xvEPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(75O8C)
EPA 738-R-99-011
November 1999
Reregistration
Eligibility Decision (RED)
Folpet
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
,(75080)
EPA-738-F99-016
September 1999
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Folpet
Pesticides sold or distributed in the United States must be registered by '
EPA, based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in scientific
knowledge, the law requires that pesticides which were first registered before
November 1, 1984, be reregistered to ensure that they meet today's more stringent
standards. &
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health and
environmental effects of each pesticide. To implement provisions of the Food
Quality Protection Act of 1996, EPA considers the special sensitivity of infants and
children to pesticides, as well as aggregate exposure of the public to pesticide
residues from all sources, and the cumulative effects of pesticides and other
compounds with common mechanisms of toxicity. The Agency develops any
negation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters pesticides that meet me safety standard of
the FQPA and can be used without posing unreasonable risks to human health or
the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for its
decision m a Reregistration Eligibility Decision (RED) document. This fact sheet
summarizes the information in the RED document for reregistration case 0630
folpet.
Folpet is a fungicide used to control scab (sphaceloma) on avocados- wood
rot fungi, mold/mildew, and spoilage fungi on wood and other surfaces.
Formulations include liquid, ready to use, 0.3 to 0.7%; wettable powder 44
to 50%; and technical, solid 88%.
Folpet is applied by dip treatment, foliar treatment, soaking, spraying and as
a paint additive, wood surface treatment, and high volume spray.
Regulatory Folpet was first registered as a pesticide in the U.S in 1948 EPA issued a
History Registration Standard for folpet in June 1987. A January 1993 Data Call-in fDCD
required additional data.
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Currently, four folpet manufacturing use products are registered and twelve
end-use products are registered. The registrant has requested voluntary
cancellation of two end-use products, EPA registrations 66222-8 and 7401-231,
which have been suspended for lack of supporting data. The cancellations are being
processed. The proposed cancellation was published in the Federal Register on
August 4, 1999 for a 180 day comment period. The RED assumes that these uses
will be canceled in the near future.
Human Health Toxicity
Assessment In studies using laboratory animals, folpet generally has been shown to be of
low acute toxicity. However, it is moderately toxic by the inhalation route and has
been placed in Toxicity Category n (the second highest of four categories) for this
effect. Folpet has also been placed in Toxicity Category E for eye irritation.
Dietary Exposure
People may be exposed to residues of folpet through the diet. Tolerances or
maximum residue limits have been established for apples, avocados, cranberries,
cucumbers, grapes, lettuce, melons, onion (dry bulb), strawberries, and tomatoes
(see 40 CFR 180.191). EPA has reassessed the folpet tolerances and found that
tolerances for apples, cranberries, cucumbers, grapes, lettuce, melons, onion (dry
bulb), strawberries, and tomatoes must be converted to import tolerances because
the US registrations for these commodities are being canceled. Also, a new
tolerance must be established for raisins because folpet concentrates'in raisins. The
avocado tolerance is being amended to indicate that it is limited to a regional
registration for the state of Florida.
The Codex Alimentarius Commission has established temporary maximum
residue ^fc (TMRL) for folpet on cucumber, grapes, potatoes, and strawberries.
EPA has assessed the dietary risk posed by folpet, considering food and
water sources of potential residues, and quantifying dietary exposure on acute and
chr°nic bases. For the acute dietary (food only) assessment, EPA used a
probablistic exposure analysis, finding that the acute population adjusted dose
(aPAD) was below the Agency's level of concern. A risk estimate that is less than
100% of the acute population adjusted Dose (acute PAD)—that is, the dose at
which an individual could be exposed on any given day and no adverse health
effects would be expected—does not exceed the Agency's risk concern. At the
99.9th percentile, exposure to the most sensitive sub-group (females age 13-50)
was found to be about 25% of the aPAD for folpet.
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EPA also assessed the chronic (non-cancer) dietary risk using average field
trial data and percent crop treated information. The Agency found that the chronic
population adjusted dose (cPAD) was below the Agency's level of concern. A
risk estimate that is less than 100% of the cPAD—the dose at which an individual
could be exposed and not expect an adverse health effect—does not exceed the
Agency's risk concern. For all subgroups, the exposure is less than 1% of the
cPADforfblpet.
