HEP Revisions
to the Occupational Risk Assessment for the RED Document.)
8. Handlers opening and loading bags of seed that have been commercially treated with captan
must wear a long-sleeved shirt, long pants, shoes plus socks, and chemical resistant gloves
(MOE = 2400, see page 3 of the September 30, 2004 Captan HEP Revisions to the
Occupational Risk Assessment for the RED Document). There will be no dust/mist respirator
or eye-protection requirement for handling bags of seed treated with captan.
A number of updates have also been made to the 1999 Captan RED label table, for purposes of
clarification. Among the updates are the following:
1. "Wettable powder formulations must prohibit aerial application on their end-use product labels,
unless packaged in water-soluble packets," has been added to the Manufacturing Use Products
section of the table.
2. Handler PPE requirements have been divided by use site. See the attached Table A: Summary
of Required Worker Personal Protective Equipment.
3. Chemical resistant aprons have been added to all formulations when mixing, loading, cleaning
up spills, cleaning equipment, or otherwise exposed to the concentrate.
4. Statements for closed system engineering controls have been added for formulations added
during the manufacturing process, and for wettable powders labeled for seed or seed piece
treatments.
5. The prohibition, "Do not apply this product to seeds or seed pieces," for wettable powders in
water soluble packages has been removed.
6. The REIs have been relocated to the appropriate place in the Application Restrictions section
under Directions for Use on the label table.
7. Early Entry Personal Protective Equipment, Double Notification Requirements, and Additional
Requirements are all specified for products with WPS uses only.
8. Spray Drift language has been modified. An additional requirement for a maximum nozzle
height of 4 feet above the crop canopy with ground boom application has been added.
9. The REI for blueberries, grapes, raspberries, blackberries, dewberries, and ornamentals grown
for commercial or research use is 48 hours.
10. The section "Products Intended for Occupational Use (Non-WPS only)" has been combined
with the "End Use Products Intended for Occupational Use (WPS and Non-WPS)" section.
11. Application restrictions for products used on turf have expanded to specify a prohibition on
applications to turf in residential sites, apartment buildings, day care centers, playgrounds, sports
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fields or other residential areas.
12. Application restrictions for formulations added to paints will now require the paint product label
to also list "shoes and socks" as required protection in addition to long-sleeved shirt, and long
pants when using the product.
13. The statement, "do not allow this product to drift," was deleted from application restrictions for
liquid sprays under Products Intended Primarily for Residential/Consumer/Homeowner Use.
If you have any questions on the captan RED or any of the revisions listed above, please
contact the Chemical Review Manager, Cathryn O'Connell at (703) 308-0136.
Sincerely,
Debra Edwards, Ph.D.
Special Review and Reregistration Division
Attachments:
Table A: Summary of Required Worker Personal Protective Equipment
Table B: Summary of Required Labeling Changes for Captan
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Table A: Summary of Required Worker Personal Protective EC
Exposure Scenario
Mixing/Loading Wettable Powder (WP) for aerial
application
Mixing/Loading WP for airblast, groundboom, high
pressure sprayer, golf courses , chemigation
Adding WP to paint at manufacturer
Mixing/Loading wettable powder for soil and
greenhouse bench treatment, root-dips, or post-
harvest fruit dips
Mixing/Loading dust for soil and greenhouse bench
treatment, or post-harvest fruit dips
Mixing/Loading WP or dust for seed treatment
Drying, bagging, or sewing bags of seed, or handling,
cutting, and sorting seed pieces treated with a
wettable powder or dust formulation
Mixing/Loading liq./flowables for aerial, airblast,
groundboom, root-dips, soil and greenhouse bench
treatments, or post-harvest fruit dips
Mixing/Loading liquid/flowables for seed treatment
Drying, bagging, or sewing bags of seed, or handling,
cutting, and sorting seed pieces treated with a liquid
or dry flowable formulation
Planting of treated seed
Aerial, airblast, groundboom application
Application to golf courses (ground equip.)
Applying ready-to-use paint with brush or roller
Applying ready-to-use paint w/ sprayer
Applying High Pressure Spray
Operation of fruit dip process
Mixing/Loading liquid flowables then applying w/
low pressure handwand
Flagger
Baseline
PPE
Required
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
uipment
Additional PPE
Required
Chemical-resistant gloves,
chemical resistant apron
Chemical-resistant gloves,
dust/mist respirator, chemical
resistant apron
Chemical-resistant gloves,
dust/mist respirator, chemical
resistant apron
Chemical-resistant gloves,
dust/mist respirator, chemical
resistant apron
Chemical-resistant gloves,
dust/mist respirator, chemical
resistant apron
Chemical-resistant gloves,
dust/mist respirator, chemical
resistant apron
Chemical resistant gloves,
dust/mist respirator
Chemical-resistant gloves ,
chemical resistant apron
Chemical-resistant gloves,
chemical resistant apron
Chemical resistant gloves
Chemical-resistant gloves
no
no
no
Water -proof gloves, dust/mist
respirator
Chemical-resistant gloves
Chemical-resistant gloves,
chemical-resistant apron
Chemical-resistant gloves ,
chemical resistant apron
no
Engineering
Controls
water soluble
package
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
restricted to
mechanical
operations only
n/a
n/a
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Table B: Summary of Required Labeling Changes for Captan
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
"Only for formulation into a fungicide for the following use(s) [fill blank only with those uses that are
being supported by MP registrant]:"
"Wettable powder formulations must prohibit aerial application on their end-use product labels, unless
packaged in water-soluble packets."
Directions for Use
One of these statements
may be added to allow
reformulation of the
product for specific use
or all additional uses
supported by a formulator
or user group
"This product may be used to formulate products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding
support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the MP label
if the formulator, user group, or grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
Directions for Use
Environmental Hazards
Statements required by
the RED and Agency
label policies
"This chemical is toxic to fish. Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or other waters unless in accordance with the requirements of a National
Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified
in writing prior to discharge. Do not discharge effluent containing this product to sewer systems
without previously notifying the local sewage treatment plant authority. For guidance contact your
state Water Board or Regional Office of the EPA."
Precautionary
Statements
Page 6 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
E|i(L|Ise. Produ«:t»,
Handler PPE
requirements established
by the RED' for wettable
powders formulated in
water-soluble packages
except formulations
labeled exclusively for
seed, seed piece, or
manufacturing uses
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are (registrant inserts correct chemical
resistant material). If you want more options, follow the instructions for category [insert A, B, C, D, E,
F, G, or H] on an EPA chemical-resistance category selection chart."
"All mixers, loaders, applicators, flaggers, and other handlers (including handlers participating in
seeding and transplanting as part of root-dip or greenhouse-soil treatments) must wear:
- long-sleeved shirt and long pants,
- shoes plus socks,
- chemical resistant gloves except for flaggers, pilots, and applicators driving motorized ground equipmen
- chemical resistant apron when mixing/loading, participating in dip treatments, cleaning up spills,
cleaning equipment, or otherwise exposed to the concentrate.
See engineering controls for additional requirements."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Page 7 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Handler PPE
requirements established
by the RED' for wettable
powders (not in water
soluble packages), except
formulations labeled
exclusively for seed, seed
piece, or manufacturing use
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are (registrant inserts correct chemical
resistant material). If you want more options, follow the instructions for category [insert
A,B,C,D,E,F,G, or H] on an EPA chemical-resistance category selection chart."
"All mixers, loaders, applicators, and other handlers (including handlers participating in seeding and
transplanting as part of root-dip or greenhouse-soil treatments) must wear:
- long-sleeved shirt and long pants,
- shoes plus socks,
- chemical resistant gloves except for applicators driving motorized ground equipment,
- chemical resistant apron when mixing/loading, participating in dip treatments, cleaning up spills,
cleaning equipment, or otherwise exposed to the concentrate,
- NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number
prefix TC-21C or a NIOSH-approved respirator with any N2, R, P, or HE filter when mixing/loading,
cleaning up spills, cleaning equipment, or otherwise exposed to the concentrate.
See engineering controls for additional options."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Handler PPE
requirements established
by the RED' for any
formulation added to
paint, soaps, cosmetics,
adhesives or other
products during the
manufacturing process
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are (registrant inserts correct chemical
resistant material). If you want more options, follow the instructions for category [insert
A,B,C,D,E,F,G, or H] on an EPA chemical-resistance category selection chart."
"All mixers, loaders, applicators, and other handlers must wear:
- long-sleeved shirt and long pants,
- shoes plus socks,
- chemical resistant gloves,
- NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number prefix TC-21C or
a NIOSH-approved respirator with any N2, R, P, or HE filter.
See engineering controls for additional options."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Page 8 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Handler PPE
requirements established
by the RED' for liquid or
dry flowable (water
dispersable granules)
formulations, except
formulations labeled
exclusively for seed, seed
piece, or manufacturing
uses
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are (registrant inserts correct chemical
resistant material). If you want more options, follow the instructions for category [insert
A,B,C,D,E,F,G, or H] on an EPA chemical-resistance category selection chart."
"All mixers, loaders, applicators, and other handlers (including handlers participating in seeding and
transplanting as part of root-dip or greenhouse-soil treatments) must wear:
- long-sleeved shirt and long pants,
- shoes plus socks,
- chemical resistant gloves, except for pilots, flaggers, or applicators driving motorized ground
equipment,
- chemical resistant apron when mixing/loading, participating in dip treatments, cleaning up spills,
cleaning equipment, or otherwise exposed to the concentrate."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Handler PPE
requirements established
by the RED1 for dust
formulations, except
formulations labeled
exclusively for seed, seed
piece, or manufacturing
uses
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are (registrant inserts chemical resistant
materials). If you want more options, follow the instructions for category [insert A,B,C,D,E,F,G, or
H] on an EPA chemical-resistance category selection chart."
"All loaders, applicators and other handlers (including handlers participating in seeding and
transplanting as part of greenhouse-soil treatments) must wear:
- long-sleeved shirt and long pants,
- chemical resistant gloves,
- shoes plus socks,
- chemical resistant apron when loading, cleaning up spills, or cleaning equipment,
- NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number
prefix TC-21C or a NIOSH-approved respirator with any N2, R, P, or HE filter."
Precautionary Statement
Hazards to Humans and
Domestic Animals
Page 9 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Handler PPE
requirements established b}
the RED1 for liquid and
dry flowable formulations
labeled exclusively for
seed treatment and/or
seed piece treatment
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct chemical
resistant material). If you want more options, follow the instructions for category [insert A, B, C, D, E,
F, G, or H] on an EPA chemical-resistance category selection chart.
All mixers, loaders, applicators, and other handlers must wear:
- long-sleeved shirt and long pants,
- shoes plus socks,
- chemical resistant gloves except when sewing bags of treated seed,**
- chemical resistant apron when mixing/loading, cleaning up spills, cleaning equipment, or otherwise
exposed to the concentrate.
See engineering controls for additional options."
For seed treatment uses, add:
"Persons drying or bagging treated seeds or sewing bags containing treated seeds are handlers and
must wear handler personal protective equipment."
For seed piece treatment uses, add:
"Persons cutting, sorting, or otherwise handling treated seed pieces are handlers and must wear
handler personal protective equipment."
"Note: if the product is labeled solely for seed piece treatment, then the "except when sewing bags
of treated seed" phrase should be dropped from the chemical-resistant glove statement.
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Page 10 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Handler PPE
requirements established
by the RED' for wettable
powder formulations,
labeled exclusively for
seed treatment and/or
seed piece treatments
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct chemical
resistant material). If you want more options, follow the instructions for category [insert A, B, C, D, E,
F, G, or H] on an EPA chemical-resistance category selection chart.
All mixers, loaders, applicators, and other handlers must wear:
- long-sleeved shirt and long pants,
- shoes plus socks,
- chemical resistant gloves except when sewing bags of treated seed, **
- chemical resistant apron when mixing/loading, cleaning up spills, cleaning equipment, or otherwise
exposed to the concentrate,
- NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number
prefix TC-21C or a NIOSH-approved respirator with any N2, R, P, or HE filter.
See engineering controls for additional options."
For seed treatment uses, add:
"Persons drying or bagging treated seeds or sewing bags containing treated seeds are handlers and
must wear handler personal protective equipment."
For seed piece treatment uses, add:
"Persons cutting, sorting, or otherwise handling treated seed pieces are handlers and must wear
handler personal protective equipment."
"Note: if the product is labeled solely for seed piece treatment, then the "excepf when sewing bags
of treated seed" phrase should be dropped from the chemical-resistant glove statement.
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Page 11 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Handler PPE
requirements established
by the RED1 for dust
formulations labeled
exclusively for seed
treatment and/or seed
piece treatments
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct chemical
resistant material). If you want more options, follow the instructions for category [insert A, B, C, D, E,
F, G, or H] on an EPA chemical-resistance category selection chart.
All loaders, applicators, and other handlers must wear:
- long-sleeved shirt and long pants,
- shoes plus socks,
- chemical resistant gloves except when sewing bags of treated seed, **
- chemical resistant apron when loading,-cleaning up spills, or cleaning equipment,
- NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number prefix TC-21C or
a NIOSH-approved respirator with any N2, R, P, or HE filter."
For seed treatment uses, add:
"Persons drying or bagging treated seeds or sewing bags containing treated seeds are handlers and
must wear handler personal protective equipment."
For seed piece treatment uses, add:
"Persons cutting, sorting, or otherwise handling treated seed pieces are handlers and must wear
handler personal protective equipment."
"Note: if the product is labeled solely for seed piece treatment, then the "axcepf when sewing bags
of treated seed" phrase should be dropped from the chemical-resistant glove statement.
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry.
Precautionary
Statements: Hazards to
Humans and Domestic
Animals after PPE
requirements
Page 12 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Engineering controls for
wettable powder
formulations packaged in
water-soluble packets
"Engineering Controls"
"Water-soluble packets when used correctly qualify as a closed loading system under the WPS.
Mixers and loaders using water-soluble packets (1) must wear the PPE specified above for mixers and
loaders and (2) must be provided and have immediately available for use in an emergency, such as a
broken package, spill, or equipment breakdown a NIOSH-approved dust mist filtering respirator with
MSHA/NIOSH approval number prefix TC-21C or a NIOSH-approved respirator with any N2, R, P, or
HE filter."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE and
User Safety
Requirements
Engineering controls for
formulations added to
paint, soaps, cosmetics,
or adhesives during the
manufacturing process
"Engineering Controls:"
"When handlers use closed systems designed by the manufacturer to enclose the pesticide to prevent
it from contacting handlers or other people AND the system is functioning properly and is used and
maintained in accordance with the manufacturer's written operating instructions, the handlers need
only wear long-sleeve shirt, long pants, chemical resistant gloves, shoes, and socks. However, the
respirator must be immediately available for use in an emergency, such as a spill or equipment
breakdown."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE and
User Safety
Requirements
Engineering controls for
wettable powder and dust
formulations labeled for
seed treatments or seed
piece treatments.
"Engineering Controls"
"When handlers use closed systems designed by the manufacturer to enclose the pesticide to prevent
it from contacting handlers or other people AND the system is functioning properly and is used and
maintained in accordance with the manufacturer's written operating instructions, the handlers need
only wear long-sleeve shirt, long pants, chemical resistant gloves, shoes, and socks. However, the
respirator must be immediately available for use in an emergency, such as a spill or equipment
breakdown."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
and User Safety
Requirements
User Safety
Recommendations
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and
put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash the outside of gloves
before removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary
Statements under:
Hazards to Humans
and Domestic Animals
immediately following
Engineering Controls
(Must be placed in a
box)
Page 13 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Environmental Hazards
for products used in seed
treatments only
"Environmental Hazards"
"This chemical is toxic to fish. Do not contaminate water when disposing of equipment washwaters
or rinsate."
Precautionary
Statements under
Environmental Hazards
Environmental Hazards
for products used for
outdoor terrestrial uses
"Environmental Hazards"
"This chemical is toxic to fish. Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high water mark. Drift and runoff from treated areas
may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when
cleaning equipment or disposing of equipment washwaters or rinsate."
Precautionary
Statements under
Environmental
Hazards
Restricted-Entry Interval
for products that contain
uses within the scope of
the Worker Protection
Standard for Agricultural
Pesticides (WPS)-see
PR Notice 93-7
"Do not enter or allow worker entry into treated areas during the restricted
entry interval (REI)."
Directions for Use,
Agricultural Use
Requirements Box
Early Entry Personal
Protective Equipment for
products with WPS uses
"Early Entry PPE"
"PPE required for early entry to treated areas that is permitted under the Worker Protection Standard
and that involves contact with anything that has been treated, such as plants, soil, or water, is:
- coveralls,
- chemical-resistant gloves made of any water-proof material,
- shoes plus socks,
- protective eyewear."
Directions for Use,
Agricultural Use
Requirements Box
Double Notification
Requirements for
products with WPS uses
"Double Notification: Notify workers of the application by warning them orally and by posting
warning signs at entrances to treated areas."
Directions for Use,
Agricultural Use
Requirements Box
Page 14 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Additional Requirements
for products with WPS
To mitigate eye irritation concerns from post application exposures, the Agency is
requiring the following statement:
"Eye-Protection: For at least seven days following the application of captan:
1. at least one container designed specifically for flushing eyes must be available in operating
condition at the WPS-required decontamination site for workers entering the area treated with captan,
and
2. workers must be informed orally, in a manner they can understand:
- that residues in the treated area may be highly irritating to their eyes,
- that they should take precautions, such as refraining from rubbing their eyes, to keep the
residues out of their eyes,
- that if they do get residues in their eyes, they should immediately flush their eyes with the
eyeflush container that is located at the decontamination site, and
- how to operate the eyeflush container."
Directions for Use,
Agricultural Use
Requirements Box
Application Restrictions
for all products except
products labeled
exclusively for seed, seed
piece, or manufacturing
uses.
"Do not apply this product in a way that will contact workers or other persons, either directly or
through drift. Only protected handlers may be in the area during application."
Directions for Use
Application Restrictions
for products labeled
exclusively for seed, seed
piece, or manufacturing
uses.
"Do not apply this product in a way that will contact workers or other persons. Only protected
handlers may be in the area during application."
Directions for Use
Page 15 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Spray Drift language for
products applied
outdoors as a spray
"SPRAY DRIFT MANAGEMENT"
"Avoiding spray drift at the application site is the responsibility of the applicator. The interaction of
many equipment-and-weather-related factors determine the potential for spray drift. The applicator
and the grower are responsible for considering all these factors when making decisions."
"Apply only as a medium or coarser spray (ASAE standard 572) or a volume mean diameter of 300
microns or greater for spinning atomizer nozzles."
"Apply only when the wind speed is 2-10 mph at the application site."
Additional requirements for aerial applications:
"The boom length must not exceed 75% of the wingspan or 90% or the rotor blade diameter."
"Release spray at the lowest height consistent with efficacy and flight safety. Do not release spray at
a height greater than 10 feet above the crop canopy."
"When applications are made with a crosswind, the swath will be displaced downwind. The applicator
must compensate for this displacement at the downwind edge of the application area by adjusting the
path of the aircraft upwind."
"Do not make applications into temperature inversions."
Additional requirements for ground boom application:
"Do not apply with a nozzle height greater than 4 feet above the crop canopy."
Directions for Use
Page 16 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Application Restrictions
for wettable powders not
in water-soluble
packaging
"Do not apply this product with aerial equipment."
Directions for Use
Other Use/Application
Restrictions
"For foliar applications:"
"The maximum application rate for almonds is 4.5 Ib ai/acre, with a maximum seasonal application
rate of 20 Ib ai/acre from prebloom through postharvest Preharvest interval (PHI) = 30 days.
Restricted Entry Interval is 24 hours. Almond hulls may be fed to livestock."
"The maximum application rate for apples is 4 Ib ai/acre, with a maximum seasonal application rate
of 32 Ib ai/acre from prebloom through postharvest. Preharvest interval (PHI) = 0 days. Restricted
Entry Interval is 24 hours."
"The maximum application rate for apricots is 2.5 Ib ai/acre, with a maximum seasonal application
rate of 12.5 Ib ai/acre from prebloom through postharvest. Preharvest interval (PHI) = 0 days.
Restricted Entry Interval is 24 hours."
"The maximum application rate for blueberries is 2.5 Ib ai/acre, with a maximum seasonal
application rate of 35 Ib ai/acre from prebloom through postharvest. Preharvest interval (PHI) = 0
days. Restricted Entry Interval is 48 hours."
"The maximum application rate for cherries is 2 Ib ai/acre, with a maximum seasonal application
rate of 14 Ib ai/acre from prebloom through postharvest. Preharvest interval (PHI) = 0 days.
Restricted Entry Interval is 24 hours."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Page 17 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
"The maximum application rate for grapes is 2 Ib ai/acre, with a maximum seasonal application rate
of 12 Ib ai/acre from prebloom through postharvest Preharvest interval (PHI) = 0 days. Restricted
Entry Interval is 48 hours."
"The maximum application rate for nectarines is 4 Ib ai/acre, with a maximum seasonal application
rate of 24 Ib ai/acre from prebloom through postharvest. Preharvest interval (PHI) = 0 days.
Restricted Entry Interval is 24 hours."
"The maximum application rate for peaches is 4 Ib ai/acre, with a maximum seasonal application
rate of 32 Ib ai/acre from prebloom through postharvest. Preharvest interval (PHI) = 0 days. Restricted
Entry Interval is 24 hours."
"The maximum application rate for plums/fresh prunes is 3 Ib ai/acre, with a maximum seasonal
application rate of 27 Ib ai/acre from prebloom through postharvest. Preharvest interval (PHI) = 0
days. Restricted Entry Interval is 24 hours."
"The maximum application rate for strawberries is 3 Ib ai/acre, with a maximum seasonal
application rate of 24 Ib ai/acre from prebloom through postharvest. Preharvest interval (PHI) = 0
days. Restricted Entry Interval is 24 hours."
"The maximum application rate for raspberries and blackberries is 2 Ib ai/acre, with a maximum
seasonal application rate of 10 Ib ai/acre per season. Preharvest interval (PHI) = 3 days. Restricted
Entry Interval is 48 hours."
"The restricted entry interval (REI) for dewberries is 48 hours."
"The restricted entry interval (REI) for ornamentals grown for commercial or research use is 48 hours."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Page 18 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
"For post-harvest fruit dips:"
"For apples, pears, and cherries use 1.25 Ib ai/100 gallons of water."
"For use in mechanical fruit-dip operations only. Hand dipping of fruit is prohibited."
"For applications to turf (sod farms):"
"The maximum application rate for turf (sod farms) is 4.3 Ib ai/acre, with a maximum seasonal
application rate of 8.6 Ib ai/acre per season.
Restricted Entry Interval is 48 hours."
"Do not harvest sod until 48 hours after application."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Page 19 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
For seed treatments, root dips, and soil treatments:
All planter box-type or hopper-box seed treatments
"12 hour restricted entry interval (REI) for planter box-type or hopper-box seed treatment uses.
Exception: Once the seeds are planted in soil or other planting media, the Worker Protection Standard
allows workers to enter the treated area without restriction if there will be no contact with the
soil/media subsurface."
All soil treatments and root dips
"48 hour restricted entry interval (REI) for soil treatments and root dips : For soil and greenhouse
bench treatments and root dips, once the treatment and any seeding or transplanting tasks done as
part of the treatment are complete, the 48-hour REI begins. Exception, once the seeds or transplants
are planted in the soil, the Worker Protection Standard allows workers to enter the treated area without
restriction if there will be no contact with the soil subsurface."
alfalfa, clover, lespedeza, or trefoil seeds
"For slurry seed treatments use 4 ounce ai/100 Ib seed."
"For dust seed treatments use 6 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed."
barley seeds
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
"For dust seed treatments use 1.5 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.8 ounce ai/100 Ib seed."
bean seeds
"For slurry seed treatments use 1.3 ounce ai/100 Ib seed."
"For dust seed treatments use 1.9 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Page 20 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
beets (table) seeds
"For slurry seed treatments use 6 ounce ai/100 Ib seed."
"For dust seed treatments use 9 ounce ai/100 Ib seed."
bluegrass seeds
"For slurry seed treatments use 4.1 ounce ai/100 Ib seed."
"For dust seed treatments use 6 ounce ai/100 Ib seed."
broccoli, Brussel sprouts, cabbage, and cauliflower seeds
"For slurry seed treatments use 1.1 ounce ai/100 Ib seed."
"For dust seed treatments use 1.1 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed.
carrot seeds
"For slurry seed treatments use 4.4 ounce ai/100 Ib seed."
"For dust seed treatments use 6.75 ounce ai/100 Ib seed."
cantaloupe, cucumber, or tomato seeds
"For slurry seed treatments use 1.6 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
collards or kale seeds
"For slurry seed treatments use 0.5 ounce ai/100 Ib seed."
corn (field) seeds
"For slurry seed treatments use 1.1 ounce ai/100 Ib seed."
"For dust seed treatments use 1.1 ounce ai/100 Ib seed."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Page 21 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
corn (sweet) seeds
"For slurry seed treatments use 2ounce ai/100 Ib seed."
"For dust seed treatments use 2 ounce ai/100 Ib seed."
"For planter box seed treatments use 1 ounce ai/100 Ib seed."
cottonseeds (acid delinted)
"For slurry seed treatments use 2.5 ounce ai/100 Ib seed."
"For dust seed treatments use 1.5 ounce ai/100 Ib seed."
cottonseeds (machine delinted)
"For slurry seed treatments use 2.25 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
cottonseeds (fuzzy)
"For slurry seed treatments use 3.5 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
cottonseeds (reginned)
"For slurry seed treatments use 3.5 ounce ai/100 Ib seed."
cottonseeds (unspecified)
"For planter box seed treatments use 1 ounce ai/100 Ib seed."
cowpeas
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
eggplant seeds
"For slurry seed treatments use 2.7 ounce ai/100 Ib seed."
"For dust seed treatments use 4.5 ounce ai/100 Ib seed."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Page 22 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
flax seeds
"For slurry seed treatments use 2 ounce ai/100 Ib seed."
"For dust seed treatments use 2.6 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed."
grass seed
"For slurry seed treatments use 4.1 ounce ai/100 Ib seed."
"For dust seed treatments use 9 ounce ai/100 Ib seed."
mustard or rape seeds
"For slurry seed treatments use 0.8 ounce ai/100 Ib seed."
oat seeds
"For slurry seed treatments use 2 ounce ai/100 Ib seed."
"For dust seed treatments use 2 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.8 ounce ai/100 Ib seed."
okra seeds
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
onion seeds
"For pelleting, use 0.8 pound ai/ Ib seed."
"For seeder box seed treatments use 0.75 pound ai/3 Ib seed."
peanut seeds
"For slurry seed treatments use 3 ounce ai/100 Ib seed."
"For dust seed treatments use 3 ounce ai/100 Ib seed."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Page 23 of 30
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Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
pea seeds
"For slurry seed treatments use 1.3 ounce ai/100 Ib seed."
"For dust seed treatments use 1.9 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
pepper seeds
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
potato seed pieces
"For dust seed piece treatments use 1.2 ounce ai/100 Ib seed."
radish seeds
"For slurry seed treatments use 1.1 ounce ai/100 Ib seed."
"For dust seed treatments use 1.1 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed."
rutabaga seeds
"For slurry seed treatments use 2.3 ounce ai/100 Ib seed."
"For dust seed treatments use 3.4 ounce ai/100 Ib seed."
rye seeds
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
"For dust seed treatments use 1.5 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed."
safflower seeds
"For planter box seed treatments use 1 ounce ai/100 Ib seed."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Page 24 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
sesame seeds
"For slurry seed treatments use 0.8 ounce ai/100 Ib seed."
sorghum seeds (milo)
"For slurry seed treatments use 3 ounce ai/100 Ib seed."
sorghum seeds (hulled)
"For slurry seed treatments use 3 ounce ai/100 Ib seed."
"For dust seed treatments use 3 ounce ai/100 Ib seed."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Page 25 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
soybean seeds
"For slurry seed treatments use 1.3 ounce ai/100 Ib seed."
"For dust seed treatments use 1.9 ounce ai/100 Ib seed."
"For planter box seed treatments use 1.75 ounce ai/100 Ib seed."
spinach seeds
"For slurry seed treatments use 3.3 ounce ai/100 Ib seed."
"For dust seed treatments use 4.5 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
squash, pumpkin, muskmelon, or watermelon seeds
"For slurry seed treatments use 1 ounce ai/100 Ib seed."
"For dust seed treatments use 1.5 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
sugar beet seeds (eastern US)
"For slurry seed treatments use 6 ounce ai/100 Ib seed."
sugar beet seeds (western US)
"For slurry seed treatments use 3 ounce ai/100 Ib seed."
sugar beet seeds (unspecified)
"For slurry seed treatments use 6 ounce ai/100 Ib seed."
"For dust seed treatments use 9 ounce ai/100 Ib seed."
"For planter box seed treatments use 2 ounce ai/100 Ib seed."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Page 26 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
Sunflower seeds
"For slurry seed treatments use 2 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
Swiss chard seeds
"For slurry seed treatments use 6 ounce ai/100 Ib seed."
"For dust seed treatments use 9 ounce ai/100 Ib seed."
Turnip seeds
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
Wheat seeds
"For slurry seed treatments use 1 ounce ai/100 Ib seed."
"For dust seed treatments use 2 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.8 ounce ai/100 Ib seed."
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
Entry Restrictions for
products containing
directions for use as a
postharvest fruit dip
Po st-Application/Entry Restrictions:
"Do not contact or allow others to contact the treated fruit until sprays have dried.
If no WPS uses on the
label, place the
statements in the
Directions for Use
Under General
Precautions and
Restrictions
If WPS uses are also on
the labeling, place
these statements in a
Nonagricultural Use
Requirements box as
specified in PR Notice
93-7 and 93-11
Page 27 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Entry Restrictions for
products containing
directions for use on golf
courses or on
ornamentals in
landscapes or other
commercial settings
(non-WPS ornamental
use patterns)
For dust formulations:
- "Do not enter or allow others to enter until dusts have settled."
For all other formulations:
- "Do not enter or allow others to enter until sprays have dried."
If no WPS uses on the
label, place the
statements in the
Directions for Use
Under General
Precautions and
Restrictions
If WPS uses are also on
the labeling, place
these statements in a
Nonagricultural Use
Requirements box as
specified in PR Notice
93-7 and 93-11
Application Restriction
for seed that has been
treated with this product
that is then packaged or
bagged for future use
Seed that has been treated with this product that is then packaged or bagged for future use must
contain the following labeling:
"This bag contains seed treated with captan. When opening this bag or loading/pouring the treated
seed, wear long-sleeved shirt, long pants, shoes, socks, and chemical resistant gloves."
"Treated Seed - Do Not Use for Food, Feed, or Oil Purposes."
Directions for Use
Application Restrictions
for products used on turf
"The maximum application rate for golf course turf and turf in commercial settings is 4.3 Ib ai/acre with
a maximum seasonal application rate of 8.6 Ib ai/acre."
"Do not apply to turfgrass in residential sites, including homes, apartment buildings, daycare centers,
schools, playgrounds, parks, recreational areas, sports fields or other residential areas."
Directions for Use
Page 28 of 30
-------
Description
Application Restrictions
for formulations added to
paints
Summary of Required Labeling Changes for Captan (as of 1 1/2004)
Required Labeling
This product cannot be added to paint products unless the paint product label contains the following
statements:
"When using this product, wear long-sleeved shirt, long pants, shoes and socks."
"When applying this product with a sprayer, also wear waterproof gloves and a NIOSH-approved
dust mist filtering respirator with MSHA/NIOSH approval number prefix TC-21C or a NIOSH-approved
respirator with any N2, R, P, or HE filter."
Placement on Label
Directions for Use
Products Ijnten$le4 IMmfirilf for Re»f 4qntt«l/€on»wmRr/ponieojf ner Utc
Environmental Hazards
Early Entry Restrictions
Application Restrictions
for all products
Other Use/Application
Restrictions
"Environmental Hazards"
"This chemical is toxic to fish. Do not apply directly to water. Do not contaminate water when
disposing of equipment washwaters or rinsate."
For dust formulations:
"ENTRY RESTRICTIONS: Do not allow people or pets to enter the treated area until dusts have
settled."
For all other formulations:
"ENTRY RESTRICTIONS: Do not allow people or pets to enter the treated area until sprays have
dried."
"Do not apply this product in a way that will contact any person or pet, either directly or through drift.
Keep people and pets out of the area during application."
"Do not apply to residential lawns."
Precautionary
Statements after User
Safety
Recommendations
under "Environmental
Hazards"
Directions For Use in
General Precautions
and Restrictions
Directions For Use in
General Precautions
and Restrictions
Directions For Use in
General Precautions
and Restrictions
Page 29 of 30
-------
Summary of Required Labeling Changes for Captan (as of 11/2004)
Description
Required Labeling
Placement on Label
Maximum Application
Rates
For use on ornamentals as a root dip:
Azalea, carnation, chrysanthemum: 0.3 ounce ai/gallon
For use on gladiolus corms: 0.3 ounce ai/gallon
For use on tuberous begonia: 1.2 ounce ai/gallon
For use on azalea, carnation, chrysanthemum, and roses: 0.2 ounce ai/gallon
For use as a seed treatment:
beans, cabbage, corn, melons, peas, squash: 0.02 ounce ai/pound seeds
beets, Swiss chard: 0.08 ounce ai/pound seeds
spinach: 0.04 ounce ai/pound seeds
For post-harvest use on apple and peach trees and grapes:
apple and peach trees and grapes: 0.02 ounce ai/gallon
Directions For Use
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more
protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
2 The registrant must drop the N type filter from the respirator statement if the pesticide product contains or is used with oil.
Page 30 of 30
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United States Prevention, Pesticides EPA 738-R-99-015
Environmental Protection And Toxic Substances November 1999
Agency (7508C)
&EPA Reregistration
Eligibility Decision (RED)
CAPTAN
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case #0120 which includes
the active ingredient captan. The enclosed Reregistration Eligibility Decision (RED), which was
approved on September 30, 1999, and contains the Agency's evaluation of the data base of these
chemicals, its conclusions of the potential human health and environmental risks of the current
product uses, and its decisions and conditions under which these uses and products will be eligible
for reregistration. The RED includes the data and labeling requirements for products for
reregistration. It may also include requirements for additional data (generic) on the active
ingredients to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from the receipt of this
letter. The second set of required responses is due 8 months from the date of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of suspension
against your products.
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both pesticide law (FIFRA) and the food and drug law
(FFDCA). This RED takes into account, to the extent currently possible, the new safety standard
set by FQPA for establishing and reassessing tolerances. However, it should be noted that in
continuing to make reregistration determinations during the early stages of FQPA implementation,
EPA recognizes that it will be necessary to make decisions relating to FQPA before the
implementation process is complete. In making these early case-by-case decisions, EPA does not
intend to set broad precedents for the application of FQPA. Rather, these early determinations
will be made on a case-by-case basis and will not bind EPA as it proceeds with further policy
development and any rulemaking that may be required.
-------
If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will pursue whatever
action may be appropriate, including but not limited to reconsideration of any portion of this
RED.
If you have questions on the required generic data requirements or wish to meet with the
Agency on specific decisions made in the RED, please contact the Special Review and
Reregistration Division representative Kylie Rothwell at 703-308-8055. Address any questions
on product specific data requirements or specific changes required to the Special Review and
Reregistration Division representative Karen Jones at 703-308-8047.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Enclosures
-------
-------
SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You must
submit the appropriate response forms (following the instructions provided) within 90 days
of the receipt of this RED/DCI letter; otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original application
form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregi strati on) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregi strati on. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National Technical
Information Service, publication #PB92-221811; telephone number 703-605-6000).
c. Generic or Product Specific Data Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
d Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
-------
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by the analysis of five batches. If you
choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR §158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
e Certification With Respect to Citation of Data Complete and sign EPA form 8570-
34 and 8570-35 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregi strati on determination within 14 months after the RED has been
issued.
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-------
REREGISTRATION ELIGIBILITY DECISION
CAPTAN
LIST A
CASE 120
-------
-------
TABLE OF CONTENTS
CAPTAN REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 3
D. Data Requirements 4
E. Regulatory History 5
III. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
1. Identification of the Active Ingredient 6
2. Manufacturing-Use Products 7
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Toxicology Endpoint Selection 8
(1) Reference and Population Adjusted Doses 9
(2) Studies Used to Support the Endpoint Selection 10
b. Acute Toxicity 13
c. Chronic Toxicity/Carcinogenicity 13
d. Metabolism 14
2. Dose Response Assessment 14
a. Special Sensitivity of Infants and Children (FQPA Safety
Factor) 14
3. Dietary Risk and Exposure From Food 16
a. Summary of Residue Data Requirements 16
b. Summary of Risks from Food 17
c. Dietary Exposure from Drinking Water 18
d. Occupational Handlers Risk and Exposure 21
(1) Scenarios/Assumptions in Occupational Assessment
21
(2) Occupational Handlers Risk Conclusions 25
(3) Occupational Incidents 25
e. Occupational Post-Application Exposure and Risk 26
(1) Assumptions for Occupational Post-Application .... 26
(2) Occupational Postapplication Risk Conclusions .... 27
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f. Residential Exposure and Risk 27
(1) Residential Handler Risk 28
(2) Residential Post-application Risk 28
g. Aggregate Risk 29
C. Environmental Assessment 33
1. Ecological Toxicity Data 33
a. Toxicity to Terrestrial Animals 33
b. Toxicity to Aquatic Animals 35
c. Toxicity to Plants 37
2. Environmental Fate 38
a. Environmental Fate Assessment 38
b. Environmental Fate and Transport 39
c. Degradation 39
d. Mobility 41
e. Accumulation 42
f. Field Dissipation 42
g. Spray Drift 42
h. Water Resources 43
(1) Ground Water 43
(2) Surface Water 45
3. Ecological Exposure and Risk Characterization 47
a. Risk Quotient (RQ) and the Level of Concern (LOC) 47
b. Exposure and Risk to Nontarget Terrestrial Animals 48
(1) Birds 48
(2) Mammals 52
(3) Terrestrial Insects 55
(5) Freshwater Fish 56
(6) Freshwater Invertebrates 57
(7) Estuarine and Marine Animals 57
c. Ecological Risk Due to Seed Treatments 57
d. Endangered Species 58
e. Risk Characterization Summary 58
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 61
A. Determination of Eligibility 61
1. Eligibility Decision 62
2. Eligible and Ineligible Uses 62
B. Regulatory Position 62
1. Food Quality Protection Act Findings 63
2. Tolerance Reassessment 66
a. Human Health Risk Mitigation 72
3. Occupational (both Worker Protection Standard and non-WPS)
Labeling Rationale 81
4. Other Labeling Requirements 83
a. Endangered Species Statement 83
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b. Spray Drift Management 83
V. ACTIONS REQUIRED OF REGISTRANTS 84
A. Manufacturing-Use Products 84
1. Additional Generic Data Requirements 84
2. Labeling Requirements for Manufacturing-Use Products 84
B. End-Use Products 85
1. Additional Product-Specific Data Requirements 85
2. Labeling Requirements for End-Use Products 85
3. Required Labeling Changes Summary Table 85
C. Existing Stocks 109
VI. APPENDICES 111
A. Table of Use Patterns Subject to Reregistration 113
B. Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision 115
C. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision 129
D. Generic Data Call-In 163
1. Generic Data Call-In Chemical Status Sheet 181
2. Generic DCI Response Forms Inserts (Insert A) plus Instructions 182
3. Requirements Status and Registrants' Response Forms (Insert B) plus
Instructions 185
E. Product Specific Data Call-In 191
1. Product Specific Chemical Status Sheets 204
2. Data Call-in Response Form for the Product Specific Data(Form A
inserts) Plus Instructions 205
3. Product Specific Requirement Status and Registrant's Response
Forms (Form B inserts) and Instructions 207
4. EPA Batching of End-Use Products for Meeting Data Requirements
for Reregistration 215
5. List of All Registrants Sent This Data Call-In (insert) Notice 226
F. List of Available Related Documents and Electronically Available Forms. 227
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CAPTAN REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis
John Faulkner
Steve Jarboe
Rich Michell
Environmental Fate and Effects Assessment
Iwona Mayer
Kevin Costello
Harry Craven
Richard Mahler
Norman Birchfield
Health Effects Risk Assessment
David Hrdy
Thurston Morton
Sanju Diwan
Paula Deschamp
Shiela Piper
Registration Support
Cynthia Giles-Parker
Risk Management
Kylie Rothwell
Kathryn Boyle
Susan Jennings
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Environmental Risk Branch I
Environmental Risk Branch I
Environmental Risk Branch III
Environmental Risk Branch I
Environmental Risk Branch I
Reregi strati on Branch IV
Reregi strati on Branch IV
Reregi strati on Branch IV
Reregi strati on Branch II
Chemistry and Exposure Branch I
Fungicide Herbicide Branch
Reregistration Branch III
Reregistration Branch III
Reregistration Branch III
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CNS Central Nervous System
CSF Confidential Statement of Formula
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWLOC Drinking Water Level of Comparison
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observational Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
ug/g Micrograms Per Gram
ug/L Micrograms per liter
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No Observable Effect Concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOAEL No Observed Adverse Effect Level
OPP Office of Pesticide Programs
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PAD Population Adjusted Dose, the Reference Dose adjusted to include the FQPA Safety Factor
PADI Provisional Acceptable Daily Intake
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q/ The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RTU Ready to Use Pesticide
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 © of FIFRA)
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The US Environmental Protection Agency has completed its reregi strati on eligibility
decision for the pesticide captan (N-trichloromethylthio-4-cyclohexene-l,2-dicarboximide). The
Agency has considered generic data to support the reregistration of captan and determined that
these data are sufficient to support reregistration of products containing captan, except for those
with uses on turf and aerially-applied wettable powder formulations. Products applied to turf at
sod farms or golf courses are eligible for reregistration; uses at all other turf sites are being
voluntarily canceled. Wettable powder formulations that are applied aerially are eligible for
reregistration, provided either: 1) the products are packaged in water soluble packaging; or 2) the
application rates are reduced to a level that is no higher than 1.2 Ib ai/A.
This reregistration decision also considered the requirements of the "Food Quality
Protection Act of 1996" (FQPA) which amended the Federal Food Drug and Cosmetic Act and
the Federal Insecticide Fungicide and Rodenticide Act, the two Federal statutes that provide the
framework for pesticide regulation in the United States. FQPA became effective immediately
upon enactment on August 3, 1996 and the new REDs are being evaluated under the new
standards imposed by FPQA. The Act directs EPA to consider the potential for increased
susceptibility of infants and children, to evaluate the toxic effects of pesticide residues, and to
develop a screening program to determine whether pesticides produce endocrine disrupting
effects.
Captan is a non-systemic fungicide used to control diseases in orchard crops, berries,
seeds, turf, and ornamentals. Captan is also incorporated into paint and adhesives as an in-can
preservative. The pesticide has several formulations and is applied by various methods, including
aerial, airblast, and groundboom. Captan is also applied as a postharvest dip to apples, cherries
and pears. Captan's technical registrants are Tomen Agro, Incorporated, and Makhteshim-Agan
of North America, who are both members of the Captan Stewardship Task Force.
Reregistration Eligibility
The Agency has concluded, under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), that captan products, when labeled and used as specified in this document, will not
cause unreasonable adverse effects on human health or the environment and are, therefore, eligible
for reregistration. The Agency has conducted both human health and ecological risk assessments
for captan, and has also evaluated data on its major degradates, THPI and THPAm. The Agency
has determined that THPAm has no toxicological significance. However, THPI does have
toxicological significance and was included in the dietary risk assessment. For captan, the
carcinogenic process is thought to be triggered by the highly reactive but short-lived metabolite
thiophosgene. The Agency has classified parent captan as a B2 (probable human) carcinogen.
Since THPI is not believed to contribute to the carcinogenicity of captan, it is not factored into
the cancer risk assessment.
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Human Health Effects
The human health risk assessment evaluated toxicological and exposure data to develop
dietary, drinking water, residential, aggregate and occupational exposure analyses, and to assess
the adequacy of existing tolerances. Because the available studies demonstrated no indication of
increased sensitivity of animals to in utero or postnatal exposure to captan and the database is
complete, the Agency determined that there is no evidence of special sensitivity to infants and
children. Therefore, the FQPA Safety Factor was removed (reduced to IX) for captan and the
RfD equals the PAD.
The developmental endpoint in rabbits, with a NOAEL of 10 mg/kg/day, was selected for
the acute Reference Dose and the short- and intermediate-term dermal risk assessments. A three-
generation reproduction study in rats is the basis for the chronic RfD. The NOAEL in the study
was 12.5 mg/kg/day. Captan is severely irritating to the eyes and is classified in the Toxicity
Category I.
The Agency is aware of a proposed common mechanism of carcinogenicity between
captan and folpet, which implicates their common metabolite, thiophosgene. Because
thiophosgene is so highly reactive in animal systems, its residues cannot be scientifically
quantified. Without measurable residues of the common metabolite, it is difficult to relate
exposures of captan to those of folpet since the rate of thiophosgene formation may be different
for both compounds. The Agency has conducted a conservative aggregate assessment for
thiophosgene, assuming that it may cause cancer through both captan and folpet, and has
determined that this conservative risk is not of concern.
To determine the risk from captan in foods, the Agency conducted acute and chronic
dietary analyses. An acute probabilistic dietary risk assessment estimated that acute dietary
exposure to be 36% of the acute population adjusted dose (aPAD) at the 99.9th percentile.
Chronic dietary exposure was assessed using refinements such as anticipated residues and percent
crop treated information. The chronic non-cancer dietary risk from exposure to captan is <2% of
the chronic population adjusted dose (cPAD). The upper bound dietary cancer risk for the U.S.
population is 1.3 x 10"7, which is below the Agency's level of concern for lifetime excess cancer
risk. The Agency has also determined that there is no risk concern from the consumption of
captan residues in drinking water.
Residential exposure to captan may occur either during or after a captan application to
home gardens, ornamental flowers, shrubs, or seeds. Exposure may also occur to golfers from
treated golf courses. Because of concern about toddlers exposed to treated lawns, the technical
registrants have agreed to voluntarily cancel these uses. For all other residential uses, exposure
and risks do not exceed the Agency's level of concern.
The Agency has determined that acute and chronic dietary (food and water) and cancer
aggregate risks are not of concern. Residential exposure from the use of captan around the home
VI
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does not exceed the Agency's level of concern when aggregated with food and drinking water
exposure.
For occupational scenarios, most risk estimates were well above 100 (values below 100
are a concern for captan) with cancer risks ranging from 1.3 x 10"5 to 1.7 x 10"9. There is a
concern for mixers and loaders of wettable powder for the aerial application of captan. The
Agency believes that this risk will be adequately mitigated by requiring water soluble bags or a
suitable reduction in application rate. Reentry Intervals were also reevaluated during the RED
process and new REIs are being established ranging from 12- hours for seed treatment uses to 4-
days for ornamentals.
The Agency has reassessed captan food and feed tolerances under the standards of FQPA.
Because THPI was detected in plant metabolism studies at less than 10% of total residues, the
tolerance expression for plant commodities should remain as captan per se. Because captan is
extensively metabolized to TFDPI in animal tissues, the tolerance expression for captan residues in
animal commodities should include THPI as well as captan. Crop group tolerances are being
established for various groups of related vegetables. Many of these tolerances support seed
treatment only, as the foliar applications have not been permitted since the PD4 was issued in
1989. The crop subgroup tolerance for caneberries (raspberries and blackberries) is being
established to support Special Local Needs registrations in Oregon, Ohio, Pennsylvania, South
Carolina, and Washington.
Ecological Risks
For ecological risk, only acute toxicity to freshwater fish is of concern. The Agency is
requiring label modifications, including updated spray drift language, that are expected to mitigate
this risk. There are no reported fish kills. Additionally, the Agency has determined that captan is:
practically nontoxic to avian species, both on an acute and subacute basis; not acutely toxic to
mammals, and relatively nontoxic to insects. Terrestrial and aquatic plant toxicity is not a
concern. Both THPI and TUP Am were found to be non-toxic to fish species tested. The Agency
is requiring a 96 - hour oyster shell deposition study, however, these data are considered
confirmatory and are not expected to change the conclusions of this risk assessment.
For environmental fate concerns, captan dissipates rapidly, with a half-life of less than 1
day, determined by hydrolysis and soil aerobic studies. THPI and TUP Am are not expected to
persist in ground and surface water.
Risk Mitigation
To reduce the risks posed by captan, the Agency is requiring the following mitigation
measures for captan-containing products:
Voluntary cancellation of the residential turf use;
vn
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Water-soluble packaging for the wettable powder formulation used aerially
Various Personal Protective Equipment, including chemical-resistant gloves,
aprons/coveralls, eye protection, and dust/mist respirators;
Revised labeling to reduce the risks to non-target aquatic organisms;
Eye wash stations for occupational field workers; and
Double notification for workers entering treated fields.
Before reregistering the products containing captan, the Agency is requiring that product
specific data, revised Confidential Statements of Formula (CSF) and revised labeling be submitted
within eight months of the issuance of this document. These data include product chemistry for
each registration and acute toxicity testing. After reviewing these data and any revised labels and
finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a
product. Those products which contain other active ingredients will be eligible for reregi strati on
only when the other active ingredients are determined to be eligible for reregi strati on.
Vlll
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,
1984. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and the submission of data to fulfill the requirements. The fifth phase is a
review by the U.S. Environmental Protection Agency (referred to as "The Agency") of all data
submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredients are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-
170) was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately and EPA
initiated an intensive process, including consultation with registrants, States, and other interested
stakeholders, to make decisions on the new policies and procedures that will be appropriate as a
result of enactment of FQPA. This process will include a more in depth analysis of the new safety
standard and how it should be applied to both food and non-food use pesticides. The FQPA does
not, however, amend any of the existing reregistration deadlines set forth in §4 of FIFRA.