In addition, EPA assessed the dietary cancer risk from residues in food using
the same exposure information as used in the chronic (non-cancer) assessment and
a cancer potency factor or Q,* of 0.00186 (ing/kg/day)-'. The Agency found a
cancer risk of 9.8 x 10'8 for folpet, which is less than the Agency's level of concern
oflxlO'6.
The dietary risk from water, as weU as the aggregate risk assessment for
folpet is discussed in the FQPA Considerations portion of this factsheet.
Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders, and applicators)
may be exposed to folpet during and after normal use of the wettable powder and
liquid ready to use formulations in agricultural, residential, and manufacturing
settings.
Human Risk Assessment
Folpet generally is of medium acute toxicity, but causes developmental
effects in animal studies and has been classified as a Group B2, probable human
carcinogen. Food crop uses are registered including avocados in the US and
apples, cranberries, cucumbers, grapes, lettuce, melons, onions, strawberries, and
tomatoes imported from other countries However, dietary exposure to folpet
residues in foods is extremely low, as is the cancer risk posed to the general
population.
Of greater concern is the risk posed to folpet handlers, particularly
mixers/loaders who come into contact with folpet while adding it to paint during
manufacture. Exposure and risk to workers will be mitigated by the use of PPE
required by the WPS, supplemented by a dust/mist respirator and chemical
resistant gloves as required by this RED. Post-application reentry workers will be
required to observe a 24-hour Restricted Entry Interval, which is set by the WPS
For folpet, a 24-hour REI is required because folpet is classified as Toxicity
Category E for acute inhalation toxicity and for eye irritation.
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I , , • ': , ".'!!'
FQPA Considerations
The Agency has determined that the established tolerances for folpet,-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 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 folpet residues in this
population subgroup.
*
In determining whether or not infants and children are particularly susceptible
to toxic effects from folpet 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, folpet has a complete database for
developmental and reproductive toxicity. Reliable studies cited earlier in this
document indicate limited concern for special sensitivity of young organisms to
folpet (see Section nib). However, the Agency has determined that the Safety
Factor can be reduced to 3X based on the developmental and reproductive toxicity
studies available for folpet, as described previously in Section m(B)l(d) of this
document. The Agency has retained a 3X FQPA safety factor to ensure adequate
protection of infants and children. This FQPA safety factor applies only to females
13-50 for acute and short-term exposures. Therefore, the Agency has concluded
that a total uncertainty factor of 300 is adequate to protect infants and children.
This uncertainty factor was incorporated into the risk assessment.
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, there are 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. There are also
pesticides that produce a common toxic metabolite, in which case common
mechanism of activity will be assumed.
In the case of folpet, the Agency is aware of a proposed common mechanism
of carcinogenicity with captan. Captan and folpet share a common metabolite,
thiophosgene, which is believed to be responsible for the carcinogenic effects '
observed with both compounds. Thiophosgene is a highly reactive, short-lived
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species which is produced in the gut and believed to cause tumors through the
irritation of the duodeum. Because it is so short lived, its residues cannot be
quantified. Without measurable residues of the common metabolite, it is difficult at
this time 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 worse
case estimate. When this is done, the risks do not exceed the Agency's level of
concern.
The Agency considers residential postapplication exposure to folpet from its
use in sealants and coatings to be negligible because dermal and inhalation
exposures are likely to be minimal. Therefore, EPA has considered only residential
handler exposure together with dietary and drinking water exposures in its
aggregate risk assessment.
In assessing acute aggregate dietary risk, EPA used a NOAEL of 10
mg/kg/day from a developmental study in rabbits. Because the selected endpoint is
from a developmental toxicity study, the sub-population of females, 13-50 years
old, is the subgroup of interest. EPA estimates that residues of folpet in diets of
females 13-50 years old accounts for 25% of the acute PAD. This leaves 75% of
the acute PAD for aggregate risk. The DWLOC corresponding to 75% of the
acute PAD is 670 ppb. Because the modeled ground water concentration is only
0.06 ppb and the modeled peak surface water concentration is 156 ppb, aggregate
acute exposure and risk are not of concern.