Therefore, in light of the unaffected statutory deadlines with respect to reregistration, the Agency
will continue its ongoing reregistration program while it continues to determine how best to
implement FQPA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of captan including the risk to infants and children for any potential dietary,
drinking water, dermal or oral exposures, and cumulative effects as stipulated under the FQPA.
The document consists of six sections. Section I is the introduction. Section II describes captan,
its uses, data requirements and regulatory history. Section III discusses the human health and
environmental assessment based on the data available to the Agency. Section IV presents the
reregistration decision for captan. Section V discusses the reregistration requirements for captan.
Finally, Section VI contains the Appendices that support this Reregistration Eligibility Decision.
Additional details concerning the Agency's review of applicable data are available upon request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregi strati on Eligibility Decision:
! Common Name: Captan
! Chemical Name: N-trichloromethylthio-4-cyclohexene-l,2-
dicarboximide
! Chemical Family: Dicarboximides
! CAS Registry Number: 133-06-2
! OPP Chemical Code: 081301
! Empirical Formula: C9H8C13NO2S
! Trade and Other Names: Merpan, Orthocide, Vondcaptan, Vancide-89, SR-
46
! Basic Manufacturer: Gustafson, LLC; Makhteshim-Agan of North
America; Drexel Chemical Co.; and Tom en Agro,
Inc.
B. Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods.
Type of Pesticide: Fungicide or antimicrobial pesticide
Use Sites: Variety of terrestrial food/feed crops, greenhouse food
crops, indoor food (fruit dips), indoor non-food (e.g.,
paints, adhesives, etc.), seed treatments and ornamental sites
Target Pests: Numerous fungi and microbials
Formulation Types: Dust (5 to 75%), emulsifiable concentrate (6 to 29%),
flowable concentrate (10 to 75%), ready-to-use liquid (14
to 30%), liquid soluble concentrate (12%), solid (62 to
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90%), water dispersible granules (75%), wettable powder
(6 to 80%), wettable powder/dust (5 to 50%)
Application Techniques: Applied at all phases of crop growth including: seed,
foliage, blossom, soil, fruit, dormant, dip, and post-harvest commodity treatment.
Also used in industrial applications as a bacteriostat.
Methods: Broadcast treatment, chemigation, dust, dip, and seed
treatment to soil and spot treatments
Equipment: Aerial equipment; airblast; chemigation equipment; dip tank;
drill box; duster; hand held duster; liquid seed treater;
paintbrush; paper bag; planter/seed box; power duster; seed
treater; slurry-type seed treater; spray-dip machine;
sprayers; squeeze applicator; tank; and tank-type sprayer
C. Estimated Usage of Pesticide
The table below summarizes the best available estimates for the pesticide uses of captan.
These estimates are derived from a variety of published and proprietary sources available to the
Agency. The data, reported on an aggregate and site (crop) basis, reflect annual fluctuations in
use patterns as well as the variability in using data from various information sources.
Domestic Foliar lisa
Site
Almonds
Apples
Apricots
Blackberries
Blueberries
(huckleberries)
Cherries, Sweet
Cherries, Tart
Dewberries
Grapes
Nectarines
Peaches
Plums
Acres
Grown
(000)
429
572
19
N/A
59
64
64
N/A
825
29
212
64
ge of Captan
Acres
Treated (000)
Wtd
Avg
80
270
4
N/A
36
8
18
N/A
40
3
86
8
Est
Max
112
376
8
N/A
41
12
28
N/A
100
8
118
16
% of Crop
Treated
Wtd
Avg
19%
47%
18%
N/A
61%
12%
28%
N/A
5%
10%
41%
13%
Est
Max
26%
66%
42%
N/A
69%
19%
44%
N/A
12%
27%
56%
25%
LB AI Applied
(000)
Wtd
Avg
300
2,000
13
N/A
250
18
62
N/A
100
13
550
32
Est
Max
382
3,600
30
N/A
495
40
120
N/A
250
29
692
61
Avg Rate of
Application
#app
/yr
1.2
4.3
1.0
N/A
3.7
1.9
3.2
N/A
2.1
1.3
3.6
1.0
Ibai/
A/app
3.2
1.7
3.7
N/A
1.9
1.2
1.1
N/A
1.2
3.2
1.8
3.8
States of Most Usage
(state and % ai used)
CA 100%
MI NY PA NC VT VA 59%
MI ME NJ 88%
MI OR 90%
NY MI 86%
CA NY AZ MO AR VA 83%
CA 100%
SC AL MI NJ PA AR 57%
MI CA 92%
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Site
Prunes
Raspberries
Strawberries
Total
Acres
Grown
(000)
80
11
50
Acres
Treated (000)
Wtd
Avg
25
7
31
616
Est
Max
44
8
45
915
% of Crop
Treated
Wtd
Avg
31%
62%
63%
Est
Max
55%
68%
89%
LB AI Applied
(000)
Wtd
Avg
93
36
540
4006
Est
Max
164
53
1,086
7000
Avg Rate of
Application
#app
/yr
1.2
3.1
8.2
Ibai/
A/app
3.2
1.6
2.1
States of Most Usage
(state and % ai used)
CA 100%
WA OR 93%
FLCAPA83%
Post Harvest
Apples
Cherries
Pears
-
N/A
-
-
N/A
-
-
N/A
-
11%
N/A
20%
22%
N/A
40%
3
N/A
0.2
-
N/A
-
-
N/A
-
-
N/A
-
SOURCES: EPA data (1987-97), USDA (1990-97), and National Center for Food and Agricultural Policy (1992 data). Tables exclude all uses that
have been cancelled as a result of the 1989 Special Review Decision.
COLUMN HEADINGS:
Weighted average is based on the most recent years, with more reliable data weighted more heavily
Estimated Maximum is estimated from available data.
Average application rates are calculated from the weighted averages.
NOTES ON TABLE DATA - Calculated numbers may not agree due to rounding to nearest 1000 for acres treated (0 acres =< 500) and to nearest
whole percentage for % of crop treated (0% = < 0.5%). Dash (-) indicates NOT available or insufficient data in EPA sources.
Seed Treatment - Usage of Captan in 1990
Seed Treated
Corn
Sweet corn
Beans
Peas
Potatoes
Soybeans
Sorghum
Peanuts
Cotton
Rice
Total Seed
% Seeds
Treated
100%
80%
80%
90%
11%
5%
100%
60%
50%
0%
Seed Treated
(million Ibs)
1,020
18
144
99
290
141
77
106
147
2.042
App Rate
Ib ai/1000 Ib seed
0.7
1.0
1.0
1.0
0.8
0.7
1.6
1.6
1.4
Applied
Ib ai (000)
714
18
144
99
246
98
123
170
206
-
1.818
Seeding Rate
Lb seed/Acre
14
16
60
220
2,000
60
7
102
24
-
Ib ai/Acre
on Seeds
0.01
0.02
0.06
0.22
1.70
0.04
0.01
0.16
0.03
0.00
Acres Planted
(000)
72,857
1,100
2,384
451
145
2,342
10,694
1,040
6,133
-
97.147
SOURCES: EPA data (1991)
D. Data Requirements
The Agency required the registrants to submit studies as specified in 40 CFR Section 158.
Data from these studies are sufficient to characterize the risks associated with the uses described
in this document. Appendix B includes all data requirements identified by the Agency for
currently registered uses needed to support reregi strati on.
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E. Regulatory History
Captan was first registered as a pesticide under the Federal Insecticide, Fungicide and
Rodenticide Act in 1951 for the control of fungal diseases of fruit crops. Prior to 1980, there
were many use-patterns registered and tolerances established for this broad spectrum fungicide.
Currently, there are 159 registered products (including 17 State and Local Needs) containing
captan.
In 1980, EPA published a Notice of Rebuttable Presumption because it had concluded that
there were adequate data to determine that captan could induce oncogenic effects in experimental
mammals (mice and rats). In addition, mutagenicity studies demonstrated that captan could cause
gene mutations in bacteria, in eukaryotic microorganisms and in mammalian cells in culture. The
public notice requested that registrants and other interested persons submit rebuttals and other
information on the presumption and to submit any other data on the risks and benefits of captan.
A DCI issued April 29, 1985 required the submission of residue chemistry and toxicology
studies. Subsequently, a proposed-decision was published (50 FR 25884), which was quickly
followed by a supporting document entitled, "Captan Special Review Position Document 2/3."
Based on cancer risks, it was proposed that all food-uses of captan be canceled and that all seed
treatments be retained. The proposal allowed time for additional residue chemistry data to be
submitted to refine the amount of residues used in the dietary assessments. The proposal also:
allowed the continued feeding of detreated corn seed to cattle and hogs, if fed at least fourteen
days prior to slaughter; required workers to wear dust masks and impermeable gloves when
applying, mixing or loading captan formulations; and required harvesters and weedpickers to wear
water-resistant gloves when working in fields or nurseries in which ornamentals have been treated
with captan formulations. For non-agricultural uses of captan, the Agency proposed that:
persons incorporating captan into products such as adhesives, plastics and paints wear
impermeable gloves, respirators and protective clothing; and labels be amended to require
impermeable gloves when applying oil-based paints for home or professional use.
In March, 1986, the Agency issued a Registration Standard for captan. The Registration
Standard summarized the data that had been submitted in support of the captan registration and
identified data gaps that needed to be addressed in order to reregister all captan pesticide
products. A 1988 Data Call-In Notice required the submission of a 90-day rat inhalation study
and a 90-day dermal study in rats.
In 1989, the Agency published the Position Document (PD4) to conclude the Special
Review of captan (54 FR 8116). This notice announced the conclusion of the Agency's Special
Review and risk/benefit analysis of captan registrations. EPA evaluated the issues raised in the
PD 2/3 and additional data received during the Special Review process. With this notice, the
Agency determined that the following uses of captan could remain: all non-food uses, seed
treatments, and a subset of the existing food uses (almonds, apples, apricots, blackberries,
blueberries, plant-bed for celery, cherries, dewberries, plant-bed for eggplant, grapes, lettuce,
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mangoes, nectarines, green onions, peaches, post-harvest on pears, plant-bed for peppers, plant-
bed for pimentos, plums/prunes, raspberries, plant-bed for spinach, taro, and plant-bed for
tomatoes). Some of these uses have been subsequently canceled by the registrants. The notice
also disallowed the use of captan on: avocados, beans, beets, broccoli, Brussels sprouts, cabbage,
canteloupes, carrots, cauliflower, celery (foliar), collards, corn (sweet), cotton, crabapples,
cranberries, cucumbers, eggplant (foliar), grapefruit, honeydew, kale, leeks, lemons, limes,
muskmelon, mustard greens, onions (dry bulb), oranges, pears (pre-harvest), peas, peppers
(foliar), pimentos (foliar), pineapple, potatoes, pumpkin, quince, rhubarb, rutabagas, shallots,
soybeans, squash, tangerines/tangelos, tomatoes (foliar), turnips, and watermelon.
Later in 1989, the Agency issued a proposed rule (54 FR 35891) to revoke the feed
additive regulation (40 CFR 186.500). The final rule revoking the tolerances was published on
August 4, 1993 (58 CFR 1430-2). Additional tolerances were revoked on January 25, 1999 (63
FR 57067-77)
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The product chemistry data base for captan is incomplete. To maintain continued
registration of captan following issuance of the RED, the product chemistry data gaps identified in
Appendix B must be fulfilled. These data are considered confirmatory and are not expected to
change the conclusions of this risk assessment.
1. Identification of the Active Ingredient
Captan [(N-trichloromethylthio-4-cyclohexene-l,2-dicarboximide) (trade names: Merpan,
Orthocide, Vondcaptan, Vancide-89 and SR-46)] belongs to the chemical class of dicarboximides
or chlorinated organosulfur compounds.
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ecu
Captan
Empirical Formula:
Molecular Weight:
CAS Registry No.:
PC Code:
IUPAC Name:
THPI (Captan metabolite)
C9H8C13NO2S Molecular Weight: 151.16
300.61 Empirical Formula: C8N9O2
133-06-2
081301
1,2,3,6-tetrahydro-N-(trichloromethylthio)phthalimide
Pure captan is a colorless crystalline solid with a melting point of 178° C; a vapor pressure
of <1.3 mPa at 25°C; and an octanol/water partition coefficient of 610 at 25°C.
Solubility of captan in water is 3.3 mg/1 at 25 °C and it is soluble in acetone, ethyl alcohol,
kerosene, xylene, chloroform, and benzene.
2. Manufacturing-Use Products
There are nine manufacturing-use products registered at this time: an 88% formulation
intermediate and an 88% technical (19713-258, 19713-500) registered to Drexel Chemical
Company; an 88% technical registered to Gustafson, Inc. (7501-24); an 88% technical registered
to Makhteshim-Agan of North America Inc. (11678-1); three 88% technicals and an 87%
formulation intermediate registered to Tomen Agro, Inc. (66330-31, 66330-32, 66330-33 and
66330-34, respectively), and an 88% formulation intermediate registered to Sostram (72304-3).
Both Tomen Agro, Inc. and Makhteshim-Agan are members of the Captan Stewardship Task
Force.
B. Human Health Assessment
1. Toxicology Assessment
The toxicology database is adequate to assess health hazards resulting from exposure to
captan. In acute toxicity studies, captan is not toxic via the oral route, and has low toxicity via
the dermal and inhalation routes. Captan is severely irritating to the eyes. Repeated dose toxicity
studies (e.g. 21-day dermal, 90-day subchronic inhalation and chronic oral) indicate that
thiophosgene causes local irritation of the skin, larynx or lining of the gastrointestinal (GI) tract
depending upon the site where it is generated.
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In chronic studies, captan causes cancer in mice and rats. The Agency has classified
captan as a B2 (probable human) carcinogen, based on an increased incidence of intestinal tumors
in mice. It also caused an increased incidence of renal neoplasms in male Charles River CD rats
and an increased incidence of uterine sarcomas in Wistar rats. A Qx* approach is used for cancer
risk assessment.
Captan is a member of the N-trihalomethylthio group of compounds (including folpet)
which metabolize to the highly reactive species thiophosgene. Much of the observed toxicity of
captan can be explained by the release of thiophosgene, which is a highly reactive, short-lived
metabolite. Thiophosgene is likely responsible for the irritant properties of captan and may be
responsible for the intestinal tumors in mice, although its exact mode of action is unclear.
Because of rapid metabolism of captan and high reactivity of its thiophosgene metabolite, these
chemicals are unlikely to accumulate in the body.
At doses that are maternally toxic, captan causes developmental effects in experimental
animals producing delayed ossification and post-implantation loss in hamsters, and increases in
skeletal defects in rabbits. At doses that are toxic to the parent, captan causes decreased pup
litter weights in a reproduction study.
a. Toxicology Endpoint Selection
The Agency has established toxicological endpoints for acute and chronic dietary, as well
as occupational and residential (dermal and inhalation) exposure risk assessments for captan. The
selection of these toxicological endpoints is based on a comprehensive evaluation of the available
toxicology data as well as the use pattern/exposure profile for captan.
For deriving the acute Reference Dose (RfD), the Agency selected the developmental
NOAEL of 10 mg/kg/day from the prenatal developmental toxicity study in rabbits. This
endpoint was selected because it is thought that the observed developmental effects could occur
following a single exposure, however, since these effects can occur only in utero, they are
applicable only to the acute risk assessment for females (ages 13-50). Following a review of the
available toxicology database, the Agency did not identify any other ex utero toxicological
endpoint that could be attributed to a single exposure of captan. This review included
consideration of the maternal effects noted in the developmental toxicity studies; however, the
maternal effects noted in these studies (mortality, decreased body weight and food consumption)
were not attributed to a single dose of captan. Therefore, no separate acute endpoint was
selected for the general population, which includes infants and children. Thus, a risk assessment
was conducted only for the females (13 - 50).
The developmental endpoint in rabbits, with a NOAEL of 10 mg/kg/day, was also selected
for the short- and intermediate-term dermal risk assessments. The 21-day dermal toxicity study in
rabbits was not selected for these risk assessments, even though it is the most appropriate route of
exposure. In this study, repeated dermal application of captan caused dermal irritation, but only
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minimal systemic effects (reductions in body weight, body weight gain, and food consumption) at
a dermal dose of 1000 mg/kg/day, with a systemic NOAEL of 110 mg/kg/day. However, effects
on fetuses are not investigated in a guideline 21-day dermal toxicity study. Thus, because of the
potential for occupational or residential dermal exposure to pregnant women, the more
conservative NOAEL from the oral developmental toxicity study in rabbits was considered
appropriate for the short- and intermediate-term dermal risk assessments.
Summary of Doses and Endpoints Selected for Captan Risk Assessments
Exposure
Scenario
Acute Dietary
Female 13+
Chronic Dietary
Dose
(mg/kg/day)
NOAEL=10
UF = 100
FQPA = 1
Endpoint
30 mg/kg/day based on increased
skeletal defects (27 pre-sacral
vertebrae) in fetuses. Applies to
females 13+ only; no appropriate
endpoint for general population.
Study
Developmental
Toxicity Study in
Rabbits
Acute RfD=aPAD = 0.1 mg/kg/day
NOAEL=12.5
UF = 100
FQPA = 1
25 mg/kg/day based on decreased pup
body weight
One- and three-
generation repro
Studies-Rat
Chronic RfD = cPAD = 0.13 mg/kg/day
Correction for oral to dermal exposure necessary (0.4% per hour; dermal absorption factor)
Short- and
Intermediate-Term
(Dermal)
Long-Term (Dermal)
Oral
NOAEL=10
UF = 100
None
30 mg/kg/day based on increased
skeletal defects (27 pre-sacral
vertebrae)
Use pattern and exposure indicate no
need for long-term risk assessment
Developmental
Toxicity Study in
Rabbits
Use 100% lung absorption relative to oral absorption
All Durations
(Inhalation)
Qi*
Oral
NOAEL=10
UF = 100
2.4 x 10-3
30 mg/kg/day based on increased
skeletal defects (27 pre-sacral
vertebrae)
Based on findings of intestinal tumors
in mice
Developmental
Toxicity Study in
Rabbits
Mouse
Oncogenicity
(1) Reference and Population Adjusted Doses
As indicated earlier, the Agency is establishing an acute Reference Dose (RfD) of 0.1
mg/kg/day, based on a NOAEL of 10 mg/kg/day from a developmental study in rabbits. In this
study, post-implantation loss, reduced mean fetal weight, and increased skeletal defects in fetuses
were observed at 30 mg/kg/day. This dose reflects application to the NOAEL of an uncertainty
factor of lOOx to account for interspecies extrapolation and intraspecies variability. The acute
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RfD is appropriate for assessing acute dietary risk for females 13-50 years only. No acute RfD is
needed to assess dietary risks for other population subgroups, as no other acute dosing toxicity
study showed any other effects.
A three-generation reproduction study in rats is the basis for the chronic RfD. The
NOAEL in the study was 12.5 mg/kg/day, based on decreased mean litter weights at the next
higher dose level of 25 mg/kg/day. The chronic RfD of 0.13 mg/kg/day is obtained by application
of an uncertainty factor of 100 for interspecies and intraspecies variability.
Although the NOAEL chosen for the chronic RfD is slightly greater than the NOAEL
chosen for the acute RfD; the endpoints are similar when considering the spacing of the dosages
of the two studies and the fact that the two studies used different species. For practical purposes,
the numbers (10 versus 12.5 mg/kg/day) are considered numerically equivalent; therefore, no
attempt was made to adjust either the acute or chronic RfD to accommodate differences in
exposure duration.
The population adjusted dose (PAD) refers to an RfD which has been adjusted to take into
account the FQPA safety factor. The RfD is calculated by dividing the NOAEL by the
uncertainty factors. Numerically, the PAD is defined as the RfD divided by the FQPA safety
factor. For captan, the RfD equals the PAD, since the safety factor is IX.
To estimate human cancer risks, the Agency recommended a linear, low dose
extrapolation approach for captan. Based on intestinal tumors in mice and using a (body
weight)374 scaling factor, a Ql* of 2.4x10"3 (mg/kg/day)"1 was calculated.
(2) Studies Used to Support the Endpoint Selection
Developmental Toxicity in Rabbits (MRTD 41826901)
In a developmental toxicity study, 20 New Zealand White rabbits per dose group received
either 10, 30, or 100 mg captan/kg/day by oral gavage from gestation days 7 through 19.
Maternal NOAEL/LOAEL were considered to be 10 and 30 mg/kg/day, based upon
reduced body weight gain, decreased food consumption and anorexia. Developmental
NOAEL/LOAEL were considered to be 10 and 30 mg/kg/day, based upon increased
skeletal defects (27 pre-sacral vertebrae) in fetuses at 30 mg/kg/day. There was increased
post-implantation loss, reduced mean fetal weight, and altered growth at 100 mg/kg/day.
The endpoints selected are based on the developmental toxicity NOAEL of 10 mg/kg/day
with increased skeletal defects observed at 30 mg/kg/day.
10
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One- and Three-generation Reproductive Studies in Rats (MRIDs 00120315 and
00125293)
In both studies, captan was tested in COBS CD rats. In the one-generation study, captan
was tested at 6, 12.5 or 25 mg/kg/day. This study showed no effects on parents or pups
at 6, 12.5 or 25 mg/kg/day. The NOAEL for pups was determined to be 12.5 mg/kg/day
as a more protective endpoint for pups.
In the three-generation study, captan was tested at 25, 100, 250 or 500 mg/kg/day. The
maternal toxicity NOAEL and LOAEL were considered to be 12.5 and 25 mg/kg/day,
respectively, based on decreased body weight gain and food consumption. The offspring
toxicity NOAEL and LOAEL were considered to be 12.5 and 25 mg/kg/day, respectively,
based on decreased pup and litter weights. Pup survival was reduced at 250 mg/kg/day
and higher dose levels. Parental toxicity was observed at 100, 250 and 500 mg/kg/day,
which indicated a NOAEL of 25 mg/kg/day.
The endpoints selected are based on the NOAEL of 12.5 mg/kg/day with decreased mean
litter weights observed at the next higher dose level of 25 mg/kg/day. The one- and three-
generation studies are acceptable together and the two studies also show that pups and
parents are equally sensitive.
Oncogenicitv Rat (MRIDs 00120316. 00129157. 00129163. 00129164. 00153207)
Two carcinogenicity studies were performed on rats. In the first study, Charles River CD
strain rats were fed diets containing 0, 25, 100 or 250 mg/kg/day of captan for 2 years.
The NOAEL for systemic effects was 25 mg/kg/day. At the LOAEL of 100 mg/kg/day,
males displayed: hepatocellular hypertrophy; increased relative organ weight for kidneys
(males and females); increased relative organ weight for heart, brain, liver and
thyroid/parathyroid (males) and decreased body weight. At the same dosage, females
displayed: increased relative organ weight for kidneys and decreased body weight. There
was a significant increasing trend in males for the combined adenomas and carcinomas of
the kidney in male rats. There was no increased incidence of renal cortical/tubular cell
neoplasia in females.
In another carcinogenicity feeding study, Wistar rats were fed diets containing 0, 6.25, 24
or 98 mg/kg/day of captan for 30 months. The NOAEL/LOAEL for systemic toxicity
were at least 98 mg/kg/day. There was no increase in the incidence of renal
cortical/tubular cell neoplasms. There was a slight but statistically significant increase in
uterine sarcomas in the high dose group.
11
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Oncogenicity Mouse (MRIDs None and 00068076)
Three carcinogenicity studies were performed on mice. In the first study, B6C3F1 mice
were fed diets containing 0, 900, and 2,400 mg/kg/day of captan for 80 weeks followed by
no treatment for 33 weeks. The NOAEL for systemic toxicity was 900 mg/kg/day and the
LOAEL for systemic toxicity was 2400 mg/kg/day based on decreased mean body weight.
Male and female mice had an increased incidence of combined duodenal adenoma/polyps
or adenocarcinomas at 2400 mg/kg/day, with the first reported tumor at 91 weeks. There
was a minimal increase in hyperplasia of the duodenal mucosa noted in the high dose
males (National Cancer Institute, 1977. Bioassay of Captan for Possible Carcinogenicity.
Technical Report Series No. 15).
In a second study, ICR derived CD-I Charles River mice were initially fed diets containing
0, 2000, 6000 or 10000 ppm of captan for 4 weeks. Subsequently captan concentrations
were increased to 0, 6000, 10000 or 16000 ppm (900, 1500 or 2400 mg/kg/day for
females and 900, 1000 or 2400 mg/kg/day for males) for the remainder of the study. The
NOAEL for systemic toxicity was not established. The LOAEL for systemic toxicity was
6000 ppm, the lowest dose tested, based on decreased body weight gain and food
consumption (no quantitative information was available). There was an increased
incidence of small intestinal (primarily duodenal) adenomas/polyps and carcinomas at all
dose levels. A positive dose-related trend for an increased incidence of duodenal tumors
in both sexes was also observed. Proliferative duodenal changes appeared to occur earlier
in the high-dose males. There was also a statistically significant increase in gastric and
duodenal hyperplasia in both sexes and in jejunal hyperplasia in females. This study
satisfies the toxicological data requirement for a carcinogenicity study [83-2 (b)] in mice.
In a third study, Charles River CD-I mice were fed diets containing 0, 15, 60, 120, or 900
mg/kg/day and the study was terminated at 22 months due to increased mortality in the
high-dose males. The NOAEL for systemic toxicity was 120 mg/kg/day and the LOAEL
for systemic toxicity was 900 mg/kg/day based on increased mortality in males and
reduced weight gain throughout the study in both sexes. There was a small increase in
small intestinal tumors (benign and malignant) in the male and female high-dose groups.
The results of an Agency audit of this study suggested that there was a problem with
achieving and maintaining the appropriate dose levels throughout the study. (MRTD
00126845)
Using Oral Studies to Approximate Dermal and Inhalation Dosing
Oral endpoints are used for all risk assessments. These assessments assume that captan is
absorbed through the skin at 0.4% per hour of the dosage that would be absorbed orally during
the same time period. The assessments also assume that captan is taken up through the inhalation
pathway to the same degree as oral ingestion; i.e., this standard assumption indicates that
absorption by the inhalation and oral routes are considered to be equivalent.
12
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b. Acute Toxicity
Acute toxicity values and categories for captan are summarized in the following table:
Overview of Acute Toxicity
Guideline
81-1
81-2
81-3
81-4*
81-5*
81-6*
Test
Oral LD50 - rat
Dermal LD50 - rat
Inhalation LC50 - rat
Eye Irritation - rabbit
Dermal Irritation -
rabbit
Dermal Sensitization -
guinea pig
MRID
00054789**
40021401**
00148070**
00128621
40021401
00054791
Results
LD.,o = 9 g/kg (M)
LD.,o > 2 g/kg
LC50 = 0.72 mg/L (M)
LC50 = 0.87 mg/L (F)
Irreversible corneal opacity
at 21 days in unwashed eyes
Not an irritant at 3 days
Moderate skin sensitizer
Category
IV
III
III
I
IV
N/A
Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization are not
required to support reregistration of the active ingredient. Data are presented for information
purposes.
The acute toxicity endpoints, listed above, are for informational purposes only. The data
supporting these endpoints do not meet current acceptability criteria. The acceptability status of
these data may be reassessed during product reregistration.
c. Chronic Toxicity/Carcinogenicity
For human cancer risk assessment, the Agency recommended a linear, low dose
extrapolation approach for captan. Based on intestinal tumors in mice, a Qt* of 2.4xlO"3
(mg/kg/day)"1 was calculated.
The Agency has classified captan as a B2 (probable human) carcinogen based on an
increased incidence of intestinal tumors in mice. Captan was also found to have caused an
increased incidence of renal neoplasms in male Charles River CD rats and an increased incidence
of uterine sarcomas in Wistar rats.
The Captan Task Force has submitted several mechanism studies for captan. The Agency
has reviewed these studies and determined that they do not contribute any additional information
to the mode of action nor have any bearing on the cancer risk assessment. Similar mechanistic
type studies have been reviewed and considered by the Agency for folpet which has a common
metabolite, thiophosgene, with captan. Following review of these data, the Agency reaffirmed its
decision and that the linear low dose extrapolation model should continue to be used for risk
13
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assessment. Therefore, a reconsideration for captan according to the 1996 Draft Cancer Risk
Assessment guidelines was not required.
d. Metabolism
The Agency evaluated the metabolism of captan based on several studies. A rat
metabolism study evaluated the breakdown of captan in mammalian species. Two plant, one
lettuce and one tomato, metabolism studies determined how parent captan is metabolized by
crops. In addition, two animal metabolism studies, one poultry and one ruminant, determined
what metabolites may be present in animals that have consumed captan-treated forage and feed
products.
The first step in the metabolism of captan is the cleavage of captan's N-S bond to form
tetrahydrophthalimide (THPI) and a derivative of the trichloromethylthio side chain. This
cleavage frequently occurs in the GI tract, though it may also occur in the blood. THPI and the
trichloromethylthio side chain are each further metabolized through independent pathways.
For the pathway involving the trichloromethylthio side chain group, four metabolites are
formed, including the highly reactive species thiophosgene. Although much of the toxicity of
captan is attributed to thiophosgene, this moiety is not likely to be found in tissues due to its short
half-life, and therefore, captan is regulated as the parent compound itself.
For the THPI pathway, a total of 7 metabolites are formed. Unlike thiophosgene, THPI is
stable enough to be found in total captan residues. Heretofore, the tolerance expression for
captan for all commodities has included only the parent compound. Because captan is extensively
metabolized to THPI in animal tissues, the tolerance expression for captan residues in animal
commodities should include THPI as well as captan. Since THPI comprises less than 10% of the
total captan residue for plants (based on metabolism studies), the tolerance expression in plant
RACs and processed commodities should remain as captan per se.
For purposes of non-cancer dietary risk assessment, the combined residues of captan and
THPI are considered to comprise the residue of concern. For purposes of carcinogenic risk
assessment, only parent captan is considered since the carcinogenicity of captan is believed to be
associated with the reactive thiophosgene moiety.
2. Dose Response Assessment
a. Special Sensitivity of Infants and Children (FQPA Safety
Factor)
FQPA directs the Agency to "ensure that there is a reasonable certainty that no harm will
result to infants and children" from aggregate exposure to a pesticide chemical residue in setting
and reassessing tolerances. The law further states that in the case of threshold effects, for
14
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purposes of providing this reasonable certainty of no harm, "an additional tenfold margin of safety
for the pesticide chemical residue and other sources of exposure shall be applied for infants and
children to take into account potential pre- and post-natal toxicity and completeness of the data
with respect to exposure and toxicity to infants and children. Notwithstanding such requirement
for an additional margin of safety, the Administrator may use a different margin of safety for the
pesticide residue only if, on the basis of reliable data, such margin will be safe for infants and
children."
In determining what safety factor is appropriate for assessing risks to infants and children,
EPA considers all available reliable data and makes a decision using a weight-of-evidence
approach. This approach takes into account the completeness and adequacy of the toxicity and
exposure data bases, the nature and severity of the effects observed in pre- and post-natal studies,
and other information such as epidemiological data.
There are no data gaps for the assessment of the effects of captan following in utero
and/or postnatal exposure. Prenatal developmental toxicity studies in hamsters and rabbits, and
two reproduction studies in rats (a one-generation and a three-generation study considered
together) were submitted in support of captan reregi strati on and were judged to be acceptable.
The Agency has determined, based on a weight-of-the-evidence review of the available data, a
developmental neurotoxicity study is not required for captan.
The available studies demonstrated no indication of increased quantitative or qualitative
sensitivity of rats, rabbits or hamsters to in utero and/or postnatal exposure to captan. In the
prenatal developmental toxicity study in hamsters, delayed ossification and postimplantation loss
occurred at 400 mg/kg/day (the developmental LOAEL), while in dams, decreased body weight
and mortality were observed at a LOAEL of 200 mg/kg/day. The developmental NOAELs for
maternal and developmental toxicity in the prenatal developmental hamster study were 50 and 200
mg/kg/day, respectively. In the prenatal developmental toxicity study in rabbits, the maternal and
developmental NOAELs were equivalent (10 mg/kg/day). Fetal findings (an increase in 27th
presacral vertebrae, a skeletal variation) were observed at the same dose level (30 mg/kg/day)
which caused maternal anorexia and decreased food consumption and a decrease of over 128g in
mean maternal body weight. In combined results of the one- and three-generation reproduction
studies in rats, both parental and offspring LOAELs were established based upon decreased body
weight at 25 mg/kg/day.
The selection of a developmental endpoint for risk assessment, has no bearing on the
conclusion that captain does not cause an increased susceptibility in the developmental studies.
Assessment of increased susceptibility is based on the evaluation of both the quantitative and
qualitative aspects of the effects seen in the fetuses in relation to those seen in the dams (i.e.,
whether the developmental findings were seen in the presence or absence of maternal toxicity, and
whether the observations in dams and fetuses indicate, for example, differential severity of toxicity
or the potential for long-term consequences). The acute nature of developmental effects observed
15
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at a maternally toxic dose are attributable to the life stage of the organism; i.e., that the fetus is
undergoing a unique period of rapid cellular differentiation, proliferation, and organization.
In summary, the results of these studies demonstrated that toxicity to the offspring
occurred at equivalent or higher doses than parental toxicity, indicating that there is no
quantitative susceptibility. Additionally, a comparison of the treatment-related findings in the
adult animals and in their offspring, as described, did not indicate a qualitative difference in the
relative severity of the response to treatment by the offspring following perinatal exposure at the
LOAELs. Therefore, the Agency has determined that the 10X factor for enhanced sensitivity to
infants and children (as required by FQPA) for captan should be removed (reduced to IX).
Exposure methodologies were not found to indicate a concern for potential risk to infants
and children. This determination was based on the following information: 1) the dietary exposure
assessment for captan is a refined, realistic estimate of what is likely to be consumed; 2) captan
residues are primarily surface residues and are likely to be removed by peeling, washing, and
cooking; 3) the models used to assess drinking water exposure to captan are considered to
provide realistic but somewhat conservative estimates; and 4) although some assumptions used in
the residential exposure models are modified to better reflect the use patterns of captan in the
home, the result is likely an over-estimate of exposure.
3. Dietary Risk and Exposure From Food
a. Summary of Residue Data Requirements
All data requirements for magnitude of the residue in plants have been evaluated. All data
are adequate to reassess captan tolerances in light of canceled and revised uses. Field data on
fruit and nut orchard crops and grapes are available reflecting multiple foliar applications of
wettable powder, flowable concentrate, or dry flowable formulations with appropriate PHIs and
geographic representation. Data on postharvest fruit dip are available for apples, cherries, and
pears. Data from seed treatments using the wettable powder, flowable concentrate and dust
formulations on representative crop seed and potato seed-pieces indicate that these uses will not
result in detectable residues of captan in/on edible commodities.
All magnitude of the residue in processed food/feed data have been evaluated and deemed
adequate to determine the extent to which residues concentrate in food/feed items upon
processing of the raw agricultural commodity. Data pertaining to reduction of captan residues on
plant commodities were submitted in response to the Special Review of captan. Studies
conducted on apples, cantaloupe, cucumbers, grapefruit, lemons, lettuce, oranges, squash,
strawberries, and spinach indicate that residues are substantially reduced by washing and are
almost non-detectable after peeling. Cooking studies on celery, cucumbers, squash, and spinach
indicate that residues of captan are almost non-detectable after cooking, with a corresponding
increase in the THPI residues.
16
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Adequate methodology is available for enforcement of tolerance residues of captanper se
in/on plant commodities. A GC/electron capture detection (EC) method included in PAM, Vol. II
as Method I is the preferred enforcement method. Other methods in PAM Vol. II that use
colorimetry to analyze surface residues from plant tissues are not acceptable. THPI is completely
recovered through Protocol D, but not through Protocol E (PESTDATA, PAM, Vol. 1,
Appendix, 8/93).
b. Summary of Risks from Food
The Agency has conducted three separate dietary analyses to determine the risk from
captan in foods on an acute, chronic (non-cancer), and chronic (cancer) basis. Commodities with
canceled registrations or for registrations for which tolerances have been recommended for
revocation were not included in any of the analyses. Residues of captan plus the metabolite THPI
were included in the anticipated residues for chronic (non-cancer) exposure and acute exposure in
meat and milk. Because the metabolite THPI is not considered carcinogenic, the cancer risk
assessment was conducted using only the residues of captanper se.
To assess acute dietary exposure, the Agency conducted an acute probabilistic dietary
(food) exposure analysis using the Dietary Exposure Evaluation Model (DEEM ). Residues in
food items were estimated using residue field trials, USDA/PDP and FDA pesticide monitoring
data, and reduction/concentration factors when available. The acute analysis evaluated the dietary
exposure based on individual consumption data from USDA's 1989-1992 Nationwide Continuing
Surveys for Food Intake by Individuals (CSFII). For acute assessment, exposure was compared
to the acute population adjusted dose (aPAD). The acute probabilistic dietary risk for captan is
below the Agency's level of concern. Dietary exposure for females 13-50 years at the 99.9th
percentile is 36% of the aPAD.
TM
To assess chronic dietary exposure, a DEEM chronic exposure analysis was performed
using anticipated residues and percent of crop treated information to estimate the anticipated
residue contribution (ARC) for the general U.S. population and 22 subgroups. For the chronic
(non-cancer) assessment, exposure was compared to the chronic population adjusted dose
(cPAD). The chronic non-cancer dietary risk from exposure to captan does not exceed the
Agency's level of concern, with all population subgroups having exposure values <2% of the
cPAD. To the extent that this analysis uses anticipated residues, percent-crop-treated information
and not published (recommended) tolerances, it is not a "worst-case" picture of the chronic
dietary exposure to captan.
The dietary cancer risk does not exceed the Agency's level of concern. The upper bound
dietary cancer risk for the U.S. population was estimated to be 1.3 x 10"7 from all food uses of
captan supported for reregi strati on. The upper bound cancer risk from captan is below the level
that the Agency generally considers a concern for excess lifetime cancer risk.
17
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Summary of Dietary Risks
Risk Type
Chronic
Cancer1
Acute
Population
Anticipated Residue
Contribution
U.S. Population
Infants
U.S. Population
Females 13-50 (99.9th percentile)
Exposure
(mg/kg/day)
0.000664
0.001629
0.00005
0.036
% PAD or
cancer risk
0.5% of cP AD
1.3%ofcPAD
1.3 x 10-7
36% aPAD
1 Based on the Q/ of 2.4 x 10'3 (mg/kg/day)'1.
The acute dietary risk assessment for captan used the latest percent crop treated, revised
anticipated residues, average residues from field trial data and/or monitoring data, and residue
reduction/concentration upon processing. The acute probabilistic dietary risk for captan is below
the Agency's level of concern (% Population Adjusted Dose <100%) for the Females 13 - 50
subgroups at the 99.9th percentile of exposure.
c. Dietary Exposure from Drinking Water
To assess the risk posed to human health from consumption of water containing captan
residues, the Agency conducted three separate risk assessments to account for acute, chronic
(non-cancer) and chronic (cancer) exposure. Each of these assessments used identical estimates
for the expected concentration of captan in drinking water from both surface and groundwater
sources. Based on these assessments, the Agency has determined that the consumption of
drinking water containing residues of captan is not a concern.
Groundwater
The Agency has modeled groundwater resources using SCI-GROW. SCI-GROW is
based on the fate properties of the pesticide, the application rate, and the existing body of data
from small-scale ground water monitoring studies. Since the model assumes that the pesticide is
applied at its maximum rate in areas where the ground-water is particularly vulnerable to
contamination, the estimated maximum concentration derived using SCI-GROW should be
considered a high-end to bounding the estimate of acute exposure.
The SCI-GROW model (ver. 2.0) predicts that groundwater concentrations of captan and
THPI residues are not likely to exceed 3.4 jig/L. The SCI-GROW estimate was based on the
maximum captan application rate of 32 Ibs ai/A per year (8 applications of 4 Ibs ai/A, 8
applications of 2.26 Ib ai/A for THPI), aerobic soil metabolism half life of 1.3 days (an average
half life of 10.7 days for THPI), and a Koc value of 200 mL/g (2.2 mL/g for THPI).
18
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Surface Water
Due to the range of field dissipation half-lives (2.5 to 24 days), substantial amounts of
captan could be available for runoff to surface waters for a few days to several weeks post-
application. Most captan runoff is expected to occur via dissolution in runoff water as opposed to
adsorption to eroding soil. Based on its environmental fate properties, captan should not persist
in surface waters under most hydrological or chemical conditions.
The major captan degradate of toxicological concern, THPI, exhibits low soil/water
partitioning (Kd values < 1), indicating that most runoff will occur via dissolution in runoff water
as opposed to adsorption to eroding soil. THPI degrades at rates comparable to those of captan
(relatively rapidly) under aerobic conditions.
The State of Illinois (Moyer and Cross 1990) sampled 30 surface water sites for pesticides
at various times from October 1985 through October 1988. Captan was included in the analyses
because of its substantial use in Illinois. Total (dissolved and adsorbed to suspended sediment)
captan was not detected above a detection limit of 0.05 ug/L in any of 580 samples collected from
the 30 sites sampled.
The Agency also used computer modeling (PRZM-EXAMS) to estimate captan residues
at a single surface water site over multiple years. Based on the model predictions and the
environmental fate characteristics of THPI, the Agency predicts that THPI will reach drinking
water from the current use pattern. Each site represents reasonably high exposure and was
simulated over 36 years. The Agency recommends that 668 ppb be considered as a conservative
estimate for acute surface drinking water levels of THPI. The average chronic level for 365 days
(1 year) is 10.8 ppb.
The Tier 2 estimated environmental concentration (EEC) for captan is 4 ppb for peaches
90-days after application. Since THPI is not considered a carcinogen, surface and ground water
EECs (4 ppb and 0.02 ppb, respectively) for captan per se will be compared to the cancer
DWLOC for captan.
DWLOCs for Acute Exposure
Acute DWLOCs were calculated based on acute dietary (food) exposure and standard
body weights and water consumption figures. These standard values are: 70kg/2L/day (adult
male), 60 kg/2L/day (adult female), and 10 kg/L/day (child). To calculate the DWLOC, the acute
dietary food exposure was subtracted from the acute PAD using the equation:
DWLOCacute Cwg/L) = [acute water exposure (mg/kg/day) x body weight(kg)].
[consumption (L/day) x 10"3 mg///g]
where acute water exposure (mg/kg/day) = [aPAD - acute food (mg/kg/day)].
19
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These calculations resulted in the following values:
Acute Exposure and DWLOC
Population
Subgroup
Females 13-50
Aprte PAD
tmgVkgfday)
0.1
Food
Exposure
f - /•
(mg/kgfday)
0.036
Water
Exposure
(ing/kg/day)
0.064
DWLOeacute
/
-------
[IxlO'6 - 1.3 xlO'7] x 70kg/2L/day x 103 jig'mg = 13 = DWLOCcancer
2.4xlO-3(mg/kg/day)-1
Using conservative dietary exposure values and a conservative equation (male
consumption is greatest among the three, hence the greatest exposure is expected) a resulting 13
ppb drinking level of comparison is greater than all the model drinking number values generated
for chronic scenarios for both ground and surface water (0.02 ppb and 4.0 ppb respectively.).
Drinking water with dietary consumption is not a concern for purposes of this risk assessment.
d. Occupational Handlers Risk and Exposure
Occupational exposure to captan residues via dermal and inhalation routes can occur
during handling, mixing, loading, and applying activities. Postapplication occupational dermal
exposure is expected during harvesting and scouting activities.
Based on the toxicological criteria and potential for exposure, the Agency has conducted
dermal and inhalation exposure assessments for the occupational handler. In addition, the Agency
has conducted a postapplication dermal exposure assessment for occupational uses.
(1) Scenarios/Assumptions in Occupational Assessment
The Agency has identified 14 exposure scenarios to represent occupational handler
exposure during mixing, loading, and applying captan to agricultural crops and non-agricultural
use sites. These occupational scenarios reflect a broad range of application equipment,
application methods, and use sites. The scenarios were classified as short-term (1-7 days) and
intermediate-term (1 week to several months) based primarily on the frequency of exposure. A
long-term exposure duration is not expected.
The Agency's first step in performing a handler exposure assessment is to complete a
baseline exposure assessment. The baseline scenario generally represents a handler wearing long
pants, a long-sleeved shirt, shoes, socks and no chemical-resistant gloves. If the level of concern
is met or exceeded, then increasing levels of risk mitigation, such as PPE (personal protective
equipment) and engineering controls, are used to recalculate the MOEs until exposure is
sufficiently reduced to achieve an appropriate margin of exposure.
Exposure for all captan use scenarios (except for potato seed piece treatment and potato
planting) was developed using the Pesticide Handlers Exposure Database (PHED) Version 1.1.
The PHED was developed by Health Canada, The American Crop Protection Association, and
EPA. PHED was initially released for public use in 1992. PHED is a generic/surrogate exposure
database containing a large number of measured values of dermal and inhalation exposure for
pesticide workers (e.g., mixers, loaders, and applicators) involved in handling and applying
pesticides. The database currently contains data for over 2000 monitored exposure events. Use
of surrogate or generic data is appropriate since it is generally believed that the physical
21
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parameters of the handling and application process (e.g., the type of formulation used, the method
of application, and the type of clothing worn), not the chemical properties of the pesticide, control
the amount of dermal and inhalation exposure. Thus, PHED typically allows exposure and risk
assessments to be conducted with a much larger number of observations than are normally
available from a single exposure study.
The dermal unit exposures from PHED are reported as the best fit mean to simulate
workers wearing long pants, long-sleeved shirts, shoes, socks and chemical-resistant gloves,
unless noted. The best fit mean is the composite total dermal exposure based on using the
geometric mean for lognormal distributed data, arithmetic mean for normal distributed data, and
the median for all other distribution types. The inhalation exposure values are reported as
geometric means (lognormal distributions), unless otherwise noted. For mixer/loaders of wettable
powder formulations, an 80% protection factor was included to account for use of dust/mist
respirators.
Seed and Seed-piece Treatment
The Agency is addressing two occupational exposure scenarios associated with the seed
and seed-piece treatment use:
1. Bulk Seed Treatment: To address occupational exposures while operating
commercial or smaller on-farm bulk seed treatment equipment, the Agency has
considered a special study conducted in 1980 to assess the potential exposure of
workers during seed potato treatment. In that study, the investigators monitored
handlers pouring captan into seed hoppers of potato seed-piece dusting machines,
handlers cutting and sorting the treated potato seed-pieces, operators of potato
seed-piece planters, and observers involved in the planting operations.
2. Seed Treatment, Planter Box: There are no activity-specific data to address the
use of captan as a planter-box seed treatment, at planting time. To address this
scenario, the mixer/loader data for wettable powder formulations available in the
Agency's Pesticide Handlers Exposure Database (PHED VI. 1) were used. The
Agency determined that soybeans were the crop most likely to require planter-box
seed treatment, as most other crop seeds are normally pretreated. The activity
consists of adding a small quantity of captan to soybean seed after it has been
loaded into the soybean planter seed hoppers. Captan is either mixed into the top
few inches of seed to help disperse the captan dust or left alone to be mixed by
normal shaking of the hopper as it moves through the field. The assumptions used
for this scenario include the treatment of enough soybean seed to plant 100
acres/day (six-row planter with 30 inch rows planted at 4 mph), and a treatment
rate of 0.066 Ib ai/bushel at 1.13 bushels planted per acre. Individuals are
estimated to use captan 5 days per year as planter box treatment.
22
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Spray Treatments
Captan is applied via sprayer to almonds, apples, apricots, blueberries, cherries, grapes,
plums, strawberries, caneberries, nectarines, peaches, and ornamentals. Captan is applied via
airblast, groundboom, aerial and chemigation.
Surrogate exposure data to address handler exposure for these applications are available in
the Agency's PHED VI. 1. Handlers are assumed to use captan 7 days per season for strawberries
and 3 days per season for the remaining fruit crops.
Almonds and strawberries were considered the crops most likely to be treated by aircraft
because strawberries are grown in rows and almonds occasionally need emergency treatments
during periods of extensive rain when ground equipment cannot be used. Although the registrant
has indicated that treating 350 acres of strawberries by aircraft is unrealistic, the assessment for
strawberry fields is representative of mixing/loading for all aircraft applications. The Agency has
determined that, though such strawberry acreage is rare, it is possible to treat 350 acres in a day.
In addition, almonds are routinely treated in 350 acre increments. Furthermore, the 1994 USDA
Agricultural Chemical Usage data do not refute the 350 acre estimate. Strawberries are also
likely to be treated by groundboom equipment and orchard and trellis crops are assumed to be
treated by airblast equipment. Surrogate data are available to distinguish handler exposure for
individuals treating dwarf fruit trees and trellis crops, such as grapes, from those individuals
treating traditionally cultivated orchards.
The risk assessment for groundboom applications to strawberries is assumed to be a
reasonable worst-case surrogate for applications to field-grown ornamentals. An exposure
assessment for greenhouse ornamentals will be conducted only for the hand-held equipment
scenarios, such as high pressure and backpack sprayers.
For the high pressure exposure scenario in greenhouses, the Agency assumes one hour per
day for mixing/loading and applying the pesticide 26 days per year. Although it is unlikely that a
backpack sprayer could deliver 100 gallons per hour, the Agency assumes one pound ai handled
per day for 26 days per year.
Greenhouse soil treatments are similar to the greenhouse foliar treatments. The only
exception is when the application is directed to the soil around the plants rather than the foliage.
Therefore, the exposure and risk assessment for applications to greenhouse ornamentals using
hand-held equipment is a reasonable worse-case surrogate for greenhouse soil treatments.
Application to Golf Courses
There are surrogate data available to address application of captan to golf courses. For
this use, the Agency has assumed the use of groundboom equipment, and that a typical golf
course consists of 40 acres of fairways. The golf course is assumed to be treated 10 times a year.
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In-Plant Additives for Paints. Plastics. Rubber, and Adhesives
Data are available in PHED VI. 1 to address worker exposure to captan used as a
preservative/fungicide in paints, vinyl, plastics, rubber, and adhesives. Mixer/loader data available
in PHED were used to address workers adding captan during the manufacturing of these
industrial products, since these uses appear to be similar to those of an agricultural mixer/loader.
Captan is weighed then added to the various products which are typically made in batches (e.g.,
paint). Although plastic and vinyl are relatively inert, captan is used to control molds attacking
plasticizers (such as ethylene glycol), which are added to enhance the properties of plastics such
as toughness and flexibility.
According to information available at the time of the PD 2/3, captan's use as an additive to
industrial products was very limited. It was anticipated that an even lower market share could be
expected in the future. Exposure scenarios addressing the addition of captan into specialty paints
having pesticidal claims and into adhesives to promote longer shelf-life were selected as
representative scenarios for the industrial uses.
For captan formulated into paint products, a rate of 12 Ibs ai/100 gallons paint was used,
with a total of 36 Ibs ai/day added. The use of captan in these products is reportedly limited; thus,
EPA estimates that workers will be exposed 10 days per year.
Commercial painter exposures while applying paints containing captan were also
estimated. The commercial exposure assessments were conducted using PHED VI. 1. EPA
estimates that commercial painters are exposed 15 days per year for 70 years. The painter
assessment is used as a reasonable worse-case surrogate for other secondary handler exposures to
products such as adhesives.
Post-Harvest Fruit Dip Applications for Apples. Cherries, and Pears
There are no activity-specific data to address the use of captan as a postharvest dip
treatment for apples, cherries, and pears to control spoilage during storage and transit. The main
activity is the mixing/loading of captan into the dip/drench tank. Most of the application is
mechanized and involves relatively low exposure potential. These activities include overseeing
the apples being conveyed in and out of the dip/drench area, and operating forklifts to convey
field boxes or bulk bins of fruit for dipping or storage. Dipping the fruit by hand involves
relatively high exposure potential. Although EPA has no data to assess the exposures and risks
from hand dipping, these data are being called in with this RED. The only data available in PHED
VI. 1 to address this scenario are those for the mixer/loader handling a wettable powder. This
activity is assumed to result in the highest exposure. In the PD 2/3, it was determined that a
mixer/loader would prepare four batches per day for a period of 6 weeks (in West Virginia) to 32
weeks (in Washington state). The dip tank sizes are assumed to range from 1000 to 3000 gallons,
which amounts to 30-160 days exposed per year.
24
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(2) Occupational Handlers Risk Conclusions
A single non-cancer endpoint effect was identified for both dermal and inhalation
exposures. For certain handler activities, dermal exposure was assumed to occur once daily and
subsequent absorption was assumed to result from a single exposure event where residues remain
on the skin for 8 hours and are absorbed at 0.4% per hour. For other handler activities, dermal
absorption at 0.4% per hour was assumed to result from continuous exposure for 8 hours during a
single day. MOEs below 100 for combined dermal and inhalation exposure represent a risk
concern for the Agency.
Most short- and intermediate-term risks to handlers using captan are above 100. MOEs
that are above 100 range from 240 to 43,000. Of the risk estimates for the 14 scenarios, only
three were below 100: mixing/loading wettable powders for aerial applications and chemigation,
use by professional lawn care operators, and handlers loading wettable powders for seed-piece
treatment.
For mixing/loading to support aerial applications and chemigation, the Agency has
determined that inhalation exposure is a large component of the combined dermal and inhalation
exposure estimate. These risks can be mitigated with the use of water-soluble packaging, in
which case the MOE of 41 becomes 1000. Alternatively, application rates could be reduced to
1.2 Ibs ai/A or less.
To estimate cancer risk, inhalation exposure was combined with dermal exposure to
provide an equivalent oral dose for comparison against the Qt* 2.4 x 10"3 (mg/kg/day)"1. No
handler risk exceeded 5.9 x 10"6. Most handler scenarios have cancer risks in the 10"7 and 10"8
range, which do not exceed the Agency's level of concern for occupational handlers.
(3) Occupational Incidents
Captan is in Toxicity Category I for primary eye irritation and is a moderate skin
sensitizer. According to the information provided in incident reports reviewed by the California
Pesticide Illness Surveillance Program between 1982 and 1990, there were 14 eye/skin incidents
reported for reentry workers, 14 eye/skin incidents reported for mixer/loader/applicators, and 10
eye/skin incidents reported for other activities such as dipping flowers, preparing root and bulb
dips, moving recently treated seed with forklifts, and exposure to spray drift.
There are many uncertainties associated with eye/skin incidence reporting and the
Agency's ability to mitigate these adverse effects. Some of the uncertainties include:
The majority of incident reports are associated with pesticide applications that are applied
as tank mixes. These tank mixes often involve other active ingredients which may also be
irritants or sensitizers;
25
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Symptoms such as conjunctivitis and irritation can be caused by soil, sweat, and foreign
objects such as plant material irrespective of any pesticide used;
Eye incidents are typically under-reported for reasons such as fear of employer reprisal,
migrant workers not wanting to attract attention to themselves, and the cost of medical
treatment; and
Few states require incident reporting. Captan is used more frequently in areas outside
California (one of the few states requiring physicians to report pesticide incidents) where
conditions, such as high humidity, favor the plant diseases controlled by captan.
e. Occupational Post-Application Exposure and Risk
The Agency has determined that there is potential exposure to persons entering treated
sites following application of captan-containing products for the purposes of harvesting low
growing fruits, harvesting tree fruits, scouting, weeding, hoeing, and other non-harvesting
activities, pruning and thinning fruit crops. Post-application exposure is particularly likely
following foliar applications to ornamentals (field and greenhouse), golf-course and sod farm
turfgrass. Post-application exposure is likely to be less significant in industrial and manufacturing
settings. Postapplication scenarios were classified as intermediate-term (7 days to several
months) based primarily on the frequency of exposure.
Current labels include a restricted-entry interval (REI) of 4 days, however, the use on
strawberries has an REI of 24 hours. The current labels allow early entry for an unlimited length
of time during the last 48 hours of the REI, provided early-entry PPE is worn.
(1) Assumptions for Occupational Post-Application
The following assumptions and factors were used to complete the postapplication
exposure and risk assessment:
Average work day interval represents an 8 hour workday.
Average body weight of an adult postapplication worker is 60 kg (non-cancer risk
concerns) or 70 kg (cancer risk concerns).
Dislodgeable foliar residues (DFRs) represent combined captan and THPI residues; the
combined values were used for exposure assessment for short-and intermediate-term risk;
THPI was not included in the exposure for cancer risk.
26
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(2) Occupational Postapplication Risk Conclusions
To estimate non-cancer risks, MOEs for various REIs were derived by a comparison of
dermal exposure estimates against a NOAEL of 10 mg/kg/day for intermediate exposure.
To estimate cancer risk for harvesters, the Agency assumed 80 days (national use) and 120
days (California) for the number of days exposed per year, and 35 years of exposure over a 70
year lifetime. The Qt* of 2.4xlO"3 (mg/kg/day)"1 was used to calculate risk. The assessment
shows risks ranging from 1.8 x 10"5 to 7.7 x 10"6. The assumption of 80 to 120 days of exposure
to 24-hour post application residues is conservative. The risks presented are considered a worst-
case scenario because they do not address percent crop treated or typical rates. Actual risks are
expected to be much lower.
The REIs that will be established are: 12- hours for seed treatment uses; 24-hours for
strawberries, almonds, apples, apricots, cherries, nectarines, plums/fresh prunes, and peaches; 3-
days (72-hours) for blueberries, raspberries, blackberries, and grapes; 4-days (96-hours) for
ornamentals, and 24-hours for soil treatments.
f. Residential Exposure and Risk
Residential exposure to captan residues via dermal and inhalation routes can occur during
handling, mixing, loading, and applying activities. Postapplication residential dermal exposure is
expected during gardening or other recreational activities. Based on toxicological criteria and
potential for exposure, the Agency has conducted dermal and inhalation exposure assessments for
the occupational and residential handler, and for occupational and residential postapplication
dermal and inadvertent oral ingestion exposure to adults and/or children.
Potential captan residential use sites may include lawns, ornamentals, fruit trees, and
strawberries. According to the National Home and Garden Pesticide Use Survey Final Report,
Volume 1 (March, 1992), the major use of captan in the home garden is on edible food crops
(about 65%), followed by roses and other ornamentals (about 26%), and lawns (about 8%). It is
available to the home gardener as dust (D), wettable powder (WP) and emulsifiable concentration
(EC) formulations containing captan at 6 - 50% active ingredient. Captan is also incorporated
into paints and adhesives as an industrial preservative.
Equipment for residential uses include low-pressure handwand, hose-end sprayer,
backpack sprayer, and shaker can. In addition, powders or dusts may be mixed dry with
vegetable seeds in a bag or jar prior to planting, or mixed with water to form a solution for
dipping root cuttings, bulbs, and corms to prevent seed rot or damping off.
27
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(1) Residential Handler Risk
Captan may be applied at 7- to 14-day intervals throughout the growing season; however,
the duration of exposure is expected to be short-term (1-7 days) for residential handlers because it
is unlikely that home gardens would require continuous daily applications for a period of time
greater than one week. Short-term risks to residential handlers do not exceed the Agency's level
of concern. MOEs range from 240 to over 100,000.
Cancer risk estimates to residential handlers do not exceed the Agency's level of concern.
The results of the cancer risk assessment indicate that risks for all residential handler scenarios are
in the 10'7 and 10'8 range.
(2) Residential Post-application Risk
Although captan may be absorbed through the skin or respiratory tract, postapplication
inhalation exposure is expected to be minimal for all residential scenarios, including applying
captan-treated paint. Only dermal exposure is expected for postapplication harvesting activities.
Based on the half-life of captan residues on leaf surfaces (10 to 43 days), the duration of
postapplication dermal exposure is expected to be either short-term (1-7 days) or intermediate-
term (1 week to several months).
The Agency is concerned about toddlers exposed to captan through residential uses on
lawns. The MOE for toddlers' hand-to-mouth contact from residues on low-growing plants is
approximately 11. The MOE for toddlers' hand-to-mouth contact from residues on turf is 2. To
mitigate this use, the technical registrants have agreed to voluntarily cancel the use of captan on
all turf, except at sod farms and golf courses. To ensure toddlers are not exposed to residues of
captan on treated sod, the Agency is establishing a 48-hour harvesting prohibition interval.
Based on the currently registered maximum application rate to turf, MOEs are 20 and 25
for adults and toddlers, respectively. However, when the application rates to turf are reduced,
these risks are effectively mitigated and MOEs for both groups are above 100. MOEs for dermal
exposure in treated gardens ranged from 2,000 to 45,500.
Dermal postapplication exposures and risk to youths and adults playing golf at golf
courses did not exceed the Agency's level of concern. The Agency determined that the MOEs are
110,000 and 180,000 for youth and adult golfers, respectively. This assessment assumed 4 hours
of play for 18 holes of golf.
Cancer risk estimates from postapplication exposure do not exceed the Agency's level of
concern. The results of the cancer risk assessment indicate that risks for all assessed residential
postapplication scenarios are in the 10"7 and 10"8 range.
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g. Aggregate Risk
In examining aggregate risk, FQPA directs EPA to take into account available information
concerning exposures from the pesticide residue in food and all other exposures for which there is
reliable information. These other sources of exposure can include pesticide residues in drinking
water, exposure from pesticides uses in and around the home, and exposure in non-residential
settings, such as, parks, schools, etc.
Acute Aggregate Risk
An acute aggregate assessment estimates risk from one day's exposure to food and water.
Acute exposure (food only) to captan was 36% of the aPAD for females 13-50 years of age (the
only population of concern for acute exposure), which does not exceed the Agency's level of
concern. Since drinking water monitoring data for captan were not available, drinking water levels
of comparison (DWLOCs) were calculated and compared to estimated environmental
concentrations (EECs) that were generated by the PRZM-EXAMS and SCI-GROW models. The
EECs for surface and ground water were less than the acute DWLOCs, indicating that acute
aggregate exposure to captan does not exceed the Agency's level of concern.
Short-Term Aggregate Risk
Aggregate short-term risk assessments provide estimates resulting from residential
exposures of 1-7 days duration, plus food and water exposures. Typically, high-end residential
exposure estimates are added to estimates of food and water exposure for comparison to an
appropriate NOAEL from a toxicity study. For captan, the developmental and maternal toxicity
endpoint of 10 mg/kg/day from a developmental toxicity study is used for short-term assessments.
Three major aggregate short-term exposure scenarios were considered reflecting the turf,
ornamentals/fruit trees, and paint additives uses of captan. Exposures to golfers was not included
in the aggregate assessment because the risks posed by this scenario is expected to be negligible.
Use of captan on turf results in postapplication exposures to children which exceed the
Agency's level of concern, based on hand-to-mouth exposure. Because any additional exposure
via food or drinking water would only cause risk estimates to further exceed the level of concern,
the Agency concludes that aggregate short-term exposures resulting from use of captan on turf
exceeds the level of concern. These uses are being voluntarily canceled to mitigate this risk.
Residential exposure from use of captan on fruit trees/ornamentals or from painting does
not exceed the Agency's level of concern when aggregated with food and drinking water
exposure. Aggregate exposure scenarios include application residential scenarios. The painting
scenario is calculated for adults only and assumes that children do not paint.
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Aggregate Short-Term Risks for Captan
Scenario
Ornamental/
Fruit Tree
Airless Paint
Sprayer
Mixer/Loader/Applicator
Exposure
(mg/kg/day)
0.029
0.025
MOE*
345
400
Food
Exposure
(mg/kg/day)
0.0007
0.0007
MOE
14,300
14300
Total
Exposure
(mg/kg/day)
0.03
0.026
MOE
330
390
DWLOC
(ppb)
2,100
2,220
*Exposures compared to NOAEL of 10 mg/kg/day from Developmental Toxicity Study in Rabbits.
Allowable short-term water exposure (mg/kg/day) x body weight (kg)
DWLOC,,,
water consumption (L/day) x 10"3 (mg///g)
where Allowable short-term water exposure =NOAEL/UF - chronic food exposure - residential exposure
As an example, exposure to adults who are mixing/loading/applying to ornamentals:
Allowable short-term water exposure = (10/100) - 0.001 - 0.029 = 0.07 mg/kg/day
0.07mg/kg/day*60kg = 2,100 ppb DWLOCST adult females
0.001(mg/ng)2L/day
Chronic (Non-cancer) Aggregate Risk
A chronic aggregate assessment estimates risk from long term exposure to food and water
and also includes residential exposure if any long term scenarios are identified. No chronic non-
cancer exposure scenarios are expected from residential uses of captan.
DWLOCs for chronic dietary exposure were discussed earlier in this document. The
calculations indicate that DWLOCs greatly exceed estimated environmental concentrations and
therefore there is no concern for chronic aggregate food and water exposure.
Chronic (Cancer) Aggregate Risk
Aggregate cancer assessments estimate risk from lifetime exposures to food and water
plus residential exposure. Multiple residential exposure scenarios may be included in aggregate
cancer assessments if they have a reasonable probability of occurrence over a lifetime. As in the
previous aggregate assessments, exposures to golfers was not included because the risks are
expected to be negligible. Risks of 10"6 or less are considered to be of negligible risk concern for
the general population.
The following table illustrates aggregate cancer risks associated with some residential
exposure scenarios. It should be noted that use on turf is not included in the table because
noncancer risks were not acceptable by themselves for turf uses of captan.
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Aggregate Cancer Risks for Captan
Residential Exposure Activity
Primary handler - Mixing/loading/applying
wettable powders to fruit trees
Secondary handler - Painting with a brush
Postapplication - Ornamentals
Residential
Cancer
Risk
6.5xlO'7
8.5 x lO'8
4.2 x 10'8
Food
Cancer
Risk
1.3 x 10'7
1.3 x lO'7
1.3 x 10'7
Aggregate
Food and
Residential
7.8 x 10'7
2.2 x lO'7
1.7 x 10'7
DWLOC cancer
ppb
3.2
11
12
DWLOCcancer= Allowable water risk x body weight (kg)
Q!* (mg/kg/day)"1 x water consumption (L/day) x 10"3 mg///g
Allowable water risk = 10"6 - Food risk - Residential risk
Example: Painting with a brush
Allowable water risk = 10'6 - l.SxlO'7 - 8.5x10'8 = 7.8 x 10'7
7.8 xlO'7 * 70kg
= 11 ppb DWLOC^,
2.4 x 10'3 (mg/kg/day)-1 * 0.001 mg/ug * 2 L/day
Water models predict environmental concentrations of captan in ground and surface water
of 0.02 ppb and 4.0 ppb respectively. A DWLOC cancer greater than 4.0 ppb is obtained for any
residential scenario (or combination of plausible scenarios) with a risk estimate of less than
2.3xlO"7. Although mixing/loading/applying wettable powders to fruit trees is associated with a
cancer risk of 6.5 x 10"7, this risk level still only yields an aggregate risk of 1.05 x 10"6. Therefore,
no residential aggregate scenario is of a concern to the Agency for cancer.
Captan and folpet share a common metabolite, thiophosgene, which is believed to be
responsible for the carcinogenic effects of these compounds. Thiophosgene is a highly reactive,
short-lived species. Studies indicate that thiophosgene causes local irritation of the site with
which it comes in contact, and is believed to cause tumors through the irritation of the duodenum.
Because they are so short-lived, thiophosgene residues cannot be quantified. Without measurable
residues of the common metabolite, it is difficult to relate exposures of captan to those of folpet
since the rate of formation of thiophosgene may be different for both compounds. However,
assuming that the carcinogenic effects observed in both pesticides are due solely to the metabolite
thiophosgene, the Agency believes it is reasonable to add the estimated cancer risks from the
individual aggregate risks from both folpet and captan to obtain a worst case estimate. For
captan, the dietary cancer risk estimate for the US population from exposure to residues in/on
food is 1.3 x 10"7. For folpet, the dietary cancer risk estimate for the US population from
exposure to residues in/on food is 9.8 x 10"8. If these two risks are added together the total risk
is 2.3 x 10"7 The aggregate cancer Drinking Water Level of Comparison (DWLOCcancer) based
on this total cancer risk estimate is 11 ppb, using the captan Qx* of 2.4 x 10"3. The estimated
environmental concentration (EECs) for folpet are 1 ppb (sw) and less than 1 ppb (gw). The
EECs for captan are 4 ppb (sw) and less than 1 ppb (gw). The largest EEC of 4 ppb is less than
the DWLOC, the Agency's level of concern. This aggregate assessment is for dietary exposure
31
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only. The tumor of concern occurs in the GI tract (duodenum/jejunum-ileum) as a result of oral
dosing. The relevance of dermal exposure to a GI tract tumor is unknown at this time. Thus, the
Agency concludes that an aggregate cancer risk estimate considering dietary (food and water)
exposure only for captan and folpet based on their common metabolite thiophosgene is
appropriate.
e. Cumulative Effects
Section 408(b)(2)(D)(v) of the Food Quality Protection Act requires that, when
considering whether to establish, modify, or revoke a tolerance, the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The Agency believes that "available
information" in this context might include not only toxicity, chemistry, and exposure data, but also
scientific policies and methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although the Agency has some
information in its files that may turn out to be helpful in eventually determining whether a
pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues concerning common
mechanism of toxicity in a meaningful way. EPA has begun a pilot process to study this issue
further through the examination of particular classes of pesticides. The Agency hopes that the
results of this pilot process will increase the Agency's scientific understanding of this question,
such that EPA will be able to develop and apply scientific principles for better determining which
chemicals have a common mechanism of toxicity and evaluating the cumulative effects of such
chemicals. The Agency anticipates, however, that even as its understanding of the science of
common mechanisms increases, decisions on specific classes of chemicals will be heavily
dependent on chemical specific data, much of which may not be available at present.
At this time, the Agency does not know how to apply the information in its files
concerning common mechanism issues to most risk assessments; however, there are pesticides for
which the common mechanism issues can be resolved. An example of this would be pesticides
that are toxicologically dissimilar to existing chemical substances (in which case the Agency can
conclude that it is unlikely that a pesticide shares a common mechanism of activity with other
substances) and pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
FQPA requires the Agency to consider the cumulative exposure to pesticides operating by
a common mechanism of toxicity. Policy to permit the estimation of cumulative exposure is
currently under development but is not yet complete. At such time as policy defining how to
conduct a cumulative assessment has been finalized, the risk assessments of captan (and folpet)
will be revisited to determine whether a common mechanism is operative with any other pesticide
and, if so, whether a cumulative risk assessment is warranted.
32
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c.
Environmental Assessment
1. Ecological Toxicity Data
In addition to estimating risk to human health, the Agency also assesses risks to terrestrial
species and aquatic organisms, including avian species, mammals, and fish. The exposure and risk
estimates that follow represent major agricultural use sites and reflect both the range of terrestrial
and of aquatic non-target exposure scenarios expected with the use of captan on terrestrial plants.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
In order to establish the toxicity of captan to avian species, the Agency required an avian
single-dose oral (LD50) study on one species (preferably mallard or bobwhite quail); two subacute
dietary studies (LC50) on one species of waterfowl (preferably the mallard duck) and one species
of upland game bird (preferably bobwhite quail).
The results reported in the following tables indicate that captan is practically non-toxic to
the Northern bobwhite quail and mallard, on both an acute and subacute dietary basis.
Avian Acute Oral Toxicity Findings
Species
Northern bobwhite
Mallard Duck
% a.i.
Tech
Tech
LDSO mg/kg
> 2,150
>2000
Citation
GS0120-045
GS9999-001
Toxicity Category
practically nontoxic
practically nontoxic
Satisfies
Guideline
Yes
Yes
Avian Subacute Dietary Toxicity Findings
Species
Northern Bobwhite
Mallard
Mallard
Northern Bobwhite
Northern Bobwhite
% a.i.
Tech
Tech
90%
90%
Tech
LC50
ppm
> 2,400
>5000
>5200
>5200
>4640
Citation
(MRID)
00022923
00022923
43869803
43869802
00104686
Toxicity Category
slightly toxic or practically non-toxic
practically non-toxic
practically non- toxic
practically non- toxic
slightly toxic or practically non-toxic
Satisfies
Guideline
Yes
Yes
Yes
Yes
No
The studies are acceptable and fulfill guideline requirements. (MRIDs 43869802, 43869803,
GS0120045, GS9999001, 00022923, 00104686).
33
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(2) Birds, Chronic
Since captan has repeated exposure through multiple applications, avian reproduction
studies are required. The avian reproduction studies for captan indicate that exposure up to 1000
ppm in the diet does not affect reproduction. Multiple foliar applications of captan result in peak
maximum predicted residues slightly above 1000 ppm, however, when the exposure and risk are
further refined to consider concentrations and methods of application, the resulting predicted
residues are below this concentration. Therefore, no further data are needed and the guideline
requirement is fulfilled. This issue is further discussed in the Exposure and Risk to Nontarget
Terrestrial Animals section. (MRTDs 00098295, 00098296).
(3) Mammals, Acute and Chronic
Mammal testing was not required by the Agency's Ecological Effects Division since
captan is not acutely toxic. Mammalian data are reported in the following table.
Mammalian Toxicity Findings
Species
Rat
Rabbit
Hamster
Rat
Rat
Test Type
Acute oral
Developmental
Developmental
One generation
Three generation
NOEL
ppm
LD50 9g/kg
330
2000
>500
250
LOEL ppm
990
4000 incr. resorption
>500
500 reduced pup wt
Citation
(MRID)
00054789
41826901
00086803
00120315
00125293
The acute oral LD50 was used to determine toxicity. The mammalian data indicate that
captan is practically non-toxic to the rat on an acute oral basis (MRID 00054789).
(4)
Insects
A honey bee acute contact LD50 study is required when the proposed use will result in
honey bee exposure. Studies on the honeybee using technical captan indicate that the LD50 is
greater than 10//g a.i./bee, and that there is 9.8% mortality at 215 //g a.i./bee. There is sufficient
information to characterize captan as relatively nontoxic to honeybees. The guideline requirement
is fulfilled (MRTD 00113613, 05001991).
34
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b. Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the acute toxicity of captan to freshwater fish, the Agency required
LWO freshwater fish toxicity studies. Both a coldwater species (preferably the rainbow trout), and
a warmwater species (preferably the bluegill sunfish) should be used.
two
Freshwater Fish Acute Toxicity Findings
Species
Bluegill sunfish
Bluegill sunfish
Fathead minnow
Brook trout
Coho salmon
Harlequin fish
Brown trout
% a.i.
90
88.4
88.4
88.4
90
89
90
96-hr LC50
ppb ai
310
72
65
34
137
300
26.2
Citation
(MRID)
GS0120042
00057846
00057846
00057846
40098001
05020144
40098001
Toxicity Category
highly toxic
very highly toxic
very highly toxic
very highly toxic
highly toxic
highly toxic
very highly toxic
Satisfies
Guideline
Yes
Yes
Yes
Yes
Yes
No
Yes
The results of the 96-hour acute toxicity studies indicate that captan is highly to very
highly toxic to fish. The guideline requirements are fulfilled for testing with technical material
(MRID GS0120042, 00057846, 40098001, 05020144).
The Agency waived the acute formulated product testing with a 50% wettable powder
(WP) formulation since the confidential statement of composition for the captan 50 WP and 80
WP end use products showed that the major and minor inerts are not likely to enhance the toxicity
of captan.
Degradate testing was required because captan is short-lived (hydrolyzes at pH 7 in about
6 hrs) and the major degradate(s) are believed to be stable and exist at concentrations greater than
10%. The following data were submitted on the major degradates of captan, THPI and THPAm.
Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
Rainbow trout
% a.i.
96% THPI
95% THPAm
96-hr.LC50
(ppb)
>120,000
> 126,000
Citation
(MRID)
43869806
44738801
Toxicity Category
practically non toxic
practically non toxic
Satisfies
Guideline
Yes
Yes
35
-------
There is sufficient information to characterize THPI and THPAm as practically non-toxic
to fresh water fish. Considering these results, bluegill studies will not be required. The guideline
requirement using THPI and THPAm are fulfilled (MRIDs 43869806, MRTD 44738801).
A fish full life cycle on parent captan has been submitted, therefore the fish early life stage
study will not be required. The results from this study indicate that fathead minnow growth and
survival is affected between 16.5 and 39.5 ppb. The NOEL is 16.5 ppb, and the LOEL is 39.5
ppb. The guideline requirement for the fish full life cycle testing is fulfilled (MRTD 00057846).
(2)
Freshwater Invertebrates
The minimum testing required to assess the hazard of a pesticide to freshwater
invertebrates is a freshwater aquatic invertebrate toxicity test, preferably using first instar
Daphnia magna or early instar amphipods, stoneflies, mayflies, or midges. The results from a test
using first instar Dapnia magna are shown in the following table:
Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
Daphnia magna
Daphnia magna
Daphnia magna
% a.i.
Tech
93%
90%
Tech
48-hr. EC50
(ppm)
>7.1
>3.25
8.4
1.3 (26 hr.)
Citation
(MRID)
00070751
43869807
GS0120041
00002875
Toxicity Category
moderately toxic or less
moderately toxic or less
moderately toxic
moderately toxic
Satisfies
Guideline
No
No
Yes
No
There is sufficient information to characterize captan as moderately toxic to Daphnia
magna. The guideline requirement is fulfilled (MRTD 00070751, GS0120041, 00002875,
43869807).
Since degradate testing is required, data were submitted on 96% THPI (%a.i.) using
Daphnia magna. Results indicated that the 48-hr LC50 is greater than 113 ppm a.i. There is
sufficient information to characterize the captan degradate THPI as practically non-toxic to
Daphnia magna. (MRID 43869808). The guideline requirement is fulfilled. The results of the
rainbow trout study with THPAm demonstrate that the 96-hour LC50 was greater than 126 ppm,
and the NOEC was 126 ppm. From these results, the Agency determined that THPAm is
practically non-toxic to the rainbow trout (MRID 44738801), and there will be no requirement to
test Daphnia magna with THPAm.
Aquatic invertebrate life-cycle testing was required because captan is applied repeatedly by
air blast or aerial equipment and may contaminate waterways via drift and runoff. Results from a
submitted study using parent captan indicate reproductive effects in Daphnia magna occur at
nominal concentrations between 0.56 and 1.0 ppm. This study was conducted as a static renewal;
36
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neither the concentrations of parent captan nor THPI were measured in the test solutions. The
reduced length and decreased number of young seen at 1.0 ppm are attributed to captan since
THPI appears to be lOOx less toxic acutely than parental captan. Although continuous exposure
to parental captan would yield a lower NOEL, static renewal is more representative of aquatic
organism exposure to captan under field conditions. Subsequent applications of captan would
mimic the repeated dosing of the static renewal study. In light of these factors and the greater
sensitivity offish, the value added of repeating this study is low. The Agency is not requiring
additional data at this time. (MRTD 44148801)
(3) Estuarine and Marine Animals, Acute
The foliar use of captan on turf, lawns, and golf courses could result in exposure to
estuaries and marine environments, and therefore acute toxicity testing with estuarine and marine
organisms was required.
The requirements under this category include a 96-hour LC50 for an estuarine fish, a 96-
hour LC50 for shrimp, and either a 48-hour embryo-larvae study or a 96-hour shell deposition
study with oysters, using technical captan. The registrant has recently submitted two 96-hour
acute toxicity studies, one using sheepshead minnow and another using saltwater mysid. (MRTDs
44806504, 44806503), and these studies are in review. A 96-hour shell deposition study is still
required, as an earlier study (MRTD 00127865) was conducted using the dungeness crab, which is
not a preferred test species. This study showed captan to be moderately toxic to dungeness crab.
The Agency is not requiring testing using formulated products at this time, pending submission
and evaluation of technical testing.
c. Toxicity to Plants
(1) Terrestrial
Tier 1 terrestrial plant testing (seedling emergence and vegetative vigor) would normally
be required for captan due to phytotoxicity label statements (the captan 50WP label indicates that
necrotic spotting of immature leaves of some orchard crops may occur under certain conditions).
However, based on captan's use as a seed treatment, and since captan is non-systemic, the
Agency is not requiring a Tier II emergence study. In addition, the vegetative vigor study would
not likely demonstrate the occurrence of spotting on the usual non-woody species. Therefore, the
vegetative vigor study is also waived.
(2) Aquatic
Aquatic plant testing is required for captan since it has outdoor non-residential terrestrial
uses and it may move off-site during application by drift. Testing on the following five species
was required due to effects seen in tests with several algal species using captan: Selenastrum
37
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capricornutum, Lemna gibba, Skeletonema costatum, Anabaenaflosaquae, and a freshwater
diatom. Tier 2 toxicity data on technical captan are listed below:
Nontarget Aquatic Plant Toxicity Findings
Species
Selenastrum capricornutum
Skeletonema costatum
Pavlova lutheri
Isochrysis galbana
Scenedesmus subspicatus
Anabaenaflosaque
Lemna gibba
% a.i.
90
99.8
99
99
92.7
99.8
99.8
EC50 ppm
1.77
0.18
0.55
0.21
0.32
1.2
12.7 (7-day)
Citation (MRID)
43869809
44806502
40228401
40228401
252586
44806501
44806503
Satisfies Guideline
Yes
Yes
No
No
No
Yes
Yes
The results indicate that several algae species experienced a 50% inhibition in growth at
less than 1 ppm (MRTD 40228401). Species other than those tested previously are required. The
registrant has submitted studies with three other aquatic species: Lemna gibba, Anabaena
flosaquae, and Skeletonemema costatum. (MRIDs 44806501, 44806502, 44806503). The
Agency has sufficient information to use for the risk assessment, and additional data is not
required at this time.
Though not required by the Agency, the registrant submitted a study with THPI on the
alga Selenastrum capricornutum. The results indicate that aquatic concentrations of THPI up to
180 ppm are not toxic to Selenastrum capricornutum. (MRID 43869810).
2.
Environmental Fate
a.
Environmental Fate Assessment
Captan degrades rapidly in the environment with a half-life of less than one day.
Hydrolysis and aerobic soil metabolism appear to be the major routes of captan dissipation in the
environment. In water and soil, the sulfur-nitrogen bond cleaves, separating the trichloro-
methylthio (TCMT) and tetrahydrophthalimide (THPI) moieties of the molecule. The TCMT
moiety degrades moderately rapidly to rapidly by aerobic soil metabolism to CO2, thiophosgene,
and inorganic sulfur and chlorine. Thiophosgene dissipation is expected to be dependent on
volatilization (est. vapor pressure=29.7 mm Hg and estimated Henry's Law constant=0.00586
atm-m3 mole"1). However, thiophosgene was not detected as a volatile component in any of the
submitted laboratory studies. THPI also degrades moderately rapidly to rapidly by aerobic soil
metabolism to a series of ring-containing products (including THPAm) and ultimately to CO2.
38
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Captan photodegradation on soil also occurs, but is secondary to hydrolysis and aerobic
soil metabolism. Evidence indicates that residues of THPI may be present in soil several months
following captan application. THPI is potentially mobile and may leach in the soil profile.
Freundlich Kd values for THPI ranged from 0.01 to 0.17 mL/g in six soils. THPI may move with
surface runoff.
b. Environmental Fate and Transport
Parent captan degrades relatively rapidly. However, there is a potential for the degradate
THPI to reach ground and surface water due to application rates and multiple applications of
captan.
c. Degradation
Hydrolysis: 14C-trichloromethyl captan hydrolyzed in sterile aqueous buffer solutions at pH 5, 7,
and 9, with half-lives of 18.8 hr, 4.9 hr, and 8.3 min, respectively. Two unidentified degradates,
both of which degraded rapidly to 14CO2, were detected in the study (MRID 41176301).
Two other hydrolysis studies were also reviewed. One study (MRID 00096974) provided
information on the hydrolysis of 14C-carbonyl captan, and described the fate of the ring portion of
the molecule in sterile aqueous solutions at a pH range of 2-9. Another study (MRID 40208101)
provided acceptable information on the hydrolysis of 14C-trichloromethyl captan at pH 9. Taken
together, these three studies fulfill the data requirement. (MRIDs 00096974, 40208101,
41176301).
Photodegradation In Water: Because hydrolysis, not photolysis, was responsible for captan
degradation in an aqueous photolysis study reviewed previously, the Agency concluded that the
photodegradation in water data requirement for captan would be fulfilled upon submission of
acceptable hydrolysis data for pH 5. The Agency concluded that captan is stable to photolysis in
aqueous solution at pH 5. No additional data on the photodegradation of captan in water are
required at this time (MRIDs 40208102 and 41176301).
Photodegradation on Soil: In studies where 14C-captan labeled in the cyclohexene and trichloro-
methyl positions was applied to moist sandy loam soil and irradiated with natural sunlight, captan
degraded with half-lives of 5 and 15 days, respectively. The half-lives for dark controls were 10
and 21 days, respectively. After 5 days of irradiation of 14C-cyclohexene captan, 21.3% of the
applied radioactivity was present as tetrahydrophthalamide (THPI) and 9.4% was present as
cyclohex-4-ene-2-cyano-l-carboxylic acid (THCY). No other single degradate contained more
than 3.2% of the applied radioactivity. For 14C-trichloromethyl captan, the only reported
degradate was 14CO2, which comprised 41.7% of the applied radioactivity after 16 days of
irradiation.
39
-------
The soil photolysis data submitted are acceptable and fulfill the data requirement. No
additional data for captan photodegradation on soil are required at this time (MRID 40658009,
40658010).
Aerobic Soil Metabolism: Carbonyl-labeled captan, incubated aerobically in a sandy loam,
degraded very rapidly with 99% degradation by day 7. Ninety-five percent of the applied 14C was
present as 14CO2 after 322 days. THPI and THPAm were the major degradates identified. The
maximum reported THPI concentration occurred at day 7, when 66% of the applied radioactivity
was present in this degradate. Other soil metabolites of captan in quantities exceeding 0.01 ppm
were tetrahydrophthalic acid (THPAI), 5,6 dihydroxyhexahydrophthalamide (diol), and THPI-
epoxide.
In an aerobic soil metabolism study using trichloromethyl (TCM)-labeled active ingredient,
captan degraded with a half-life of less than 1 day in a sandy loam. After 1 day, 46% of the
applied radioactivity was detected as 14CO2, 19.4% was undegraded captan, and 16.7% was unex-
tractable 14C residues. No non-volatile metabolites were detected. In a study submitted in
support of captafol, a compound similar to captan in structure and degradation products, THPI
degraded with a half-life of approximately 4 days. Other degradation products were not identified
(MRIDs 00070414 and 40658007).
Two studies were submitted to determine the degradation rates of THPI in soil. For THPI,
the data provided supplemental information that shows 10 ppm THPI degraded with half-lives
(using best fit equations) of 5.4, 5.8 and 19.5 days, respectively, in aerobically incubated Hyde
Farm sandy loam, Speyer 2.2 loamy sand, and Speyer 2.1 sand soils. The Agency calculated half-
lives that were similar (using linear regression of the natural logarithms - (In) of concentration):
5.8, 6.9 and 20 days, respectively, for Hyde Farm sandy loam, Speyer 2.2 loamy sand, and Speyer
2.1 sand soils. THPI accounted for less than 0.1 ppm at Day 26 (Hyde Farm sandy loam), Day 33
(Speyer 2.2 loamy sand), and at Day 50 (Speyer 2.1 sand soil). The study did not identify any
degradates of THPI. (MRID 43868902).
Anaerobic Soil Metabolism: After 1 day of aerobic incubation followed by 29 days of anaerobic
incubation, only 4.0% of the radioactivity applied to a sandy loam soil was undegraded
trichloromethyl-labeled [14C] captan, 85.6% had evolved as 14CO2, 0.8% was uncharacterized, and
16.6% was unextractable. About 80% of the parent captan had degraded during the 1-day
aerobic period. In addition to THPI, THPAm, and THPAI, a cyano-acid metabolite of captan,
THCY, was identified. Up to 20% of the applied radioactivity was detected as THCY. THCY
and THPAm were stable in anaerobic conditions (MRID 40658008).
In another anaerobic soil metabolism study, carbonyl-labeled [14]C captan was completely
degraded after one week of anaerobic soil conditions. Qualitative reporting of results indicated
that four metabolites, including THPI and THPAm, were detected with very little 14CO2 evolved,
implying that the degradates formed were stable to further anaerobic degradation (MRTD
00098881).
40
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Aerobic Aquatic Metabolism: This study determined the fate of captan and degradates in
water-sediment systems with two contrasting types of sediment. The Old Basing water system, a
method for extracting test sediment, included clay loam at a pH of 8.0 with 12.5 % organic
carbon, and the Virginia water system included a loamy sand at a pH of 6.2 with 3.1% organic
carbon. The application rate was chosen to simulate accidental spraying into a water body during
normal agricultural practices.
The study provides acceptable information that shows captan degrades in the aerobic
aquatic environment with a half-life of less than 24 hours in soil and water. This study fulfills the
guideline requirement. Maximum concentrations of degradates detected, as a percentage of
parent captan applied, were: 81.2% THPI at Day 0, 27% THPAm at Day 7, 10.8% THPAI at
Day 14, and 9.4% THPI epoxide at Day 1. (MRIDs 00096974, 40114502).
The Agency calculated the half-life of THPI in the Old Basing system to be 7 days. THPI
concentrations in the Virginia water system decreased from 51.1% of applied at Day 30 to less
than 0.1 % by Day 60.
The Agency concluded that once captan reaches surface water and hydrolyses (within 24
hours), the degradates (THPI, THPAm, THPAI, and THPI epoxide) probably will not persist in
surface water longer than 60 days (MRTD 43868905).
d. Mobility
Leaching, Adsorption/Desorption: Soil thin layer chromotography (TLC) data indicate that
captan is slightly mobile to relatively immobile in various soils. These data, combined with the
hydrolysis, soil metabolism, and terrestrial field data (see below) indicate that captan is labile, and
demonstrate that the parent compound is not likely to leach significantly in soil.
Two of captan's degradates, THPI and THPAm, appear to have the potential to be mobile
in the soil and to reach surface water via runoff and/or erosion during periods of precipitation
and/or irrigation. (MRTD 43868911). As further confirmatory data, laboratory data submitted for
captafol, a pesticide with a chemical structure similar to captan, also indicate that the degradates
THPI and THPAm are mobile. (MRTD 40658011).
Laboratory Volatility: Volatility does not appear to be an important route of dissipation for
parent captan. Over a 9-day period, approximately 0.003% of ring-labeled captan volatilized
from a sand soil treated at a rate of 1 Ib a.i./A. Approximately 3.9% of the applied radioactivity
volatilized from TCM-labeled captan. None of the labeled volatiles were parent captan (MRTD
00160301).
41
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e. Accumulation
Bioaccumulation in Aquatic Organisms: Two studies, one each for cyclohexene-labeled and
TCM-labeled captan, were reviewed and indicate that residues do not accumulate substantially in
bluegill sunfish. When exposed to a nominal concentration of 5 jig/L of ring-labeled 14C-captan
for 28 days, bluegill sunfish had 14C bioaccumulation factors of 102X, 126X, and 113X for edible,
non-edible, and whole fish tissue, respectively. After a 14-day depuration period, 14C-residues in
edible tissue, non-edible tissue, and whole fish declined by 94%, 96%, and 95%, respectively.
Degradates in exposure water and fish metabolites were not identified. Accumulated residues
were largely eliminated during the depuration period. The data requirement is satisfied and the
Agency is not requiring additional fish accumulation data for captan at this time. (MRTD
40756601, 40756602, 40225601, 00160301).
f. Field Dissipation
Terrestrial Field Dissipation: Six studies were submitted, all of which provide supplemental
information.
Parent captan degraded with half-lives of 2.5 to 24 days and was relatively immobile to
slightly mobile at six sites. The maximum depth at which captan was detected was 6-12 inches.
The degradate THPI was detected at all sites and declined to less than detectable (0.01 ppm)
levels between 14 and 184 days after the final captan treatment. THPI was relatively immobile to
slightly mobile in the study soils. Its maximum depth of detection was 6-12 inches.
The field studies provide relatively consistent estimates of the parent compound's half-life
and the rates of formation and decline of THPI. It is unlikely that any further studies of this type
will change the overall assessment of the dissipation, degradation, mobility, or accumulation of
captan residues in the environment. Therefore, the Agency is not requiring additional terrestrial
field dissipation data at this time (MRID 40823901, 40893601, 40893602, 40893603, 40932201,
40932202).
g. Spray Drift
No captan-specific studies were reviewed. Droplet size spectrum and drift field evaluation
studies (guidlines 201-1 and 202-1) were required since the captan products may be applied by
aircraft and orchard airblast and due to the concern for potential risk to nontarget aquatic
organisms. However, to satisfy these requirements, the registrant, in conjunction with other
registrants, formed the Spray Drift Task Force (SDTF). The SDTF has completed and submitted
to the Agency its series of studies which are intended to characterize spray droplet drift potential.
Factors which appear to affect drift potential and considered in the studies of similiarly applied
pesticides include application methods, application equipment, meteorological conditions, crop
geometry, and droplet characteristics.
42
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The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
State Lead Agencies for pesticide regulation and other parties to develop the best spray drift
management practices. The Agency is now requiring interim mitigation measures for aerial
applications that must be placed on product labels/labeling as specified in Section V . The Agency
has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a
membership of U.S. pesticide registrants, and is developing a policy on how to appropriately
apply the data and the AgDRTFT computer model to its risk assessments for pesticides applied by
air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may
impose further refinements in spray drift management practices to reduce off-target drift and risks
associated with aerial as well as other application types where appropriate. In the interim, the
following spray drift related language is required on product labels that are applied outdoors in
liquid sprays (except mosquito adulticides), regardless of application method: "Do not allow this
product to drift."
h. Water Resources
(1) Ground Water
Modeling
SCI-GROW (Screening Concentrations in Groundwater) is a model for estimating
concentrations of pesticides in groundwater and is based on the fate properties of the pesticide,
the application rate, and the existing body of data from small-scale groundwater monitoring
studies. The model assumes that the pesticide is applied at its maximum rate in areas where the
groundwater is particularly vulnerable to contamination. Usually a considerable portion of any
use area will have groundwater that is less vulnerable to contamination than the areas used to
derive the SCI-GROW estimates. The model is based on permeable (sandy) soils that are
vulnerable to leaching and that overlie shallow (10 to 30 feet deep) groundwater. The estimated
maximum concentration derived using SCI-GROW should be considered an upper-bound estimate
of acute exposure. If the risk associated with this estimate is exceeded either at the acute or
chronic endpoints, refinement of the exposure estimate will be necessary to better characterize
actual exposures.
The screening estimate was made based on a maximum application rate of 32 Ibs ai/A per
year for captan and calculated maximum application rate of 21.36 Ib ai/A for THPI. The THPI
application rate was derived by multiplying the maximum annual rate of 32 Ib ai/A of captan by
0.66, which is the maximum amount of THPI detected in the aerobic soil metabolism study as a
percentage of applied captan. The Agency used the aerobic soil metabolism half-life of 1.3 days
for captan (an average half-life of 10.7 days for THPI) and a Koc value for captan of 200 mL/g
(2.2 mL/g for THPI). The SCI-GROW screening model (ver. 2.0) predicts captan residues of
0.02 //g/L in groundwater and cumulative captan residue (captan and THPI) of 3.4 //g/L.
43
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Monitoring
The information from the Pesticides in Ground Water Database (PGWD) provides only a
limited picture of captan's leaching potential. The PGWD provides the largest compilation of
captan ground water data, detailing results of analyses performed no later than 1990. There are
few data that suggest that captan will leach to ground water as a result of normal agricultural use.
The California summary in the PGWD does not detail whether the samples taken were from
known captan use areas, or were part of large-scale survey studies.
Captan was not detected in the National Pesticide Survey. The greatest number of samples were
taken in California between 1984 and 1989. Four samples had detections of captan out of 1158
analyzed with a range of concentrations from 0.1 to 0.5 ppb.
The PGWD reports that no captan was detected in 670 samples taken from 7 other states
between 1983 and 1990. However, the study summaries indicated that the majority were not
specifically designed to sample captan use areas. Survey studies in Illinois, Indiana, Texas and
Virginia were designed to characterize regional ground-water or drinking-water quality. Specific
use of captan was not investigated in Maine, Rhode Island and Oregon.
As discussed earlier, the environmental fate data for captan suggests that it would not
pose a risk for leaching to ground water. At a pH level of 7.0, captan degrades to THPI by
hydrolysis with a half-life of 5 to 6 hours. At a pH of 9.0, the half-life is only 3.6 to 8 minutes.
Therefore, degradation of captan to THPI would begin with mixing of the fungicide with water
for application.
Captan applied to foliage will not be immediately available for infiltration into the soil.
Studies from the mid-1980's addressed the dissipation of captan from foliage, and derived a range
of half-lives of 3 to 13 days. A further study done on strawberries in California led to a foliar
dislodgeable residue half-life estimate of 9 days. Previous Agency calculations used a foliar half-
life of 10 days. Any captan that reaches the soil surface after application would be subject to an
aerobic soil metabolism half-life of less than a day. Therefore, parent captan is unlikely to pose a
risk of ground water contamination. A concentration of 0.5 ppb is recommended for highly
conservative exposure estimates.
THPI: There are no data on captan degradate THPI, either in the PGWD or in the National
Pesticide Survey. However, fate data for THPI suggest that this degradate would be unlikely to
leach to ground water under most agricultural scenarios. Although laboratory studies show THPI
to be quite mobile, the aerobic soil metabolism half-lives for THPI calculated for three soils were
6, 7 and 19.5 days. The soils for which the 6 and 19.5 day half-lives calculated were from the
same sandy soil types (85 and 90% sand, respectively), but the 19.5 day half-life pertains to the
soil with an organic matter content of 0.7%, as opposed to 3.7% for the other. Therefore, soils
that are quite sandy and have very low organic matter contents seem to provide the only scenario
in which THPI might leach to ground water. Data suggest that even under this scenario, the
amount of THPI that might be available for leaching is limited.
44
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Captan is applied foliarly, and has a reported foliar dissipation rate of 9 or 10 days (Willis
and McDowell, 1987). It also degrades almost completely by hydrolysis in less than a day.
Therefore, unless significant amounts of captan are inadvertently applied to the soil by drift, or a
significant rainstorm washes all applied captan from foliage soon after application, all THPI
formed will not be uniformly made available for leaching by a single effective application to the
soil. It is not clear from our data what percentage of parent captan is converted to THPI by
hydrolysis. However, THPI formed through aerobic soil degradation of captan accounted for a
maximum 66% of the parent compound in laboratory studies.
Furthermore, a very small portion of crops (orchard fruit trees) to which captan is applied
will be grown on sandy soils with very low organic matter. In addition, most crops on the captan
label have fewer than half of their total acreage treated with captan. The one exception to both
statements is strawberries, which are grown predominantly on such soils, and which are almost
universally treated with captan. The potential for leaching is reduced for strawberries by the use of
plastic sheeting mulch and subsoil drip irrigation. In Florida, one of the major states where
strawberries are grown, the very shallow depth to ground water makes it very likely that THPI
concentrations could be found in ground water.
(2) Surface Water
Due to the range of field dissipation half-lives (2.5 to 24 days), substantial amounts of
captan could be available for runoff to surface water for a few days to several weeks post-
application. The relatively low soil/water partitioning of captan for 4 soils indicates that most
captan runoff will be via dissolution in runoff water as opposed to adsorption to eroding soil.