Short and intermediate term aggregate risk estimates do not exceed the
Agency's level of concern. Short and intermediate term aggregate risk estimates
considered only two potential homeowner exposure scenarios: application of
Ready-to-Use paint or stain with either a paint brush or an airless sprayer. The
highest exposure, from the airless sprayer, represents a short-term MOE of 407.
The chronic dietary exposure from folpet represents less than 1% of the chronic
PAD. This leaves 99% of the PAD available for aggregate risk, which corresponds
to short-term DWLOC of 228 ppb available for water. The modeled 56-day
GENEEC value is 1 ppb, and the modeled concentration of folpet in groundwater
is 0.06 ppb. Because the short-term DWLOC is greater than the modeled
concentrations of folpet in surface or groundwater, the short-term aggregate risk is
not of concern.
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Environmental
Assessment
In assessing chronic aggregate dietary risk, the Agency used the same
exposure assumptions for estimating the chronic (non-cancer) and cancer risk. The
drinking water assessment used modeling, as above, to predict ground and surface
water concentrations of folpet. Chronic dietary (food) exposure to the US
population accounts for less than 1% of the chronic PAD. This leaves 99% of the
chronic PAD for aggregate risk. The DWLOC corresponding to 99% of the
chronic PAD is 890 ppb, which is far greater than the modeled groundwater
concentration of 0.06 ppb and the modeled surface water concentration of 3 ppb.
Therefore, the Agency concludes that the aggregate chronic exposure and risk from
residues in food and water are not of concern.
Ecological Effects Risk Assessment
The ecological risk assessment and risk mitigation recommendations for
folpet are based on the present limited use of folpet. At present, the only potential
ecological risks are from the use of folpet on avocados in Florida. Only a very
small percentage of Florida avocados are treated with folpet.
Acute and chronic risks to birds and mammals from folpet are not of
concern, even at maximum label application rates and frequencies. Folpet also
does not appear to pose a risk to honeybees or other insects.
Folpet is highly toxic to most aquatic animal species tested. Based on
toxicity test results and results of conservative modeling of folpet concentrations in
water, airblast application of folpet to avocados in Florida are expected to exceed
high acute risk LOCs for all aquatic animals. Because folpet is applied directly to
leaves of avocado trees, only a small amount of folpet will be available for long
range spray drift to water. Chronic LOCs are not expected to be exceeded for fish
or aquatic invertebrates.
Folpet degrades rapidly in water to the degradates, PI and PAL The
degradate PI has been shown to be only slightly toxic to aquatic animals. No
toxicity data are available on PAL However, since PAI is not expected to be
lexicologically significant and usage is limited to two counties in Florida, no
additional data will be required at this time. However, if the use pattern changes,
the Agency may reconsider this position.
The current spray drift label advisory should be continued. Additional drift
mitigation practices may be identified following review of the Spray Drift Task
Force database.
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A fall plant exposure and risk assessment cannot be done with the existing
data. Because of the limited use area, no additional data or mitigation are required
at this time. However, additional aquatic plant testing would be required with any
expansion of folpet use.
Endangered Species
Risk Mitigation
The Agency has concerns about the exposure of threatened and endangered
species to folpet. Levels of concern (LOG) are expected to be exceeded for
aquatic organisms exposed to single or multiple applications of this fungicide. There
are a number of endangered species in avocado growing regions in Florida. These
include the Everglades snail kite, whose primary diet consists of apple snails.
Although folpet is highly toxic to aquatic invertebrates, such as apple snails, the
nearest avocado groves are approximately 3 miles from the Everglades. Therefore,
the most likely route of exposure to snails would be long range spray drift, which is'
unlikely to occur but cannot be quantified at this time. The current spray drift label
advisory should be continued. Additional drift mitigation practices may be identified
Mowing review of the Spray Drift Task Force database. After its review of the
new studies, the Agency will determine whether a reassessment of the potential
risks to nontarget organisms is warranted.