Captan is susceptible to rapid abiotic hydrolysis and to fairly rapid microbiological
degradation under both aerobic and anaerobic conditions. Consequently, it is not expected to
persist in surface waters under most hydrological or chemical conditions. Its relatively low
soil/water partitioning indicates that most of the captan in surface waters will be dissolved in the
water column as opposed to adsorbed to suspended and bottom sediment. As discussed earlier,
the bioaccumulation potential for captan is relatively low.
The State of Illinois (Moyer and Cross 1990) sampled 30 surface water sites for pesticides
at various times from October 1985 through October 1988. Substantial use in Illinois was a
criterion for pesticides being included in the analyses. Total (dissolved and adsorbed to
suspended sediment) captan was not detected above a detection limit of 0.05 ug/L in any of 580
samples collected from the 30 sites sampled.
The major degradates, THPI and THPAm, exhibit low soil/water partitioning indicating
that most of their runoff will be via dissolution in runoff water as opposed to adsorption to
eroding soil. Both degrade at rates comparable to those of captan (relatively rapidly) under
aerobic conditions.
45
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Based on fate characteristics and model predictions, the Agency believes THPI could
reach surface drinking water sources. Surface water concentrations were modeled with PRZM2
and EXAMS using the Georgia peach scenario that produced the highest 90-day aquatic pesticide
level for captan. Chemical-specific inputs, standard model parameters and the PRZM2 input file
are available. The results of the PRZM2-EXAMS simulation of THPI concentrations resulting
from maximum label use-rate of captan on peaches are shown below.
Average THPI Concentration (ppb)
Frequency (years)
1/10
Peak
668
96-Hour
385
21-Day
123
60-Day
50.9
90-Day
34.1
Yearly
10.8
The Agency recommends that 668 ppb be considered as a highly conservative estimate for
acute surface drinking water levels of THPI. Average chronic levels for 90 and 365 days are 34.1
and 10.8 ppb, respectively.
Tier 2 surface water modeling used the following data for input into the PRZM-EXAMS
modeling. The following shows the scenarios used:
Parameter Value
Soil Koc 200 L/g
Aerobic soil half-life 1.25 days
Anaerobic soil half-life 1.85 days
Photolysis half-life (pH 7) 0.42 days
Hydrolysis (pH 5, 7 and 9)0.8, 0.25, 0.006 days
Water Solubility 3.3 mg/L
Vapor Pressure 8.0 E-8 Torr
Henry's Law Constant 9.59 E-10 Atm. M3Mor'
PRZM-EXAMS Modeling Input Scenarios
Crop
Almonds
Apple
Peaches
Prunes
Cherries
Blueberries
Location
Los Angeles, CA
Columbia, NY
Spartanburg, SC
Los Angeles, CA
San Joaquin, CA
Van Burn, MI
Weather
(MLRA)
C-20
R-144B
P-136
C-20
C-17
L-97
Soil
Rincon Silty clay loam
Lehigh Silt loam
Cecil Sandy loam
Rincon Silty clay loam
Chino Silt loam
Rimer Loamy sand
Soil Taxonomy
Mollic Haploxeralf
Aquic Hapludalf
Typic Hapludult
Mollic Haploxeralf
Aquic Haploxeroll
Arenic Hapludalf
46
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3. Ecological Exposure and Risk Characterization
a. Risk Quotient (RQ) and the Level of Concern (LOC)
The Levels of Concern are criteria to indicate potential risk to nontarget organisms. The
criteria indicate whether a chemical, when used as directed, has the potential to cause undesirable
effects on nontarget organisms. There are two general categories of LOC (acute and chronic) for
each of the four nontarget faunal groups and one category (acute) for each of two nontarget floral
groups. To determine whether an LOC has been exceeded, a risk quotient must be derived and
compared to the LOC's. A risk quotient is calculated by dividing an appropriate exposure
estimate, e.g. the estimated environmental concentration, (EEC) by an appropriate toxicity test
effect level, e.g. the LC50. Acute effect levels are as follows:
-EC25 (terrestrial plants),
-EC50 (aquatic plants and invertebrates),
-LC50 (fish and birds), and
-LD50 (birds and mammals)
Chronic effect levels are as follows:
-NOEL (sometimes referred to as the NOEC) for avian and mammal reproduction
studies, and either
-The NOEL for chronic aquatic studies, or
-The Maximum Allowable Toxicant Concentration (MATC), the geometric mean
of the NOEL and the LOEL (sometimes referred to as the LOEC) for chronic
aquatic studies.
When the risk quotient exceeds the LOC for a particular category, the Agency presumes a
risk of concern to that particular category. Risk presumptions are presented along with the
corresponding LOC's.
47
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Levels of Concern (LOG) and associated Risk Presumption
IF...
THEN the Agency presumes...
Mammals and Birds
The acute RQ > LOC of 0.5,
The acute RQ >LOC of 0.2,
The acute RQ > LOC of 0. 1,
The chronic RQ > LOC of 1
High acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in Endangered species
Chronic risk and
Chronic effects may occur in Endangered species
Fish and Aquatic Invertebrates
The acute RQ > LOC of 0.5
The acute RQ > LOC of 0. 1
The acute RQ >LOC of 0.05
The chronic RQ > LOC of 1
High acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in Endangered species
Chronic risk and
Chronic effects may occur in Endangered species
Plants
The RQ > LOC of 1
The RQ > LOC of 1
High risk
Endangered plants may be affected
No separate criteria exist for restricted use or chronic effects for plants.
b. Exposure and Risk to Nontarget Terrestrial Animals
(1) Birds
Residues found on dietary food items following captan application are compared to LC50
values to predict hazard. The maximum concentrations of residues of captan which may be
expected to occur on selected avian or mammalian dietary food items following both single and
multiple foliar application rates are provided in the tables below. Residues per Ib ai applied for
the four food types are developed from Hoerger and Kenaga (1972) and Kenaga (1973), with
modifications suggested by Fletcher et. al. (1994); the "broadleaf plants" category includes forage
and is considered applicable to small insects while the "fruits" category includes seeds and is
considered applicable to large insects.
There are no definitive risk quotients for avian acute risk since definitive LC50s are not
available (3 deaths occurred at 5200 ppm in the bobwhite quail study --MRTD 43869802, but no
mortality was reported at 4640 ppm in MQRTD 00104686). The following terrestrial exposure
table for a single application shows that no acute avian LOCs are exceeded for any use pattern.
48
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Terrestrial EECs - Single Application"
Use Site
Almonds
Apples
Peaches
Nectarines Turf
Pears
Plums/fresh prunes
Strawberries
Apricots
Blueberries
Cherries
Grapes
Applic. rate
4.5
4
3
2.5
2
Food item
short grass
long grass
broadleaf plants/ insects
seeds
short grass
long grass
broadleaf plants/ insects
seeds
short grass
long grass
broadleaf plants/ insects
fruits/seeds
short grass
long grass
broadleaf plants/ insects
fruits/seeds
short grass
long grass
broadleaf plants/ insects
fruits/seeds
max EEC (ppm)
1,260
578
709
79
960
440
540
60
720
330
405
45
600
275
338
38
480
220
270
30
Maximum residues from a single application are below the no-mortality levels for all
species tested and are thus unlikely to result in avian mortality from dietary exposure.
For multiple applications, a terrestrial exposure model called FATE is used to estimate
residues based on accumulation from repeat applications at a given interval and degradation rate
due to estimated foliar dissipation. Since actual foliar half-life data are not available, the
dissipation half-life (9 days) was estimated, based partly on dislodgeable residue information
available to the Agency. Where maximum residue values are used, captan concentrations are
expressed as EEC maximum (max) and average maximum (avg. max.). When mean values are
used captan concentrations are expressed as EEC average mean.
49
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Ter
restrial EECs - Multiple Ap
Use Site
Almonds
Turf
Apples
Peaches
Nectarines
Pears
Plums/fresh
prunes
Strawberries
Apricots
Blueberries
App. rate
(Ibs ai/A)
4.5
4
4
4
3
3
2.5
No. of
apps.
5
8
7
8
9
7
14
slications*
Applic.
interval
(days)
5
7
7
3
7
7
7
Food item
short grass
long grass
broadleaf
plants/insects
seeds
short grass
long grass
broadleaf
plants/insects
seeds
short grass
long grass
broadleaf
plants/insects
seeds
short grass
long grass
broadleaf
plants/insects
seeds
short grass
long grass
broadleaf
plants/insects
fruits/seeds
short grass
long grass
broadleaf
plants/insects
fruits/seeds
short grass
long grass
broadleaf plants
fruits/seeds
EEC
(ppm)
max.
3,368
1,545
1,895
211
2,272
1278
142
2,250
1,161
1266
159
3,921
1,797
2205
245
1714
786
964
107
1688
949
105
1439
660
811
91
EEC
(ppm)
avg.
max.
2168
1220
1572
859
95
1485
835
2589
1187
1456
1170
658
1113
626
70
1038
585
EEC
(ppm)
max.
mean
1192
630
797
422
1388
588
735
607
321
598
316
510
271
EEC
(ppm)
avg.
mean
767
406
N/A
N/A
N/A
N/A
526
278
917
388
486
415
220
394
208
368
196
50
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Use Site
Cherries
Grapes
App. rate
(Ibs ai/A)
2
No. of
apps.
7
Applic.
interval
(days)
3
Food item
short grass
long grass
broadleaf
plants/insects
fruits/ seeds
EEC
(ppm)
max.
1,865
855
1,049
117
EEC
(ppm)
avg.
max.
1219
686
EEC
(ppm)
max.
mean
660
350
EEC
(ppm)
avg.
mean
432
229
Each of the above crop groupings has a similar use pattern. The number of applications (based on
maximum seasonal rates) and application intervals for underlined crops are considered representative.
Foliar half-life used is 9 days.
For the sites evaluated, estimated maximum residues resulting from multiple applications
at the maximum rates and minimum intervals are below the no-mortality level in all avian LC50
tests. Thus, it appears unlikely that these dietary residues would result in avian mortality.
Avian reproduction testing was conducted at up to 1000 ppm, with no effects reported.
An evaluation of all foliar uses at the maximum label rates; multiple applications and minimum
intervals would potentially result in maximum residues greater than 1000 ppm on most avian food
items. However, without data for higher concentrations, the Agency cannot determine if higher
residues could cause adverse reproductive effects. A refinement of the exposure assumptions for
orchards suggests lower residues and therefore less likelihood for chronic risk. The refined
exposure assessment is based on the following assumptions:
1) Maximum residues were outliers resulting from a direct application. Note that in the
case of short grass the maximum (240 ppm) vs. the mean value (85 ppm) differ by 3X.
2) To be consistent with the assumption in aquatic exposure models for aerial or mist
blowers, only a portion (<100%) of the application rate is assumed to hit or be retained in
the target area at the time of or shortly after application.
3) The duration of a bird's exposure to the specific dose level should be considered.
Assuming a direct application of 100% of the applied rate reaches the orchard floor to
contaminate short grass (as contrasted with a bare floor, long grass or even an intermediate
substrate such as broadleaf vegetation) these average residues for short grass in almond orchards
could range from 767 to 2168 ppm (based on mean and maximum values respectively). Given the
previously mentioned assumptions for orchard uses, chronic risks to both birds and small ground-
dwelling mammals will be based on average mean values unless stated otherwise. Since none of
the average mean values exceed the NOEL of 1000 ppm, there does not appear to a chronic risk
to birds from captan's use in orchards.
51
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Captan's use on crops such as strawberries and turf results in a direct application to avian
food items; consequently the average maximum value was compared to the NOEL for a
preliminary chronic risk assessment resulting in risk quotients are between 1 and 2.2. Repeating
the avian reproduction study would reduce the uncertainty, but the value added would be low. In
the case of turf, residues could be reduced as result of increased biomass as the grass grows and
the subsequent cutting and potential removal of clippings (especially on the intensively cared-for
turf— greens, tees and lawns). Strawberries grown commercially (where direct application of
captan use is likely to occur) will have little if any competing vegetation - especially if the
strawberries are grown using plastic mulches. Since captan residues are below 1000 ppm for
insects, fruit and the strawberry plants, no chronic risk is anticipated.
(2)
Mammals
Small mammal exposure is addressed using the acute oral LD50 values converted to
estimate a LC50 value for dietary exposure. The estimated LC50 uses the following formula:
LC50 = LD;o x body weight (g)
food cons, per day (g)
Small Mammal Food Consumption in PPMs (Based on an LD50 = 9 gm/kg)
Small Mammal
Meadow Vole
Adult Field Mouse
Least Shrew
Body Weight
(gm)
46 gms
13 gms
5 gms
% Weight
Eaten/Day
61%
16%
110%
Food/Day (gm)
28.1 gms
2.1 gms
5.5 gms
Est. LC50/Day
(ppm)
14733 ppm
557 14 ppm
8181 ppm
The above table is based on information contained in Principles of Mammology by D. E. Davis and F. Golly,
published by Reinhold Corporation, 1963.
The estimated LC50 is then compared to the residues listed above to calculate a risk
quotient (EEC/LC50). The estimated LC50 in these calculations can be considered as the
concentration of toxicant in a day's diet, lethal to 50% of a test population.
Single applications of captan to almonds, apples, peaches, nectarines, turf, plums/fresh
prunes, strawberries, apricots, blueberries, cherries and grapes with single application rates
ranging from 2-4.5 Ibs a.i/A result in risk quotients (RQ) less than 0.1. The exposure estimates
used for terrestrial risk assessment are based on the work of Hoerger and Kenaga (1972) as
modified by Fletcher et al. (1994). All of the single application residues leave a predicted residue
below the level of concern for all acute risk categories of mammals, including endangered species.
Acute and chronic risk quotients for multiple applications were also evaluated. The
quotients serve as a screen for depicting the potential acute and chronic risk to small mammals.
The chronic risk quotients are expressed based on the range of NOELs of 250 and 2000 ppm
52
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extracted from mammalian reproduction and developmental studies. The following table indicates
that the acute restricted and endangered species LOCs are exceeded for almonds and peaches, and
that the acute endangered species LOG is exceeded for all other sites. Chronic risk to small
mammals is predicted to occur for all foliar uses when residues are based on maximum estimated
exposure values.
Quotients — Multiple Ap
Use Site
Turf
Almonds
Apples
Peaches
Pears
Plums/fresh prunes
Strawberries
Apricots
Cherries
Grapes
App. rate
4
4.5
4
4
3
3
2.5
2
plications, Maximum EEC*
# Apps.
8
5
7
8
9
7
14
7
App. interval (days)
7
5
7
3
7
7
7
3
Small mammal
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
Acute RQ
0.15
<0.1
0.16
0.23
<0.1
0.23
0.17
<0.1
0.17
0.27
<0.1
0.27
0.12
<0.1
0.12
0.11
<0.1
0.11
0.1
<0.1
0.1
0.13
<0.1
0.13
Chronic RQ
1.14-9.1
0.07-0.6
0.64-5.1
1.7-13.5
0.11-0.84
0.95-7.6
1.3-10.1
0.1-0.64
0.71-5.7
2.0-15.7
0.12-9.8
1.1-8.8
0.9-6.9
0.05-0.43
0.5-3.9
0.8-6.8
0.5-3.8
0.1-0.6
0.7-5.8
0.1-0.36
0.4-3.2
0.9-7.5
0.1-0.47
0.5-4.2
Each of the above crop groupings has a similar use pattern. The number of applications (based on maximum seasonal rates) and application intervals
for underlined crops are considered representative. Foliar half-life used is 9 days. The current standardized models are as follows: -meadow vole
consuming short grass; -adult field mouse consuming seeds; -least shrew consuming forage and small insects
Multiple application risk quotients have been calculated based on the following
assumptions:
53
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1. The turf use is a direct application to food of the following: short grass for the
herbivore (the meadow vole) and the insects for the insectivore (the shrew) and the seeds
of the granivore (field mouse). Acute risk will be based on maximum Fletcher residues and
chronic risk will be compared to the average maximum Fletcher residue values.
2. Strawberry use is direct application to food of ground foraging insectivores, fruit eaters
and herbivores (see above). Acute and chronic risk is based on the same principle as turf.
3. Most other crops are orchard crops with indirect application to non-target plant
material. Cover on orchard floors could vary from bare ground to short grass, long grass
or broadleaf plants. The understory would not be sprayed directly, but contaminated by
some spray at the time of application and by material dripping from tree canopy. The
understory could be food for the vole. The broadleaf plants value (between the short
grass and long grass) is used for the herbivorous meadow vole. The field mouse and the
shrew would ingest seeds and insects on the floor that have not been sprayed directly.
Mammal Risk Quotients*
Use Site
Turf
Almonds
Apples
Peaches
Pears
Plums/fresh prunes
Strawberries
Apricots
App. rate
4
4.5
4
3
3
2.5
# Apps.
8
5
7
9
7
14
App. interval (days)
7
5
7
7
7
7
Small mammal
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
Acute RQ
0.17**
<0.1
0.17**
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
0.11**
<0.1
0.11**
<0.1
<0.1
<0.1
Chronic RQ
0.8-6.3***
<0.3
0.4-3.4***
<0.3-1.6
<0.3
<0.3-1.6
<0.3-1.1
<0.3
<0.3-1.1
<0.3-1.9
<0.3-1.9
<0.3-0.9
<0.3
<0.3-0.9
0.5-4.4***
<0.3
0.3-2.5***
<0.3-0.8
<0.3
<0.3-0.8
54
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Use Site
Cherries
Grapes
App. rate
2
# Apps.
7
App. interval (days)
3
Small mammal
meadow vole
field mouse
least shrew
Acute RQ
<0.1
<0.1
<0.1
Chronic RQ
<0.3-0.9
<0.3
<0.3-0.9
Note: number of applications (based on maximum seasonal rates) and application intervals for underlined crops are representative of crop groupings.
Estimated foliar "half-life" used is 9 days. The current standardized models are as follows: -meadow vole consuming short grass; -adult field mouse
consuming seeds; -least shrew consuming forage and small insects. Broadleaf plants value is used to calculate meadow vole risk quotients in orchard
crops.
* Multiple Applications: Mean maximum EEC for acute risk (except as noted); Average Mean EEC for chronic risk(except as noted)
** Maximum Fletcher residue value
*** Average maximum Fletcher residue value
With multiple applications, the acute endangered species LOG is exceeded for turf use, as
is the chronic risk for herbivores and insectivores. The magnitude of this risk may be small if this
use is for spot treatment on sod farms, golf greens, or even home lawns. Strawberries potentially
exceed endangered species concern for small insectivores and herbivores. No other sites exceed
any of the acute LOCs. The multiple applications of uses of captan for almonds, apples and
peaches exceed the chronic LOG for herbivores by slightly over 1.0. The actual risk could be
lower as the residues (even though they were the average mean value over the application period)
were based on the understory being directly sprayed. The indirect spray values are likely less than
those predicted for a direct spray. Consequently, the chronic risk would be further reduced. The
acute and chronic risk from captan's use on strawberries is uncertain depending upon the use of
maximum (some risk) or mean Fletcher residue values (minimal risk).
(3) Terrestrial Insects
Ecological toxicity data on honey bees indicate that captan does not appear to pose a risk
to insects. No further risk assessment will be conducted.
(4) Nontarget Aquatic Animals
Expected Aquatic Concentrations: The Agency uses the GENeric Expected Environmental
Concentration program (GENEEC) to calculate screening level EECs in water based on drift and
runoff from a 10 hectare field to a 1 hectare x 2 meter deep water body. These EEC's take into
account degradation in the field prior to a rain event as well as degradation and partitioning in the
pond. Since the Agency does not have a refined exposure scenario for turf, the GENEEC
program was used. GENEEC was also used to estimate the exposure from typical use rates for
the following sites: almonds, apples, peaches, prunes, and cherries.
A refined EEC is included for those use sites that the Agency modeled using the Pesticide
Root Zone Model (PRZM2) to simulate pesticide movement off site via drift and field runoff, and
the Exposure Analysis Modeling System (EXAMS II) to simulate pesticide fate and transport in
an aquatic environment (one hectare x 2 meter deep).
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Estimated Environmental Concentrations (EECs) for Captan*
Crop
Turf
Almonds
Apples
Peaches
Prunes
Cherries
Blueberries
Application
Method
foliar
spray blast
spray blast
spray blast
spray blast
spray blast
spray blast
Application
Rate in Ibs a.i./A
(No. of applies.)
4.0 (8)
4.5 (5)
4.0 (8)
4.0 (8)
3.0 (9)
2.0 (7)
2.5(14)
Initial
EEC
(ppb)
43.4
91.7
49.6
104.8
57.9
6.9
36.8
4-day
EEC
(ppb)
11.6
19.8
10.6
19.5
13.1
2.0
6.7
21-day
EEC
(ppb)
2.2
5.5
3.3
6.9
3.8
1.1
1.7
60-day
EEC
(ppb)
0.8**
3.3
2.9
6.0
3.5
0.97
1.6
90-day
EEC
(PPI>)
2.6
2.0
4.0
2.6
0.65
1.5
*EECs for all sites, except turf, from Agency review using PRZM2 (version 2.3) and EXAMS II. Turf EECs from GENEEC model.
"average 56-day EEC
(5) Freshwater Fish
The acute and chronic risk quotients are reported below:
Risk Quotients (RQ) for Freshwater Fish
Crop/appl, rate (Ib ai/A)/ # of appls.
Turf (4.0)/ 8
Almonds (4.5)7 5
Apples (4.0)/ 8
Peaches (4.0)/ 8
Prunes (3.0)/9
Cherries (2.0)7 7
Blueberries (2.5)7 14
Acute RQ
1.6
3.5
1.9
4.0
2.2
0.3
1.4
Chronic RQ
0.03
0.10
0.08
0.16
0.10
0.03
0.05
Acute RQ = initial EEC/LC50 (LC50 for brown trout, most sensitive species, = 26.2 ppb); Chronic RQ =
90-day EEC*/geometric mean offish full life-cycle NOEL and LOEL (= 25.5 ppb, fathead minnow)
*56-day EEC for turf (GENEEC model)
Foliar turf applications and air blast applications to fruit and nut crops (except cherries)
are expected to exceed high acute risk, restricted use, and endangered species LOCs for fish. Use
on cherries exceeds only the restricted use and endangered species LOCs. These RQ's are based
on the lowest fish LC50. The three lake trout studies illustrate that, regardless of the test
conditions: (flow through vs static) or duration (24 vs 96 hour) the LC50 values are very similar
(53 - 75 ppb for 24 hr LC50 and 49 - 53 for 96 hr LC50). Although using an LC50 of 50 ppb
would reduce the risk quotient by approximately one half, the acute high risk, restricted use and
and endangered species LOG remain exceeded except for cherries where only the endangered
species LOG is exceeded.
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Chronic risk to fish is not expected based on the MATC (geometric mean of the NOEL
and LOEL) derived from fathead minnow fish full life when compared to the EEC averaged over
90 days. A lower MATC can be estimated for the most sensitive fish, brown trout, by dividing an
application factor of 5.3 into 26.2 ppb (the brown trout 96 hour LC50). The middle value was
selected simply to strike a balance between the other values. Utilizing the application of 5.3
results in a MATC of 4.8 ppb for the brown trout. Since this value is not exceeded by the highest
90 day EEC (3.0 ppb) there does not appear to be a chronic risk to fish.
(6) Freshwater Invertebrates
The acute and chronic risk quotients are reported below:
Risk Quotients (RQ) for Freshwater Invertebrates
Crop/application rate (Ib
ai/A)
Turf (4.0)
Almonds (4.5)
Apples (4.0)
Peaches (4.0)
Prunes (3.0)
Cherries (2.0)
Blueberries (2.5)
Acute RQ
0.03
0.08
0.04
0.08
0.04
0.01
0.03
Chronic RQ
<002
<002
<0.02
<0.02
<0.02
<0.02
<0.02
lowest LC50 for D. magna = 1300 ppb; acute RQ = initial EEC/LC50; chronic NOEL < 560 ppb.
The endangered species acute LOG is exceeded for the following modeled sites: turf,
almonds, and peaches. There does not appear to be a chronic risk to aquatic invertebrates for any
use. It is not likely that the daphnia chronic NOEL would be lower than the highest 21 day EEC,
much less the next highest 21 day EEC of 6.9 ppb for peaches.
(7) Estuarine and Marine Animals
In order to assess the risk to estuarine organisms from the turf use the Agency requires a
96-hour LC50 study for an estuarine fish, shrimp, and a 48-hour embryo larvae study OR a 96-
hour shell deposition study with oysters. The registrant recently submitted a 96-hour LC50 study
with the sheepshead minnow and a static toxicity study with the saltwater mysid, and must submit
a 96-hour shell deposition study.
c. Ecological Risk Due to Seed Treatments
Foliar treatments of captan would generally be expected to pose a greater risk to aquatic
life because of repeat applications, runoff, and drift. Also, foliar treatments are not soil-
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incorporated whereas seed treatments would be to varying degrees. The Agency does not
currently have the capacity to estimate runoff resulting from seed treatments.
In general, seed treatments have the potential to pose risks to birds since seeds could be
attractive as a food item. In the case of captan, however, the chemical is generally in the
practically nontoxic category for birds, implying low risk. The highest exposure, and thus risk,
would appear to be with grass seed. That use is at the highest labeled application rate (9 oz.
ai/100 Ibs of seed). Captan is broadcast, as opposed to being placed in furrows, and is applied to
lightly cover the seeds, allowing for germination. This rate translates into approximately 5625
ppm on the seeds. If a bird's diet were composed entirely of treated seeds, the residues would be
slightly higher than the highest test level in most dietary studies, where no mortality was seen.
Since a bird's diet does not consist entirely of seeds, there is expected to be no risk.
d. Endangered Species
The Agency has concerns about the exposure of threatened and endangered animal and
fish species to captan. With multiple applications, the acute endangered species LOG has been
exceeded on turf. Additionally, LOCs are exceeded for endangered species of freshwater fish for
all foliar, turf and spray blast applications including almonds, apples, peaches, prunes, cherries and
blueberries. LOCs are exceeded for endangered species of freshwater invertebrates for turf,
almonds and peaches.
The Agency is developing a crop-based program - the Endangered Species Protection
Program to identify all pesticides whose use may cause adverse impacts on endangered and
threatened species, and to implement mitigation measures that will eliminate the adverse impacts.
The program would require use restrictions to protect endangered and threatened species at the
county level. Consultations with the Fish and Wildlife Service may be necessary to assess risks to
newly listed species or from proposed new uses. In the future, the Agency plans to publish a
description of the Endangered Species Program in the Federal Register and have available
voluntary county-specific bulletins. Because the Agency is taking this approach for protecting
endangered and threatened species, it is not imposing label modifications at this time through the
RED. Rather, any requirements for product use modifications will occur in the future under the
Endangered Species Protection Program.
e. Risk Characterization Summary
The ecological risk analysis indicates that captan is relatively a short-lived fungicide in
terrestrial environments. Persistence of the parent in ground or surface water is not expected.
Direct and indirect evidence indicates that residues of THPI and TUP Am may persist in the soil
for several months following captan application. Neither of the major degradates is likely to leach
to ground water except in cases where soils are quite sandy and of low organic matter content.
No acute or chronic toxicity to birds was recorded at any of the concentrations tested
(maximum levels of 5000 ppm and 1000 ppm, respectively). The potential for chronic risk to
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avian species is uncertain because test animals were not dosed at levels sufficient to cause an
effect. Although risk quotients were therefore not established for avian species, mulitple
applications of captan at the minimum application interval would potentially result in maximum
residues greater than the 1000 ppm NOEL for most avian food items.
A refinement of the exposure assumptions for orchards suggests lower residues and
therefore less likelihood for chronic risk. The refined exposure assessment is based on the
following:
1) Maximum residues were outliers resulting from a direct application. Note that in the
case of short grass the maximum (240 ppm) vs. the mean value (85 ppm) differ by 3X.
2) Direct application to avian food items will only occur in the cases of turf, strawberries
and insects and fruits in the orchard canopy.
3) To be consistent with the assumption in aquatic exposure models for aerial or mist
blowers, only a portion (<100%) of the application rate is assumed to hit or be retained in
the target area at the time of or shortly after application.
4) The duration of a bird's exposure to the specific dose level should be considered.
Assuming a direct application of 100% of the applied rate reaches the orchard floor to
contaminate short grass (as contrasted with a bare floor, long grass or even an intermediate
substrate such as broadleaf vegetation) these average residues for short grass in almond orchards
could range from 767 to 2168 ppm (based on mean and maximum values respectively). Only the
higher value exceeds the NOEL by 2. Given the previously mentioned assumptions for orchard
uses, chronic risks to birds will be based on average mean values unless stated otherwise. Since
none of the average mean values exceed the NOEL of 1000 ppm there does not appear to a
chronic risk to birds from captan's use in orchards.
Captan's use on strawberries and turf results in a direct application to avian food items;
consequently the average maximum value was compared to the NOEL for a preliminary chronic
risk assessment. The NOEL (>1000 ppm) is exceeded in some instances; the risk quotients are
between 1 and 2.2. Repeating the avian reproduction study would reduce the uncertainty, but the
value added would be low. In the case of turf, residues could be reduced as result of increased
biomass as the grass grows and the subsequent cutting and potential removal of clippings
(especially on the intensively cared-for turf— greens, tees and lawns). Strawberries grown
commercially (where direct application of captan use is likely to occur) will have little if any
competing vegetation — especially if the strawberries are grown using plastic mulches. Since
captan residues are below 1000 ppm for insects, fruit and the strawberry plants, no chronic risk is
anticipated.
Acute risk to mammals is not expected from the use of captan according to label
directions. However, there is chronic risk to mammals predicted for all foliar uses at the
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maximum predicted EECs. Captan was considered non-toxic to the required insect test species,
the honeybee.
Captan is acutely toxic to fish and predicted EEC's exceed levels of concern for acute risk
to freshwater fish for most crops simulated. Chronic risk to fish is not anticipated at any of the
single or multiple use rates. The EECs used for these assessments are based on the maximum
application rates and minimum application intervals allowed on the captan label.
Typical rates are usually less than the maximum label rates. The following tables show
that although the resulting EECs are less than those for maximum application rates, acute levels of
concern for freshwater fish are still exceeded when captan is applied at typical rates.
Estimated Environmental Concentrations (EECs) for Captan*
Crop
Turf
Almonds
Almonds
Apples
Peaches
Prunes
Cherries
Blueberries
Application
Method
foliar
spray blast
spray blast
spray blast
spray blast
spray blast
spray blast
spray blast
Typical Appl.
No. of applies, x
(rate)
1 x (2.7)
2 x (2.7)
3x(2.3)
3x1.6
1 x (2.7)
2x(2.3)**
Initial
EEC (ppb)
27.5
28.1
23.9
16.6
27.5
23.9
....
21-day
EEC
(Ppb)
....
1.4
1.4
1.2
0.9
1.4
1.2
...
56-day
EEC
(ppb)
_
0.5
0.5
0.4
0.3
0.5
0.4
...
*Maritz report of 1991 (EPA)
"Higher than maximum label rate
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Risk Quotients (RQ) for Freshwater Fish
Total seasonal application
rate (Ib ai/A)
Turf —
Almonds (3.1)
Apples (8.0)
Peaches (4.3)
Prunes (3.7)
Cherries (5.0)
Acute RQ
1.0 *
0.8 *
0.6 *
1.0 *
0.8 *
Acute RQ = initial EEC/LC50 (LC50 for brown trout, most sensitive species, = 26.2 ppb)
* exceeds high acute, restricted use and endangered species LOC's
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing an active ingredient
are eligible for reregistration. The Agency has previously identified and required the submission
of data to support reregistration of products containing captan. The Agency has completed its
review of these data. Appendix B identifies the generic data that the Agency reviewed as part of
its determination of reregistration eligibility of captan and lists those studies that the Agency
found acceptable.
These data were also sufficient to allow the Agency to determine that captan, labeled and
used as specified in this Reregistration Eligibility Decision, can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore finds that
products registered for these specific uses containing captan as the sole active ingredient are
eligible for reregistration, provided actions are taken as specified in this document. Actions
needed to reregister particular products are addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the review and
evaluation of the data required for reregistration, the current guidelines for conducting acceptable
studies to generate these data, and published scientific literature. Although the Agency has found
most uses of captan are eligible for reregistration, it should be understood that the Agency may
take appropriate regulatory action, and/or require the submission of additional data to support the
registration of products containing captan, if new information comes to the Agency's attention or
if the data requirements for registration (or the guidelines for generating such data) change.
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1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient captan, the Agency has
sufficient information on the health effects of captan and on its potential for causing adverse
effects in fish, wildlife, and the environment. The Agency has determined that captan products,
labeled and used as specified in this Reregi strati on Eligibility Decision, will not pose unreasonable
risks of adverse effects to humans or the environment. Therefore, the Agency concludes that
products containing captan are eligible for reregi strati on, subject to the terms and conditions of
this RED, except for those with uses on turf and aerially-applied wettable powder formulations.
Products applied to turf at sod farms or golf courses are eligible for reregi strati on; uses at all
other turf sites are being voluntarily cancelled. Wettable powder formulations that are applied
aerially are eligible for reregi strati on, provided either: 1) the products are packaged in water
soluble packaging; or 2) the application rates are reduced to a level that is no higher than 1.2 Ib
ai/A.
2. Eligible and Ineligible Uses
The Agency has determined that some uses of captan are eligible for reregi strati on under
the conditions specified in this Reregi strati on Eligibility Decision. The uses of captan on turf,
other than sod farms and golf courses, and the aerial use of the wettable powder formulations
require changes before they may be eligible for reregi strati on.
B. Regulatory Position
To lessen the risks posed by captan, EPA is requiring the following mitigation measures
for captan-containing products:
Voluntary cancellation of all turf uses, other than those at sod farms or golf
courses, to lessen the hand-to-mouth ingestion risk to toddlers.
Various combinations of chemical-resistant gloves, chemical resistant
aprons/coveralls, eye protection, water soluble packaging for wettable powders,
and dust/mist respirators to lessen the risks to workers
Labeling changes to lessen risks to nontarget aquatic organisms. Specific label
language is provided in Section V of this document.
The following is a summary of the Agency's regulatory position and rationale for
managing risks associated with the use of captan. Where labeling revisions are imposed, specific
language is set forth in Section V of this document.
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1. Food Quality Protection Act Findings
a. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for captan, with the amendments and
changes specified in this document, meet the safety standards under the FQPA amendments to
section 408(b)(2)(D) of the FFDCA, that there is a reasonable certainty of no harm for the general
population. In reaching this determination, EPA has considered the available information on the
aggregate exposures (both acute and chronic) from non-occupational sources, food and drinking
water. Section 408(b)(2)(D)(v) of the Food Quality Protection Act requires that, when
considering whether to establish, modify, or revoke a tolerance, the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The Agency believes that "available
information" in this context might include not only toxicity, chemistry, and exposure data, but also
scientific policies and methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although the Agency has some
information in its files that may turn out to be helpful in eventually determining whether a
pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues concerning common
mechanism of toxicity in a meaningful way.
EPA has begun a pilot process to study this issue further through the examination of
particular classes of pesticides. The Agency hopes that the results of this pilot process will
increase the Agency's scientific understanding of this question such that EPA will be able to
develop and apply scientific principles for better determining which chemicals have a common
mechanism of toxicity and evaluating the cumulative effects of such chemicals. The Agency
anticipates, however, that even as its understanding of the science of common mechanisms
increases, decisions on specific classes of chemicals will be heavily dependent on chemical specific
data, much of which may not be available at present.
At this time, the Agency does not know how to apply the information in its files
concerning common mechanism issues to most risk assessments; however, there are pesticides for
which the common mechanism issues can be resolved. For example, pesticides that are
toxicologically dissimilar to existing chemical substances (in which case the Agency can conclude
that it is unlikely that a pesticide shares a common mechanism of activity with other substances)
and pesticides that produce a common toxic metabolite (in which case common mechanism of
activity will be assumed).
Captan and folpet share a common metabolite, thiophosgene, which is believed to be
responsible for the carcinogenic effects of these compounds. Thiophosgene is a highly reactive,
short-lived species. Studies indicate that thiophosgene causes local irritation of the site with which
it comes in contact, and is believed to cause tumors through the irritation of the duodenum.
Because they are so short-lived, thiophosgene residues cannot be quantified. Without measurable
residues of the common metabolite, it is difficult to relate exposures of captan to those of folpet
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since the rate of formation of thiophosgene may be different for both compounds. However,
assuming that the carcinogenic effects observed in both pesticides are due solely to the metabolite
thiophosgene, the Agency believes it is reasonable to add the estimated cancer risks from the
individual aggregate risks from both folpet and captan to obtain a worst case estimate. For
captan, the dietary cancer risk estimate for the US population from exposure to residues in/on
food is 1.3 x 10"7. For folpet, the dietary cancer risk estimate for the US population from
exposure to residues in/on food is 9.8 x 10"8. If these two risks are added together the total risk
is 2.3 x 10"7 The aggregate cancer Drinking Water Level of Comparison (DWLOCcancer) based
on this total cancer risk estimate is 11 ppb, using the captan Qx* of 2.4 x 10"3. The estimated
environmental concentration (EECs) for folpet are 1 ppb (sw) and less than 1 ppb (gw). The
EECs for captan are 4 ppb (sw) and less than 1 ppb (gw). The largest EEC of 4 ppb is less than
the DWLOC, the Agency's level of concern. This aggregate assessment is for dietary exposure
only. The tumor of concern occurs in the GI tract (duodenum/jejunum-ileum) as a result of oral
dosing. The relevance of dermal exposure to a GI tract tumor is unknown at this time. Thus, the
Agency concludes that an aggregate cancer risk estimate considering dietary (food and water)
exposure only for captan and folpet based on their common metabolite thiophosgene is
appropriate.
In assessing acute aggregate dietary risk, EPA used a NOAEL of 10 mg/kg/day from a
developmental study in rabbits. Because the NOAEL is from a developmental study the sub-
population of females 13 - 50 years, is the subgroup of interest. The acute dietary risk assessment
was a highly refined, and therefore reasonably realistic, probabilistic (Monte Carlo) assessment
that used anticipated residues and percent crop treated data. EPA estimates that residues of
captan in diets of females 13 - 50 years accounts for 36% of the acute PAD. This leaves 64% of
the acute PAD for aggregate risk. The DWLOC corresponding to 64% of the acute PAD is
approximately 1900 ppb. Because the predicted ground water concentration is only 3.40 ppb and
the predicted peak surface water concentration is 668 ppb, aggregate acute exposure and risk are
not of concern.
The chronic (non-cancer) aggregate assessment was performed using percent crop treated
data, and anticipated residues which considered USDA and FDA pesticide monitoring data and
reduction/concentration factors. The drinking water assessment used modeling, as above, to
predict ground and surface water concentrations of captan. Chronic dietary exposure to the US
population accounts for less than 1% of the chronic PAD. This leaves 99% of the chronic PAD
for aggregate risk. For the general population, the DWLOC corresponding to 99% of the chronic
PAD is approximately 4500 ppb, which is far greater than the predicted groundwater
concentration of 3.4 ppb and the predicted surface water concentration of 10.8 ppb. Therefore,
the Agency concludes that the aggregate chronic exposure and risk are not of concern.
b. Determination of Safety for Infants and Children
The Agency has determined that the established tolerances for captan, with amendments
and changes as specified in this document, meet the safety standards under the FQPA amendments
to section 408(b)(2)(C) of the FFDCA, and that there is a reasonable certainty of no harm for
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infants and children. The safety determination for infants and children considers the factors noted
above for the general population, but also takes into account the possibility of increased dietary
exposure due to the specific consumption patterns of infants and children, as well as the possibility
of increased susceptibility to the toxic effects of captan residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic
effects from captan residues, EPA considered the completeness of the database for developmental
and reproductive effects, the nature of the effects observed, and other information. Based on the
current data requirements, captan has a complete database for developmental and reproductive
toxicity. Reliable studies cited earlier in this document demonstrated no increased sensitivity of
rats, rabbits or hamsters to in utero and or post-natal exposure to captan. The Agency has
determined that the Safety Factor can be removed (reduced to IX) based on the developmental
and reproductive toxicity studies available for captan, as described previously in Section
III(B)2(a) of this document. Therefore, the Agency has concluded that a total uncertainty factor
of 100 (10X for interspecies extrapolation, i.e. using animal data for humans, 10X for intraspecies
variability, i.e. differences in how humans react to a pesticide, and IX for the FQPA safety factor
for protection of infants and children) is adequate to protect infants and children.
EPA estimates that the residues of captan in the diets of infants and children, specifically
the sub-population infants less than 1-year, account for approximately 1.5% of the chronic PAD.
As discussed earlier, at this level of contribution from food the drinking water dietary contribution
is far below the predicted concentration. Therefore, aggregate chronic exposure and risk to
infants and children are not of concern.
The Agency has not yet made a final decision concerning the possible common mechanism
of toxicity and the potential for cumulative effects of captan and other compounds. Also, the
Agency is in the process of formulating guidance for conducting cumulative risk assessment.
When the guidance is completed, peer reviewed, and finalized, captan will be revisited to assess
cumulative effects, if warranted. Therefore, for the purposes of the tolerance reassessments in
this RED document, EPA has considered the risks of captan only.
During the early stages of the FQPA implementation process, the Agency recognizes that
some decisions will be made as if FQPA were fully in place. These early case-by case decisions
are not intended to set broad precedent regarding the application of FQPA to other Agency
regulatory determinations nor are these meant to constrain the Agency as it proceeds with further
policy development and future rulemaking. Therefore, the Agency may, at a later date, reconsider
actions or decisions as described in this RED.
c. Endocrine Disrupter Effects
FQPA requires EPA to develop a screening program to determine whether certain
substances (including all pesticides and inerts) "may have an effect in humans that is similar to an
effect produced by a naturally occurring estrogen, or such other endocrine effect..." EPA has
been working with interested stakeholders, including other government agencies, public interest
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groups, industry and research scientists to develop a screening and testing program as well as a
priority setting scheme to implement this program. The Agency's proposed Endocrine Disrupter
Screening Program was published in the Federal Register of December 28, 1998 (63 FR 71541).
The Program uses a tiered approach and anticipates issuing a Priority List of chemicals and
mixtures for Tier 1 screening in the year 2000. As the Agency proceeds to implement this
program, further testing of captan and end-use products for endocrine effects may be required.
2.
Tolerance Reassessment
Tolerances for plant and animal commodities currently listed in 40 CFR §180.103(a) are
for residues of captan per se. This tolerance definition is to be retained for plant commodities;
however, the tolerance expression for residues in livestock commodities should be "the combined
residues of captan and its metabolite THPI...". Section 180.103 should be subdivided as follows:
(al) General - for plant commodities, (a2) General - for animal commodities, (b) Section 18
Emergency Exemptions - reserved, (c) Regional Registrations - reserved, and (d) Indirect or
Inadvertent Residues - reserved.
A Federal Register Notice was published on February 5, 1998, proposing to revoke the
following tolerances: avocados, garlic, leeks, shallots, taro, and pimentos. The final revocation
notice was published in the Federal Register on October 26, 1998, and became effective on
January 25, 1999. Captan is not applied directly on pears, as a foliar spray, but may be applied as
a post-harvest application. All applications of captan to caneberries (raspberries and blackberries)
are 24(c) registrations, that is, Special Local Needs (SLNs) in Oregon, Washington, Ohio,
Pennsylvania, and South Carolina. The reassessed tolerances are presented below.
Tolerance Reassessment Summary for Captan
Commodity
Current
Toleranc
e
(ppm)
Tolerance
Reassessmen
t(ppm)
Comment/Correct Commodity Definition
Tolerances listed under 40 CFR §180.103 (al)
Almonds
Almond hulls
Apples
Apricots
Beans, dry
2
100
25
50
25
0.25
75
25
10
Reassign
Formerly interim tolerance in 40 CFR §180.103 (b); re-
establish permanent; data indicate tolerance can be
lower
Formerly interim tolerance in 40 CFR §180.103 (b); re-
establish permanent; data indicate tolerance can be
lower
Available data indicate tolerance can be lowered
Formerly interim tolerance under 40 CFR §180.103 (b);
Crop Group Tolerance to be established for legume
vegetables
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Commodity
Beans, succulent
Beet, greens
Beet (roots)
Blackberries
Blueberries (huckleberries)
Brassica (cole) Leafy Vegetables
(Seed treatment only)
Broccoli
Brussels sprouts
Bulb Vegetables
(Seed treatment only)
Cabbage
Caneberries
Cantaloupes
Carrots
Cauliflower
Celery
Cereal Grains
(Seed treatment only)
Cereal Grain (Forage, Fodder,
and Straw)
(Seed treatment only)
Cherries
Current
Toleranc
e
(ppm)
25
100
2
25
25
None
2
2
None
2
None
25
2
2
50
None
None
100
Tolerance
Reassessmen
t (ppm)
Reassign
Reassign
Reassign
Reassign
20
0.05
Reassign
Reassign
0.05
Reassign
25
Reassign
Reassign
Reassign
Reassign
0.05
0.05
50
Comment/Correct Commodity Definition
Formerly interim tolerance under 40 CFR §180.103 (b);
Crop Group Tolerance to be established for legume
vegetables
Crop Group Tolerance to be established for leaves of
root and tuber vegetables
Crop Group Tolerance to be established for root and
tuber vegetables
Crop Subgroup Tolerance to be established for
caneberries
The available data indicate the tolerance can be
lowered; tolerance of 20 is also compatible with
CODEX
Crop Group Tolerance; represents non-detectable
residues of captan.
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Subgroup Tolerance
Crop Group Tolerance to be established for cucurbit
vegetables
Crop Group Tolerance to be established for root and
tuber vegetables
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Group Tolerance to be established for leafy
vegetables (except Brassica)
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance; represents non-detectable
residues of captan
Available data indicate tolerance can be lowered
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Commodity
Collards
Corn, sweet (K+ CWHR)
Cottonseed (seed treatment only)
Cucurbit Vegetables
(Seed treatment only)
Cucumbers
Dewberries
Dill, seed (Seed treatment only)
Eggplants
Flax, seed (Seed treatment only)
Flax, straw (Seed treatment
only)
Foliage of Legume Vegetables
(Seed treatment only)
Fruiting Vegetables (except
cucurbits) (Seed treatment only)
Grapes
Grasses (Forage and Hay)
Honey dew melons
Kale
Leafy Vegetables (except
Brassica) (Seed treatment only)
Leaves of Root and Tuber
Vegetables (Seed treatment
only)
Legume Vegetables (succulent or
dried) (Seed treatment only)
Current
Toleranc
e
(ppm)
2
2
2
None
25
25
None
25
None
None
None
None
50
None
25
2
None
None
None
Tolerance
Reassessmen
t (ppm)
Reassign
Reassign
0.05
0.05
Reassign
Reassign
0.05
Reassign
0.05
0.05
0.05
0.05
25
0.05
Reassign
Reassign
0.05
0.05
0.05
Comment/Correct Commodity Definition
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Group Tolerance to be established for cereal
grains
Cotton, seed. Non-detectable residues of captan
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance to be established for cucurbit
vegetables
Crop Subgroup Tolerance to be established for
caneberries
Represents non-detectable residues of captan.
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Represents non-detectable residues of captan.
Represents non-detectable residues of captan.
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance; represents non-detectable
residues of captan
Available data indicate tolerance can be lowered
Represents non-detectable residues of captan
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance; represents non-detectable
residues of captan
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Commodity
Lettuce
Mangoes
Muskmelons
Mustard greens
Nectarines
Non-Grass Animal Feeds
(Forage, Fodder, Straw, and
Hay)
(Seed treatment only)
Onions, dry bulb
Onions, green
Okra (Seed treatment only)
Peaches
Peanuts (Seed treatment only)
Peanut hay (Seed treatment only)
Pears (post-harvest only)
Peas, dry
Peas, succulent
Plums (fresh prunes)
Peppers
Potatoes
Pumpkins
Rape, seed (Seed treatment only)
Current
Toleranc
e
(ppm)
100
50
25
2
50
None
25
50
None
50
None
None
25
2
2
100
25
25
25
None
Tolerance
Reassessmen
t (ppm)
Reassign
Revoke
Reassign
Reassign
25
0.05
Reassign
Reassign
0.05
15
0.05
0.05
25
Reassign
Reassign
10
Reassign
Reassign
Reassign
0.05
Comment/Correct Commodity Definition
To establish crop group tolerance for leafy vegetables
(except Brassica)
No registered products for this use
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Available data indicate tolerance can be lowered
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance to be established for bulb
vegetables
Crop Group Tolerance to be established for bulb
vegetables
Represents non-detectable residues of captan.
Available data indicate tolerance can be lowered;
tolerance of 15 also compatible with CODEX
Represents non-detectable residues of captan.
Represents non-detectable residues of captan.
Represents non-detectable residues of captan.
Crop Group Tol. to be established for legume
vegetables
Crop Group Tol. to be established for legume
vegetables
Available data indicate tolerance can be lowered
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Formerly interim tolerance established under 40 CFR
§180.103 (b); Crop Group Tolerance to be established
for root and tuber vegetables
To establish crop group tolerance for cucurbit
vegetables
Represents non-detectable residues of captan
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Commodity
Rape, forage
(Seed treatment only)
Raspberries
Root and Tuber Vegetables
(Seed treatment only)
Rutabagas (roots)
Safflower seed
(Seed treatment only)
Sesame seed
(Seed treatment only)
Soybeans, dry
Soybeans, succulent
Spinach
Squash, summer
Squash, winter
Strawberries
Sunflower, seeds
(Seed treatment only)
Sunflower, forage
(Seed treatment only)
Tomatoes
Turnip, greens
Turnips, roots
Watermelons
Current
Toleranc
e
(ppm)
None
25
None
2
None
None
2
2
100
25
25
25
None
None
25
2
2
25
Tolerance
Reassessmen
t (ppm)
0.05
Reassign
0.05
Reassign
0.05
0.05
Reassign
Reassign
Reassign
Reassign
Reassign
20
0.05
0.05
Reassign
Reassign
Reassign
Reassign
Comment/Correct Commodity Definition
Represents non-detectable residues of captan
Crop Subgroup Tol. to be established for caneberries
Crop Group Tolerance; represents non-detectable
residues of captan.
Crop Group Tol. to be est. for root and tuber vegetables
Represents non-detectable residues of captan.
Represents non-detectable residues of captan.
Crop Group Tol. to be est. for legume vegetables
Crop Group Tol. to be est. for legume vegetables
Crop Group Tolerance to be established for leafy
vegetables (except Brassica)
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Available data indicate tolerance can be lowered;
tolerance of 20 is also compatible with CODEX
Represents non-detectable residues of captan.
Represents non-detectable residues of captan.
Crop Group Tolerance to be established for fruiting
vegetable (except cucurbit)
Crop Group Tolerance to be established for leaves of
root and tuber vegetables
Crop Group Tol. to be est. for root and tuber vegetables
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Tolerances required under 40 CFR §180.103 (a2)
Cattle, fat
Cattle, mbyp
0.05
0.05
0.15
0.30
Tolerance increase to include THPI in expression
Tolerance increase to include THPI in expression
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Commodity
Cattle, meat
Goats, fat
Goats, mbyp
Goats, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Milk
Sheep, fat
Sheep, mbyp
Sheep, meat
Current
Toleranc
e
(ppm)
0.05
None
None
None
0.05
0.05
0.05
None
None
None
None
None
None
None
Tolerance
Reassessmen
t (ppm)
0.20
0.15
0.30
0.20
0.15
0.30
0.20
0.15
0.30
0.20
0.10
0.15
0.30
0.20
Comment/Correct Commodity Definition
Tolerance increase to include THPI in expression
Tolerance increase to include THPI in expression
Tolerance increase to include THPI in expression
Tolerance increase to include THPI in expression
Codex Harmonization
Several maximum residue limits (MRLs) for captan have been established by Codex in
various commodities. Codex MRLs are defined in terms of captan per se. Currently, the captan
residues regulated by Codex and the U.S. are all plant commodities and are therefore equivalent.
Codex MRLs and Applicable U.S. tolerances.
Commodity
Apple
Blueberries
Citrus fruits
Dried grapes
Peach
Pear
MRL (mg/kg)1
25
20
152
52
15
25
US Tolerance (ppm)
25
25
N/A
N/A
50
25
Recommendation
US tolerance to be decreased to 20 ppm
US tolerance to be revoked.
US tolerance to be decreased to 15 ppm.
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Commodity
Strawberry
Tomato
MRL (mg/kg)1
20
15
US Tolerance (ppm)
25
0.05
Recommendation
US tolerance to be decreased to 20 ppm
US tolerance to be revoked; to establish crop
group tolerance for Fruiting Vegetables
(except cucurbits); seed treatment only
JA11 captan MRLs are final (CXL).
JMPR 1990 had proposed to withdraw the CXL in view of no expected uses.
The following conclusions can be made regarding efforts to harmonize the U.S. tolerances
with the Codex MRLs:
Compatibility between U.S. tolerances and Codex MRLs exists for apples and pears.
No questions of compatibility exist with respect to commodities where: (1) no Codex
MRLs have been established but U.S. tolerances exist; or (2) Codex MRLs have been
established but U.S. tolerances do not exist.
a. Human Health Risk Mitigation
(1) Acute Dietary Mitigation
Acute dietary exposure is below the Agency's level of concern for the population of
concern (females 13-50 years of age). The 99.9th percentile of acute exposure through food to
females 13-50 years occupies 36% of the acute PAD. No additional mitigation is required.
(2) Chronic (non-cancer) Dietary Mitigation
The chronic dietary risk from captan is below the Agency's level of concern. The most
exposed group is infants less than 1-year old. The exposure to this group occupies less than 1.3%
of the chronic PAD. No additional mitigation is required.
(3) Chronic (cancer) Dietary Mitigation
The dietary cancer risk for captan is below the Agency's level of concern. The upper
bound dietary cancer risk was calculated to be 1.3 x 10"7 for all registered uses of captan,
including refinements such as processing factors and percent crop treated data. No additional
mitigation is required.
(4) Worker Mitigation
Agricultural uses of captan must have MOEs (Margins of Exposure) greater than or equal
to 100 when considering short-term and intermediate-term scenarios, for both dermal and
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inhalation exposures. Additionally, since captan has been classified as a carcinogen, the
occupational cancer risk considers both dermal and inhalation exposures. As a general rule,
occupational cancer risks should be in the range of 10"4 to 10"6 or lower. For captan, carcinogenic
risks vary from 1.3 x 10"5 to 1.7 x 10"9. Thus, no additional mitigation to address occupational
carcinogenic risks is required.
For Mixer/Loaders
Wettable powder (aerial application): The total margin of exposure (MOE) for workers
mixing/loading a wettable powder formulation for aerial application is 41 even with the use of
chemical-resistant gloves and a dust/mist respirator. The Agency will require water soluble
pouches, and chemical-resistant gloves to mitigate the risks when mixing/loading wettable
powders for aerial applications. With this mitigation the MOE becomes 1000. A chemical-
resistant apron is not required since the high inhalation exposure is the primary factor in requiring
the use of water soluble pouches.
Wettable powder (chemigation application): The aerial application scenario will be
used as the surrogate for chemigation. The Agency will require the use of an engineering control
(water soluble pouches), and chemical-resistant gloves to mitigate the risks when mixing/loading
wettable powders for chemigation.
Wettable powder (airblast application): The total MOEs for workers mixing/loading a
wettable powder formulation for airblast application of captan range from 270 to 530 with the use
of chemical-resistant gloves and a dust/mist respirator. The Agency will require the use of
chemical-resistant gloves and a dust/mist respirator when mixing/loading wettable powders for
airblast applications.
Wettable Powder (groundboom application): The total MOE for workers
mixing/loading a wettable powder formulation for groundboom application of captan is 710 with
the use of chemical-resistant gloves and a dust/mist respirator. The Agency will require the use of
chemical-resistant gloves and a dust/mist respirator when mixing/loading wettable powders for
groundboom applications.
Wettable Powder (greenhouse - high pressure spray): The total MOE for workers
mixing/loading a wettable powder formulation for a high pressure spray in a greenhouse is
approximately 43,000 with the use of chemical-resistant gloves and a dust/mist respirator. The
Agency will require the use of chemical-resistant gloves and a dust/mist respirator when using a
high pressure spray.
Wettable Powder (golf course - ground equipment): The total MOE for workers
mixing/loading a wettable powder formulation for applying by ground equipment on a golf course
is 240 with the use of chemical-resistant gloves and dust/mist respirator. The Agency will require
the use of chemical-resistant gloves and a dust/mist respirator for applying by ground equipment
on a golf course.
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Wettable Powder (adding to paints or adhesives - industrial use): The total MOEs
for workers mixing/loading a wettable powder formulation for adding to paints and adhesives in a
manufacturing operation range from 1,400 to 5,400 with the use of chemical-resistant gloves and
a dust/mist respirator. The Agency will require the use of chemical-resistant gloves and a
dust/mist respirator for adding captan to paints and adhesives.
Wettable Powder (seed treatment): The total MOEs for workers mixing/loading a
wettable powder formulation for a seed treatment such as use in a hopper box range from 78 with
the use of chemical-resistant gloves to 12,000 with the use of chemical-resistant gloves and a
dust/mist respirator. The Agency will require the use of chemical-resistant gloves and a dust/mist
respirator for handlers who are treating seeds.
Wettable Powder or Dust (soil and greenhouse bench treatment): The previous
scenario wettable powder (seed treatment) will be used as the surrogate for the use of a dust
formulation for soil and greenhouse bench treatments. The Agency will require the use of
chemical-resistant gloves and a dust/mist respirator for handlers working a captan end-use
product into the soil and for handlers seeding and transplanting into the treated soil immediately at
the time of application.
Wettable Powder (fruit dips): The total MOE for workers mixing/loading a wettable
powder formulation for preparing a solution for dipping apples, pears, or cherries is 1,200 with
the use of chemical-resistant gloves and a dust/mist respirator. Thus the Agency will require the
use of chemical-resistant gloves and a dust/mist respirator when mixing/loading a solution for use
as a dip.
Liquids/FSowable (aerial): The total MOE for workers mixing/loading a liquid
formulation for an aerial application of captan is 350 with the use of chemical-resistant gloves.
Thus the Agency will require the use of chemical-resistant gloves when mixing/loading
liquid/flowables for aerial application.
Liquids/FSowable (airblast): The total MOEs for workers mixing/loading a
liquid/flowable formulation for an airblast application of captan ranges 2,300 to 4,600 with the
use of chemical-resistant gloves. Thus the Agency will require the use of chemical-resistant
gloves when mixing/loading liquid/flowables for airblast application.
Liquids/Flowable (groundboom): The total MOE for workers mixing/loading a
liquid/flowable formulation for an aerial application of captan is 6,200 with the use of chemical-
resistant gloves. Thus the Agency will require the use of chemical-resistant gloves when
mixing/loading liquid/flowables for groundboom application.
Handling of Treated Seed
Use of Treated Seed: Handlers may need to move/place treated seed when drying or
bagging, or loading treated bags of seed into planting equipment. Additionally, captan can also be
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used on seed potatoes, which can then require cutting and sorting. The Agency will require that
handlers using open bags of treated seed wear a dust/mist respirator, chemical-resistant gloves
and eye-protection. Captan end-use products that can be used to treat seed potatoes will require
the use of a dust/mist respirator, chemical-resistant gloves and eye-protection when cutting and
sorting treated seed potatoes.
For Applicators
Aerial: At baseline, the total MOE for workers applying captan using aerial equipment is
2,500. No additional mitigation is required.
Airblast: At baseline, the total MOEs for workers applying captan using airblast
equipment vary from 240 to 1,100. No additional mitigation is required.
Groundboom: At baseline, the total MOE for workers applying captan using
groundboom equipment is 11,000. No additional mitigation is required.
Planting of Treated Seeds (including potato seed pieces): At baseline, using captan
specific data the total MOE for the observer riding on the rear of the planter was 2083. No
additional mitigation is required.
Golf courses (ground equipment): At baseline, the total MOE for workers applying
captan to golf courses using ground equipment is 3,600. No additional mitigation is required.
Paints (brush): At baseline, the total MOE for commercial painters applying captan
containing paint using brushes is 690. No additional mitigation is required.
Paints (sprayer): The total MOE for commercial painters applying captan containing
paint using a sprayer with the use of a dust/mist respirator is 72. The Agency will require the use
of a dust/mist respirator and waterproof gloves when applying captan-containing paint with a
sprayer, which results in an MOE of 160.
Paints (roller): Although no data were available to assess the exposure from this
scenario, the Agency does not expect the risk to be significantly higher than that of the paint brush
scenario. No additional mitigation is required. However, the Agency will require submission of
data to assess this scenario.
High Pressure Spray: The total MOE for workers applying captan using high pressure
spray equipment is 5,300 with the use of chemical-resistant gloves. The Agency will require the
use of chemical-resistant gloves.
Post-Harvest Fruit Dip: There are no activity specific data to address the use of a
solution of captan as a dip for apples, cherries, and pears. Once the solution has been mixed,
most of the application is mechanized (such as operating fork lifts) and the potential for exposure
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is considered to be low. Due to the absence of data, the Agency will restrict post-harvest dipping
activities to mechanized activities only - no hand dipping. Workers who are assisting in the
mechanized activity must wear chemical-resistant gloves and chemical-resistant apron.
Mixer/Loader/Applicator
Wettable Powder (low pressure handwand): The total MOE for workers
mixing/loading/applying a wettable powder formulation of captan using a low pressure handwand
is 9,000 with the use of chemical-resistant gloves. The Agency will require the use of chemical-
resistant gloves.
Liquid/Flowable (low pressure handwand): The total MOE for workers
mixing/loading/applying a liquid/flowable formulation of captan using a low pressure handwand is
270,000 with the use of chemical-resistant gloves. The Agency will require the use of chemical-
resistant gloves.
Backpack/Knapsack: The total MOEs for workers mixing/loading/applying a captan
solution using a back/knapsack vary from 1,400 to 5,500 with the use of chemical-resistant
gloves. The Agency will require the use of chemical-resistant gloves.
Root Dip Treatment: No data are available to assess this scenario. The Agency will
require the submission of exposure data to assess this scenario. Until these data are submitted,
reviewed by the Agency, and used to re-evalaute this scenario, the Agency will require the use of
a chemical-resistant apron and chemical-resistant gloves, which is assumed will provide adequate
protection.
Fl agger
Flagger: At baseline, the total MOE for flaggers is 840. No additional mitigation is
required.
Post-application Exposure
Since captan is toxicity category I for eye irritation, under the Worker Protection Standard
interim REI policy a 48-hour reentry interval (REI) is required for harvesters. However, the
captan registrant has submitted chemical specific data on strawberries, grapes and peaches that
can be used to establish REIs. These three crops were used as surrogates for all other crops to
which captan can be foliar-applied.
Captan can be used as a seed treatment for a variety of crops and as a foliar spray to
almonds, apples, apricots, blueberries, caneberries (raspberries and blackberries), cherries, grapes,
nectarines, peaches, strawberries, and ornamentals.
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Seed Treatments: The Agency is establishing a 12-hour REI for seed treatment uses.
Exception: Once the seeds are planted in soil or other planting media, the Worker Protection
Standard allows workers to enter the treated area without restriction if there will be no contact
with the soil/media subsurface.
Strawberries, Almonds, Apples, Apricots, Cherries, Nectarines, Plums/fresh Prunes,
and Peaches: Based on the risks that were calculated from the submitted strawberry and peach
data, the Agency is establishing a 24-hour REI for strawberries, almonds, apples, apricots,
cherries, nectarines, and peaches.
Blueberries, caneberries, and grapes: The risks that were calculated from the submitted
grape data were MOEs of 60 on Day 2 and 170 on Day 5. Since the target MOE of 100 would
be achieved between Day 2 and Day 5, the Agency is establishing a 3-day (72-hour) REI for
blueberries, caneberries, and grapes.
Ornamentals: The risks that were calculated from the submitted strawberry data, as well
as data from other sources, considered that ornamental workers could work with captan-treated
plants from three to six hours per day. Working three hours the MOE was 400 on Day 1.
Working six hours the MOE was 100 on Day 5. Due to the uncertainties in the number of hours
that workers would be in contact with captan-treated soils and plants, the Agency is establishing a
4-day REI for ornamentals, which is the REI that is on the current labels. The current labels
allow early entry for an unlimited length of time during the last 48 hours of the REI, provided
early-entry PPE is worn. For ornamental uses only, this will be maintained.
Soil Treatments: Based on the interim WPS REI policy, the Agency is establishing a 48-
hour REI for soil and greenhouse bench treatments. Once the treatment, and immediately
following seeding and transplanting activities are complete, the surface of the soil cannot be
disturbed for 48 hours.
Sod Farms: Based on the interim WPS REI policy, the Agency is establishing a 48-hour
REI for sod farms. The Agency is also establishing an additional harvesting prohibition interval of
48 hours.
Early-Entry PPE: The following early entry PPE is required: long-sleeved shirt, long
pants, coveralls, shoes and socks, chemical-resistant gloves, and protective eyewear. Double
notification is not required. Protective eyewear is required because captan is classified as toxicity
category I for eye irritation potential.
Eye-Protection: In addition to the entry restrictions discussed above, the Agency is
establishing additional post-application requirements due to eye irritation concerns. Under the
Worker Protection Standard a 48-hour REI would be established for captan. However, by the
end of the 48-hour interval, the residues from captan would not necessarily have dissipated to a
level where eye irritation is no longer a concern. The information available to the Agency
indicates re-entry incidents can occur 5 to 8 days after application. Due to the uncertainties in
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determining a set time interval when eye irritation from residues are no longer a concern, the
Agency sought an alternative to an REI as the only means of adequately mitigating eye irritation
concerns. To mitigate eye irritation concerns from post-application exposures, the Agency is
requiring that, for at least seven days following the application of captan:
- At least one container designed specifically for flushing eyes is available in operating
condition at the WPS-required decontamination site for workers entering the area treated
with captan, and
- Workers are informed orally, in a manner they can understand:
that residues in the treated area may be highly irritating to their eyes,
that they should take precautions, such as refraining from rubbing their
eyes, and to keep the residues out of their eyes,
that if they do get residues in their eyes, they should immediately flush their
eyes with the eyeflush container that is located at the decontamination site,
and
how to operate the eyeflush container.
The following table summarizes the personal protective equipment (PPE) that are required
for each use scenario of captan. These PPE are required either to mitigate a risk that was
identified during the reregi strati on process, or because the risk assessment supporting
reregi strati on assumed that these PPE were being used by pesticide handlers or applicators.
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Summary of Required Worker Personal Protective Equipment
Exposure Scenario
Mixing/Loading WP for aerial or
chemigation
Mixing/Loading WP for airblast,
groundboom, high pressure sprayer, golf
courses
Adding WP to paint at manufacturer
Mixing /Loading WP for seed treatment
Mixing/Loading post-harvest fruit dips
Mixing/Loading wettable powder or dust
for soil and greenhouse bench treatment
Mixing/Loading liq./flowables for aerial,
airblast or groundboom
Handling treated seeds
Aerial, airblast, groundboom application
Planting of treated seed
Application to golf courses (ground
equip.)
Applying ready-to-use paint with brush
or roller
Applying ready-to-use paint w/ sprayer
Applying High Pressure Spray
Operation of fruit dip process
Mixing/Loading WP or liquid flowables
then applying w/ low pressure handwand
Mixing/Loading then applying w/
backpack/knapsack
Mixing/Loading then applying as root-
dip
Flagger
Baseline
PPE
Required
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
Additional PPE
Required
Chemical-resistant gloves
Chemical-resistant gloves,
dust/mist respirator
Chemical-resistant gloves,
dust/mist respirator
Chemical-resistant gloves,
dust/mist respirator
Chemical-resistant gloves,
dust/mist respirator
Chemical-resistant gloves,
dust/mist respirator
Chemical-resistant gloves
Chemical-resistant gloves,
dust/mist respirator,
eye protection
no
no
no
no
Water-proof gloves,
Dust/mist respirator
Chemical-resistant gloves
Chemical-resistant gloves,
Chemical-resistant apron
Chemical-resistant gloves
Chemical-resistant gloves
Chemical-resistant gloves,
Chemical-resistant apron
no
Engineering
Controls
water soluble pouch
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
restricted to
mechanical
operations only
n/a
n/a
n/a
n/a
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(5) Residential Mitigation
Handler
Residents (homeowners) may purchase captan formulated as a wettable powder, dust or
liquid or in a ready-to-use paint. Thus, residential exposure can occur when applying paints
containing captan with a brush, a sprayer, or a roller. Other exposures can occur when
homeowners mix and then use a captan-containing solution to treat their fruit trees and
ornamentals. Data were not available to assess applying paint with a paint roller,
mixing/loading/applying a solution of captan as a dip treatment, or loading/applying a dust
formulation with a shaker can or in a bag. The Agency is requiring the submission of exposure
data to assess these scenarios (see Section V). The MOEs for all other scenarios are greater than
100, therefore, no additional mitigation is required.
Post-Application
Dermal postapplication exposures and risk to youths and adults playing golf at golf
courses did not exceed the Agency's level of concern. The Agency determined that the MOEs are
over 100,000 for youth and adult golfers, respectively. Therefore, no mitigation is necessary.
Around the home both adults and children can be exposed to residues of captan that
remain after application is complete. Based on the available data both dermal and inhalation post-
application exposure from captan-containing paints is expected to be negligible. All MOEs for
both adults and children were greater than 100; no additional mitigation is required.
(6) Drinking Water Mitigation
The Agency's upper bound estimates of acute, chronic, and carcinogenic drinking water
exposure are below the appropriate Drinking Water Level of Comparison (DWLOC). Therefore,
the risk from drinking water is below the Agency's level of concern. No additional mitigation is
required.
(7) Aggregate Mitigation
As discussed earlier, aggregate acute or chronic (non-cancer) food and drinking water
exposures are not expected to exceed 100% of the acute or chronic PAD, respectively. No
additional mitigation is required.
Generally, an aggregate carcinogenic assessment considers dietary (food and water) and
residential (handler and post-application) exposures. The Agency considers residential post-
application exposure to captan from its use in paints to be negligible because dermal and
inhalation exposures are likely to be minimal. Therefore, the Agency has considered only
residential handler exposure together with dietary and drinking water exposure in its aggregate
risk assessment. The aggregate cancer risk, including drinking water and residential handler
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exposure, as previously explained, is less than the Agency's level of concern. No additional
mitigation is required.
A short-term aggregate risk assessment considers consumption of food and water and
short-term residential exposures. Residential exposure from use of captan on fruit trees and
ornamentals does not exceed the Agency's level of concern when aggregated with food and
drinking water exposures. Exposure to adults from painting aggregated with exposures from
food and drinking water also does not exceed the Agency's level of concern.
However, the use of captan results in post-application hand-to-mouth exposures to
children which do exceed the Agency's level of concern. Since these post-application exposures
alone exceed the Agency's level of concern, an aggregate assessment which would only further
exceed the level of concern was not performed.
(8) Ecological Risk Mitigation
Mammalian and Avian Mitigation
There is a chronic risk to small herbivorous mammals following multiple applications at
application rates greater than 4 Ib ai/acre. Only reducing the label application rates can reduce
these risks. However, the Agency does not expect chronic risk to occur since application rates
are generally less than label maximums and the only uses with rates greater than 4 Ib ai/A are
almonds (at 4.5 Ib ai/acre) and turf at sod farms and golf courses (to be reduced to 4.3 Ib ai/acre).
Aquatic Species Mitigation
Captan is acutely toxic to fish and exceeds acute high risk for fish for all application rates,
except cherries. Chronic risk to fish is not anticipated at any of the single or multiple use rates.
The Agency will require protective measures for foliar applications similar to those for aerial
applications to minimize exposure due to drift and run-off to aquatic sites near the crop treatment
area. Additional data are needed for a complete risk assessment to further assess risks to
estuarine and marine organisms.
3. Occupational (both Worker Protection Standard and non-WPS)
Labeling Rationale
During the reregistration process, EPA considers all relevant generic and product-specific
information to decide what protections and risk mitigation are needed for all products. Products
may be used in various occupational settings, which may or may not be covered by the Worker
Protection Standard (WPS).
The 1992 Worker Protection Standard for Agricultural Pesticides (WPS) established
certain worker-protection requirements (personal protective equipment, restricted-entry intervals,
etc.) to be specified on the label of all products that contain uses covered by the WPS. Uses
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covered by the WPS include all commercial and research uses on farms, forests, nurseries, and in
greenhouses to produce agricultural plants (including food, feed, and fiber plants, trees, turf grass,
flowers, shrubs, ornamentals, and seedlings). The WPS covers not only uses on plants, but also
uses on the soil or planting medium the plants are (or will be) grown in. The WPS labeling
requirements pertaining to personal protective equipment (PPE), restricted-entry intervals (REI),
and notification are interim. These requirements are to be reviewed and revised, as appropriate,
during reregi strati on and other Agency review processes.
There are many products that contain captan. Some products containing captan are
intended primarily for occupational use and some are intended primarily for homeowner use.
Most of the occupational uses are covered under the WPS.
Personal Protective Equipment for Handlers (Mixers. Loaders. Applicators, etc.)
Personal protective equipment requirements usually are set by specifying one or more pre-
established PPE units - sets of items that are almost always required together. For example, if
chemical-resistant gloves are required, then long-sleeve shirts, long pants, socks, and shoes are
assumed and are also included in the required minimum attire. If the requirement is for two layers
of body protection (coveralls over a long- or short-sleeve shirt and long or short pants), the
minimum must also include (for all handlers) chemical-resistant footwear and chemical-resistant
headgear for overhead exposures and (for mixers, loaders, and persons cleaning equipment)
chemical-resistant aprons.
For each end-use product, PPE requirements for pesticide handlers will be determined by
comparing the PPE requirements based on the toxicity of the active ingredient, as listed in the
earlier table, with the PPE required based on the acute toxicity of the end-use product. The more
stringent choice for each type of PPE (i.e., bodywear, hand protection, footwear, eyewear, etc.)
would apply to the end-use product. As discussed in the risk mitigation section above, the
additional PPE is needed due to captan's classification as toxicology category I for eye irritation.
Post-Application/Entry Restrictions
Under the Worker Protection Standard (WPS), interim restricted-entry intervals (REIs)
for all uses covered by the WPS are based on the acute toxicity of the active ingredient. The
toxicity categories of the active ingredient for acute dermal toxicity, eye irritation potential, and
skin irritation potential are used to determine the interim WPS REI. If one or more of the three
acute toxicity effects are in toxicity category I, the interim WPS REI is established at 48 hours. If
none of the acute toxicity effects are in category I, but one or more of the three is classified as
category II, the interim WPS REI is established at 24 hours. If none of the three acute toxicity
effects are in category I or II, the interim WPS REI is established at 12 hours. A 48-hour REI is
increased to 72 hours when an organophosphate pesticide is applied outdoors in arid areas. In
addition, the WPS specifically retains two types of REI's established by the Agency prior to the
promulgation of the WPS: (1) product-specific REI's established on the basis of adequate data,
and (2) interim REI's that are longer than those that would be established under the WPS.
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The WPS prohibits routine entry to perform hand labor tasks during the REI and requires
PPE to be worn for other early-entry tasks that require contact with treated surfaces. Under the
WPS, these personal protective equipment requirements for persons who must enter areas that
remain under a restricted-entry interval are based on the acute toxicity category of the active
ingredient.
For captan, the Agency has determined that no regulatory action is needed as the result of
acute or other adverse effects of the active ingredient. The early-entry PPE requirements will be
established on the basis of the acute dermal toxicity category, skin irritation potential category,
and eye irritation potential category of the end-use products.
4. Other Labeling Requirements
The Agency is also requiring other use and safety information to be placed on the labeling
of all end-use products containing captan. For the specific labeling statements, refer to Section V
of this document.
a. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species Protection
Program") to identify all pesticides whose use may cause adverse impacts on endangered and
threatened species and to implement mitigation measures that will eliminate the adverse impacts.
The program would require use restrictions to protect endangered and threatened species at the
county level. Consultations with the Fish and Wildlife Service may be necessary to assess risks to
newly listed species or from proposed new uses. In the future, the Agency plans to publish a
description of the Endangered Species Program in the Federal Register and have available
voluntary county-specific bulletins. Because the Agency is taking this approach for protecting
endangered and threatened species, it is not imposing label modifications at this time through the
RED.
In the future, the Agency plans to publish a description of the Endangered Species
Program in the Federal Register. EPA is in the process of developing county-specific bulletins
that specify measures to protect endangered and threatened species. Although bulletins have not
yet been developed for all counties where they will be needed, EPA has completed and distributed
over 300 county bulletins.
b. Spray Drift Management
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
State Lead Agencies for pesticide regulation to develop the best spray drift management practices.
The Agency is now requiring interim measures that must be placed on product labels/labeling as
specified in Section V. The Agency has completed its evaluation of the new data base submitted
by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is developing a
policy on how to apply the data and the AgDRTFT computer model to its risk assessments. After
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the policy is in place, the Agency may impose further refinements in spray drift management
practices to reduce off-target drift and risk associated with aerial as well as other application types
where appropriate.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements, responses and labeling changes necessary for
the reregistration of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of captan for the eligible uses has been
reviewed and determined to be substantially complete. Specific product chemistry data is required
for each of the technical grade active ingredients and the formulation intermediates. These
requirements will be specified by registration number in the Data Call In. Additionally, the
following guideline data requirements must be provided to support the continuing registration:
72-3 (b) Acute Estuarine/Marine Toxicity - Mollusk
81-1 Acute Oral Toxicity (rat)
81-2 Acute Dermal Toxicity (rat/rabbit)
81-3 Acute Inhalation Toxicity (rat)
875.2400 Dermal Exposure1
875.2500 Inhalation Exposure1
These data are considered to be confirmatory and are not expected to change the
conclusions of this RED.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP) labeling must be
revised to comply with all current EPA regulations, PR Notices and applicable policies. The MP
labeling must bear the labeling contained in the table at the end of this section.
Required for root dip treatments - Conduct studies concurrently in indoor and outdoor sites. The
studies must be sufficient to account for both the occupational (peach pre-plant) and the residential
scenarios.
Required for application of paint by roller - See note above.
Required for residential application of dusts by shaker can and in a bag. Studies must be conducted
concurrently for outdoor sites.
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B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and if
not, commit to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to the instructions
in the Requirement Status and Registrants Response Form provided for each product.
2. Labeling Requirements for End-Use Products
Label changes are necessary to implement mitigation measures outlined in Section IV
above. These changes include updated PPE restrictions, and ecological restrictions. Specific
language to implement these changes is specified in the following table.
3. Required Labeling Changes Summary Table
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Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Manufacturing Use Products
One of these statements
may be added to a label
to allow reformulation of
the product for a specific
use or all additional uses
supported by a formulator
or user group
One of these statements
may be added to allow
reformulation of the
product for specific use
or all additional uses
supported by a formulator
or user group
"Only for formulation into a fungicide for the following use(s):
Seed treatment: alfalfa, clover, barley, beans (snap, cowpeas, lentils, soybeans), beets (table and
sugar), bluegrasses, broccoli, Brussels sprouts, cabbage, cauliflower, carrots, cucumber, collards,
corn (field and sweet), cotton, eggplant, flax, grasses, kale, lespedeza, lettuce, melons (cantaloupe,
honeydew, watermelon, and muskmelons), mustard greens, oats, okra, onion, peanuts, peas, peppers,
potatoes, radish, rape, rutabaga, rye, safflower, sesame, sorghum (milo and hulled), spinach, squash,
pumpkin, sunflower, Swiss chard, tomato, trefoil, turnips, wheat
Foliar treatment: almonds, apples, apricots, blueberries, cherries, grapes, nectarines, peaches,
plums/fresh prunes, strawberries, caneberries (raspberries, blackberries, dewberries)
Post-harvest dip: apples, cherries, pears
Pre-plant root dip: peaches
Non-Food/Ornamentals: azaleas, begonias, camellias, carnations, chrysanthemums, conifers,
dichondra, gladiolus, turf (sod farm and golf course), flowering plants, roses
Soil: seedbeds and greenhouse bench treatments
Indoor/industrial: paints, plastics, adhesives, coatings
"This product may be used to formulate products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding
support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the MP label
if the formulator, user group, or grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
Directions for Use
86
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Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Environmental Hazards
Statements required by
the RED and Agency
label policies
"This chemical is toxic to fish. Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or other waters unless in accordance with the requirements of a National
Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been
notified in writing prior to discharge. Do not discharge effluent containing this product to sewer
systems without previously notifying the local sewage treatment plant authority. For guidance
contact your state Water Board or Regional Office of the EPA."
Precautionary
Statements
End Use Products Intended for Occupational Use (WPS and Non-WPS)
Handler PPE
requirements for wettable
powders formulated in
water soluble packages
Personal Protective Equipment (PPE)
"Some materials that are chemical-resistant to this product are (registrant inserts correct chemical-
resistant material). If you want more options, follow the instructions for category [insert A, B, C, D,
E, F, G, or H] on an EPA chemical-resistance category selection chart."
All mixers, loaders, applicators, flaggers, and other handlers (including handlers participating in
transplanting as part of root dip treatments) must wear:
- long-sleeved shirt and long pants,
- shoes plus socks.
- chemical resistant gloves (except for flaggers, pilots, and applicators driving motorized equipment)
- chemical resistant apron when participating in dip treatments.
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Handler PPE
requirements for wettable
powders (not in water
soluble packages).
Personal Protective Equipment (PPE)
"Some materials that are chemical-resistant to this product are (registrant inserts correct chemical-
resistant material). If you want more options, follow the instructions for category [insert
A,B,C,D,E,F,G,orH]on
an EPA chemical-resistance category selection chart."
"All mixers, loaders, applicators, and other handlers (including handlers participating in seeding and
transplanting as part of root-dip or greenhouse-soil treatments and persons handling/cutting/sorting
treated potato seed pieces) must wear :
- long-sleeved shirt and long pants,
- shoes plus socks.
- chemical resistant gloves (except applicators driving motorized equipment),
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
87
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Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
- chemical resistant apron when participating in dip treatments.
In addition, a NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number
prefix TC-21C or a NIOSH-approved respirator with any N2, R, P, or HE filter must be worn by all
handlers except (1) applicators driving motorized equipment and (2) mixers/loader/applicators
participating in backpack, low-pressure handwand/handgun, and dip treatments."
Handler PPE
requirements for
liquid/flowables
Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct chemical-
resistant material). If you want more options, follow the instructions for category [insert
A,B,C,D,E,F,G,orH]on
an EPA chemical-resistance category selection chart."
All mixers, loaders, applicators, flaggers, and other handlers (including handlers participating in
transplanting as part of root dip treatments) must wear:
- long-sleeved shirt and long pants,
- shoes plus socks.
- chemical resistant gloves (except for flaggers, pilots, and applicators driving motorized
equipment,)
- chemical resistant apron when participating in dip treatments.
Handler PPE
requirements for dusts
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts chemical resistant
materials). If you want more options, follow the instructions for category [insert A,B,C,D,E,F,G,or
H] on an EPA chemical-resistance category selection chart."
All mixers, loaders, applicators and other handlers(including handlers participating in seeding and
transplanting as part of greenhouse-soil treatments) must wear:
- long-sleeved shirt and long pants
- chemical resistant gloves
- shoes plus socks
- dust mist filtering respirator with MSHA/NIOSH approval number prefix TC-21C or a NIOSH
approved respirator with any N2, R, P, or HE filter
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry.'
Precautionary
Statements: Hazards to
Humans and Domestic
Animals after PPE
requirements
Engineering controls for
products formulated in
water-soluble packets.
"Engineering Controls"
"IMPORTANT: Water-soluble packets when used correctly qualify as a closed loading system under
the WPS. Mixers and loaders using water-soluble packets (1) must wear the PPE specified above for
mixers and loaders and (2) must be provided a NIOSH-approved dust/mist respirator (type specified
below), and (3) must have the respirator immediately available for use in an emergency, such as a
broken package, spill, or equipment breakdown. The respirator must be either a dust mist filtering
respirator with MSHA/NIOSH approval number prefix TC-21C or a NIOSH-approved respirator
with any N2, R, P, or HE filter."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
requirements
User Safety
Recommendations
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and
put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash the outside of gloves
before removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary
Statements under:
Hazards to Humans
and Domestic Animals
immediately following
Engineering Controls
(Must be placed in a
box)
Environmental Hazards
for products used in seed
treatments only
"Environmental Hazards"
"This chemical is toxic to fish. Do not contaminate water when disposing of equipment washwaters
or rinsate."
Precautionary
Statements under
Environmental
Hazards
Environmental Hazards
for products used for
outdoor terrestrial uses
"Environmental Hazards"
"This chemical is toxic to fish. Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high water mark. Drift and runoff from treated areas
may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when
cleaning equipment or disposing of equipment washwaters or rinsate."
Precautionary
Statements under
Environmental
Hazards
89
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Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Restricted-Entry Interval
for WPS products as
required by Supplement
Three of PR Notice 93-7
"Do not enter or allow worker entry into treated areas during the restricted
entry interval (REI) of:"
"12 hours for planter box-type or hopper-box seed treatment uses. Exception: Once the seeds are
planted in soil or other planting media, the Worker Protection Standard allows workers to enter the
treated area without restriction if there will be no contact with the soil/media subsurface."
"24 hours for strawberries, almonds, apples, apricots, cherries, nectarines, plums/fresh prunes, and
peaches"
"48 hours for soil treatments and root dips: For soil and greenhouse bench treatments and root dips,
once the treatment and any seeding or transplanting tasks done as part of the treatment are complete,
the 48-hour REI begins. Exception, once the seeds or transplants are planted in the soil, the Worker
Protection Standard allows workers to enter the treated area without restriction if there will be no
contact with the soil subsurface."
"48 hours for sod farms"
"72 hours for blueberries, raspberries, blackberries, dewberries, and grapes"
" 96 hours for ornamentals. Exception: For the last 48 hours of the REI, workers may enter the
treated area to perform hand labor or other tasks involving contact with anything that has been
treated, such as plants, soil or water, without time limit, if they wear the early-entry PPE listed
below.
Directions for Use,
Agricultural Use
Requirements Box
Early Entry Personal
Protective Equipment
Early Entry PPE
"PPE required for early entry to treated areas that is permitted under the Worder Protection Standard
and that involves contact with anything that has been treated, such as plants, soil, or water, is:
- coveralls,
- protective eyewear,
- chemical-resistant gloves made of any water-proof material,
- shoes plus socks."
Directions for Use,
Agricultural Use
Requirements Box
Additional Post-
Application
Requirements
Eye-Protection: To mitigate eye irritation concerns from post-application exposures, the Agency is
requiring that, for at least seven days following the application of captan:
1. at least one container designed specifically for flushing eyes is available in operating condition at
Directions for Use,
Agricultural Use
Requirements Box
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Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
the WPS-required decontamination site for workers entering the area treated with captan, and
2. workers are informed orally, in a manner they can understand:
-- that residues in the treated area may be highly irritating to their eyes,
-- that they should take precautions, such as refraining from rubbing their eyes, to keep the
residues out of their eyes,
-- that if they do get residues in their eyes, they should immediately flush their eyes with the
eyeflush container that is located at the decontamination site, and
-- how to operate the eyeflush container.
Double Notification
Requirements
Double Notification: Notify workers of the application by warning them orally and by posting
warning signs at entrances to treated areas."
Directions for Use,
Agricultural Use
Requirements Box
Application Restrictions
for products applied as
liquid sprays (regardless
of application equipment)
"Do not allow this product to drift."
"Do not apply this product in a way that will contact workers or other persons, either directly or
through drift. Only protected handlers may be in the area during application."
Directions for Use
Foliar Drift language for
products applied by foliar
spray application
"Foliar Spray Drift Management"
"Avoiding spray drift from foliar applications is the responsibility of the applicator. Similar to aerial
spray drift, the interaction of many equipment-and-weather-related factors determine the potential
for spray drift from foliar applications. To protect water resources, the applicator and the grower are
responsible for considering all these factors when making decisions."
Directions for Use
Spray Drift language for
products applied aerially
"Aerial Spray Drift Management"
"Avoiding spray drift at the application site is the responsibility of the applicator. The interaction of
many equipment-and-weather-related factors determine the potential for spray drift. The applicator
and the grower are responsible for considering all these factors when making decisions."
Directions for Use
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Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Drift Language for
products applied aerially
"The following drift management requirements must be followed to avoid off-target drift movement
from aerial applications to agricultural field crops. These requirements do not apply to applications
using dry formulations.
1. The distance of the outer most nozzles on the boom must not exceed 3/4 the length of the
wingspan or rotor.
2. Nozzles must always point backward parallel with the air stream and never be pointed downwards
more than 45 degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the information covered in the Aerial
Drift Reduction Advisory Information."
Directions for Use
Drift Language for
products applied aerially
"Aerial Drift Reduction Advisory"
"This section is advisory in nature and does not supersede the mandatory label requirements."
"INFORMATION ON DROPLET SIZE"
"The most effective way to reduce drift potential is to apply large droplets. The best drift
management strategy is to apply the largest droplets that provide sufficient coverage and control.
Applying larger droplets reduces drift potential, but will not prevent drift if applications are made
improperly, or under unfavorable environmental conditions (see Wind, Temperature and Humidity,
and Temperature Inversions)."
Directions for Use
92
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Summary of Required Labeling Changes for Captan
Description
Drift Language for
products applied aerially
Drift Language for
products applied aerially
Drift Language for
products applied aerially
Drift Language for
products applied aerially
Required Labeling
"CONTROLLING DROPLET SIZE"
"Volume - Use high flow rate nozzles to apply the highest practical spray volume. Nozzles with
higher rated flows produce larger droplets.
Pressure - Do not exceed the nozzle manufacturer's recommended pressures. For many nozzle types
lower pressure produces larger droplets. When higher flow rates are needed, use higher flow rate
nozzles instead of increasing pressure.
Number of nozzles - Use the minimum number of nozzles that provide uniform coverage.
Nozzle Orientation - Orienting nozzles so that the spray is released parallel to the airstream produces
larger droplets than other orientations and is the recommended practice. Significant deflection from
horizontal will reduce droplet size and increase drift potential.
Nozzle Type - Use a nozzle type that is designed for the intended application. With most nozzle
types, narrower spray angles produce larger droplets. Consider using low-drift nozzles. Solid stream
nozzles oriented straight back produce the largest droplets and the lowest drift."
"BOOM LENGTH"
"For some use patterns, reducing the effective boom length to less than 3/4 of the wingspan or rotor
length may further reduce drift without reducing swath width."
"APPLICATION HEIGHT"
"Applications should not be made at a height greater than 10 feet above the top of the largest plants
unless a greater height is required for aircraft safety. Making applications at the lowest height that is
safe reduces exposure of droplets to evaporation and wind."
Placement on Label
Directions for Use
Directions for Use
Directions for Use
93
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Drift Language for
products applied aerially
"SWATH ADJUSTMENT"
"When applications are made with a crosswind, the swath will be displaced downward. Therefore,
on the up and downwind edges of the field, the applicator must compensate for this displacement by
adjusting the path of the aircraft upwind. Swath adjustment distance should increase, with
increasing drift potential (higher wind, smaller drops, etc.)"
Directions for Use
Drift Language for
products applied aerially
"WIND"
"Drift potential is lowest between wind speeds of 2-10 mph. However, many factors, including
droplet size and equipment type determine drift potential at any given speed. Application should be
avoided below 2 mph due to variable wind direction and high inversion potential. NOTE: Local
terrain can influence wind patterns. Every applicator should be familiar with local wind patterns and
how they affect spray drift."
Directions for Use
Drift Language for
products applied aerially
"TEMPERATURE AND HUMIDITY"
"When making applications in low relative humidity, set up equipment to produce larger droplets to
compensate for evaporation. Droplet evaporation is most severe when conditions are both hot and
dry."
Directions for Use
Drift Language for
products applied aerially
"TEMPERATURE INVERSIONS"
"Applications should not occur during a temperature inversion because drift potential is high.
Temperature inversions restrict vertical air mixing, which causes small suspended droplets to remain
in a concentrated cloud. This cloud can move in unpredictable directions due to the light variable
winds common during inversions. Temperature inversions are characterized by increasing
temperatures with altitude and are common on nights with limited cloud cover and light to no wind.
They begin to form as the sun sets and often continue into the morning. Their presence can be
indicated by ground fog; however, if fog is not present, inversions can also be identified by the
movement of smoke from a ground source or an aircraft smoke generator. Smoke that layers and
moves laterally in a concentrated cloud (under low wind conditions) indicates an inversion, while
smoke that moves upward and rapidly dissipates indicates good vertical air mixing."
Directions for Use
94
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Drift Language for
products applied aerially
"SENSITIVE AREAS"
"The pesticide should only be applied when the potential for drift to adjacent sensitive areas (e.g.
residential areas, bodies of water, known habitat for threatened or endangered species, non-target
crops) is minimal (e.g. when wind is blowing away from the sensitive areas)."
Directions for Use
Application Restrictions
for wettable powders not
in water-soluble
packaging
"Do not apply this product with aerial or chemigation equipment"
Directions for Use
Application Restrictions
for wettable powders in
water-soluble packaging
"Do not apply this product to seeds or seed pieces."
Directions for Use
Other Use/Application
Restrictions
For foliar applications:
"The maximum application rate for almonds is 4.5 Ib ai/acre, with a maximum seasonal application
rate of 20 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 30 days. Note the Restricted Entry
Interval is 24 hours. Almond hulls may be fed to livestock."
"The maximum application rate for apples is 4 Ib ai/acre, with a maximum seasonal application rate
of 32 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 0 days. Note the Restricted Entry
Interval is 24 hours"
"The maximum application rate for apricots is 2.5 Ib ai/acre, with a maximum seasonal application
rate of 12.5 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 0 days. Note the Restricted Entry
Interval is 24 hours"
"The maximum application rate for blueberries is 2.5 Ib ai/acre, with a maximum seasonal
application rate of 35 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 0 days. Note the
Restricted Entry Interval is 72 hours"
"The maximum application rate for cherries is 2 Ib ai/acre, with a maximum seasonal application
rate of 14 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 0 days. Note the Restricted Entry
Interval is 24 hours"
Directions for Use
under General
Precautions and
Restrictions and/or
Applications
Instructions
95
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
"The maximum application rate for grapes is 2 Ib ai/acre, with a maximum seasonal application rate
of 12 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 0 days. Note the Restricted Entry
Interval is 72 hours."
"The maximum application rate for nectarines is 4 Ib ai/acre, with a maximum seasonal application
rate of 24 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 0 days. Note the Restricted Entry
Interval is 24 hours."
"The maximum application rate for peaches is 4 Ib ai/acre, with a maximum seasonal application
rate of 32 Ibai/acre per crop cycle*. Preharvest interval (PHI) = 0 days. Note the Restricted Entry
Interval is 24 hours."
"The maximum application rate for plums/fresh prunes is 3 Ib ai/acre, with a maximum seasonal
application rate of 27 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 0 days. Note the
Restricted Entry Interval is 24 hours."
"The maximum application rate for strawberries is 3 Ib ai/acre, with a maximum seasonal
application rate of 24 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 0 days. Note the
Restricted Entry Interval is 24 hours."
"The maximum application rate for raspberries and blackberries is 2 Ib ai/acre, with a maximum
seasonal application rate of 10 Ib ai/acre per season. Note the Restricted Entry Interval is 24 hours.
Preharvest interval (PHI) = 3 days"
* Crop cycle is defined as prebloom through postharvest.
Other Use/Application
Restrictions (continued)
For post-harvest fruit dips:
"For apples, pears, and cherries use 1.25 Ib ai/100 gallons of water."
"For use in mechanical fruit-dip operations only. Hand dipping of fruit is prohibited."
For applications to turf (sod farms):
"The maximum application rate for turf (sod farms) is 4.3 Ib ai/acre, with a maximum seasonal
application rate of 8.6 Ib ai/acre per season. Note the Restricted Entry Interval is 48 hours.
Harvesting Prohibition Interval = 48 hours"
96
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions (continued)
For seed treatments:
alfalfa, clover, lespedeza, or trefoil seeds
"For slurry seed treatments use 4 ounce ai/100 Ib seed."
"For dust seed treatments use 6 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed."
barley seeds
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
"For dust seed treatments use 1.5 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.8 ounce ai/100 Ib seed."
bean seeds
"For slurry seed treatments use 1.3 ounce ai/100 Ib seed."
"For dust seed treatments use 1.9 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed."
beets (table) seeds
"For slurry seed treatments use 6 ounce ai/100 Ib seed."
"For dust seed treatments use 9 ounce ai/100 Ib seed."
bluegrass seeds
"For slurry seed treatments use 4.1 ounce ai/100 Ib seed."
"For dust seed treatments use 6 ounce ai/100 Ib seed."
broccoli, Brussel sprouts, cabbage, and cauliflower seeds
"For slurry seed treatments use 1.1 ounce ai/100 Ib seed."
"For dust seed treatments use 1.1 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed."
carrot seeds
"For slurry seed treatments use 4.4 ounce ai/100 Ib seed."
"For dust seed treatments use 6.75 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
97
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
cantaloupe, cucumber, or tomato seeds
"For slurry seed treatments use 1.6 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
collards or kale seeds
"For slurry seed treatments use 0.5 ounce ai/100 Ib seed."
corn (field) seeds
"For slurry seed treatments use 1.1 ounce ai/100 Ib seed."
"For dust seed treatments use 1.1 ounce ai/100 Ib seed."
corn (sweet) seeds
"For slurry seed treatments use 2ounce ai/100 Ib seed."
"For dust seed treatments use 2 ounce ai/100 Ib seed."
"For planter box seed treatments use 1 ounce ai/100 Ib seed."
cottonseeds (acid delinted)
"For slurry seed treatments use 2.5 ounce ai/100 Ib seed."
"For dust seed treatments use 1.5 ounce ai/100 Ib seed."
cottonseeds (machine delinted)
"For slurry seed treatments use 2.25 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
cottonseeds (fuzzy)
"For slurry seed treatments use 3.5 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
cottonseeds (reginned)
"For slurry seed treatments use 3.5 ounce ai/100 Ib seed."
cottonseeds (unspecified)
"For planter box seed treatments use 1 ounce ai/100 Ib seed."
98
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
cowpeas
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
eggplant seeds
"For slurry seed treatments use 2.7 ounce ai/100 Ib seed."
"For dust seed treatments use 4.5 ounce ai/100 Ib seed."
Other Use/Application
Restrictions (continued)
flax seeds
"For slurry seed treatments use 2 ounce ai/100 Ib seed."
"For dust seed treatments use 2.6 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed.'
grass seed
"For slurry seed treatments use 4.1ounce ai/100 Ib seed."
"For dust seed treatments use 9 ounce ai/100 Ib seed."
mustard or rape seeds
"For slurry seed treatments use 0.Bounce ai/100 Ib seed."
oat seeds
"For slurry seed treatments use 2ounce ai/100 Ib seed."
"For dust seed treatments use 2 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.8 ounce ai/100 Ib seed."
okra seeds
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
onion seeds
"For pelleting, use 0.8 pound ai/ Ib seed."