To lessen the risks posed by folpet, EPA is requiring the Mowing mitigation
measures for folpet-containing products:
Gloves and dust/mist respirator or equivalent engineering controls are
required to lessen the risks to workers adding the wettable powder to
paints and stains during the manufacturing process; and
An Environmental Hazard warning is required to lessen risks to
nontarget aquatic organisms. Specific label language is provided in
Section V of the RED.
Additional Data EPA is requiring the following additional generic studies for folpet to confirm
ReqUired its regulatory assessments and conclusions:
Guideline 830.7050,UV/Visible Absorption for the PAI
Guideline 860.1200, Direction for Use
Guideline 860.1380, Storage Stability for avocados, cucumber, and
melon
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Guideline 860.1480, Magnitude of the Residue in Meat and Milk (Ruminant
Feeding Study)
Guideline 850.1300, Chronic Daphnia Toxicity
Guideline 870.3700, Prenatal Developmental Toxicity in the New
Zealand White Rabbit
Guideline 875(series), Exposure Monitoring for application with wood
dip and paint roller.
These data are confirmatory; i.e., they are not expected to change the
conclusions of this RED.
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of Formula
(CSFs), and revised labeling for reregistration.
Product Labeling All folpet end-use products must comply with EPA's current pesticide
Changes Required Product labeling requirements and with the following. For a comprehensive list of
labeling requirements, please see the folpet RED document.
PPE for workers adding wettable powder to sealants and coatings during
manufacturing process: Chemical resistant gloves and a dust/mist respirator are
required. If available, engineering controls such as closed loading systems are an
adequate substitute for the PPE.
Regulatory
Conclusion
REI: Since folpet is in toxicity category n for inhalation exposure and eye
irritation, a 24-hour restricted entry interval (REI) is required for avocado
harvesters. Early entry PPE is required for any workers who enter treated avocado
orchards before the 24-hour REI.
Environmental Hazard Statement: "This chemical is highly toxic to fish and other
aquatic organisms. Do not apply directly to water. Do not contaminate water
when disposing of equipment, washwater, or rinsate."
The use of currently registered products containing folpet in accordance with
approved labeling will not pose unreasonable risks or adverse effects to humans or
the environment. Therefore, the Agency has determined that all supported folpet
products are eligible for reregistration under the conditions specified in this RED.
Products containing folpet for use on avocados and in coatings and sealants are
eligible for reregistration. As mentioned previously, the registrants are not
supporting other folpet uses and have requested voluntary cancellation of
agricultural, ornamental, and greenhouse registrations (EPA Registration numbers
;.f i tin : ,.
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66222-8 and 7401 -231). These unsupported uses were suspended due to lack of
supporting data and are ineligible for reregistration.
Folpet products will be reregistered once the required product-specific data,
revised Confidential Statements of Formula, and revised labeling are received and '
accepted by EPA.
For MOre EPA is requesting public comments on the Reregistration Eligibility Decision
Information (RED) document for folpet during a 60-day time period, as announced in a Notice
of Availability published in the Federal Register. To obtain a copy of the RED
document or to submit written comments, please contact the Pesticide Docket,
Public Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs (OPP), US EPA,
Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet are available on the Internet.
See http://www.epa.gov/REDs.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information (EPA/NCEPI),
PO Box 42419, Cincinnati, OH 45242-2419, telephone
1-800-490-9198; fax 513-489-8695.
Following the comment period, the folpet RED document also will be
available from the National Technical Information Service (NTTS), 5285 Port Royal
Road, Springfield, VA 22161, telephone 703-605-6000.
For more information about EPA's pesticide reregistration program, the
folpet RED, or reregistration of individual products containing folpet, please contact
the Special Review and Reregistration Division (7508W), OPP, US EPA,
Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticide Telecommunications Network (NPTN). Call toll-free 1-800-
858-7378, from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm Eastern
Standard Time, seven days a week. Their internet address is
ace.orst.edu/info/nptn.
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UNITED. STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MATT
NOV - 2 1999
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 folpet which includes the
active ingredients folpet. The enclosed Reregister!™ F.lipMify rw;^ pi^ which wag fid
on September 30, 1999 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 ^registration The
RED includes the data and labeling requirements for products for reregistration. It may also include
reqiurements 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.