"For seeder box seed treatments use 0.75 pound ai/3 Ib seed."
peanut seeds
"For slurry seed treatments use 3 ounce ai/100 Ib seed."
99
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
"For dust seed treatments use 3 ounce ai/100 Ib seed."
pea seeds
"For slurry seed treatments use 1.3 ounce ai/100 Ib seed."
"For dust seed treatments use 1.9 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
pepper seeds
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
For dust seed treatments use 2.25 ounce ai/100 Ib seed."
potato seed pieces
"For dust seed piece treatments use 1.2 ounce ai/100 Ib seed."
radish seeds
"For slurry seed treatments use 1.1 ounce ai/100 Ib seed."
"For dust seed treatments use 1.1 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed.'
rutabaga seeds
"For slurry seed treatments use 2.3 ounce ai/100 Ib seed."
"For dust seed treatments use 3.4 ounce ai/100 Ib seed."
rye seeds
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
"For dust seed treatments use 1.5 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib seed.'
safflower seeds
"For planter box seed treatments use 1 ounce ai/100 Ib seed."
sesame seeds
"For slurry seed treatments use 0.8 ounce ai/100 Ib seed."
100
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
sorghum seeds (milo)
"For slurry seed treatments use 3 ounce ai/100 Ib seed."
sorghum seeds (hulled)
"For slurry seed treatments use 3 ounce ai/100 Ib seed."
"For dust seed treatments use 3 ounce ai/100 Ib seed."
Other Use/Application
Restrictions (continued)
soybean seeds
"For slurry seed treatments use 1.3 ounce ai/100 Ib seed."
"For dust seed treatments use 1.9 ounce ai/100 Ib seed."
"For planter box seed treatments use 1.75 ounce ai/100 Ib seed.'
spinach seeds
"For slurry seed treatments use 3.3 ounce ai/100 Ib seed."
"For dust seed treatments use 4.5 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
squash, pumpkin, muskmelon, or watermelon seeds
"For slurry seed treatments use 1 ounce ai/100 Ib seed."
"For dust seed treatments use 1.5 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
sugar beet seeds (eastern US)
"For slurry seed treatments use 6 ounce ai/100 Ib seed."
sugar beet seeds (western US)
"For slurry seed treatments use 3 ounce ai/100 Ib seed."
sugar beet seeds (unspecified)
"For slurry seed treatments use 6 ounce ai/100 Ib seed."
"For dust seed treatments use 9 ounce ai/100 Ib seed."
"For planter box seed treatments use 2 ounce ai/100 Ib seed."
sunflower seeds
101
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
"For slurry seed treatments use 2 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.5 ounce ai/100 Ib seed."
Swiss chard seeds
"For slurry seed treatments use 6 ounce ai/100 Ib seed."
"For dust seed treatments use 9 ounce ai/100 Ib seed."
Turnip seeds
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
Wheat seeds
"For slurry seed treatments use 1 ounce ai/100 Ib seed."
"For dust seed treatments use 2 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.8 ounce ai/100 Ib seed."
Placement on Label
102
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Products Intended for Occupational Use (Non-WPS only)
Handler PPE
Requirements for
wettable powders
(presume no aerial or
chemigation
applications)
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct chemical-
resistant material). If you want more options, follow the instructions for category [insert A, B, C, D,
E, F, G, or H] on an EPA chemical-resistance category selection chart."
"All mixers, loaders, applicators, and other handlers (including handlers participating in
transplanting as part of root-dip treatments and persons handling/cutting/sorting treated potato seed
pieces) must wear:
- long-sleeved shirt and long pants,
- shoes plus socks.
- chemical resistant gloves (except applicators driving motorized equipment),
- chemical resistant apron when participating in dip treatments.
In addition, a NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval number
prefix TC-21C or a NIOSH-approved respirator with any N2, R, P, or HE filter must be worn by all
handlers except (1) applicators driving motorized equipment and (2) mixers/loader/applicators
participating in backpack, low-pressure handwand/handgun, and dip treatments."
Handler PPE
Requirements for
liquid/flowables (presume
no aerial or chemigation
applications).
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct chemical
resistant materials). If you want more options, follow the instructions for category [insert
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection chart."
All mixers, loaders, applicators, and other handlers (including handlers participating in
transplanting as part of root dip treatments) must wear:
- long-sleeved shirt and long pants,
- shoes plus socks.
- chemical resistant gloves (except for applicators driving motorized equipment)
- chemical resistant apron when participating in dip treatments.
103
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Handler PPE
Requirements for dusts
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts chemical resistant
materials). If you want more options, follow the instructions for category [insert A,B,C,D,E,F,G,or
H] on an EPA chemical-resistance category selection chart."
All mixers, loaders, applicators and other handlers (including handlers participating in seeding and
transplanting as part of greenhouse-soil treatments) must wear:
- long-sleeved shirt and long pants
- chemical resistant gloves
- shoes plus socks
- dust mist filtering respirator with MSHA/NIOSH approval number prefix TC-21C or a NIOSH
approved respirator with any N2, R, P, or HE filter
Handler PPE
Requirements for
wettable powders added
to paints or adhesives at
the manufacturing
process
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts correct gloves). If
you want more options, follow the instructions for category [insert A, B, C, D, E, F, G, or H] on an
EPA chemical-resistance category selection chart."
"All mixers, loaders, applicators and other handlers must wear:
- Long-sleeved shirt and long pants,
- chemical resistant gloves,
- shoes plus socks,
- dust mist filtering respirator with MSHA/NIOSH approval number prefix TC-21C, or a NIOSH
approved respirator with any N2, R, P, or HE filter."
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry:
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
after PPE
Requirements
104
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Engineering Controls for
dusts and wettable
powders added to paints
or adhesives in the
manufacturing process
"Engineering Controls"
"When handlers use closed systems designed by the manufacturer to enclose the pesticide to prevent
it from contacting handlers or other people AND the system is functioning properly and is used and
maintained in accordance with the manufacturer's written operating instructions, the handlers need
not wear the dust/mist respirator. However, the respirator must be immediately available for use in
an emergency."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
(Immediately after PPE
and User Safety
Requirements)
User Safety
Recommendations
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and
put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash the outside of gloves
before removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary
Statements under:
Hazards to Humans
and Domestic Animals
immediately following
Engineering Controls
(Must be placed in a
box)
Environmental Hazards
"Environmental Hazards"
"This chemical is toxic to fish. Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high water mark. Drift and runoff from treated areas
may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when
cleaning equipment or disposing of equipment washwaters or rinsate."
Entry Restrictions for
liquid/flowables and
wettable powders (not
required for wettable
powders added to paints
or adhesives)
"Post-Application/Entry Restrictions:
-- For applications to ornamentals at non-commercial sites and golf-course turfgrass, do not enter or
allow others to enter until sprays have dried."
~ For applications to seeds: All persons handling unbagged treated seed must be wearing the
personal protective equipment required on this labeling for handlers.
~ For post-application fruit dips: Do not contact or allow others to contact the treated fruit until
sprays have dried."
Directions For Use
under General
Precautions and
Restrictions
105
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Early Entry Restrictions
for dust formulations
"Post-Application Restrictions:
- For applications to seeds: All persons handling unbagged treated seed must be wearing the personal
protective equipment required on this labeling for handlers.
Directions For Use
under General
Precautions and
Restrictions
Application Restrictions
for products used in
commercial seed
treatment
"Seed that has been treated with this product that is then packaged and offered for sale or
distribution must contain the following labeling:
This bag contains seed treated with captan. To avoid possible adverse health effects, when opening
this bag to load the treated seed, wear long-sleeved shirt, long pants, shoes plus socks, chemical-
resistant gloves, NIOSH-approved dust-mist respirator (dust mist filtering respirator with
MSHA/NIOSH approval number prefix TC-21C, or a NIOSH approved respirator with any N2, R, P,
or HE filter) and eye protection."
"Labels attached to treated bags of seed must state:'Treated Seed - Do Not Use for Food, Feed, or Oil
Purposes'."
Directions for Use
Application Restrictions
for all dusts and wettable
powders used to treat
potato seed pieces
"When handling/cutting/sorting treated potato seed pieces, wear long-sleeved shirt, long pants, shoes
plus socks, chemical-resistant gloves, NIOSH-approved dust-mist respirator (dust mist filtering
respirator with MSHA/NIOSH approval number prefix TC-21C, or a NIOSH approved respirator
with any N2, R, P, or HE filter) and eye protection."
Directions for Use
Application Restrictions
(not required for wettable
powder added to paints or
adhesives)
"The maximum application rate for turf (golf course) is 4.3 Ib ai/acre with a maximum seasonal
application rate of 8.6 Ib ai/acre."
"Do not apply to home lawns, parks, schools, and other recreational areas."
Directions for Use
Restrictions for products
applied as liquid sprays
(any type of equipment) -
not for wettable powders
added to paints or
adhesives
"Do not allow this product to drift."
"Do not apply this product in a way that will contact workers or other persons, either directly or
through drift. Only protected handlers may be in the area during application."
Directions for Use
106
-------
Summary of Required Labeling Changes for Captan
Description
Application Restrictions
for wettable powders
added to paints or
adhesives
Other Use/ Application
Restrictions
Required Labeling
"This product cannot be added to paint or adhesive products unless the paint or adhesive product
label contains the following statements:"
"When using this product, wear long-sleeved shirt and long pants. When applying this product by
sprayer, water-proof gloves and a NIOSH -approved dust mist filtering respirator (MSHA/NIOSH
approval number prefix TC-21C) or a NIOSH approved respirator with any N2, R, P, or HE filter
must also be used."
For seed treatment rates: see Occupational Use (WPS and non-WPS) section
For application rates also see Products Intended Primarily for Residential/Consumer/Homeowner
section
Placement on Label
Directions for Use
Directions for Use
Products Intended Primarily for Residential/Consumer/ Homeowner Use
Environmental Hazards
Early Entry Restrictions
for liquid formulations
Early Entry Restrictions
for dry formulations
Application Restrictions
for products applied as
liquid sprays (any
equipment)
"Environmental Hazards"
"This chemical is toxic to fish. Do not apply directly to water. Do not contaminate water when
disposing of equipment washwaters or rinsate."
"ENTRY RESTRICTIONS: Do not allow people or pets to enter the treated area until sprays have
dried"
"ENTRY RESTRICTIONS: Do not allow people or pets to enter the treated area until dusts have
settled."
"Do not allow this product to drift."
"Do not apply this product in a way that will contact any person or pet, either directly or through
drift. Keep people and pets out of the area during application."
Precautionary
Statements after User
Safety
Recommendations
under "Environmental
Hazards"
Directions For Use in
General Precautions
and Restrictions
Directions For Use in
General Precautions
and Restrictions
107
-------
Summary of Required Labeling Changes for Captan
Description
Required Labeling
Placement on Label
Other Use/Application
Restrictions
"Do not apply to lawns."
Maximum Application
Rates
For use on ornamentals as a root dip:
Azalea, carnation, chrysanthemum: 0.3 ounce ai/gallon
For use on gladiolus corms: 0.3 ounce ai/gallon
For use on tuberous begonia: 1.2 ounce ai/gallon
For use on azalea, carnation, chrysanthemum, and roses: 0.2 ounce ai/gallon
For use as a seed treatment:
beans, cabbage, corn, melons, peas, squash: 0.02 ounce ai/pound seeds
beets, Swiss chard: 0.08 ounce ai/pound seeds
spinach: 0.04 ounce ai/pound seeds
For post-harvest use on apple and peach trees and grapes: 0.02 ounce ai/gallon
108
-------
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on Eligibility Decision (RED). Persons
other than the registrant may generally distribute or sell such products for 50 months from the
date of the issuance of this RED. However, existing stocks time frames will be established
case-by-case, depending on the number of products involved, the number of label changes, and
other factors. Refer to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal
Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell captan products bearing old
labels/labeling for 26 months from the date of issuance of this RED. Persons other than the
registrant may distribute or sell such products for 50 months from the date of the issuance of this
RED. Registrants and persons other than registrants remain obligated to meet pre-existing
Agency imposed label changes and existing stocks requirements applicable to products they sell or
distribute.
109
-------
110
-------
VI. APPENDICES
111
-------
112
-------
APPENDIX A - Table of Use Patterns Subject to Reregistration
Appendix is over 80 pages long and is not being included in the RED. Copies of Appendix A
are available upon request as per the instructions in Appendix E.
113
-------
114
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case number 0120 covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to captan in all products, including
data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column
lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number if no MRTD number has been assigned. Refer to the
Bibliography appendix for a complete citation of the study
115
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT
USE
PATTERN
CITATION(S)
PRODUCT CHEMISTRY
Gustafson, Inc.
7501-24
Using formulators exemption (repack)
Tomen Agro, Inc.
66330-31, 66330-32, 66330-33, and 66330-34
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
Chemical Identity All
Start. Mat. & Mnfg. Process All
Formation
of Impurities All
Preliminary Analysis All
Certification of limits All
Analytical
Color
Method All
N/A
Physical State N/A
Odor
All
Melting Point All
Boiling Point N/A
Density
Solubility
All
All
CSF
40021301
40021301
40021301
CSF
40021201
N/A
N/A
40021202
40021202,40231801
N/A
40021202,40231801
40021202,40231801
116
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT USE
PATTERN
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Vapor Pressure N/A
Dissociation Constant N/A
Octanol/Water Partition All
pH All
Stability All
Oxidizing/Reducing/Action All
Flammability N/A
Explodability All
Storage Stability All
Viscosity N/A
Miscibility N/A
Corrosion Characteristics All
Makhteshim-Agan of North America
11678-1
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
Chemical Identity All
Start, Mat, & Mnfg. Process All
Formation of Impurities All
Preliminary Analysis All
Certification of limits All
Analytical Method All
Color N/A
Physical State N/A
Odor N/A
Melting Point All
Boiling Point N/A
Density All
CITATION(S)
N/A
N/A
40021201
40021202,40231801
40021202,40231801
DATA GAP FOR MUP
N/A
DATA GAP FOR MUP ONLY
DATA GAP FOR MUP ONLY
N/A
N/A
DATA GAP FOR MUP ONLY
CSF
40121701,40231301
40121701
40021201
CSF
40021201
N/A
N/A
N/A
40231201
N/A
40231201
117
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT
USE
PATTERN
CITATION(S)
63-8 Solubility All
63-9 Vapor Pressure N/A
63-10 Dissociation Constant N/A
63-11 OctanoS/Water Partition All
63-12 pH All
63-13 Stability All
63-14 Oxidizing/Reducing Action All
63-15 FSammability N/A
63-16 Explodability All
63-17 Storage Stability All
63-18 Viscosity N/A
63-19 Miscibility N/A
63-20 Corrosion Characteristics All
Drexel Chemical Company
19713-258
REFS lists this as a formulation intermediate, will be
addressed in Product DCI
40231201
N/A
N/A
40021202
40231201
40231201
DATA GAP
N/A
DATA GAP FOR MUP ONLY
DATA GAP FOR MUP ONLY
N/A
N/A
DATA GAP FOR MUP ONLY
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral -
Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
ABCHIKL GS0120045, GS9999001, 00020560
M 00151236
ABCHIKL
M
ABCHIKL
M
00022923, 00104686, 43869802
00022923, 43869803
118
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT
71-4A
71-4B
72-1A
72-1B
72-1C
72-1D
72-2A
72-3A
72-3B
72-3C
72-4A
72-4B
72-5
122-1A
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Bluegill (TEP)
Fish Toxicity Rainbow
Trout
Fish Toxicity Rainbow
Trout (TEP)
Fish Toxicty Rainbow Trout
(THPI)
Fish Toxicity Rainbow
Trout (THPAm)
Invertebrate Toxicity
Estuarine/Marine Toxicity -
Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Early Life Stage Fish
Life Cycle Invertebrate
Life Cycle Fish
Seed Germination/Seedling
USE
PATTERN
ABCK
ABCK
ABCHIKL
M
ABCK
ABCHIKL
M
ABCK
ABCK
ABCHIKL
M
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
CITATION(S)
00098295
00098296, 00104083
GS0120042, 05020144, 00057846
WAIVED
00057846
WAIVED
43869806
44738801
00070751, GS0120041, 00002875,
43869807
44806504
DATA GAP
44806503
00057846
44148801
00057846
WAIVED
Emergence
122-1B Vegetative Vigor
ABCK
WAIVED
119
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT
123-2
141-1
Aquatic Plant Growth
Honey Bee Acute Contact
USE
PATTERN
ABCK
ABCK
CITATION(S)
44806501, 44806502, 44806503
05001991
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-8
82-1A
82-1B
82-2
82-4
82-7
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity -
Rat
Primary Eye Irritation -
Rabbit
Primary Dermal Irritation -
Rabbit
Dermal Sensitization -
Guinea Pig
Acute Neurotoxicity - rat
90-Day Feeding - Rodent
90-Day Feeding - Non-
rodent
21-Day Dermal - Rabbit/Rat
90-Day Inhalation - Rat
Subchronic Neurotoxicity -
ACfflL
ACfflL
ACfflL
ACfflL
ACfflL
ACfflL
AH
AH
ACfflL
ACfflL
00054789, DATA GAP
4002 1401, DAT A GAP
00148070, 00086288, DATA GAP
00128621
40021401
00054791
44041501
00120316, 00129163, 00129164,
00129157
40893604
40273201
41234402
44041502
rat
83-1A Chronic Feeding Toxicity - AH
Rodent
83-1B Chronic Feeding Toxicity - AH
Non-Rodent
83-2A Oncogenicity - Rat AH
00120316, 00129163, 00129164,
00129157
40893604
00120316, 00129163, 00129164,
00153207, 00129157
120
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT
USE
PATTERN
CITATION(S)
83-2B Oncogenicity - Mouse AH
83-3A Developmental Toxicity - AH
Hamster
83-3B Developmental Toxicity - AH
Rabbit
83-4 2-Generation Reproduction AH
-Rat
84-2A Gene Mutation (Ames Test) ACfflL
84-2B Structural Chromosomal ACfflL
Aberration
84-4 Other Genotoxic Effects ACfflL
85-1 General Metabolism AH
85-2 Dermal Penetration ACHEL
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A Foliar Residue Dissipation AC
1977 NCI STUDY, 00068076,
00126845
00078623, 00086803
00093883, 41826901
00120315,00125293
00087805, 00131715, 00114210
00131725,00131727
00058608, 00098897
41505401, 41505402, 41505403,
41505404
00117083
132-1B Soil Residue Dissipation
133-3 Dermal Passive Dosimetry
Exposure
133-4 Inhalation Passive
Dosimetry Exposure
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
AC
AC
AC
ABCDEFH
I
ABC
A
40823902, 40966502, 40988601,
40988602, 40988603, 40988604,
43012903, DATA GAP
40988601, 40988602, 40988603,
40988604, 40966502
40988601, 40985601, 40966501,
40966502, DATA GAP
40988601, 40985601, 40966501,
40966502
00096974, 40208101, 41176301
40208102,41176301
40658009, 40658010
121
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT
162-1
162-2
163-1
163-2
164-1
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Leaching/Adsorption/Desor
ption
Volatility - Lab
Terrestrial Field Dissipation
USE
PATTERN
ABEFH
A
ABCEFH
AE
ABH
CITATION(S)
00070414, 40658007
00098881, 40658008
40658011
40231001
40823901, 40893601, 40893602,
165-4
Accumulation in Fish
201-1 Droplet Size Spectrum
202-1 Drift Field Evaluation
RESIDUE CHEMISTRY
171-4A Nature of Residue - Plants
ABCH
40893603,
40756601, 40756602, 40225601,
40225602, 00160301
Satisfied by Spray Drift Task Force
Satisfied by Spray Drift Task Force
00058941, 00083100, 00096978,
00098790, 00098831, 00128355,
GS120-001, 40658005, 40658006,
41746001, 42109601
171-4B Nature of Residue -
Livestock
ABCH 00058940, 00096901, 00096908,
00098786, 00128355, 00162723,
GS120-004, 40658002, 40658003,
40658004, 42568801, 42756401,
43266701, 43266702
122
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT _ U_SE___ CITATION(S)
USE
PATTERN
171-4C/D Residue Analytical Method -
Plants and Animals
ABCH 00002927, 00002928, 00003025,
00025123, 00025125, 00025129,
00035246, 00035248, 00042645,
00042646, 00045174, 00045175,
00045176, 00045179, 00045182,
00045183, 00045184, 00045188,
00045189, 00053324, 00054015,
00054016, 00070201, 00071790,
00083393, 00085525, 00085526,
00090988, 00090989, 00096910,
00098726, 00098731, 00098747,
00098751, 00098784, 00098789,
00098804, 00098810, 00098811,
00098817, 00098818, 00098894,
00117087, 00128355, GS120-008,
GS120-011, 41393001, 41386501,
41406901, 43548601
171-4E Storage Stability
171-4J Magnitude of Residues -
Meat/Milk/Poultry/Egg
171-4K Crop Field Trials
Root and Tuber Group
ABCH
ABCH
40752301, 41039101, 41557601,
42803901, 43875603
00025125, 00035246, 00035248,
00045178, 00096910, 00098751,
00098808, 00098810, 00104753,
40010501, 42296002
ABCH
Beet roots
Carrots
Potatoes
40189806, 41149104, 41306101,
41306102, 41468401
40189806, 41149104, 41306101,
41306102, 41468401
00098716, 00098894, 00054016,
40189806, 41149104, 41306101,
41306102, 41468401
123
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT _ U_SE___ CITATION(S)
USE
PATTERN
Rutabagas
Taro
Turnip roots
40189806, 41149104, 41306101,
41306102, 41468401
40189806, 41149104, 41306101,
41306102, 41468401
40189806, 41149104, 41306101,
41306102, 41468401
Leaves of root and tuber
group
Beet greens
Turnip greens
Bulb Vegetables
Garlic
Leeks
Onions, dry bulb
Onions, green
Shallots
Leafy vegetables group
Celery
ABCH
ABCH
ABCH
40189821, 41149102, 41306101,
41306102, 41468401
40189821, 41149102, 41306101,
41306102, 41468401
40189806, 41149104, 41306101,
41306102, 41468401
40189806, 41149104, 41306101,
41306102, 41468401
40189806, 41149104, 41306101,
41306102, 41468401
40189806, 41149104, 41306101,
41306102, 41468401
40189806, 41149104, 41306101,
41306102, 41468401
00070201, 00159599, 40189821,
41149102, 41306101, 41306102,
41468401
124
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT _ U_SE___ CITATION(S)
USE
PATTERN
Lettuce
Spinach
Brassica Leafy Vegetables ABCH
Group
Broccoli
Brussels sprouts
Cabbage
Cauliflower
Collards
Kale
Mustard greens
Legume Vegetables Group ABCH
Beans, dry
Beans, succulent
Peas, dry
00070201, 00159605, 40189821,
41149102, 41306101, 41306102,
41468401
00070201, 00159606, 40189821,
41149102, 41149103, 41306101,
41306102, 41468401
40189821, 41149102, 41306101,
41306102, 41468401
40189821, 41149102, 41306101,
41306102, 41468401
40189821, 41149102, 41306101,
41306102, 41468401
40189821, 41149102, 41306101,
41306102, 41468401
40189821, 41149102, 41306101,
41306102, 41468401
40189821, 41149102, 41306101,
41306102, 41468401
40189821, 41149102, 41306101,
41306102, 41468401
00046914, 00070201,
40189820,41149101,
41306102,
00046914, 00070201,
40189820,41149101,
41306102,
40189820,41149101,
41306102,
00098710,
41306101,
41468401
00098710,
41306101,
41468401
41306101,
41468401
125
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT
USE
PATTERN
CITATION(S)
Peas, succulent
Soybeans, dry
Soybeans, succulent
Fruiting vegetables group
Eggplant
Peppers
Pimentos
Tomatoes
ABCH
Curcurbit vegetable group
Cantaloupe
Cucumbers
Honeydew melons
Muskmelons
Pumpkins
Squash, summer
ABCH
40189820,41149101,
41306102,
00003025, 00071790,
40189820,41149101,
41306102,
00071790, 00096982,
40189820,41149101,
41306102,
41306101,
41468401
00096982,
41306101,
41468401
00098709,
41306101,
41468401
00098709, 40189820, 41149101,
41306101, 41306102, 41468401
40189820, 41149101, 41306101,
41306102, 41468401
40189820, 41149101, 41306101,
41306102, 41468401
00070201, 00085526, 00098708,
40189820, 40189823, 40189824,
41149101, 41306101, 41306102,
41468401
00098818, 40189820, 41149101,
41306101, 41306102, 41468401
00098709, 40189820, 41149101,
41306101, 41306102, 41468401
00098818, 40189820, 41149101,
41306101, 41306102, 41468401
00098818, 40189820, 41149101,
41306101, 41306102, 41468401
40189820, 41149101, 41306101,
41306102, 41468401
00098818, 40189820, 41149101,
41306101, 41306102, 41468401
126
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT
USE
PATTERN
CITATION(S)
Squash, winter
Watermelons
Pome fruits Group
Apples
ABCH
Pears
Stone fruits Group
Apricots
Cherries
Nectarines
Peaches
Plums (fresh prunes)
Small fruits and berries
group
Blackberries
Blueberries
Dewberries
Grapes
ABCH
ABCH
Raspberries
00098818, 40189820, 41149101,
41306101, 41306102, 41468401
00128355, 40189820, 41149101,
41306101, 41306102, 41468401
00085526, 00098711, 00098722,
00098789, 00106602, 00128355,
00159597, 40189803, 40745403,
42252201, 42252202
00070201, 00085526, 00098722,
00106602, 00128355, 40189815
00128355,40189805
00128355,40189808
00128355,40189813
00128355, 40189814, 40745406,
40745407
00128355,40189816
42712801
00046914, 00070201, 00090988,
00128355,41039101
42712801
00046914, 00070201, 00090988,
00098726, 00128355, 00159601,
00162037, 40189811, 40189812,
40745405, 42254202
00070201, 42712801, 4422201
127
-------
Data Supporting Guideline Requirements for the Reregistration of Captan
REQUIREMENT _ U_SE___ CITATION(S)
USE
PATTERN
Strawberries
Tree nuts group
Almonds
Almond hulls
Cereal grains group
Corn, sweet
ABCH
ABCH
Miscellaneous commodities ABCH
Cottonseed
171-4L Processed Food ABCH
Apples
Grapes
Plums/Prunes
171-5 Reduction of Residues
165-1 Rotational Crops (Confined) ABCH
00046914, 00070201, 00090988,
00117088, 00128355, 00159607,
40189822, 40745408
00070201, 00090988, 00098804,
00098811, 00128355, 00159596,
00162037, 40189802, 40745402
00070201, 00090988, 00098804,
00098811, 00128355, 00159596,
00162037, 40189802, 40745402
00003025, 00045176, 00070201,
00128355, GS120-039, 40189809,
41149103, 41306101, 41306102,
41468401
00002928, 00003025, 00070201,
00128355, GS120-039, 40189820,
41149101, 41306101, 41306102,
41468401
00098789, 00159597,
40189804,
00128355, 00159601,
40189812, 42296004,
00159595, 00159596,
00159599, 00159601,
42296003,
42563102
00162037,
42563101
40189817
00159597,
00159605
41404001, 42378401
128
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregi strati on Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRTD number". This number is unique to
the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRTD entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRTD), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory
could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (19??), the Agency was
unable to determine or estimate the date of the document.
129
-------
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number follows
the symbol "CDL," which stands for "Company Data Library." This accession
number is in turn followed by an alphabetic suffix which shows the relative
position of the study within the volume.
130
-------
BIBLIOGRAPHY
MRID
CITATION
00002875 Frear, D.E.H.; Boyd, J.E. (1967) Use of Daphnia magna for the microbioassay
of pesticides: I. Development of standardized techniques for rearing Daphnia and
preparation of dosage-mortality curves for pesticides. Journal of Economic
Entomology. 60(5): 1228-1236. (Also in unpublished submission received May
11, 1977 under 239-2458; submitted by Chevron Chemical Co., Richmond,
Calif; CDL:230225-A)
00002927 Devine, J.M.; Horton, W.E. (1972) Determination of Captan
N-Trichloromethylmercapto-4-cyclohexene-l,2,-dicarboximide in Cottonseed:
Report No. 120. (Unpublished study received on unknown date under OF0939;
prepared by State Univ. College-Oswego, Lake Ontario Environmental
Laboratory, submitted by Uniroyal Chemical, Bethany, Conn.; CDL:094582-A)
00002928 Uniroyal Chemical (1972) Residues in PPM: Vitavax. (Unpublished study
received on unknown date under OF0939; CDL:094582-B)
00003025 Chevron Chemical Company (1977) Residue Chemistry Data to Support the
Label Registration of Orthocide-Vitavax 20-20 Seed Protectant. Includes
method RM-JJF-1 dated Jun 25, 1976 entitled: Determination of Captan residues
in crops. (Unpublished study received May 11, 1977 under 239-2458;
CDL:230222-A)
00020560 Schafer, E.W. (1972) The acute oral toxicity of 369 pesticidal, pharmaceutical
and other chemicals to wild birds. Toxicology and Applied Pharmacology 21(?)
:315-330. (Also In unpublished submission received Apr 25, 1978 under 476-
2180; submitted by Stauffer Chemical Co., Richmond, Calif; CDL:233577-C)
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of
Environmental Pollutants to Birds: Special Scientific Report—Wildlife No. 191.
(U.S. Dept. of the Interior, Fish and Wildlife Service, Patuxent Wildlife
Research Center; unpublished report)
00025123 Chevron Chemical Company (1979) Determination of Captafol, Captan, THPI,
and 3-OH THPI in Tissues and Eggs and Determination of Captan, THPI, 3-OH
THPI, and 5-OH THPI in Milk and Cream. Undated method nos. RM-6-G-2,
RM-lG-1 and RRC-75-32. (Unpublished study received Jan 2, 1980 under
239-2211; prepared in cooperation with Stauffer Chemical Co.; CDL:099190-F)
131
-------
BIBLIOGRAPHY
MRID
CITATION
00025125 Leary, J.B.; Lai, J.C. (1976) Captan-Lactating Dairy Cow Feeding
Study-Residues in Meat. (Unpublished study received Jan 2, 1980 under
239-2211; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:099190-H)
00025129 Cheng, H.M. (1976) Metabolism of Carbonyl -14C-difolatan in Young Tomato
and Corn Plants. (Unpublished study received Jan 2, 1980 under 239-2211;
submitted by Chevron Chemical Co., Richmond, Calif; CDL: 099190-L)
00026453 Pack, D.E. (1979) The Anaerobic Soil Metabolism of Carbonyl-14C Captafol.
(Unpublished study received Jan 2, 1980 under 239-2211; submitted by Chevron
Chemical Co., Richmond, Calif; CDL: 099189-A)
00035246 Haumschild, D.; Wingender, R.J. (1972) Report to American Seed Trade
Association, Inc.: Tissue Residue Study for Captan and Tetrahydrophthalimide in
Crossbred Steers Fed Technical Captan: JJBT No. J1255. Includes methods
entitled: Determination of Captan and Determination of Tetrahydrophthalimide
(THPI). (Unpublished study received Jun 27, 1977 under 3E1367; prepared by
Industrial Bio-Test Laboratories, Inc., submitted by Stauffer Chemical Co.,
Richmond, Calif; CDL:096174-A)
00035248 Taylor, R.E.; Brunhouse, E. (1972) Captan Study for American Seed Trade
Association. Includes method RM-1E dated May 26, 1972. (Unpublished study
including letter dated Feb 1, 1973 from J.C. Calandra to Ron Harris, received
Jun 27, 1977 under 3E1367; prepared by Harris Laboratories, Inc., submitted by
Stauffer Chemical Co., Richmond, Calif; CDL:096174-D)
00042645 Rappaport, S.H.; Katague, D.B. (1978) Determination of Captan Residues in
Crops by Gas Chromatography. Method RRC-76-30R dated Mar 27, 1978.
(Unpublished study received Sep 25, 1980 under OE2427; prepared by Stauffer
Chemical Co., submitted by New Zealand, Ministry of Agriculture and Fisheries,
Wellington, New Zealand; CDL:099651-C)
00042646 New Zealand, Ministry of Agriculture and Fisheries (19??) Method for the
Determination of Captan Residues in Kiwifruit. (Unpublished study;
CDL: 099651-D)
132
-------
BIBLIOGRAPHY
MRID
CITATION
00045174 Haumschild, D.; Wingender, R.J. (1972) Report to American Seed Trade
Association, Inc.: Tissue Residue Study for Captan and Tetrahydrophthalimide in
Crossbred Steers Fed Technical Captan: IBT No. J1255. Includes undated
methods entitled: Determination of Captan and Determination of
Tetrahydrophthalimide (THPI). Prepared by Industrial Bio-Test Laboratories,
Inc. Unpublished study; 142 p.
00045175 American Seed Trade Association, Incorporated (19??) Analytical Method Used
for Residue Analysis of Captan. (Unpublished study received Mar 9, 1967 under
3E1367; CDL:096507-B)
00045176 Wilson, M. (1973) Captan Residue Report: Field Corn Seed. (Unpublished
study received on unknown date under 3E1367; submitted by American Seed
Trade Association, Inc., Kalamazoo, Mich.; CDL: 096507-C)
00045178 American Seed Trade Association, Incorporated (1973) Supplement to
American Seed Trade Association, Inc. Petition # 3F1367 for a Captan
Tolerance on Detreated Corn Seed Intended as Feed for Beef Cattle and Swine.
(Unpublished study including letter dated Apr 25, 1973 from J.C. McKay to
Harold Wright, received on unknown date under 3E1367; CDL:096507-E)
00045179 Patchett, G.G. (1973) Determination of Tetrahydrophthalamic acid Residues in
Cattle and Hog Tissues. Method no. WRC 73-38 dated May 17, 1973.
(Unpublished study received on unknown date under 3E1367; prepared by
Stauffer Chemical Co., submitted by American Seed Trade Association, Inc.,
Kalamazoo, Mich.; CDL:096507-F)
00045182 American Seed Trade Association, Incorporated (19??) Determination of Captan
Residues on Treated Seed Corn. Undated method. (Unpublished study received
Mar 9, 1967 under 3E1367; CDL:096507-J)
00045183 American Seed Trade Association, Incorporated (19??) Method for
Determination of Captan Residue on Corn. (Unpublished study received Mar 9,
1967 under 3E1367; CDL:096507-K)
00045184 Kilgore, W.W.; Winterlin, W.; White, R. (1967) Gas chromatographic
determination of Captan residues. Journal of Agricultural and Food Chemistry
15(6):1035-1037. (Also In unpublished submission received on unknown date
133
-------
BIBLIOGRAPHY
MRID
CITATION
under 3E1367; submitted by American Seed Trade Association, Inc.,
Kalamazoo, Mich.; CDL:096507-L)
00045188 Chevron Chemical Company (1972) Determination of Captan Residues in
Animal Tissues. Method RM-1E dated May 26, 1972. (Unpublished study
received on unknown date under 3E1367; submitted by American Seed Trade
Association, Inc., Kalamazoo, Mich.; CDL: 096507-Q)
00045189 Wingender, R.J. (1973) Report to American Seed Trade Association, Inc.:
Results from the Analysis of Hog Tissues for Tetrahydrophthalimide: EBT No.
D2043. (Unpublished study received Mar 9, 1973 under 3E1367; prepared by
Industrial Bio-Test Laboratories, Inc., submitted by American Seed Trade
Association, Inc., Kalamazoo, Mich.; CDL:096506-F)
00046914 Hensill, G.S. (1957) Phaltan Research Report 1957. (Unpublished study
received Oct 28, 1957 under unknown admin, no.; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:119324-A)
00053324 California Spray-Chemical Corporation (1957) Methods of Residue Analysis of
Captan or Phaltan. (Unpublished study received Feb 11, 1958 under unknown
admin, no.; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:119325-A)
00054015 California Spray Chemical Corporation (1960) The Analysis of Residues of
Captan and Phaltan. Method RM-1 dated Apr 4, 1960. (Unpublished study
received Jul 14, 1972 under 2E1215; submitted by Interregional Research
Project No. 4, New Brunswick, N.J.; CDL:091043-A)
00054016 University of Hawaii (1969) Captan-Taro Residue Study. (Unpublished study
received Jul 14, 1972 under 2E1215; prepared by Agricultural Biochemistry
Dept, Pesticide Laboratory in cooperation with Chevron Chemical Co.,
submitted by Interregional Research Project No. 4, New Brunswick, N. J.;
CDL:091043-B)
00054789 Nelson, N. (1949) A Preliminary Toxicological Study of SR-406, a Fungicide.
(Unpublished study received Jun 1, 1965 under unknown admin, no.; prepared
by New York Univ., Bellevue Medical Center, Laboratory of Industrial
134
-------
BIBLIOGRAPHY
MRID
CITATION
Toxicology, submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:001148-A)
00054791 New York University (1951) Progress Report No. 2: Continuation Studies on
SR-406. (Unpublished study received Jun 1, 1965 under unknown admin, no.;
prepared by Bellevue Medical Center, Laboratory of Industrial Toxicology,
submitted by Chevron Chemical Co., Richmond, Calif; CDL:001148-C)
00057846 Hermanutz, R.O.; Mueller, L.H.; Kempfert, K.D. (1973) Captan toxicity to
fathead minnows (Pimephales promelas), bluegills (Lepomis macrochirus), and
brook trout (Salvelinus forntinalis). Journal of the Fisheries Research Board of
Canada 30(12):1811-1817. (Also in unpublished submission received Jan 21,
1977 under 239-533; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:230401-C)
00058608 Mitchell, A.D.; Robinson, D.E.; Beck, J.C. (1980) An Evaluation of the Effect of
Captan on Unscheduled DNA Synthesis in Diploid Human Fibroblasts: Contract
Nos. 68-01-2458 and 68-02-2947; SRI Projects LSU-3493 andLSU-7558.
Final rept. (SRI International for U.S. Environmental Protection Agency;
unpublished study; CDL:244432-A)
00058940 Cheng, H.M. (1980) Metabolism of Carbonyl-14C-Captan in a Lactating Goat:
File No. 721.14/Captan. (Unpublished study received Oct 30, 1980 under
239-533; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:243629-B)
00058941 Cheng, H.M. (1980) Degradation Products of Carbonyl-14C-Captan in Apple
and Orange Processed Parts: File No. 721.14/Captan. (Unpublished study
received Oct 30, 1980 under 239-533; submitted by Chevron Chemical Co.,
Richmond, Calif; CDL:243629-D)
00068076 Wong, Z.A.; Bradfield, L.G.; Akins, B.J.; et al. (1981) Socal 1150: Lifetime
Oncogenic Feeding Study of Captan Technical (SX-944) in CD-I Mice (ICR
Derived). (Unpublished study received Jan 29, 1981 under 239-533; submitted
by Chevron Chemical Co., Richmond, Calif; CDL:244220-A; 244221; 244222;
244223; 244224; 244225; 244226)
135
-------
BIBLIOGRAPHY
MRID
CITATION
00070201 California Spray Chemical Corporation (1957) Captan Residues-Various Crops.
(Reports by various sources; unpublished study received Feb 25, 1957 under
PP0124; CDL:090426-J)
00070414 Pack, D.E. (1974) The Soil Metabolism of Carbonyl-14 C-Captan: File
No.773.21 (Unpublished study received Nov 26, 1974 under 239-533; submitted
by Chevron Chemical Co., CDL 120648-B)
00070751 Boudreau, P.; Forbis, A.D.; Cranor, W.; et al. (1980) Static Acute Toxicity of
Captan Technical (SX-1086) to Daphnia magna: ABC Report # 26633.
(Unpublished study received Jan 12, 198111 under 239-1246: prepared by
Chevron Chemical Co., Richmond, Calif; CDL: 244428-A)
00071790 Stauffer Chemical Company (1980) Residue Data of Various Chemicals,
Including Captan, on Soybeans. (Compilation; unpublished study received Dec
12, 1980 under AR 80/24; submitted by state of Arkansas for Stauffer;
CDL:243877-A)
00078623 Chevron Chemical Company (1979) Teratology Study in Hamsters: JJRDC No.
415-005. (Compilation; unpublished study, including JJRDC no. 999-015,
received Jun 20, 1979 under 239-1246; CDL: 238658-C)
00083100 Pack, D.E. (1980) Analysis of Soybeans Grown from Seed Treated with
14C-Captan~Greenhouse Study: File 721.14. (Unpublished study received Mar
23, 1981 under 239-2457; submitted by Chevron Chemical Co., Richmond,
Calif; CDL:244766-A)
00083393 California Chemical Company (1961) The Determination of and Differentiation
between Residues of Phaltan and Captan: File 740.10. Residue method RM-1A
dated Jan 31, 1961. (Unpublished study received on unknown date under
PP0283; CDL:090305-D)
00085525 Petrino, L.M. (1955) Colorimetric Estimation of Captan Surface Residue on
Fruit Samples: (Adaptation of Method Published in Analytical Chemistry, July,
1952, Page 1173). Method dated Mar 21, 1955. (Unpublished study received
May 1, 1955 under PP0015; prepared by Stauffer Chemical Co., submitted by
California Spray-Chemical Co., Richmond, Calif; CDL:090983-O)
136
-------
BIBLIOGRAPHY
MRID
CITATION
00085526 California Spray-Chemical Company (1954) Determination of Captan Residues.
(Unpublished study received May 1, 1955 under PP0015; CDL:090983-P)
00086288 Gregory, L.K.; Narcisse, J.K. (1974) The Acute Inhalation Toxicity of Orthocide
83: SOCAL 589/XIIL129 (S-647). (Unpublished study received Sep 24, 1975
under 239-729; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:140140-F)
00086803 Rodwell, D.E. (1979) Teratology Study in Hamsters: 415-005. Amendment to
the final rept. (Unpublished study received Sep 28, 1981 under 239-1246;
prepared by International Research and Development Corp., submitted by
Chevron Chemical Co., Richmond, Calif; CDL:246246-A)
00087805 Brusick, D.J.; Nguyen, T.D.; McGowan, J. (1981) Mutagenicity Evaluation of
Captan in the Somatic Cell Mutation Assay: LBI Project No. 20951. Final rept.,
rev. Includes method dated Apr 10, 1978. (Unpublished study received Sep 28,
1981 under 239-1246; prepared by Litton Bionetics, Inc., submitted by Chevron
Chemical Co., Richmond, Calif; CDL:246244-A; 246245)
00009694 Brittain, J. (1964) Preliminary Tests-Delayed Treatments: Alar. (Unpublished
study received Jun 1, 1970 under 400-EX-37; submitted by Uniroyal Chemical,
Bethany, Conn.; CDL:123446-T)
00090988 California Spray-Chemical Corporation (1957) The Results of Tests on the
Amount of Residue Remaining, Including a Description of the Analytical Method
Used: Captan. (Compilation; unpublished study received on unknown date
under PP0124; CDL:090432-D)
00090989 Curtis & Tomkins, Limited (1955) Letter sent to L.W. Hazleton dated Mar 30,
1955: Determination of captan and tetrahydrophthalimide residues on apples,
concerning lab. no. 55d40. (Incomplete; unpublished study received Apr 18,
1957 under PP0124; submitted by California Spray-Chemical Corp., Richmond,
Calif; CDL:090432-E)
00096901 Crossley, J. (1970) The Fate of Difolatan in a Lactating Ruminant (Goat); File
No. 721.14. (Unpublished study received Jun 9, 1977 under 239-2211;
submitted by Chevron Chemical Co., Richmond, Calif; CDL: 096157-C)
137
-------
BIBLIOGRAPHY
MRID
CITATION
00096908 Cheng, H.M. (1979) Metabolism of Carbonyl 14C Captafol in a Lactating Goat:
File No. 721.14. (Unpublished study received Jan 2, 1980 under 239-2211;
submitted by Chevron Chemical Co., Richmond, Calif, CDL: 099191-G)
00096910 Hillebrecht, W.R.; Riggs, R.L. (1977) Captan Milk Residue Study in Lactating
Dairy Cattle. (Unpublished study received Jan 2, 1980 under 239-2211;
prepared by Stauffer Chemical Co., submitted by Chevron Chemical Co.,
Richmond, Calif; CDL:099191-I)
00096974 Wolfe, N.L.; Zepp, R.G.;Doster, J.C. et al. (1976) Captan hydrolysis. Journal of
Agricultural and Food Chemistry 24(c):10411045. (Also in unpublished
submission received May 30, 1978 under 239-2211; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:234046-Q)
00096978 Abell, J.; Moore, J.E. (1967) Attempts To Demonstrate the Translocation of
Difolatan and Orthocide: File No. 721.13. (Unpublished study received May 30,
1978 under 239-2211; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:234046-AB)
00096982 Chevron Chemical Company (1979) Residue Data Sheet: Soybeans: Test No.
T-4546. (Compilation; unpublished study received Mar 28, 1979 under
239-2369; CDL:237912-A)
00098295 Chevron Chemical Company (1980) One Generation Reproduction Studies with
Captan (SX-1086). (Compilation; unpublished study received Apr 5, 1982 under
239-1246; CDL:247147-C)
00098296 Chevron Chemical Company (1980) Captan (SX-1086)/One Generation
Reproduction Studies, Including Diet Analyses. Includes method dated Jun 15,
1979. (Compilation; unpublished study received Apr 5, 1982 under 239-1246;
CDL:247147-D)
00098708 Chevron Chemical Company (1950) Residue Studies of Orthocide 406 on
Tomatoes. (Compilation; unpublished study received Mar 21, 1951 under
239-533; CDL:001157-B)
138
-------
BIBLIOGRAPHY
MRID
CITATION
00098709 Chevron Chemical Company (1950) Residue Studies of Orthocide 406 on
Various Vegetables. (Compilation; unpublished study received Mar 21, 1951
under 239-533; CDL:001157-C)
00098710 Davis, D.L. (1950) Residue Analysis-SR-406: Snap Beans. (Unpublished study
received Mar 21, 1951 under 239-533; submitted by Chevron Chemical Co.,
Richmond, Calif; CDL:001157-D)
00098711 Davis, D.L. (1950) Residue Analysis-SR-406: Apples. (Unpublished study
received Mar 21, 1951 under 239-533; submitted by Chevron Chemical Co.,
Richmond, Calif; CDL:001157-E)
00098716 Kohn; G.K. (1954) Captan Residues on Potatoes. (Unpublished study received
Jun 2, 1954 under 239-533; submitted by Chevron Chemical Co., Richmond,
Calif; CDL:001163-A)
00098722 Kohn, G.K. (1958) Letter sent to G.S. Hensill dated May 21, 1958: Captan
residues: postharvest treatment. (Unpublished study received Jun 20, 1958
under 239-533; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:001194-A)
00098726 Chevron Chemical Company (1950) SR-406: Residues in Various Crops.
(Compilation; unpublished study received Oct 10, 1951 under 239-1102;
CDL:001257-B)
00098731 Kittleson, A.R. (1952) Colorimetric determination of
N-trichloromethiotetrahydrophthalimide. Analytical Chemistry 24:1173-1174.
(Also In unpublished submission received Feb 21, 1973 under 1486-20;
submitted by Ferro Corp., Bedford, Ohio; CDL:006427-C)
00098747 Makhteshim Chemical Works Limited (1969) Merpan: Residue Analysis: DS
13.51.11. (Unpublished study received Apr 17, 1972 under 11678-1;
CDL:026318-B)
00098751 Chevron Chemical Company (1954) Captan Residues in Meat. (Unpublished
study received May 5, 1954 under 239-656; CDL:027009-B)
139
-------
BIBLIOGRAPHY
MRID
CITATION
00098881 Pack, P.E. (1979) The Anaerobic Soil Metabolism of Carbonyl 14 C-Captan:
File No. 721.14. (Unpublished study received Aug. 27, 1979 under 239-2457;
submitted by Chevron Chemical Co., Richmond, Calif,; CDL:240891-B)
00098784 Interregional Research Project Number 4 (1976) Determination of Captan
Pesticide in or on Taro Leaves. (Compilation; unpublished study received Jul
11, 1977 under 7E1982; CDL:097592-A)
00098786 Mitoma, C. (1972) Pilot Study to Determine the Nature and Magnitude of the
Residues from Ingestion of Captan in a Ruminating Animal: SRI Project
LSC-1697. (Unpublished study received Mar 7, 1977 under 239-2457; prepared
by Stanford Research Institute, submitted by Chevron Chemical Co., Richmond,
Calif; CDL:096129-B)
00098789 Chevron Chemical Company (1976) Captan Residue Analyses—Apples.
(Compilation; unpublished study, including test nos. T-3513 and T-3514,
received Mar 7, 1977 under 239-2457; CDL:096129-H)
00098790 DeBaun, J.R.; Gruwell, L.A.; Menn, J.J. (1975) The Fate of Captan
Carbonyl-14C on Field-grown Apple Trees: MRC-B-44. Rev. (Unpublished
study received Mar 7, 1977 under 239-2457; prepared by Stauffer Chemical Co.,
submitted by Chevron Chemical Co., Richmond, Calif; CDL:096129-I)
00098804 California Spray-Chemical Corporation (1961) Residue Data Sheet: Almonds:
Test No. T-239. (Unpublished study received Jan 24, 1962 under 239-533;
submitted by Chevron Chemical Co., Richmond, Calif; CDL:121209-A)
00098808 Chevron Chemical Company (1957) Captan: Residues in Cattle. (Compilation;
unpublished study, including cattle progress report 247, received May 9, 1961
under unknown admin, no.; CDL: 121212-C)
00098810 Cripps, J.M. (1957) Letter sent to California Spray-Chemical Corporation dated
Feb 13, 1957: Captan residues—chicken eggs, breasts, thighs and livers.