7 , QO* F°°d QuaUty Protection Act of !996 (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
reregistranon 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
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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 product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregistration Division representative Moana
Appleyard at (703)308-8175. Address any questions on required generic data to the Special Review
and Reregistration Division representative Christina Scheltema (703)308-2201.
Sincerely yours,
Enclosures
sis A. R^j Director
Special BLeview and
Reregistration Division
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SUMMARY OF INSTRUCTIONS FOR RFSPQNDTNC TO
THE REREGTSTRATTON ELIGTBTT TTV DECISION
1 DATA CALT.TN (DCT) OR "90-DAY RESPONSE "-If ^^ „— nr~ r uircd fm
reregistration, 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 date 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 genenc 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 RFOTTFSTg..^ ^ ^^ ._ _vffl
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 RF.RF.GTSTRATTON OR "8-MONTH RESPONSE"- Vm. must
submit the following items for each product within eight months of the date of this letter (RED
issuance date). v
a. Application for Registration (EPA Form 8570-1). Use only an original application
form Mark it Apphcation 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
So1!^ °fy makC labeUng Chan§eS WWch m required by ** ^D «* cu"-ent regulations (40
CFR 156.10) and policies. Submit any other amendments (such as formulation changes orlabelins
changes not related to reregistration) separately. You may, but are not required to, delete uses which
?1 £?yS ^ g f°r **&***"• For fi^ 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 #PB92-22181 1-
telephone number 703-605-6000). '
KT , £ G^ic 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 Agencv's
acceptance criteria (attached to the DCI).
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d- Two conies of the Confidential Statement of Formula fCSF> for ear.h basin and
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 Resnectto Citation of Data Complete and sign EPA form 8570-34
and 8570-35 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTTrE-rnmmPnh, r^,.n^
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 r90-DAV> AND
APPLICATIONS FOR REREGISTRATTQN (8-MONTH RESPONSES)
BvU.S. Mail:
Document Processing Desk (RED-SRKD-PRB)
Office of Pesticide Programs (7504C)
EPAf401MSt.S.W.
Washington, D.C. 20460-0001
Bv express:
,.,„ „ , VI ; ^lll'iHi I , I, ">ii , , " ,
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 reregistration determination within 14 months after the RED has been issued.
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REREGISTRATION ELIGIBILITY DECISION
FOLPET
List A
CASE 0630
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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FOLPET REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY
I. INTRODUCTION
II. CASE OVERVIEW
4
A. Chemical Overview
B. Use Profile A
• 4
C. Estimated Usage '
D. Data Requirements ,
E. Regulatory History
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment 8
1. Description of Chemical 8
2. Identification of Active Ingredient o
B. Human Health Risk Assessment 8
1. Toxicology Assessment 9
a. Hazard Profile for Folpet 9
b. Hazard Profile for Folpet Metabolites and Degradates .....11
c. Acute Toxicity of Folpet j j
d. FQPA Considerations for Folpet 11
e. Endpoint Selection for Risk Assessment 13
i. Acute Dietary 14
ii. Chronic Dietary 15
iii. Route to Route Extrapolation 18
iv. Short and Intermediate Term Dermal ] g
v. Long Term Dermal 18
vi. Short and Intermediate Term Inhalation ig
vii. Long Term Inhalation Ig
f. Endocrine Disrupter Effects 19
2. Exposure Assessment jo
a. Summary of Registered Uses 19
b. Dietary Exposure (Food Sources) . 19
i. Residue Chemistry Data 20
ii. Acute Dietary Risk Assessment 22
iii. Chronic (Non-Cancer) Dietary Risk Assessment .... 22
iv. Dietary Cancer Risk Assessment 23
v. Dietary Exposure (Drinking Water Source) 23
vi. DWLOCs for Acute Exposure . .... 24
vii. DWLOCs for Chronic (Non-Cancer) Exposure 25
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viii. DWLOCs for Chronic (Cancer) Endpoint 25
c. Occupational Exposure !... 26.