(Unpublished study received May 9, 1961 under unknown admin, no.; submitted
by Chevron Chemical Co., Richmond, Calif; CDL:121212-G)
140
-------
BIBLIOGRAPHY
MRID
CITATION
00098811 Chevron Chemical Company (1957) Captan Residues in Almonds. (Compilation;
unpublished study received May 9, 1961 under unknown admin, no.;
CDL:121212-H)
00098817 Chevron Chemical Company (1957) Residue Studies of Captan on Raisins.
(Compilation; unpublished study received Jun 25, 1957 under 239-104;
CDL:121282-A)
00098818 Pennwalt Corporation (19??) Captan Residue on Cantaloupes Treated with
Decco Salt No. 10. (Unpublished study received Aug 5, 1957 under unknown
admin, no.; CDL:121594-A)
00098831 Tagawa, H; Yamaguchi, Y. (1970) Persistence of Captan and Difolatan in Soil
and Their Absorption by Tobacco Plants from Soil. A translation of: Without
Title. Bulletin of the Hatano Tobacco Experiment Station, Yokohama,
Kangagwa, Japan 73:353. (Unpublished study received Jan 4, 1978 under
239-1246; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:232569-H)
00098894 Chevron Chemical Company (1979) Analyses for Orthocide Plus in Potatoes.
(Compilation; unpublished study received Sep 18, 1979 under 239-2474;
CDL:241047-A)
00098897 Mitchell, A.D.; Robinson, D.E.; Beck, J.C. (1981) An Evaluation of the Effect of
Captan on Unscheduled DNA Synthesis in Diploid Human Fibroblasts: SRI
Projects LSU-3493 andLSU-7558; Contract Nos. 68-01-2458 and 68-02-2947.
Final rept. (SRI International for U.S. Environmental Protection Agency;
unpublished study; CDL:244432-A)
00104083 Stromberg, K. (1975) Sub-lethal Effects of Seed Treatment Pesticides on
Breeding Hen Pheasants. Doctoral Dissertation, Michigan State Univ., Dept. of
Fisheries and Wildlife. (Unpublished study received Mar 5, 1979 under 239-579;
submitted by Chevron Chemical Co., Richmond, CA; CDL:237966-A)
00104686 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Subacute
Feeding-Reproduction Screening Bioassay-Bobwhite Quail: Captan Technical
(SX-1086): Project No. 162-123. (Unpublished study received Apr 5, 1982
141
-------
BIBLIOGRAPHY
MRID
CITATION
under 239-1246; prepared by Wildlife International, Ltd., submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:247147-B)
00104753 McKay, J.C. (1973) Letter sent to Harold Wright dated Mar 2, 1973
Determinations for residues of tetrahydrophthalamic acid-Captan. (Unpublished
study received Mar 9, 1973 under 3E1367; prepared by Stauffer Chemical Co.,
submitted by American Seed Trade Association, Inc., Kalamazoo, Mich.;
CDL:096506-D)
00106602 Stauffer Chemical Company (1975) Summary of Crop Residue Data Supporting
Registration of Captan: Imidan 16:12-WP. (Compilation; unpublished study
received Mar 21, 1975 under 476-2172; CDL: 028453-D)
00113613 Atkins, E.; Greywood, E.; Macdonald, R. (1972) Effect of Pesticides on
Apiculture: Project No. 1499. Annual rept, 1972. (Unpublished study received
Mar 28, 1975 under 5F1608; prepared by Univ. of California-Riverside, Dept.
of Entomology, Div. of Economic Entomology, submitted by ICI United States,
Inc., Wilmington, DE; CDL:094397-P)
00114210 Simmon, V.; Mitchell, A.; Jorgenson, T. (1977) Evaluation of Selected
Pesticides as Chemical Mutagens in vitro and in vivo Studies: EPA-600/1-77-
028; Contract No. 68-01-2458; Olin 3554. (Stanford Research Institute for U.S.
Environmental Protection Agency, Office of Research and Development, Health
Effects Research Laboratory; unpublished study; CDL 248284-E).
00117083 Adir, J.; Chin, T.; Ruch, G.; et al. (1982) Captan 50-WP: A Dermal Absorption
Study in Rats: T-l 1008. (Unpublished study received Sep 3, 1982 under
476-2099; submitted by Stauffer Chemical Co., Richmond, CA; CDL:248429-A)
00117087 Maddy, K.; Kahn, C.; Riddle, L.; et al. (1977) A Breakdown Study of Captan on
Strawberry Foliage and Fruit in Ventura County, California: ACF 59-372.
(California, Dept. of Food and Agriculture, Agricultural Chemicals and Feed;
unpublished study; CDL: 248429-E)
00117088 Maddy, K.; Edmiston, S.; Kahn, C.; et al. (1977) A Study of the Decay of
Captan on the Foliage and Fruit of Strawberries in Santa Cruz County,
142
-------
BIBLIOGRAPHY
MRID
CITATION
California: ACF 59-376. (California, Dept. of Food and Agriculture,
Agricultural Chemicals and Feed; unpublished study; CDL:248429-F)
00120315 Schardein, I; Aldridge, D. (1982) One Generation Reproduction Study in Rats
with Captan: 153-190; T-10486. (Unpublished study received Nov 18, 1982
under 476-2099; prepared by International Research and Development Corp.,
submitted by Stauffer Chemical Co., Richmond, CA; CDL:249019-A)
00120316 Goldenthal, E.; Warner, ML; Rajasekaran, D.; et al. (1982) 2-year Oral
Toxicity/Carcinogenicity Study of Captan in Rats: 153-097. (Unpublished study
received Nov 18, 1982 under 476-2099; prepared by International Research and
Development Corp., submitted by Stauffer Chemical Co., Richmond, CA;
CDL:249020-A; 249021; 249022; 249023; 249731)
00125293 Schardein, J.; Schwartz, C.; Thorstenson, J. (1982) Three Generation
Reproduction Study in Rats: 153-096. (Unpublished study received Jan 20,
1983 under 239-1246; prepared by International Research and Development
Corp., submitted by Chevron Chemical Co., Richmond, CA; CDL:249334-A)
00126845 Daly, I; Knezevich, A. (1983) A Lifetime Oral Oncogenicity Study of Captan in
Mice: Project No. 80-2491. Final rept. (Unpublished study received Apr 14,
1983 under 239-1246; prepared by Bio/dynamics, Inc., submitted by Chevron
Chemical Co., Richmond, CA; CDL:249943-A; 249942; 249948; 249944;
249945; 249946; 249947)
00127865 Armstrong, D.; Buchanan, D.; Caldwell, R. (1976) A mycosis caused by
lagenidium sp. in laboratory-reared larvae of the dungeness crab, cancer
magister, and possible chemical treatments. Journal of Invertebrate Pathology
28:329-336. (Also In unpublished submission received Apr 21, 1983 under
677-313; submitted by Diamond Shamrock Agricultural Chemicals, Cleveland,
OH; CDL: 071552-D)
00128355 Chevron Chemical Co. (1982) Residue Chemistry Data: Captan. (Compilation;
unpublished study received May 19, 1983 under 3F2898; CDL:071624-A;
071625; 071626)
00128621 Bullock, C. (1982) The Eye Irritation Potential of Chevron Captan 90
Concentrate: Socal 1919 (S-2086). (Unpublished study received May 25, 1983
143
-------
BIBLIOGRAPHY
MRID
CITATION
under 239-2137; submitted by Chevron Chemical Co., Richmond, CA;
CDL:250381-A)
00129157 Saunders, D. (1983) Letter sent to M. Sauerhoff dated Jun 9, 1983: Historical
data: T-10002. (Unpublished study received Jun 15, 1983 under 476-2099;
submitted by Stauffer Chemical Co., Richmond, CA; CDL:250668-A)
00129163 Stauffer Chemical Co. (1982) Revised Pages of 2-year Oral
Toxicity/Carcinogenicity Study of Captan in Rats with Captan Technical,
SX944: 153-097. (Unpublished study received Jun 15, 1983 under 476-2099;
CDL:250667-A)
00129164 Stauffer Chemical Co. (1982) Revised Pages of 2-year Oral
Toxicity/Carcinogenicity Study of Captan in Rats with Captan Technical,
SX944: 153-097. (Unpublished study received Jun 15, 1983 under 476-2099;
CDL:250667-B)
00131715 Ficsor, G.; Bordas, S.; Wade, S.; et al. (1977) Mammilian host-and
fluid-mediated mutagenicity assays of captan and streptozotocin in salmonella
typhimurium. Mutation Research 48:1-15. (Also In unpublished submission
received Nov 28, 1980 under unknown admin, no.; submitted by Stauffer
Chemical Co., Richmond, CA; CDL: 251563-E)
00131725 Tezuka, EL; Teramoto, S.; Kaneda, M.; et al. (1978) Cytogenetic and dominant
lethal studies on captan. Mutation Research 57:201207. (Also In unpublished
submission received Nov 28, 1980 under unknown admin, no.; submitted by
Stauffer Chemical Co., Richmond, CA; CDL:251563-S)
00131727 Tezuka, EL; Ando, N.; Suzuki, R.; et al. (1980) Sister-chromated exchanges and
chromosomal aberrations in cultured Chinese hamster cells treated with pesticides
positive in microbial reversion assays. Mutation Research 78:177-191. (Also In
unpublished submission received Nov 28, 1980 under unknown admin, no.;
submitted by Stauffer Chemical Co., Richmond, CA; CDL: 251563-U)
00148070 MacAskill, S.; Zwicker, G. (1985) EPA Acute Inhalation Study with Captan
Technical: Final Report: Report No. T-l 1933. Unpublished study prepared by
Stauffer Chemical Co. 85 p.
144
-------
BIBLIOGRAPHY
MRID
CITATION
00151236 Beavers, J. (1978) Acute Oral LD50 Bobwhite Quail: Orthocide Technical: Final
Report: Project No. 162-102. Unpublished study prepared by Wildlife
International, Inc. 15 p.
00153207 Bruyntjes, J. (1984) Incidence of Tumours in CPB: WU Wistar Random Rats:
Data of Control Animals from Long-term Studies: Report No. V 84/132.
Unpublished study prepared by Netherlands Org. for Apl. Sci. Res. (TNO). 12
P-
00159595 Captan Task Force (1986) Determination of Captan and THPI Residues in
Crops. Unpublished compilation of methods. 53 p.
00159596 Captan Task Force (1985) Summary of Residue Data: Orthocide SOW in
Almonds: Test No. T-6268. Unpublished compilation prepared in cooperation
with Morse Labs. 6 p.
00159597 Captan Task Force (1985) Summary of Residue Data: Orthocide SOW in Red
Delicious Apples: Test No. T-6649. Unpublished compilation prepared in
cooperation with Morse Labs. 18 p.
00159599 Captan Task Force (1985) Summary of Residue Data: Orthocide 50WP in
Celery: Test No. T-6269. Unpublished compilation prepared in cooperation with
Morse Labs. 35 p.
00159601 Captan Task Force (1985) Orthocide SOW Residues in Grapes. Unpublished
compilation prepared in cooperation with Morse Labs. 29 p.
00159605 Captan Task Force (1985) Summary of Residue Data: Orthocide SOW in Leaf
Lettuce: Test Nos. T-6276 and T-6285. Unpublished compilation prepared in
cooperation with Morse Labs. 20 p.
00159606 Captan Task Force (1986) Summary of Residue Data: Orthocide SOW in
Spinach: Test No. T-6280. Unpublished compilation prepared in cooperation
with Morse Labs. 12 p.
00159607 Captan Task Force (1985) Summary of Residue Data: Orthocide SOW in
Strawberries. Unpublished compilation prepared in cooperation with Morse
Labs. 20 p.
145
-------
BIBLIOGRAPHY
MRID
CITATION
00160301 Kenaga, E. (1980) Predicted bioconcentration factors and soil sorption
coefficients of pesticides and other chemicals. Ecotoxicology and Environ.
Safety 4:26-38.
00162037 Breault, G. (1986) Addendum to Residue Reduction of Captan and THPI on
Crops: Data Call In: R-218. Unpublished compilation prepared by Chevron
Chemical Co. 110 p.
00162723 DeBaun, I; Miaullis, I; Knarr, I; et al. (1973) The Metabolic Fate of Captan
(Trichloromethylthio-carbon-14) in the Rat:ARC/ B-34. Unpublished study
prepared by Stauffer Chemical Co. 44 p.
05001991 Stevenson, J.H. (1978) The acute toxicity of unformulated pesticides to worker
honey bees (Apis mellifera). Plant Pathology 27(1):38-40.
05020144 Tooby, T.E.; Hursey, P.A.; Alabaster, J.S. (1975) The acute toxicity of 102
pesticides and miscellaneous substances to fish. Chemistry and Industry
(London) (12):523-526.
40010501 Graham, D. (1986) Captan-Magnitude of the Residues: Poultry and Eggs
(Magnitude of Residues of Captan and its Major Metabolites in Eggs and
Chicken Tissues): Project ID. RRC 86-63. Unpublished study prepared by
Stauffer Chemical Co. 183 p.
40021201 Chevron Chemical Co. (1986) Analysis and Certification of Product Ingredients:
Project ID. 8615386. Unpublished compilation. 73 p.
40021202 Chevron Chemical Co. (1986) Physical and Chemical Characteristics: Project
ID. 8615387. Unpublished compilation. 57 p.
40021301 Chevron Chemical Co. (1986) Product Identity and Composition: Laboratory
Project ID. 8615385. Unpublished compilation. 127 p.
40021401 Morgan, R. (1986) Acute Dermal Toxicity and Skin Irritation of Captan 90 Dust
Base: Lab. Proj. ID T-12526. Unpublished study prepared by Stauffer Chemical
Co. 14 p.
146
-------
BIBLIOGRAPHY
MRID
CITATION
40098001 Mayer,F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and
Data Base for 410 Chemicals and 66 Species of Freshwater Animals. U.S. Fish
and Wildlife Service; Resource Publication 160: 579 p.
40121701 Makhteshim Chemical Works Ltd. (1987) Product Chemistry: Translation from
French to English Merpan Captan Technical: MCW 10002. Unpublished study.
15 p.
40189802 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Almond: Chevron Study No. 056131-B. Unpublished study
prepared in cooperation with Morse Laboratories. 246 p.
40189803 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Apples: Chevron Study No. 056131-C. Unpublished study prepared
in cooperation with Morse Laboratories. 454 p.
40189804 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue:
Processed Food/Feed Study: Apples: Chevron Study No. 056131-D.
Unpublished study prepared in cooperation with Morse Laboratories. 82 p.
40189805 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Apricot: Chevron Study No. 056131-E. Unpublished study
prepared in cooperation with Morse Laboratories. 163 p.
40189806 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Beet: Chevron Study No. 056131-F. Unpublished study prepared in
cooperation with Morse Laboratories. 97 p.
40189808 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Cherry: Chevron Study No. 056131-H. Unpublished study prepared
in cooperation with Morse Laboratories. 210 p.
40189809 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Corn: Chevron Study No. 056131-1. Unpublished study prepared in
cooperation with Morse Laboratories. 187 p.
147
-------
BIBLIOGRAPHY
MRID
CITATION
40189811 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Grape: Chevron Study No. 056131-K. Unpublished study prepared
in cooperation with Morse Laboratories. 378 p.
40189812 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue:
Processed Food/Feed Study: Grapes: Chevron Study 045131-L. Unpublished
study prepared in cooperation with Morse Laboratories. 154 p.
40189813 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Nectarine: Chevron Study No. 056131-M. Unpublished study
prepared in cooperation with Morse Laboratories. 151 p.
40189814 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Peach: Chevron Study No. 056131-N. Unpublished study prepared
in cooperation with Morse Laboratories. 339 p.
40189815 Reed D. Smith Associates, Inc. (1987) Magnitude of Residue: Crop Field Trials:
Pear: Chevron Study No. 05613 l-O. Unpublished study prepared in
cooperation with Morse Laboratories. 316 p.
40189816 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Plum: Chevron Study No. 056131-P. Unpublished study prepared
in cooperation with Morse Laboratories. 217 p.
40189817 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue:
Processed Food/Feed Study: Prunes: Chevron Study No. 056131-Q.
Unpublished study prepared in cooperation with Morse Laboratories. 77 p.
40189820 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Soybean: Chevron Study No. 056131-T. Unpublished study
prepared in cooperation with Morse Laboratories. 174 p.
40189821 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Spinach: Chevron Study No. 056131-U. Unpublished study
prepared in cooperation with Morse Laboratories. 121 p.
148
-------
BIBLIOGRAPHY
MRID
CITATION
40189822 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Strawberries: Chevron Study No. 056131-V. Unpublished study
prepared in cooperation with Morse Laboratories. 262 p.
40189823 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
Field Trials: Tomato: Chevron Study No. 056131-W. Unpublished study
prepared in cooperation with Morse Laboratories. 217 p.
40189824 Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue:
Processed Food/Feed Study: Tomatoes: Chevron Study No. 056131-X.
Unpublished study prepared in cooperation with Morse Laboratories. 123 p.
40208101 Pack, D. (1987) Trichloromethyl Carbo 14 Captan Hydrolysis Products:
Laboratory Project ID: MEF-0002, 8702383. Unpublished study prepared by
Chevron Chemical Co. 28 p.
40208102 Pack, D. (1986) Photolysis of Caaaptan in Sterile Aqueous Solution: Laboratory
Project ID: MEF-0001. Unpublished study prepared by Chevron Chemical Co.
13 p.
40231001 Kuzdas, C.; Frinch, R.(1980) Ames-Salmonella/Microsome Mutagenicity Test:
Chlorhexidine Diacetate: Laboratory Project No.: 728366: 748579. Unpublished
study prepared by Raltech Scientific Service. 18 p.
40231201 Makhteshim Chemical Works Ltd. (1987) Additional Product Chemistry Data:
Merpan Captan Technical: Makhteshim-Agan Project ID: MCW 10001.
Unpublished study. 10 p.
40231301 Makhteshim Chemical Works Ltd. (1987) Additional Product Chemistry Data:
Merpan Captan Technical: Makhteshim-Agan Project ID: MCW 10001.
Unpublished study. 16 p.
40231801 Thornberry, N. (1987) Physical and Chemical Characteristics: Captan Technical:
Laboratory Project ID: 8709737. Unpublished study prepared by Chevron
Chemical Co. 4 p.
149
-------
BIBLIOGRAPHY
MRID
CITATION
40273201 Johnson, D. (1987) Twenty-one Day Dermal Toxicity Study in Rabbits with
Technical Captan: Laboratory Project ID: 415-046. Unpublished study prepared
by International Research and Development Corp. 153 p.
40658002 Daun, R. (1988) Trichloromethyl-Carbon 14Captan: Nature of the Residue in
Livestock—Lactating Goats: Laboratory Project ID: HLA 6183-105.
Unpublished study prepared by Hazleton Laboratories, Inc. 67 p.
40658003 Daun, R. (1988) Trichloromethyl-Carbon 14Captan: Nature of the Residue in
Livestock—Laying Hens: Laboratory Project ID: HLA 6183-106. Unpublished
study prepared by Hazleton Laboratories America, Inc. 62 p.
40658004 Daun, R. (1988) Cyclohexene-l,2-Carbon 14Captan: Nature of the Residue in
Livestock—Laying Hens: Laboratory Project ID: HLA 6183-104. Unpublished
study prepared by Hazleton Laboratories America, Inc. 79 p.
40658005 Chen, Y. (1988) Plant Metabolism Study of Trichloromethyl-Carbon 14-Captan:
Laboratory Project ID: MEF-0009/8808900. Unpublished study prepared by
Chevron Chemical Co. 37 p.
40658006 Chen, Y. (1988) Plant Metabolism Study of Cyclohexene-l,2-Carbon
14-Captan: Laboratory Project ID: MEF-0010/8805420. Unpublished study
prepared by Chevron Chemical Co. 38 p.
40658008 Pack, D.; Verrips, I. (1988) Anaerobic Soil Metabolism of Trichhloromethyl-
Carbon 14 Captan: Laboratory Project ID: MEF0061/8809887. Unpublished
study prepared by Chevron Chemical Co. 39 p.
40658009 Ruzo, L. (1988) Soil Surface Photolysis of Carbon 14-Trichloromethyl Captan in
Natural Sunlight: Laboratory Project ID: 231. Unpublished study prepared by
Pharmacology and Toxicology Research Laboratory. 117 p.
40658010 Ruzo, L. (1988) Soil Surface Photolysis of Carbon 14 Captan in Natural
Sunlight: Laboratory Project ID: 232. Unpublished study prepared by
Pharmacology and Toxicology Research Laboratory. 109 p.
150
-------
BIBLIOGRAPHY
MRID
CITATION
40658011 Pack, D. (1987) Estimation of Soil Adsorption Coefficient of Captan from TLC
Data: Laboratory Project ID: MEF-0073/8726836. Unpublished study prepared
by Chevron Chemical Co. 39 p.
40745400 Captan Task Force (1988) Residue Data submitted for the support of the
reregi strati on of Captan Use on crops with a comparison of Air vs Ground
Concentrate and Dilute Application Methods. Transmittal of 9 studies.
40745402 Reed D. Smith Associates, Inc. (1988) Captan ... Magnitude of Residue, Crop
Field Trials: Almond: Project ID. 87-718. Unpublished compilation prepared in
cooperation with Morse Laboratories. 125 p.
40745403 Reed D. Smith Associates, Inc. (1988) Captan ... Magnitude of Residue, Crop
Field Trials: Apple: Project ID. 87-304. Unpublished compilation prepared in
cooperation with Morse Laboratories. 86 p.
40745405 Reed D. Smith Associates, Inc. (1988) Captan ... Magnitude of Residue, Crop
Field Trials: Grape: Project ID. 87-167. Unpublished compilation prepared in
cooperation with Morse Laboratories. 88 p.
40745406 Reed D. Smith Associates, Inc. (1988) Captan ... Magnitude of Residue, Crop
Field Trials: Peach: Project ID. 87-984. Unpublished compliation prepared in
cooperation with Morse Laboratories. 110 p.
40745407 Reed D. Smith Associates, Inc. (1988) Captan ... Magnitude of Residue, Crop
Field Trials: Peach (WA): Project ID. 87-916. Unpublished compilation
prepared in cooperation with Morse Laboratories. 89 p.
40745408 Reed D. Smith Associates, Inc. (1988) Captan ... Magnitude of Residue, Crop
Field Trials: Strawberry: Project ID. 87-722. Unpublished compilation prepared
in cooperation with Morse Laboratories. 107 p.
40752301 McKay, J. (1988) Captan and THPI-Storage Stability Study: Various Crops:
Interim Report: Laboratory Project ID RRC-88-35. Unpublished study prepared
by Chevron Environmental Center in cooperation with Morse Laboratories, Inc.
and Hazleton Laboratories America, Inc. 247 p.
151
-------
BIBLIOGRAPHY
MRID
CITATION
40823902 Jones, P. (1988) Captan 50-WP Dislodgeable Residue Study on New York
Apples: Project ID PAL-EF-88-10. Unpublished study prepared by Morse
Laboratories, Inc. in association with Pan-Agricultural Laboratories, Inc. 188 p.
40893604 Blair, M. (1988) One Year Oral Toxicity Study in Dogs with Captan Technical:
Project ID: IRDC 153-198. Unpublished study prepared by International
Research and Development Corp. 368 p.
40966501 Jones, P. (1988) Worker Exposure to Residues of Captan 50-WP during Peach
Harvest in California: Project ID. PAL-EF-88-16. Unpublished study prepared
by McKenzie Laboratories, Inc. 542 p.
40966502 Jones, P. (1988) Worker Exposure to Residues of Captan 50-WP during
Strawberry Harvest in California: Project ID. PAL-EF-88-15. Unpublished
study prepared by McKenzie Laboratories, Inc. 538 p.
40985601 Jones, P. (1988) Worker Exposure to Residues of Captan 50-WP During Grape
Harvest in California: Project ID PAL-EF-88-17. Unpublished study prepared
by Morse Laboratories, Inc. 484 p.
40988601 Chetram, R. (1989) Captan 50-WP Dislodgable Residue Study on California
Strawberries: Project ID: PAL-EF-88-11. Unpublished study prepared by
Pan-Agricultural Laboratories, Inc., in cooperation with McKenzie Laboratories,
Inc. 193 p.
40988602 Chetram, R. (1988) Captan 50-WP Dislodgable Residue Study on California
Tomatoes: Project ID: PAL-EF-88-14. Unpublished study prepared by
Pan-Agricultural Laboratories, Inc., in cooperation with Morse Laboratories,
Inc. 171 p.
40988603 Chetram, R. (1989) Captan 50-WP Dislodgable Residue Study on California
Grapes: Project ID: PAL-EF-88-13. Unpublished study prepared by
Pan-Agricultural Laboratories, Inc. in cooperation with McKenzie Laboratories,
Inc. 216 p.
40988604 Chetram, R. (1988) Captan 50-WP Dislodgable Residue Study on California
Peaches: Project ID: PAL-EF-88-12. Unpublished study prepared by
152
-------
BIBLIOGRAPHY
MRID
CITATION
Pan-Agricultural Laboratories, Inc., in cooperation with McKenzie Laboratories,
Inc. 240 p.
41039101 Biehn, W. (1989) Captan: Magnitude of Residue on Blueberry: IR-4 PR No.
3458. Unpublished study prepared by Morse Laboratories, Inc. 237 p.
41149101 Curry, K. (1989) Captan Magnitude of the Residue Study in Soybeans Grown
from CAPTAN-treated Seed: Project ID WRC 89-31. Unpublished study
prepared by Morse Laboratories, Inc. 125 p.
41149102 Curry, K. (1989) Captan Magnitudes of the Residue Study in Spinach Grown
from CAPTAN-treated Seed: Project ID WRC 89-32. Unpublished study
prepared by Morse Laboratories, Inc. 152 p.
41149103 Curry, K. (1989) Captan Magnitude of the Residue Study in Corn Grown from
CAPTAN-treated Seed: Project ID WRC 89-33. Unpublished study prepared by
Morse Laboratories, Inc. 144 p.
41149104 Curry, K. (1989) Captan Magnitudes of the Residue Study in Beets Grown from
CAPTAN-treated Seed: Project ID WRC 89-34. Unpublilished study prepared
by Morse Laboratories, Inc. 141 p.
41176301 Lee, K. (1989) Trichloromethyl-carbon 14 Captan- Hydrolyisis at 25
(degree) C: Project ID: Report No. WRC 89-44; Study No. ENV-011.
Unpublished study prepared by ICI Americas Inc. 37 p.
41234402 Hext, P. (1989) Captan: 90-Day Preliminary Inhalation Toxicity Study in the
Rat: Project ID's: Report No. CTL/P/2534; CTL Ref. No. Y01716/011/001.
Unpublished study prepared by ICI Central Toxicology Laboratory. 718 p.
41306101 Curry, K. (1989) Captan: Magnitude of the Residue Study on Winter Wheat
Grown from Captan-Treated Seed: Lab Project Number: RR/89/053B.
Unpublished study prepared by Morse Laboratories, Inc. 188 p.
41306102 Curry, K. (1989) Captan: Magnitude of the Residue Study on Soybean Forage
Grown from Captan-Treated Seed: Lab Project Number: RR/89/062B.
Unpublished study prepared by Morse Laboratories, Inc. 104 p.
153
-------
BIBLIOGRAPHY
MRID
CITATION
41386501 Davy, G. (1989) ICI Agrochemicals Residue Analytical Method No. 166: The
Determination of Residues of Tetrahydrophthalimide, 3-Hydroxy
Tetrahydrophthalimide and 5-Hydroxy Tetrahydrophthalimide in Milk and
Animal Tissues: A Gas Liquid Chromatographic: Mass-selective Detector
Method Using External Standardization. Unpublished study prepared by ICI
Agrochemicals. 38 p.
41393001 Yancey, M. (1989) Final Report on PR 88-5 Analytical Validation for ICI
Agrochemical Residue Analytical Method 152 for Residues of THPI, 3-Hydroxy
THPI and 5-Hydroxy THPI in Eggs: Lab Project Number: NO967-0701: ICI
Protocol NO. CAPT-CL-AM-01. Unpublished study prepared by Battelle. 27
P-
41404001 Ewing, A.; Krauter, G.; Ruzo, L. (1990) Confined Rotational Crop Study of
Ring-carbon 14 and Trichloromethyl-carbon 14-Captan with Beets Lettuce and
Wheat: Lab Project Number: PTRL-EAST 241: PTRL-WEST 137W.
Unpublished study prepared by Pharmacology & Toxicology Research
Laboratory-West. 124 p.
41406901 Davy, G.; Atreya, N. (1989) The Determination of Residues of
Tetrahydrophthalimide, 3-Hydroxy Tetrahydrophthalimide and 5-Hydroxy
Tetrahydrophthalimide in Eggs: A Gas Liquid Chromatographic Mass-selective
Detector Method Using External Standardisation. ...Method No. 152.
Unpublished study prepared by ICI Agrochemicals, Jealotts Hill Research
Station. 30 p.
41468401 Curry, K. (1990) Residue Data Review for Soybean and Wheat Seed Treatments
with Captan, Record No. 256461; ID No. 10182-293; DEB No. 6142; MRID
Nos. 413061-01 and-02 and Residue Data Review for Corn, Soybeans, Beet and
Spinach Seed Treatments with Captan, DEB No. 5589, EPA No. 239-124;
MRID Nos. 411491-01 through-04. Unpublished study prepared by Captan Task
Force, 30 p.
41505401 Trivedi, S. (1990) Captan: Excretion and Tissue Retention of a Single Oral Dose
(lOmg/kg) in the Rat: Lab Project Number: CLT/P/2820: UR0282. Unpublished
study prepared by ICI Central Toxicology Laboratory. 37 p.
154
-------
BIBLIOGRAPHY
MRID
CITATION
41505402 Trivedi, S. (1990) Captan, Excretion and Tissue Retention of a Single Oral Dose
(500 mg/kg) in the Rat: Lab Project Number: CTL-862: UR0283. Unpublished
study prepared by ICI Central Toxicology Laboratory. 37 p.
41505403 Lappin, G.; Havell, M. (1990) Captan: Biotransformation Study in the Rat: Lab
Project Number: CTL/P/2951: UR0285. Unpublished study prepared by ICI
Central Toxicology Laboratory. 42 p.
41505404 Bratt, H. (1990) Captan: Repeat Dose Study (lOmg/kg) in the Rat: Lab Project
Number: CTL/P/2958: UR0284. Unpublished study prepare by ICI Central
Toxicology Laboratory. 34 p.
41557601 McKay, J. (1990) Captan and THPI-Storage Stability Study: Various Crops.
Storage Stability Validation for Captan (N(trichlorometh ylthio)
cyclohex-4-ene-l,2-dicarboximide and THPI (tetrahydrophtalimide) in Raw and
Processed Agricultural Commodities: Lab Project Number: RR90-368B.
Unpublished study prepared by Chevron Environmental Ctr. in coop, with Morse
Labs, Inc. and Hazleton Labs America, Inc. 354 p.
41746001 Chen, Y. (1988) Plant Metabolism Study of (trichloromethyl-carbon
14Cyclohexene-l,2-carbon 14)-Captan: Lab Project Number:
MEF0010/8805420:MEF-0009/8808900. Unpublished study prepared by
Chevron Chemical Co. 41 p.
41826901 Tinston, D. (1991) Captan: Teratogenicity Study in the Rabbit: Lab Project
Number: RB0506: CTL/P/3039. Unpublished study prepared by ICI Central
Toxicology Lab. 365 p.
42109601 Yeh, S. (1988) Addendum to Carbon-14 Captan Plant Metabolism Studies: Lab
Project Number: MEF-009: MEF-010: RR 91-091B. Unpublished study
prepared by Chevron Chemical Co. 20 p.
42254201 McKay, J. (1990) Captan 50-WP: Magnitude-of-the-Residue Study on Apples:
Residue Data for Captan and Tetrahydrophthalimide: Lab Project Number:
CAPT-89-MR-02: RR 90-333B. Unpublished study prepared by ICI Americas,
Inc. and Morse Laboratories, Inc. 145 p.
155
-------
BIBLIOGRAPHY
MRID
CITATION
42254202 McKay, J. (1990) Captan 50-WP: Magnitude-of-the-Residue Study on Grapes:
Residue Data for Captan and Tetrahydrophthalimide: Lab Project Number:
CAPT-89-MR-07: RR 90-379B. Unpublished study prepared by ICI Americas,
Inc. and Morse Laboratories, Inc. 176 p.
42296002 Wiebe, L. (1991) Captan: Magnitude of the Residue of Captan Metabolites in
Bovine Meat and Milk: Lab Project Number: CAPT-90-AT-01. Unpublished
study prepared by ICI Americas, Inc. 364 p.
42296003 Riggle, B. (1991) Captan 50-WP: Magnitude-of-the-Residue Study on
Processed Apple Products: Lab Project Number: CAPT-89-PR-01. Unpublished
study prepared by ICI Americas, Inc. 186 p.
42296004 Riggle, B. (1991) Captan 50-WP: Magnitude-of-the-Residue Study on
Processed Grape Products: Lab Project Number: CAPT-89-PR-02. Unpublished
study prepared by ICI Americas, Inc. 227 p.
42378401 Yeh, S. (1992) Addendum to carbon 14-Captan Confined Rotational Crop Study
(Reference: MRID 41404001; EFGWB #90-0738): Lab Project Number: 241:
137W: RR 92-055B. Unpublished study prepared by PTRL-EAST and
PTRL-WEST. 25 p.
42563101 Iwata, Y. (1992) Captan: Magnitude of the Residue Study on Processed Grape
Products: Lab Project Number: CAPT-90-PR-02. Unpublished study prepared
by ICI Americas Inc. 140 p.
42563102 Iwata, Y. (1992) Captan: Magnitude of the Residue Study on Processed Apple
Products: Lab Project Number: CAPT-90-023B. Unpublished study prepared by
ICI Americas Inc. 336 p.
42568801 Mueller, A. (1992) Interim Report for Nature of the Residue in
Livestock-Replacement Study for MRIDs 40658002-40658004 in Response to
DEB#s 6525 and 6526. Unpublished study prepared by ICI Americas, Inc. 40
P-
42712801 Biehn, W. (1992) Captan: Magnitude of Residue on Raspberries-1991 and 1992
Trials: Lab Project Number: 3953. Unpublished study prepared by IR-4 Satellite
Lab, North Dakota State Univ. 234 p.
156
-------
BIBLIOGRAPHY
MRID
CITATION
42756401 Renwick, R.; Skidmore, M. (1993) Captan: Metabolism in Hens Following
Dosing at 10 micro-g/g in the Diet: Lab Project Number: 91JH312: RJ1345B.
Unpublished study prepared by ICI Agrochemicals. 156 p.
42803901 Rhodes, M. (1993) An Addendum to MRTOs 40752301, 41557601, and
40189801: A Summary of Storage Stability Information for Captan in Magnitude
of the Residue and Processing Studies for Foliar and Post-Harvest Uses as was
Requested in the Residue Chemistry Reregi strati on Standard Update.
Unpublished study prepared by Reed D. Smith Assocs., Morse Labs, Hazleton
Labs America, Inc. and Chevron Env. Ctr. 36 p.
43012903 Krieger, R.; Ross, J.; Thongsinthusak,; T. (1987) Assessing human exposure to
pesticides. Reviews of Environmental Contamination and Toxicology 128:1-14.
43266701 Mathis, S.; Skidmore, M. (1994) ((Carbon 14)-Trichbromethyl) Captan:
Metabolism in Hens Following Dosing at 10 mg/kg in the Diet: Nature of the
Residue in Eggs and Tissues: Final Report: Lab Project Number: 91/JH366:
RJ1639B. Unpublished study prepared by ICI Agrochemicals, Jealott's Hill
Research Station. 158 p.
43266702 Powell, S.; Miles, P.; Skidmore, M. (1994) ((Carbon 14)-Trichbromethyl)
Captan: Metabolism in Goats Following Dosing at 50 mg/kg in the Diet: Nature
of the Residues in Milk and Tissues: Final Report: Lab Project Number:
91/JH955: RJ1650B. Unpublished study prepared by ICI Agrochemicals,
Jealott's Hill Research Station. 185 p.
43393501 Provan, W.; Eyton-Jones, H.; Green, T. (1993) First Revision to The Potential of
Captan to React with DNA: Lab Project Number: CTL/R/1131: HR2172.
Unpublished study prepared by Zeneca Central Toxicology Lab. 30 p.
43393502 Robinson, M. (1994) Captan: A CTL Re-examination of Duodenal Sections
from a Lifetime Oral Oncogenicity Study in Mice (Bio/Dynamics Project No.
80-2491): Lab Project Number: CTL/T/2829. Unpublished study prepared by
Zeneca Central Toxicology Lab. lip.
43393503 Allen, S. (1994) Captan: Investigation of Duodenal Hyperplasia in Mice: Lab
Project Number: CTL/L/5674. Unpublished study prepared by Zeneca Central
Toxicology Lab. 12 p.
157
-------
BIBLIOGRAPHY
MRID
CITATION
43393504 Foster, J. (1994) Captan: Second Investigation of Duodenal Hyperplasia in Mice:
Lab Project Number: CTL/L/6022: PM0981. Unpublished study prepared by
Zeneca Central Toxicology Lab. 16 p.
43393505 Rubin, E.; Farber, J., eds. (1994) Pathology, Second Edition, p. 944-945.
Philidelphia: J.B. Lippincott Co.
43393506 Cotran, R.; Kumar, V.; Robbins, S. (1989) Robbins Pathologic Basis of Disease;
4th Edition; p. 1151-1157. Philidelphia: W.B. Saunders Co.
43393507 Leininger, J.; Jokinen, M. (1990) 27. Oviduct, Uterus, and Vagina, p. 443-459
from Pathology of the Fischer Rat: Reference and Atlas. Academic Press, Inc.
43405101 Gordon, E.; Foster, J.; Bernard, B. et al. (1994) Response to 59 FR 33941
Summarizing Data Concluding Captan is Not a Human Carcinogen: Lab Project
Number: CTF/94/1. Unpublished study prepared by Captan Task Force. 62 p.
43405102 Pritchard, D.; Lapp, G. et al. (1991) Captan: DNA Binding Study in the Mouse:
Lab Project Number: CTL/P/3380: UMO331. Unpublished study prepared by
ICI Central Toxicology Lab. 69 p.
43405103 Chidiac, P.; Goldberg, M. (1987) Lack of Induction of Nuclear Aberrations by
Captan in Mouse Duodenum. Environmental Mutagenesis. 9(1987):297-306.
43405104 Haseman, J.; Winbush, J.; O'Donnell, M. (1986) Captan: Use of Dual Control
Groups to Estimate False Positive Rates in Lab. Animal Carcinogencity Studies.
Fundamental and Applied Tox. 7(1986):573-584
43405105 Huff, J.; Cirvello, J.; Haseman, J. et al. (1991) Chemicals Associated with
Site-Specific Neoplasia in 1394 Long-Term Carcinogenesis Experiments in
Laboratory Rodents. Environmental Health Persp. 93(1991):247-270.
43405106 Anisimov, V.; Alexandrov, V.; Petrov, A. et al. (1988) Carcinogenic Effect of
N-Nitrosotriethylurea in Single Administration to Female Rats. Carcinogenesis
9(4):573-575.
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BIBLIOGRAPHY
MRID
CITATION
43405107 Owen, P.; Glaister, I; Gaunt, I. et al. (1987) Inhalation Toxicity Studies with
1,3-Butadiene 3 Two Year Toxicity/ Carcinogenicity Study in Rats. Am. Ind.
Hyg. Assoc. J. 48(5):407-413.
43405108 Anisimov, V.; Osipova, G. (1993) Carcinogenesis Induced by Combined
Neonatal Exposure to 5-Bromo-2'-Deoxyuridine and Subsequent Total-Body
X-Ray Irradiation in Rats. Cancer Letters 70(1993):81-90.
43405109 Castro, V.; Fechner, R.; Spjut, H. (1968) Captan: Induced Mesenchymal Tumors
of the Rat Genital Tract. Arch. Path. 86(NOV):475-480.
43548601 Wiebe, L.; Westberg, G.; Clark, S. (1992) Captan: Determination of Residues of
Tetrahydrophthalimide, and cis-3-, trans-3-, cis-5-, and
trans-5-Hydroxytetrahydrophthalimide in Bovine Tlissues (sic) and Milk Using
Gas Chromatography with Mass-Selective Detection: (Amended Method): Lab
Project Number: CAPT-90-AT-01: CAPTAN 91-01: RR 92-018B. Unpublished
study prepared by ICI Americas Inc. and Morse Labs, Inc. 79 p.
43875603 Meyers, T.; Wiebe, L. (1995) Captan: Stabilities of Captan in Milk and Five
Captan Metabolites in Animal Tissues and Milk During Frozen Storage at -20N
C: Lab Project Number : CAPT-90-SS-01: RR 95-021B. Unpublished study
prepared by Morse Labs, Inc. 57 p.
44148801 Stewart, K.M.; Tapp, S.A.; Stanley, S.A.; Stanley, R.D. (1991) Captan: Chronic
Toxicity to Daphnia Magnet. Laboratory Identification: T505/F (FT11/91) Study
prepared by Imperial Chemical Industries PLC. 26 p.
44227201 Biehn,W. (1997) Captan: Magnitude of Residue on Raspberries - 1995 Trials:
Lab Project Number: B3953: B3953.95 -NDR04: B3953.95 - MI21.
Unpublished study prepared by Interregional Research Project No. 4. 554 p.
44806501 Drottar, K.R., and Krueger, H.O. (1999d). Unpublished Report: "Captan: A 96-
Hour Toxicity Test with the Freshwater Alga (Anabaena flos-aquae)" Wildlife
International Ltd., Easton, MD, 493A-101A, Captan Stewardship Task Force.
April 14, 1999.
44806502 Drottar, K.R., and Krueger, H.O. (1999e). Unpublished Report: "Captan: A 96-
Hour Acute Toxicity Testwth the Marine Diatom (Skeletonema costatum)"
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BIBLIOGRAPHY
MRID
CITATION
Wildlife International Ltd., Easton, MD, 493 A-102, Stewardship Task Force.
April 14, 1999.
44806503 Drottar, K.R., and Krueger, H.O. (1999a). Unpublished Report: "Captan: A 7--
Day Toxicity Test with Duckweed (Lemna gibba G3)." Wildlife International
Ltd., Easton, MD, 493A-103, Stewardship Task Force. April 14, 1999.
44806504 Drottar, K.R., and Krueger, H.O. (1999c). Unpublished Report: "Captan: A 96-
Hour Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus)"
International Ltd., Easton, MD, 493A-103, Stewardship Task Force. April 14,
1999
44806505 Drottar, K.R., and Krueger, H.O. (1999b). Unpublished Report: "Captan: A 96-
Hour Static Acute toxicity Test with the Saltwater Mysid (Mysidopsis bahia)"
Wildlife International Ltd., Easton, MD, 493A-103, Stewardship Task Force.
April 14, 1999.
GS120-001 Lukens, R; Sisler, H. (1958) Chemical reactions involved in the fungitoxicity of
captan. Phytopathology 48:235:244. Published study.
GS120-004 Hoffman, L.; Debaun, J.; Knarr, 1; Menn, J. (1973) Metabolism of N-
(trichloromethylthio)-l,2-dicarboximide 14C-4-cyclohexene (Captan) in the rat.
Report No. ARC-B-36. Submitted by Stauffer Chemical Co.
GS120-008 Chevron Chemical Co. (1978) Determination of captan residues in crops: RM-
1F-2. Unpublished method dated June 5, 1978.
GS0120-11 Pomerantz, I. (1968) Residue method for captan, folpet, and difolatan.
Memorandum sent to Petitions Review Branch, September 9. 1968.
GS1440-12 Johnson, W.; Finley, M. (1980) Handbook of acute toxicity of chemicals to fish
and aquatic invetebrates. U.S. Fish and Wildlife service Publication No. 137
Washington, D.C.
GS0120-39 American Seed Trade Association (1973) Captan: Methods for removing
residues from corn seed that exceed any proposed tolerance. Unpublished study
submitted by American Seed Trade Association under Petition 3E1367.
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BIBLIOGRAPHY
MRID CITATION
GS0120-41 U.S. EPA (1979) 48-hr EC50 study of technical captan to Daphnia magna.
Laboratory of Terrestrial and Aquatic Biology, Chemical and Biological
Investigations Branch, Beltsville, MD.
GS0120-42 U.S. EPA (1979) 96-hr LC50 study of technical captan to bluegill. Laboratory of
Terrestrial and Aquatic Biology, Chemical and Biological Investigations Branch,
Beltsville, MD.
GS999-001 Hudson, R,; Tucker, R.; Heagle, M. (1984) Handbook of Toxicity of Pesticides
to Wildlife. U.S. D.I. Publication 153, Washington, D.C.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active ingredient(s)
identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to submit certain
data as noted herein to the U. S. Environmental Protection Agency (EPA, the Agency). These data are
necessary to maintain the continued registration of your product(s) containing this active ingredient(s).
Within 90 days after you receive this Notice you must respond as set forth in Section III below. Your
response must state:
1 .how you will comply with the requirements set forth in this Notice and its Attachments 1 through
4; or,
2.why you believe you are exempt from the requirements listed in this Notice and in Attachment 3,
Requirements Status and Registrant's Response Form, (see section III-B); or,
3.why you believe EPA should not require your submission of data in the manner specified by this
Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with its
requirements or should be exempt or excused from doing so, then the registration of your product(s)
subject to this Notice will be subject to suspension. We have provided a list of all of your products
subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list of all registrants
who were sent this Notice (Attachment 4).
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The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this information
is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107 and 2070-0057
(expiration date 3-31-99).
This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain specific
chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form (Insert A)
Attachment 3 - Requirements Status And Registrant's Response Form (Insert B)
Attachment 4 - List Of All Registrants Sent This Data Call-In Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the data needed
to support continued registration of the subject active ingredient(s). This reevaluation identified
additional data necessary to assess the health and safety of the continued use of products containing
this active ingredient(s). You have been sent this Notice because you have product(s) containing the
subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and Registrant's
Response Form (Insert B). Depending on the results of the studies required in this Notice,
additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
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You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form (Insert B), within the time
frames provided.
C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-605-6000).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will satisfy
the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for complying
with data requirements when the studies were not conducted in accordance with acceptable
standards. The OECD protocols are available from 2001 L Street, N.W., Washington, D.C. 20036
(Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED BY
THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-In(s). or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION m. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to the Agency
within 90 days after your receipt of this Notice. Failure to adequately respond to this Notice within
90 days of your receipt will be a basis for issuing a Notice of Intent to Suspend (NOIS) affecting
your products. This and other bases for issuance of NOIS due to failure to comply with this Notice
are presented in Section IV-A and IV-B.
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B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete use(s), (3)
claim generic data exemption, (4) agree to satisfy the data requirements imposed by this Notice or
(5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option, the Delete
Use(s) option or the Generic Data Exemption option is presented below. A discussion of the various
options available for satisfying the data requirements of this Notice is contained in Section III-C.
A discussion of options relating to requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form (Insert A) and the Requirements Status and Registrant's Response Form (Insert B).
The Data Call-In Response Form (Insert A) must be submitted as part of every response to this
Notice. Please note that the company's authorized representative is required to sign the first page
of the Data Call-In Response Form (Insert A) and Requirements Status and Registrant's Response
Form (Insert B) and initial any subsequent pages. The forms contain separate detailed instructions
on the response options. Do not alter the printed material. If you have questions or need assistance
in preparing your response, call or write the contact person identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active ingredient(s) that
is the subject of this Notice. If you wish to voluntarily cancel your product, you must submit
a completed Data Call-In Response Form (Insert A), indicating your election of this option.
Voluntary cancellation is item number 5 on the Data Call-In Response Form (Insert A). If
you choose this option, this is the only form that you are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provisions of this Notice which are contained in Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by eliminating the
uses of your product to which the requirements apply. If you wish to amend your
registration to delete uses, you must submit the Requirements Status and Registrant's
Response Form (Insert B), a completed application for amendment, a copy of your proposed
amended labeling, and all other information required for processing the application. Use
deletion is option number 7 on the Requirements Status and Registrant's Response Form
(Insert B). You must also complete a Data Call-In Response Form (Insert A) by signing the
certification, item number 8. Application forms for amending registrations may be obtained
from the Registration Support and Emergency Response Branch, Registration Division,
(703) 308-8358.
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If you choose to delete the use(s) subject to this Notice or uses subject to specific
data requirements, further sale, distribution, or use of your product after one year from the
due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an applicant for
registration of a product is exempt from the requirement to submit or cite generic data
concerning an active ingredient(s) if the active ingredient(s) in the product is derived
exclusively from purchased, registered pesticide products containing the active ingredient(s).
EPA has concluded, as an exercise of its discretion, that it normally will not suspend the
registration of a product which would qualify and continue to qualify for the generic data
exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the following requirements
must be met:
a. The active ingredient(s) in your registered product must be present solely
because of incorporation of another registered product which contains the subject
active ingredient(s) and is purchased from a source not connected with you; and,
b. every registrant who is the ultimate source of the active ingredient(s) in your
product subject to this DCI must be in compliance with the requirements of this
Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current "Confidential
Statement of Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Form (Insert A), and all supporting documentation. The Generic Data Exemption
is item number 6a on the Data Call-In Response Form (Insert A). If you claim a generic data
exemption you are not required to complete the Requirements Status and Registrant's
Response Form (Insert B). Generic Data Exemption cannot be selected as an option for
product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons
to provide the Agency with the required data. If the registrant(s) who have committed to
generate and submit the required data fail to take appropriate steps to meet the requirements
or are no longer in compliance with this Data Call-In Notice, the Agency will consider that
both they and you are not in compliance and will normally initiate proceedings to suspend
the registrations of both your and their product(s), unless you commit to submit and do
submit the required data within the specified time. In such cases the Agency generally will
not grant a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various options available
to satisfy the data requirements of this Notice. These options are discussed in Section III-C
of this Notice and comprise options 1 through 6 on the Requirements Status and Registrant's
Response Form (Insert B) and option 6b and 7 on the Data Call-In Response Formflnsert A).