i. Occupational Handler Exposure Scenarios 26
ii. Occupational Handler Data Sources and Assumptions
"^ • ' ':. ,.."."..•.:..: "27
iii. Occupational Handler Risk Characterization 29
iv. Incident Reports 31
V. Occupational Postapplication Exposure 31
vi. Postapplication Risk Estimates 33
d. Residential Exposure 34
i. Residential Handler Exposure Scenarios, Data Sources,
and Assumptions 34
ii. Residential Handler Risk Characterization 35
iii. Residential Postapplication Exposures and Risks 36
e. Summary of Occupational Risk Estimates 36
i. Short- and Intermediate-term Dermal Risk 36
ii. Short and Intermediate Term Inhalation Risk 36
iii. Total Noncancer Risk from Handler Exposure 36
iv. Cancer Risk From Handler Exposure 36
f. Aggregate Risk 40
i. Acute Aggregate Risk 40
ii. Short- and Intermediate-Term Aggregate Risks ' 40
iii. Chronic (Non-Cancer) Aggregate Risk 41
iv. Cancer Aggregate Risk 41
v. Cancer Aggregate Risk for Captan and Folpet 41
e. Cumulative Effects 42
Environmental Assessment 43
1. Ecological Toxicity Data 43
a, Toxicity to Terrestrial Animals 44
i. Birds, Acute and Subacute 44
ii. Birds, Chronic 45
iii. Mammals 45
iv. Insects 45
b. Toxicity to Aquatic Animals 45
i. Freshwater Fish 45
ii. Freshwater Invertebrates 43
iii. Estuarine and Marine Animals 49
c. Toxicity to Plants . " .50
i Terrestrial 50
ii. Aquatic Plant Growth 59
2. Environmental Fate and Transport Data 50
a. Degradation 50
i. Hydrolysis 50
-------
IV.
ii. Photodegradation in Water 51
iii. Photodegradation on Soil 5 j
iv. Photodegradation in Air 51
v. Aerobic Soil Metabolism 51
vi. Anaerobic Soil Metabolism 52
vii. Aerobic and Anaerobic Aquatic Metabolism 52
b. Mobility 52
i. Leaching and Adsorption/Desorption 52
ii. Volatility 53
iii. Bioaccumulation in Fish 53
iv. Field Dissipation 54
v. Spray Drift .'""].'.'."" 54
3. Water Resources Assessment 55
a. Ground Water 56
b. Surface Water 57
4. Ecological Exposure and Risk Characterization 59
a. Explanation of the Risk Quotient (RQ) and the Level of Concern
(LOC) 59
b. Exposure and Risk to Nontarget Terrestrial Animals ..'"'..60
i. Birds ,,„
ou
11. Mammals .... ^
T 62
iii. Insects 6o
c. Exposure and Risk to Nontarget Aquatic Animals ........ 63
i. Freshwater Fish 64
ii. Freshwater Invertebrates 65
iii. Estuarine and Marine Animals 55
d. Exposure and Risk to Nontarget Plants 66
e. Endangered Species >,-
f. Environmental Risk Characterization 67
RISK MANAGEMENT AND REREGISTRATION DECISION 69
A. Determination of Eligibility
1. Eligibility Decision ,„
2. Eligible and Ineligible Uses 69
C. Regulatory Position
1. Food Quality Protection Act Findings '.'.'.'.'.'.'.'.'. 70
a. Determination of Safety for U.S. Population ..... ..... 70
b. Determination of Safety for Infants and Children...... 73
c. Endocrine Disrupter Effects 74
2. Tolerance Reassessment ;
3. Human Health Risk Mitigation 77
a. Acute Dietary Mitigation 77
b. Chronic Dietary Mitigation (non-cancer) 77
-------
c. Carcinogenic Mitigation 77
d. Worker Mitigation 77
e. Residential Mitigation 78
f. Drinking Water Mitigation 79
g. Aggregate Mitigation 79
4. Ecological Risk Mitigation 79
a. Risk Mitigation for Nontarget Terrestrial Animals 79
b. Risk Mitigation for Nontarget Aquatic Animals 79
c. Risk Mitigation for Nontarget Aquatic Plants 80
d. Risk Mitigation for Endangered Species 80
5. Occupational (both Worker Protection Standard and non-WPS) Labeling
Rationale OQ
a. Personal Protective Equipment for Handlers (Mixers, Loaders,
Applicators, etc.) 81
b. Post-Application/Entry Restrictions 81