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If you choose option 6b or 7, you must submit both forms as well as any other
information/data pertaining to the option chosen to address the data requirement.
5 . Request for Data Waivers. Data waivers are discussed in Section III-D of this Notice
and are covered by options 8 and 9 on the Requirements Status and Registrant's Response
Form (Insert B). If you choose one of these options, you must submit both forms as well as
any other information/data pertaining to the option chosen to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form (Insert A) that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), then you must select one of the six options
on the Requirements Status and Registrant's Response Form (Insert A) related to data production
for each data requirement. Your option selection should be entered under item number 9,
"Registrant Response. " The six options related to data production are the first six options discussed
under item 9 in the instructions for completing the Requirements Status and Registrant's Response
Form (Insert B). These six options are listed immediately below with information in parentheses
to guide registrants to additional instructions provided in this Section. The options are:
2.
(Cost Sharing),
1 . I will generate and submit data within the specified time frame (Developing Data),
I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4. I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study),
5. I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study).
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency
deadlines and with other Agency requirements as referenced herein and in the attachments.
All data generated and submitted must comply with the Good Laboratory Practice (GLP)
rule (40 CFR Part 160), be conducted according to the Pesticide Assessment Guidelines
(PAG), and be in conformance with the requirements of PRNotice 86-5. In addition, certain
studies require Agency approval of test protocols in advance of study initiation. Those
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studies for which a protocol must be submitted have been identified in the Requirements
Status and Registrant's Response Form (Insert B) and/or footnotes to the form. If you wish
to use a protocol which differs from the options discussed in Section II-C of this Notice, you
must submit a detailed description of the proposed protocol and your reason for wishing to
use it. The Agency may choose to reject a protocol not specified in Section II-C. If the
Agency rejects your protocol you will be notified in writing, however, you should be aware
that rejection of a proposed protocol will not be a basis for extending the deadline for
submission of data.
A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost-share or agreeing to share in the cost of
developing that study. A 90-day progress report must be submitted for all studies. This 90-
day progress report must include the date the study was or will be initiated and, for studies
to be started within 12 months of commitment, the name and address of the laboratory(ies)
or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the
other information specified in the preceding paragraph, at a minimum, a brief description
of current activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form (Insert
B) are the time frames that the Agency is allowing for the submission of completed study
reports or protocols. The noted deadlines run from the date of the receipt of this Notice by
the registrant. If the data are not submitted by the deadline, each registrant is subject to
receipt of a Notice of Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this
Notice and intend to seek additional time to meet the requirement(s), you must submit a
request to the Agency which includes: (1) a detailed description of the expected difficulty
and (2) a proposed schedule including alternative dates for meeting such requirements on
a step-by-step basis. You must explain any technical or laboratory difficulties and provide
documentation from the laboratory performing the testing. While EPA is considering your
request, the original deadline remains. The Agency will respond to your request in writing.
If EPA does not grant your request, the original deadline remains. Normally, extensions can
be requested only in cases of extraordinary testing problems beyond the expectation or
control of the registrant. Extensions will not be given in submitting the 90-day responses.
Extensions will not be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.
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Option 2. Agreement to Share in Cost to Develop Data ~
If you choose to enter into an agreement to share in the cost of producing the
required data but will not be submitting the data yourself, you must provide the name of the
registrant who will be submitting the data. You must also provide EPA with documentary
evidence that an agreement has been formed. Such evidence may be your letter offering to
join in an agreement and the other registrant's acceptance of your offer, or a written
statement by the parties that an agreement exists. The agreement to produce the data need
not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms
of the agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development —
If you have made an offer to pay in an attempt to enter into an agreement or amend
an existing agreement to meet the requirements of this Notice and have been unsuccessful,
you may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements of this
Notice. EPA has determined that as a general policy, absent other relevant considerations,
it will not suspend the registration of a product of a registrant who has in good faith sought
and continues to seek to enter into a joint data development/cost sharing program, but the
other registrant(s) developing the data has refused to accept your offer. To qualify for this
option, you must submit documentation to the Agency proving that you have made an offer
to another registrant (who has an obligation to submit data) to share in the burden of
developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data. In addition, you must
demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the
other registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in
addition to anything else, offer to share in the burden of producing the data upon terms to
be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform
EPA of its election of an option to develop and submit the data required by this Notice by
submitting a Data Call-In Response Form (Insert A) and a Requirements Status and
Registrant's Response Form (Insert B) committing to develop and submit the data required
by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burdens of developing the data. In addition, the other registrant must
fulfill its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in
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the specified time frame. In such cases, the Agency generally will not grant a time extension
for submitting the data.
Option 4. Submitting an Existing Study —
If you choose to submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may only
submit a study that has not been previously submitted to the Agency or previously cited by
anyone. Existing studies are studies which predate issuance of this Notice. Do not use this
option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable,
the Agency will require you to comply with this Notice, normally without an extension of
the required date of submission. The Agency may determine at any time that a study is not
valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of
the following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw
data and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFRPart 160.
As stated in 40 CFR 160.3(7)" raw data means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result of original observations
and activities of a study and are necessary for the reconstruction and evaluation of
the report of that study. In the event that exact transcripts of raw data have been
prepared (e.g., tapes which have been transcribed verbatim, dated, and verified
accurate by signature), the exact copy or exact transcript may be substituted for the
original source as raw data. Raw data may include photographs, microfilm or
microfiche copies, computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments." The term
"specimens", according to 40 CFR 160.3(7), means "any material derived from a test
system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all
GLP-required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the
Guideline relevant to the study provided in the FIFRA Accelerated Reregistration
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Phase 3 Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
which states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you believe the study meets
the purpose of the PAG, including copies of any supporting information or data. It
has been the Agency's experience that studies completed prior to January 1970 rarely
satisfied the purpose of the PAG and that necessary raw data are usually not available
for such studies.
If you submit an existing study, you must certify that the study meets all
requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting,
you must identify any action taken by the Agency on the protocol and must indicate,
as part of your certification, the manner in which all Agency comments, concerns,
or issues were addressed in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which
does not meet the criteria outlined above but does contain factual information
regarding unreasonable adverse effects, you must notify the Agency of such a study.
If such a study is in the Agency's files, you need only cite it along with the
notification. If not in the Agency's files, you must submit a summary and copies as
required by PR Notice 86-5.
Option 5. Upgrading a Study —
If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important
to note that not all studies classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied
or corrected and why the study should be rated as acceptable to EPA. Your submission must
also specify the MRID number(s) of the study which you are attempting to upgrade and must
be in conformance with PR Notice 86-5.
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Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply
to all data submissions intended to upgrade studies. Additionally your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with
each of those criteria as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies —
If you choose to cite a study that has been previously submitted to EPA, that study
must have been previously classified by EPA as acceptable or it must be a study which has
not yet been reviewed by the Agency. Acceptable toxicology studies generally will have
been classified as "core-guideline" or "core minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the
classification would be "acceptable." With respect to any studies for which you wish to
select this option you must provide the MRID number of the study you are citing and, if the
study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of Certification with Respect to Citations of Data (in PR Notice
98-5) EPA Form 8570-34 .
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request for a low
volume/minor use waiver and the second is a waiver request based on your belief that the data
requirement(s) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver ~ Option 8 on the Requirements Status and
Registrant's Response Form (Insert B). Section 3(c)(2)(A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use pesticides. In
implementing this provision EPA considers as low volume pesticides only those active
ingredient(s) whose total production volume for all pesticide registrants is small. In
determining whether to grant a low volume, minor use waiver the Agency will consider the
extent, pattern and volume of use, the economic incentive to conduct the testing, the
importance of the pesticide, and the exposure and risk from use of the pesticide. If an active
ingredient(s) is used for both high volume and low volume uses, a low volume exemption
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will not be approved. If all uses of an active ingredient(s) are low volume and the combined
volumes for all uses are also low, then an exemption may be granted, depending on review
of other information outlined below. An exemption will not be granted if any registrant of
the active ingredient(s) elects to conduct the testing. Any registrant receiving a low volume
minor use waiver must remain within the sales figures in their forecast supporting the waiver
request in order to remain qualified for such waiver. If granted a waiver, a registrant will be
required, as a condition of the waiver, to submit annual sales reports. The Agency will
respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this Notice:
a. Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient(s). If applicable to the active ingredient(s), include
foreign sales for those products that are not registered in this country but are applied
to sugar (cane or beet), coffee, bananas, cocoa, and other such crops. Present the
above information by year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by year for each
of the past five years.
c. Total direct production cost of product(s) containing the active ingredient(s)
by year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed
separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient(s) by year for the
past five years. Exclude all non-recurring costs that were directly related to the
active ingredient(s), such as costs of initial registration and any data development.
e. A list of each data requirement for which you seek a waiver. Indicate the type
of waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill each of
these data requirements.
f A list of each data requirement for which you are not seeking any waiver and
the estimated cost to you (listed separately for each data requirement and associated
test) of conducting the testing needed to fulfill each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient(s), direct production costs of product(s)
containing the active ingredient(s) (following the parameters in item c above),
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indirect production costs of product(s) containing the active ingredient(s) (following
the parameters in item d above), and costs of data development pertaining to the
active ingredient(s).
h. A description of the importance and unique benefits of the active
ingredient(s) to users. Discuss the use patterns and the effectiveness of the active
ingredient(s) relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient(s), providing
information that is as quantitative as possible. If you do not have quantitative data
upon which to base your estimates, then present the reasoning used to derive your
estimates. To assist the Agency in determining the degree of importance of the
active ingredient(s) in terms of its benefits, you should provide information on any
of the following factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredient(s) in
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient(s), as opposed to its registered
alternatives, (c) information on the breakdown of the active ingredient(s) after use
and on its persistence in the environment, and (d) description of its usefulness
against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination regarding
a request for a low volume minor use waiver will result in denial of the request for a waiver.
2. Request for Waiver of Data —Option 9 on the Requirements Status and Registrant's
Response Form (Insert B). This option may be used if you believe that a particular data
requirement should not apply because the corresponding use is no longer registered or the
requirement is inappropriate. You must submit a rationale explaining why you believe the
data requirements should not apply. You must also submit the current label(s) of your
product(s) and, if a current copy of your Confidential Statement of Formula is not already
on file you must submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency determines
that the data requirements of this Notice do not apply to your product(s), you will not be
required to supply the data pursuant to section 3(c)(2)(B). If EPA determines that the data
are required for your product(s). you must choose a method of meeting the requirements of
this Notice within the time frame provided by this Notice. Within 30 days of your receipt
of the Agency's written decision, you must submit a revised Requirements Status and
Registrant's Response Form (Insert B) indicating the option chosen.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer, or failure
of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-In Response Form (Insert A) and a Requirements Status and
Registrant's Response Form (Insert B); or,
b. fulfill the commitment to develop and submit the data as required by this
Notice; or,
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c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the specified
time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment Guidelines,
Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the
design, conduct, and reporting of required studies. Such requirements include, but are not
limited to, those relating to test material, test procedures, selection of species, number of
animals, sex and distribution of animals, dose and effect levels to be tested or attained,
duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary report
will not be considered to fulfill the submission requirement.
C. EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or canceled if doing so would be consistent with
the purposes of the Federal Insecticide, Fungicide, and Rodenticide Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of clearly
demonstrating to EPA that granting such permission would be consistent with the Act. You must
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also explain why an "existing stocks" provision is necessary, including a statement of the quantity
of existing stocks and your estimate of the time required for their sale, distribution, and use. Unless
you meet this burden the Agency will not consider any request pertaining to the continued sale,
distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily canceled products
containing an active ingredient(s) for which the Agency has particular risk concerns will be
determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate to
the Agency that you are in full compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel your registration six months before
a 3 year study is scheduled to be submitted, all progress reports and other information necessary to
establish that you have been conducting the study in an acceptable and good faith manner must have
been submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide is
registered a registrant has additional factual information regarding unreasonable adverse effects on the
environment by the pesticide, the registrant shall submit the information to the Agency. Registrants
must notify the Agency of any factual information they have, from whatever source, including but not
limited to interim or preliminary results of studies, regarding unreasonable adverse effects on man or
the environment. This requirement continues as long as the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this Notice, call
the contact person listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data exemption
claims) must include a completed Data Call-In Response Form (Insert A) and a completed
Requirements Status and Registrant's Response Form (Insert B) and any other documents required by
this Notice, and should be submitted to the contact person identified in Attachment 1. If the voluntary
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cancellation or generic data exemption option is chosen, only the Data Call-In Response Form (Insert
A) need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance (OECA),
EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
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CAPTAN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s) containing
captan.
This Generic Data Call-In Chemical Status Sheet contains an overview of data required by this
notice, and point of contact for inquiries pertaining to the reregi strati on of captan. This attachment
is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic Data Call-In
Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form (Attachment 2),
(4) a list of registrants receiving this DCI (Attachment 4), (5) the EPA Acceptance Criteria
(Attachment 5), and (6) the Cost Share and Data Compensation Forms in replying to this Captan
Generic Data Call In (Attachment F). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for captan are contained
in the Requirements Status and Registrant's Response. Attachment C. The Agency has concluded
that additional product chemistry data on captan are needed. These data are needed to fully complete
the reregi strati on of all eligible captan products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures established by
this Notice, please contact Kylie Rothwell at (703) 308-8055.
All responses to this Notice for the generic data requirements should be submitted to:
Kylie Rothwell, Chemical Review Manager
Special Review and Registration Division (7508C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Captan
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
(INSERT A)
This Form is designed to be used to respond to call-ins for generic and product specific data for the
purpose of reregistering pesticides under the Federal Insecticide Fungicide and Rodenticide Act. Fill
out this form each time you are responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed by the
registrant as appropriate Items 8 through 11 must be completed by the registrant before submitting
a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information,
including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223, U S
Environmental Protection Agency, 401 M St, S W , Washington, D C 20460; and to the Office of
Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D C 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data call-in. Please note
that you are also responsible for informing the Agency of your response regarding any
product that you believe may be covered by this data call-in but that is not listed by the
Agency in Item 4. You must bring any such apparent omission to the Agency's attention
within the period required for submission of this response form.
Item 5. Cheek this item for each product registration you wish to cancel voluntarily. If a
registration number is listed for a product for which you previously requested voluntary
cancellation, indicate in Item 5 the date of that request. You do not need to complete any
item on the Requirements Status and Registrant's Response Form for any product that is
voluntarily canceled.
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Item 6a. Check this item if this data call-in is for generic data as indicated in Item 3 and if
you are eligible for a Generic Data Exemption for the chemical listed in Item 2 and
used in the subject product. By electing this exemption, you agree to the terms and
conditions of a Generic Data Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that you use
in your product.
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with
this and-any other outstanding Data Call-In Notice), and incorporate that product
into all your products, you may complete this item for all products listed on this
form If, however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the fact that some of your sources are
registered), you may not claim a Generic Data Exemption and you may not select
this item.
Item 6b. Check this Item if the data call-in is a generic data call-in as indicated in Item 3 and
if you are agreeing to satisfy the generic data requirements of this data call-in.
Attach the Requirements Status and Registrant's Response Form (Insert A) that
indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing use
product for which you agree to supply product-specific data. Attach the
Requirements Status and Registrants' Response Form (Insert A) that indicates how
you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product (EUP) as
indicated in Item 3 and if your product is an end use product for which you agree
to supply product-specific data. Attach the Requirements Status and Registrant's
Response Form (Insert A) that indicates how you will satisfy those requirements.
Item 8. This certification statement must be signed by an authorized representative of your company
and the person signing must include his/her title. Additional pages used in your response
must be initialed and dated in the space provided for the certification.
Item 9. Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with questions regarding your
response.
Item 11. Enter the phone number of your company contact.
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM (INSERTS)
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and product-specific
data as part of EPA's reregi strati on program under the Federal Insecticide Fungicide and Rodenticide
Act. Although the form is the same for both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for satisfying product specific data
requirements do not include (1) deletion of uses or (2) request for a low volume/minor use waiver.
These instructions are for completion of generic data requirements.
EPA has developed this form individually for each data call-in addressed to each registrant, and has
preprinted this form with a number of items. DO NOT use this form for any other active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information,
including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223, U.S.
Environmental Protection Agency, 401 M St., SW., Washington, D.C. 20460; and to the Office of
Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support the
product(s) being reregistered. These guidelines, in addition to requirements specified in the
Data Call-In Notice, govern the conduct of the required studies.
Item 5. This item identifies the study title associated with the guideline reference number and
whether protocols and 1, 2, or 3-year progress reports are required to be submitted in
connection with the study. As noted in Section III of the Data Call-In Notice, 90-day
progress reports are required for all studies.
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If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's Response
Form (Insert B).
Item 6. This item identifies the code associated with the use pattern of the pesticide. A brief
description of each code follows:
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food crop
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for testing. A brief
description of each code follows.
EP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade Active
Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant Metabolites
TEP Typical End-Use Product
TEP _ * Typical End-Use Product, Percent Active Ingredient
Specified
TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient and
Metabolites
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TGAI/PAIRA Technical Grade Active Ingredient or Pure Active Ingredient
Radiolabelled
TGAI Technical Grade Active Ingredient
TGAI/TEP Technical Grade Active Ingredient or Typical End-Use
Product
TGAI/PAI Technical Grade Active Ingredient or Pure Active Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
*See: guideline comment
Item 8. This item identifies the time frame allowed for submission of the study or protocol identified
in item 2. The time frame runs from the date of your receipt of the Data Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to comply with
each data requirement. Brief descriptions of each code follow. The Data Call-In Notice
contains a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the time frames
specified in item 8 above. By indicating that I have chosen this option, I certify that
I will comply with all the requirements pertaining to the conditions for submittal of
this study as outlined in the Data Call-In Notice and that I will provide the protocol
and progress reports required in item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or more
registrants to develop data jointly. By indicating that I have chosen this option, I
certify that I will comply with all the requirements pertaining to sharing in the cost
of developing data as outlined in the Data Call-In Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement with one or
more registrants to develop data jointly. I am submitting a copy of the form
"Certification of Offer to Cost Share in the Development of Data" that describes this
offer/agreement. By indicating that I have chosen this option, I certify that I will
comply with all the requirements pertaining to making an offer to share in the cost
of developing data as outlined in the Data Call-In Notice.
4. (Submitting Existing Data) I am submitting an existing study that has never before
been submitted to EPA. By indicating that I have chosen this option, I certify that
this study meets all the requirements pertaining to the conditions for submittal of
existing data outlined in the Data Call-In Notice and I have attached the needed
supporting information along with this response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study that EPA has
classified as partially acceptable and potentially upgradeable. By indicating that I
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have chosen this option, I certify that I have met all the requirements pertaining to
the conditions for submitting or citing existing data to upgrade a study described in
the Data Call-In Notice. I am indicating on attached correspondence the Master
Record Identification Number (MRID) that EPA has assigned to the data that I am
citing as well as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously classified by
EPA as acceptable, core, core minimum, or a study that has not yet been reviewed
by the Agency. I am providing the Agency's classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my registration
deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements concerning
low volume-minor use data waivers in the Data Call-In Notice and I request a
low-volume minor use waiver of the data requirement. I am attaching a detailed
justification to support this waiver request including, among other things, all
information required to support the request. I understand that, unless modified by
the Agency in writing, the data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data waivers
other than low volume minor-use data waivers in the Data Call-In Notice and I
request a waiver of the data requirement. I am attaching an identification of the
basis for this waiver and a detailed justification to support this waiver request. The
justification includes, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
Item 10. This item must be signed by an authorized representative of your company. The person
signing must include his/her title, and must initial and date all other pages of this form.
Item 11. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding your response.
Item 13. Enter the phone number of your company contact.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 5; or
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section
III-B); or
3. Why you believe EPA should not require your submission of product specific data
in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 5).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
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information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 03-31-99).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form (Insert A)
3 - Requirements Status and Registrant's Response Form (Insert B)
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional generic
data requirements are being imposed. You have been sent this Notice because you have product(s)
containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant's Response Form (Insert B). Depending on the results of the studies required in
this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in Insert B,
Requirements Status and Registrant's Response Form (Insert B). within the time frames provided.
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II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have
been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-605-6000).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001
L Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-03 50).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-In(s). or any other agreements entered into with
the Agency pertaining to such prior Notice. Registrants must comply with the requirements of
all Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data
must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance
of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice
or (c) request a data waiver(s).
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A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C. A discussion of
options relating to requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-in Response Form (Insert A), and the Requirements Status and Registrant's Response
Form (Insert B). The Data Call-In Response Form must be submitted as part of every response
to this Notice. In addition, one copy of the Requirements Status and Registrant's Response
Form (Insert B) must be submitted for each product listed on the Data Call-In Response Form
(Insert A) unless the voluntary cancellation option is selected or unless the product is
identical to another (refer to the instructions for completing the Data Call-In Response
Form(Insert A). Please note that the company's authorized representative is required to sign
the first page of the Data Call-In Response Form (Insert A) and Requirements Status and
Registrant's Response Form (Insert B), initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If
you have questions or need assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active ingredient that is
the subject of this Notice. If you wish to voluntarily cancel your product, you must submit a
completed Data Call-In Response Form (Insert A), indicating your election of this option.
Voluntary cancellation is item number 5 on the Data Call-In Response Form (Insert B). If you
choose this option, this is the only form that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These
options are discussed in Section III-C of this Notice and comprise options 1 through 5 on the
Requirements Status and Registrant's Response Form(Insert A) and item numbers 7a and 7b
on the Data Call-In Response Formflnsert B). Deletion of a use(s) and the low volume/minor
use option are not valid options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements
Status and Registrant's Response Form (Insert B). If you choose one of these options, you
must submit both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
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III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form (Insert A) that you agree to
satisfy the product specific data requirements (i.e. you select item number 7a or 7b), then you
must select one of the six options on the Requirements Status and Registrant's Response Form
(Insert A) related to data production for each data requirement. Your option selection should
be entered under item number 9, "Registrant Response." The six options related to data
production are the first six options discussed under item 9 in the instructions for completing
the Requirements Status and Registrant's Response Formflnsert A). These six options are
listed immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing study
that has been submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1, Developing Data ~ If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced here
in and in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFRPart 160), be conducted according to the Pesticide
Assessment Guidelines(PAG), and be in conformance with the requirements of PR Notice 86-
5.
The time frames in the Requirements Status and Registrant's Response Form (Insert A)
are the time frames that the Agency is allowing for the submission of completed study reports.
The noted deadlines run from the date of the receipt of this Notice by the registrant. If the
data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
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not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2, Agreement to Share in Cost to Develop Data ~ Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be
submitted must be noted in the agreement to cost share by the registrant selecting this option.
If you choose to enter into an agreement to share in the cost of producing the required data but
will not be submitting the data yourself, you must provide the name of the registrant who will
be submitting the data. You must also provide EPA with documentary evidence that an
agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development ~ This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an
offer to pay in an attempt to enter into an agreement or amend an existing agreement to meet
the requirements of this Notice and have been unsuccessful, you may request EPA (by
selecting this option) to exercise its discretion not to suspend your registration(s), although
you do not comply with the data submission requirements of this Notice. EPA has determined
that as a general policy, absent other relevant considerations, it will not suspend the
registration of a product of a registrant who has in good faith sought and continues to seek to
enter into a joint data development/cost sharing program, but the other registrant(s)
developing the data has refused to accept your offer. To qualify for this option, you must
submit documentation to the Agency proving that you have made an offer to another registrant
(who has an obligation to submit data) to share in the burden of developing that data. You
must also submit to the Agency a completed EPA Form 8570-32, Certification of Offer to
Cost Share in the Development of Data, Attachment 7. In addition, you must demonstrate that
the other registrant to whom the offer was made has not accepted your offer to enter into a
cost sharing agreement by including a copy of your offer and proof of the other registrant's
receipt of that offer (such as a certified mail receipt). Your offer must, in addition to anything
else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii)
and must not qualify this offer. The other registrant must also inform EPA of its election of
an option to develop and submit the data required by this Notice by submitting a Data Call-In
Response Form (Insert A) and a Requirements Status and Registrant's Response Form (Insert
B) committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burdens of developing the data. In addition, the other registrant must
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fulfill its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4, Submitting an Existing Study ~ If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed
by this Notice. You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which predate issuance of
this Notice. Do not use this option if you are submitting data to upgrade a study. (See Option
5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of
the following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements of
the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR
160.3(j)" 'raw data1 means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and activities of a
study and are necessary for the reconstruction and evaluation of the report of that
study. In the event that exact transcripts of raw data have been prepared (e.g., tapes
which have been transcribed verbatim, dated, and verified accurate by signature), the
exact copy or exact transcript may be substituted for the original source as raw data.
'Raw data' may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data from
automated instruments." The term "specimens", according to 40 CFR 160.3(k), means
"any material derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
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Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the Agency
for consideration if the registrant believes that the study clearly meets the purpose of
the PAG. The registrant is referred to 40 CFR 158.70 which states the Agency's policy
regarding acceptable protocols. If you wish to submit the study, you must, in addition
to certifying that the purposes of the PAG are met by the study, clearly articulate the
rationale why you believe the study meets the purpose of the PAG, including copies of
any supporting information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and that
necessary raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study ~ If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement
is not satisfied, you may still be required to submit new data normally without any time
extension. Deficient, but upgradeable studies will normally be classified as supplemental.
However, it is important to note that not all studies classified as supplemental are
upgradeable. If you have questions regarding the classification of a study or whether a study
may be upgraded, call or write the contact person listed in Attachment 1. If you submit data to
upgrade an existing study you must satisfy or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly articulated rationale of how the
deficiencies have been remedied or corrected and why the study should be rated as acceptable
to EPA. Your submission must also specify the MRID number(s) of the study which you are
attempting to upgrade and must be in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
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of those criteria as well as a certification regarding protocol compliance with Agency
requirements.
Option 6, Citing Existing Studies ~ If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology
studies generally will have been classified as "core-guideline" or "core minimum." For all
other disciplines the classification would be "acceptable." With respect to any studies for
which you wish to select this option you must provide the MRID number of the study you are
citing and, if the study has been reviewed by the Agency, you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-34, Certification with Respect to Citations of
Data (in PR Notice 98-5).
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form (Insert A) and
the Requirements Status and Registrant's Response Form (Insert B), as appropriate.
III-D. REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be
the only opportunity to state the reasons or provide information in support of your request. If
the Agency approves your waiver request, you will not be required to supply the data pursuant
to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements
Status and Registrant's Response Form. Product specific data requirements for product
chemistry, acute toxicity and efficacy (where appropriate) are required for all products and the
Agency would grant a waiver only under extraordinary circumstances. You should also be
aware that submitting a waiver request will not automatically extend the due date for the study
in question. Waiver requests submitted without adequate supporting rationale will be denied
and the original due date will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice
due to failure by a registrant to comply with the requirements of this Data Call-In Notice,
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pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice
of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure of
a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice on
a Data Call-In Response Formdnsert A) and a Requirements Status and
Registrant's Response Formdnsert B):
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this Notice,
unless you commit to submit and do submit the required data in the specified
time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
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IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The
grounds for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated by
reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design, conduct, and
reporting of required studies. Such requirements include, but are not limited to, those relating
to test material, test procedures, selection of species, number of animals, sex and distribution
of animals, dose and effect levels to be tested or attained, duration of test, and, as applicable,
Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this Notice or contained in PR 86-5.
All studies must be submitted in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or canceled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your
product(s) which may be suspended for failure to comply with this Notice should be
permitted, you have the burden of clearly demonstrating to EPA that granting such permission
would be consistent with the Act. You must also explain why an "existing stocks" provision is
necessary, including a statement of the quantity of existing stocks and your estimate of the
time required for their sale, distribution, and use. Unless you meet this burden the Agency
will not consider any request pertaining to the continued sale, distribution, or use of your
existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
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distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily canceled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required
by this Notice will not result in the Agency granting any additional time to sell, distribute, or
use existing stocks beyond a year from the date the 90 day response was due unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study
in an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT PQSSIBLEUNREASQNABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide
is registered a registrant has additional factual information regarding unreasonable adverse effects on
the environment by the pesticide, the registrant shall submit the information to the Agency.
Registrants must notify the Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of studies, regarding unreasonable adverse
effects on man or the environment. This requirement continues as long as the products are registered
by the Agency.
SECTION VLEVOUMIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic
data exemption claims) must include a completed Data Call-In Response Form (Insert A) and
a completed Requirements Status and Registrant's Response Form (Insert B) for product
specific data) and any other documents required by this Notice, and should be submitted to
the contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form (Insert A) need be
submitted.
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form (Insert A)
3 - Requirements Status and Registrant's Response Form (Insert B)
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data Requirements
for Reregistration
5 - List of Registrants Receiving This Notice
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CAPTAN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s) containing
captan.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data required by
this notice, and point of contact for inquiries pertaining to the reregi strati on of captan. This attachment is to
be used in conjunction with (1) the Product Specific Data Call-In Notice, (2) the Product Specific Data Call-In
Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's
Grouping of End-Use Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost
Share and Data Compensation Forms in replying to this Captan Product Specific Data Call-In (Attachment 7).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for captan are contained in the
Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded that additional data
on captan are needed for specific products. These data are required to be submitted to the Agency within the
time frame listed. These data are needed to fully complete the reregi strati on of all eligible captan products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures established
by this Notice, please contact Karen Jones at (703) 308-8047.
All responses to this Notice for the Product Specific data requirements should be submitted to:
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508C
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Captan
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this option, you
will not have to provide the data required by the Data Call-In Notice and you will not have to
complete any other forms. Further sale and distribution of your product after the effective date
of cancellation must be in accordance with the Existing Stocks provision of the Data Call-In
Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your product is
identical to another product and you qualify for a data exemption, you must respond with
"yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the EPA registration numbers
of your source(s); you would not complete the "Requirements Status and Registrant's
Response" form. Examples of such products include repackaged products and Special Local
Needs (Section 24c) products which are identical to federally registered products.
For each manufacturing use product (MUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes."
For each end use product (EUP) for which you wish to maintain registration, you must agree
to satisfy the data requirements by responding "yes." If you are requesting a data waiver,
answer "yes" here; in addition, on the "Requirements Status and Registrant's Response" form
under Item 9, you must respond with Option 7 (Waiver Request) for each study for which you
are requesting a waiver. See Item 6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed letter that
accompanies this form. For example, you may wish to report that your product has already
been transferred to another company or that you have already voluntarily canceled this product.
For these cases, please supply all relevant details so that EPA can ensure that its records are
correct.
Item 7a.
Item 7b.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item 3. This
number must be used in the transmittal document for any data submissions in response
to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's continued
registration are identified. These guidelines, in addition to the requirements specified in the
Notice, govern the conduct of the required studies. Note that series 61 and 62 in product
chemistry are now listed under 40 CFR 158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements is (are)
identified. For most product specific data requirements, all use patterns are covered by the data
requirements. In the case of efficacy data, the required studies only pertain to products which
have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the product as
formulated for sale and distribution is the test substance, except in rare cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8 months after
issuance of the Reregistration Eligibility Document unless EPA determines that a longer
time period is necessary.
Item 9 . Enter only one of the following response codes for each data requirement to show how
you intend to comply with the data requirements listed in this table. Fuller descriptions
of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By indicating that
I have chosen this option, I certify that I will comply with all the requirements pertaining to the
conditions for submittal of this study as outlined in the Data Call-In Notice. By the specified
due date, I will also submit: (1) a completed "Certification with Respect to Citations of Data
(in PR Notice 98-5)" form (EPA Form 8570-34) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly (Cost
Sharing). I am submitting a copy of this agreement. I understand that this option is available
only for acute toxicity or certain efficacy data and only if EPA indicates in an attachment to this
Notice that my product is similar enough to another product to qualify for this option. I certify
that another party in the agreement is committing to submit or provide the required data; if the
required study is not submitted on time, my product may be subject to suspension. By the
specified due date, I will also submit: (1) a completed "Certification with Respect to
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Citations of Data (in PR Notice 98-5)" form (EPA Form 8570-34) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I understand
that this option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Data Call-In Notice that my product is similar enough to
another product to qualify for this option. I am submitting evidence that I have made an
offer to another registrant (who has an obligation to submit data) to share in the cost of that
data. I am also submitting a completed "Certification of Attempt to Enter into an
Agreement with other Restraints for Development of Data " (EPA Form 8570-32). I am
including a copy of my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the required data; if the required
study is not submitted on time, my product may be subject to suspension. I understand that
other terms under Option 3 in the Data Call-In Notice (Section III-C. 1.) apply as well. By the
specified due date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-34) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been submitted previously
to the Agency by anyone (Submitting an Existing Study). I certify that this study will meet
all the requirements for submittal of existing data outlined in Option 4 in the Data Call-In
Notice (Section III-C. 1.) and will meet the attached acceptance criteria (for acute toxicity and
product chemistry data). I will attach the needed supporting information along with this
response. I also certify that I have determined that this study will fill the data requirement for
which I have indicated this choice. By the specified due date, I will also submit a completed
"Certification With Respect To Data Compensation Requirements" form (EPA Form
8570-34) to show what data compensation option I have chosen. By the specified due date,
I will also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-34) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by the Agency
as partially acceptable and upgradable (Upgrading a Study). I will submit evidence of the
Agency's review indicating that the study may be upgraded and what information is required
to do so. I will provide the MRID or Accession number of the study at the due date. I
understand that the conditions for this option outlined Option 5 in the Data Call-In Notice
(Section III-C. 1.) apply. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA Form
8570-34) and (2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
6. By the specified due date, I will cite an existing study that the Agency has classified as
acceptable or an existing study that has been submitted but not reviewed by the Agency (Citing
an Existing Study). If I am citing another registrant's study, I understand that this option is
available only for acute toxicity or certain efficacy data and only if the cited study was
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conducted on my product, an identical product or a product which EPA has "grouped" with one
or more other products for purposes of depending on the same data. I may also choose this
option if I am citing my own data. In either case, I will provide the MRID or Accession
number(s) for the cited data on a "Product Specific Data Report" form or in a similar format.
By the specified due date, I will also submit: (1) a completed "Certification With Respect To
Data Compensation Requirements" form (EPA Form 8570-34) and (2) two completed and
signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
7. I request a waiver for this study because it is inappropriate for my product (Waiver Request).
I am attaching a complete justification for this request, including technical reasons, data and
references to relevant EPA regulations, guidelines or policies. [Note: any supplemental data
must be submitted in the format required by P.R. Notice 86-5]. I understand that this is my
only opportunity to state the reasons or provide information in support of my request. If the
Agency approves my waiver request, I will not be required to supply the data pursuant to
Section 3(c)(2)(B) of FIFRA. If the Agency denies my waiver request, I must choose a
method of meeting the data requirements of this Notice by the due date stated by this Notice.
In this case, I must, within 30 days of my receipt of the Agency's written decision, submit a
revised "Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original data call-in
notice will not change. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA Form
8570-34) and (2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed letter that
accompanies this form. For example, you may wish to report that your product has already
been transferred to another company or that you have already voluntarily canceled this product.
For these cases, please supply all relevant details so that EPA can ensure that its records are
correct.
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Part B form page number 3 in the actual Printed version of the Red document
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Part B form page number 4 in the actual Printed version of the Red document
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Part B form page number 5 in the actual Printed version of the Red document
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EPA'S BATCHING OF CAPTAN PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data
requirements for reregi strati on of products containing the active ingredient Captan the Agency has batched
products which can be considered similar for purposes of acute toxicity. Factors considered in the sorting
process include each product's active and inert ingredients (identity, percent composition and biological
activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and
labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the Agency is not
describing batched products as "substantially similar" since some products within abatch may not be considered
chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the preceding
paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at any time, acute
toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single
battery of six acute toxicological studies to represent all the products within that batch. It is the registrants'
option to participate in the process with all other registrants, only some of the other registrants, or only their
own products within a batch, or to generate all the required acute toxicological studies for each of their own
products. If a registrant chooses to generate the data for a batch, he/she must use one of the products within
the batch as the test material. If a registrant chooses to rely upon previously submitted acute toxicity data,
he/she may do so provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has
not been significantly altered since submission and acceptance of the acute toxicity data. Regardless of whether
new data is generated or existing data is referenced, registrants must clearly identify the test material by EPA
Registration Number. If more than one confidential statement of formula (CSF) exists for a product, the
registrant must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the directions
given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice contains two
response forms which are to be completed and submitted to the Agency within 90 days of receipt. The first
form, "Data Call-In Response," asks whether the registrant will meet the data requirements for each product.
The second form, "Requirements Status and Registrant's Response," lists the product specific data required
for each product, including the standard six acute toxicity tests. A registrant who wishes to participate in a
batch must decide whether he/she will provide the data or depend on someone else to do so. If a registrant
supplies the data to support a batch of products, he/she must select one of the following options: Developing
Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing
an Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost
Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant
does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should
know that choosing not to participate in a batch does not preclude other registrants in the batch from citing
his/her studies and offering to cost share (Option 3) those studies.
All of these products contain the active ingredient captan (cis-N-trichloromethylthio-4-cyclohexene-1,2-
dicarboximide). Several labels report containing related derivatives as well. Some batches also contain other
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active ingredients. Batches 1 through 7B have only captan as an active ingredient and are listed first. Batch
2 may cite Batch 1. Batch 7B may cite the products in Batch 7A. The following batches, 8 through 16, have
more than one active ingredient. Those products that cannot be batched are in the last table.
A dermal sensitization study is not required. Captan is known to cause dermal sensitization in humans,
therefore, all products will automatically be labeled as such, unless an acceptable dermal sensitization test on
the product is negative.
Furthermore, due to the known severe eye irritation potential of captan, waivers will be accepted for
primary eye irritation under the condition that the guideline will be classified as category I. In addition, batches
indicated with the double asterisk (**) need to address the eye irritation guideline individually by submitting
data or requesting a waiver.
The first table batches several technicals.
BATCH
NO.
1
EPA REG. NO.
1965-11
7501-24
11678-1
19713-258
19713-500
66330-31
66330-32
66330-33
66330-34
72304-3
% of Captan and Related
Derivatives on Label
90
92
88
88
88
90
90
90
86.94
88
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
BATCH
NO.
2
EPA REG. NO.
7501-92
19713-385
% of Active Ingredients
73.3
80.1
Formulation Type
Solid
Solid
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BATCH
NO.
EPA REG. NO.
34704-430
34704-431
51036-168
66330-1
66330-3
66330-13
66330-25
66330-28
66330-29
66330-30
% of Active Ingredients
80
80
80.1
75
80.1
75
75
80.1
79.6
75
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
BATCH
NO.
EPA REG. NO.
% of Active Ingredients
Formulation Type
16-151
239-729
270-289
769-540
2935-470
19713-235
19713-261
19713-268
34704-676
42056-3
51036-166
66222-1
66330-21
50
50
50
50
50
50
50
50
50
50
48.9
50
50
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
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66330-26
66330-27
48.9
50
Solid
Solid
BATCH
NO.
4**
EPA REG. NO.
2935-484
7501-26
19713-156
19713-161
51036-167
51035-171
51036-181
66330-23
7501-27
66330-24
% of Active Ingredients
o o ci
38.52
38.25
38.5
38.5
39.6
39.6
38.2
39.6
38.25
37.66
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
BATCH
NO.
5
EPA REG. NO.
7501-8
34704-649
34704-659
% of Active Ingredients
29.35
30
30
Formulation Type
Liquid
Liquid
Liquid
BATCH
NO.
EPA REG. NO.
% of Active Ingredients
Formulation Type
400-225
7501-116
24.4
25.5
Solid
Solid
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9779-98
19713-197
34704-567
66330-12
66330-20
25.0
25
25
25.1
25
Solid
Solid
Solid
Solid
Solid
BATCH
NO.
7 A**
EPA REG. NO.
829-215
5481-250
10107-97
34704-22
34704-149
34704-654
62575-6
66330-10
66330-11
66330-15
66330-16
66330-18
% of Active Ingredients
7.5
7.5
7.5
7.5
7.5
7.5
10.1
9.9
7.4
10
7.5
10
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
BATCH
NO.
7B**
EPA REG. NO.
34704-668
66330-14
66330-17
% of Active Ingredients
5.0
5.0
5.0
Formulation Type
Solid
Solid
Solid
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The following batches contain products which have more than one active ingredient. The first batches
include two active ingredients which have already been batched: metalaxyl and sulfur. The batching for those
will remain as has already been published, and products not included in the original batching will be assigned
below if batchable and put in the unbatched table at the end of this document if not.
BATCH
NO.
8
EPA REG. NO.
4-355
572-62
829-236
% of Active Ingredients
Captan - 6.03
Malathion - 6.00
Methoxychlor - 10.00
Sulfur - 25.00
Captan - 6.0
Malathion - 6.00
Methoxychlor - 10.00
Sulfur - 25.00
Captan - 6.0
Malathion - 6.0
Methoxychlor - 9.0
Sulfur - 25.0
Formulation Type
Solid
Solid
Solid
Below are batches that include products with captan and other active ingredients not previously
batched.
BATCH
NO.
9
EPA REG. NO.
68119-14
42056-14
% Active Ingredients
Captan - 32.76
Lindane - 16.60
Captan- 33.5
Lindane - 16.60
Formulation Type
Solid
Solid
BATCH
NO.
10
EPA REG. NO.
7501-38
34704-653
66330-19
% of Active Ingredients
Captan - 12.24
Lindane - 25.00
Captan - 12.5
Lindane - 25.00
Captan - 12.5
Lindane - 25.0
Formulation Type
Solid
Solid
Solid
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BATCH
NO.
11
EPA REG. NO.
7501-36
66330-22
% of Active Ingredients
Captan - 19.6
Carboxin - 20.0
Captan - 20.0
Carboxin - 20.0
Formulation Type
Solid
Solid
BATCH
NO.
12
EPA REG. NO.
5905-252
34704-652
66330-4
66330-6
66330-7
% of Active Ingredients
Captan - 70.0
Methoxychlor- 3.0
Captan - 75.4
Methoxychlor - 3.00
Captan -73. 9
Methoxychlor - 5.0
Captan - 75
Methoxychlor - 3
Captan - 72.5
Methoxychlor - 5.0
Formulation Type
Solid
Solid
Solid
Solid
Solid
BATCH
NO.
13
EPA REG. NO.
68119-10
42056-18
% of Active Ingredients
Captan - 37.5
Diazinon - 25.0
Captan - 37.5
Diazinon - 25.00
Formulation Type
Solid
Solid
BATCH
NO.
EPA REG. NO.
% of Active Ingredients
Formulation Type
14
4-122
Captan - 12.0
Carbaryl - 0.30
Malathion - 6.00
Methoxychlor - 12.00
Liquid
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5887-162
Captan - 12.0
Carbaryl - 0.30
Malathion - 6.00
Methoxychlor - 12.00
Liquid
BATCH
NO.
15
EPA REG. NO.
68119-11
42056-11
% of Active Ingredients
Captan - 15.0
Diazinon - 15.0
Lindane - 25.0
Captan - 15.0
Diazinon - 15.00
Lindane - 25.00
Formulation Type
Solid
Solid
BATCH
NO.
16
EPA REG. NO.
7501-111
7501-153
% of Active Ingredients
Captan - 18.4
Etridiazol Terrazole - 2.5
Maneb - 18.75
PCNB - 10.0
Captan - 18.4
Etridiazol - 2.5
Maneb - 18.75
PCNB - 10.0
Formulation Type
Solid
Solid
The following products would not fit in a batch. Therefore testing must be performed on these
independently unless indicated by an asterisk. See acceptable batching for products with asterisk following
table.
EPA REG. NO.
4-59
70-179*
70-190
% of Active Ingredients
Captan - 6.0
Carbaryl - 0.5
Malathion - 3.0
Methoxychlor - 6.0
Captan - 10.0
Diazinon - 30.0
Captan - 7.0
Malathion - 5.00
Methoxychlor - 10.00
Formulation Type
Solid
Solid
Solid
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EPA REG. NO.
239-568
400-93
400-136*
572-185*
769-645
769-901
802-235
2935-522
7401-355
7401-438
7501-9
7501-43*
7501-77
7501-129
7501-130
7501-131
% of Active Ingredients
Captan - 15.0
Malathion - 7.5
Methoxychlor - 15.0
Captan - 36.7
Carboxin - 37.5
Captan - 12.3
Carboxin - 12.5
Captan - 7.0
Malathion - 4.0
Methoxychlor - 5.0
Captan - 20.0
PCNB - 14.00
Thiram - 19.00
Captan - 15.0
Malathion - 7.50
Methoxychlor - 19.75
5.1
Captan - 30.0
Maneb - 30%
Captan 6.4
Malathion - 8.07
Methoxychlor - 9.60
Captan - 10.0
Malathion - 7.50
29.35
Captan - 24.4
Carboxin - 12.5
29.35
Captan - 29.0
Thiabendazole - 0.55
Captan - 29.0
Thiabendazole - 0.55
Captan - 20.25
PCNB - 8.4
Thiabendazole - 1.0
Formulation Type
Solid
Solid
Liquid
Solid
Solid
Solid
Solid
Solid
Liquid
Liquid
Solid
Liquid
Liquid
Liquid
Liquid
Liquid
223
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EPA REG. NO.
7501-139
7501-150
10107-94
10163-194
19713-126*
19713- 145*
19713-260*
19713-362
19713-405*
29664-2
33955-408
34704-30
34704-342
34704-427
34704-650
34704-651*
34704-655*
34704-681
34704-760
42056-1
% of Active Ingredients
Captan - 45.0
Carboxin - 10.0
PCNB - 15.0
Captan - 12.78
Baytan - 6.25
Captan - 7.5
Streptomycin sulfate - 0.01
Captan - 30.0
2,6-Dichloro-4-nitroaniline - 30.0
18.86
Captan - 25.0
Diazinon - 25.00
75
80.0
78.3
37.3
Captan - 12.0
Malathion - 6.00
Methoxychlor - 12.00
5.0
10.0
50.0
Captan - 30.0
Methoxychlor - 2.00
70.0
30.0
15.0
Captan -10.0
Malathion - 10.00
Methoxychlor - 10.00
18.86
Formulation Type
Solid
Solid
Solid
Solid
Liquid
Solid
Solid
Solid
Liquid
Solid
Solid
Solide
Solid
Liquid
Solid
Liquid
Solid
Liquid
Liquid
224
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EPA REG. NO.
66330-2*
66330-5
66330-8
66330-9
66330-16
68119-6
68119-7
68119-12
% of Active Ingredients
65.0
62.9
Captan - 65.0
Methoxychlor - 10.0
62.9
7.5
Captan - 25.0
Thiabendazole - 0.68
Captan - 30.0
Thiabendazole - 0.53
Captan- 15%
Lindane - 25%
Diazinon- 15.52%
Metalaxyl - 1.0%
Formulation Type
Solid
Solid
Solid
Liquid
Solid
Solid
Liquid
Solid
*the following batching schemes are acceptable:
70-179 may cite batch 13
400-136 may cite batch 11
572-185 may cite 34704-760
7501-43 may cite batch 11
19713-126 may cite 42056-1
19713-145 may cite batch 13
19713-260 may cite batch 2
19713-405 may cite batch 2
34704-651 may cite batch 2
34704-655 may cite batch 4A
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This page has been inserted as a place marker and is replaced by an electronically generated PDCI List of
Registrants page number 1 in the actual Printed version of the Red document
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Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO I/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information'
or 'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551
or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of Data
(in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.gov/opprd001/forms/8570-l.pdf.
http://www.epa.gov/opprd001/forms/8570-4.pdf.
http://www.epa.gov/opprd001/forms/8570-5.pdf.
http://www.epa. gov/opprdOO l/forms/8570- 1 7.pdf.
http://www.epa.gov/opprd001/forms/8570-25.pdf.
http://www.epa.gov/opprd001/forms/8570-27.pdf.
http://www.epa.gov/opprd001/forms/8570-28.pdf.
http://www.epa.gov/opprd001/forms/8570-30.pdf.
http://www.epa.gov/opprd001/forms/8570-32.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR_Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.
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Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug
and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is
in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat
reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader.)
a. Registration Division Personnel Contact List
Biopesticides and Pollution Prevention Division (BPPD) Contacts
Antimicrobials Division Organizational Structure/Contact List
c. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
d. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
e. 40 CFR Part 158, Data Requirements for Registration (PDF format)
f. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional sources
of information.
These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States", PB92-221811, available through the National Technical Information Service (NTIS)
the following address:
National Technical Information Service (NTIS)
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5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting from the
passage of the FQPA and the reorganization of the Office of Pesticide Programs. We anticipate that this
publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on active
ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone
at 1-800-858-7378 or through their Web site: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended registration,
experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his
submission a stamped, self-addressed postcard. The postcard must contain the following entries to be
completed by OPP:
Date of receipt
EPA identifying number
the Product Manager assignment
Other identifying information may be included by the applicant to link the acknowledgment of receipt
to the specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying
File Symbol or petition number for the new submission. The identifying number should be used
whenever you contact the Agency concerning an application for registration, experimental use permit,
or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names, company
experimental codes, and other names which identify the chemical (including "blind" codes used when
a sample was submitted for testing by commercial or academic facilities). Please provide a CAS number
if one has been assigned.
Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical
Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
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