c. Other Labeling Requirements 82
6. Endangered Species Statement 82
7. Spray Drift Management 83
V. ACTIONS REQUIRED OF REGISTRANTS 83
A, Manufacturing-Use Products 83
1. Additional Generic Data Requirements 83
2- LabeP«g Requirements for Manufacturing-Use Products ... 84
B. End-Use Products 84
1. Additional Product-Specific Data Requirements 84
2. Labeling Requirements for End-Use Products 84
3. Required Labeling Changes Summary Table 84
C Existing Stocks 89
IV. APPENDICES 91
A. Table of Use Patterns Subject to Reregistration 92
B. Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision 1Q2
\~r*
Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision j 12
D. Generic Data Call-In 125
1. Generic Data Call-in Chemical Status Sheet 142
2. Generic DCI Response Forms Inserts (Insert A) plus Instructions
•'• '•" 143
3. Requirements Status and Registrants' Response Forms (Insert B)
plus Instructions 147
4. Product Specific Data Call-in 153
-------
5. Product Specific Chemical Status Sheets 155
6. Data Call-in Response Form for the Product Specific Data(Form A
inserts) Plus Instructions 168
Sample Response Form for the Product Specific Data CaIHn(Form A)
• • 169
7. Product Specific Requirement Status and Registrant's Response
Forms (Form B inserts) and Instructions no
Sample Requirements Status and Registrant's Response Form for the
Product Specific Data Call-In(Form B) 173
8. EPA Batching of End-Use Products for Meeting Data
Requirements for Registration 177
9. List of AH Registrants Sent This Data Call-In (insert) Notice 181
E. List of Available Related Documents and Electronically Available Forms.
182
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FOLPET REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Richard Michell
Frank Hernandez
Margaret Cogdell
Biological Analysis Branch
Economic Analysis Branch
Science Information and Analysis Branch
Environmental Fate and Effects Risk Assessment
Kevin Costello
Iwona Maher
James Hetrick
Environmental Risk Branch 1
Environmental Risk Branch 1
Fate and Monitoring Branch
Health Effects Risk Assessment
David Hrdy
Thurston Morton
Christine Olinger
Jack Arthur
Timothy Leighton
Sanju Diwan
Nicole Paquette
Registration Support
Reregistration Branch 4
Reregistration Branch 4
Reregistration Branch 2
Registration Action Branch 3
Reregistration Branch 4
Reregistration Branch 4
Reregistration Branch 2
Cynthia Giles-Parker Registration Division
Maria Rodriguez Registration Division
Marshall Swindell Antimicrobial Division
Wallace Powell Antimicrobial Division
Risk Management
Christina Scheltema
Susan Jennings
Betty Shackleford
Reregistration Branch ffl
Reregistration Branch ffl
Reregistration Branch IJJ
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-------
ADI
a.i.
ARC
CAS
CNS
CSF
DEEM
DFR
ORES
DWLOC
EEC
EP
EPA
FAO/WHO
FDA
FIFRA
FFDCA
FQPA
GLC
GM
GRAS
LC50
LD,,
LEL
LOC
LOD
LOAEL
LOEL
MATC
MCLG
mg/L
MOE
MP
MRID
N/A
NOEC
NPDES
NOEL
NOAEL
OPP
GLOSSARY OF TERMS AND ABBREVIATIONS
Acceptable Daily Intake. A now defunct term for reference dose (RfD).
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Central Nervous System
Confidential Statement of Formula
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Level of Comparison
Estimated Environmental Concentration. The estimated pesticide concentration in an environment
such as a terrestrial ecosystem. '
End-Use Product
U.S. Environmental Protection Agency
Food and Agriculture Organization/World Health Organization
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Gas Liquid Chromatography
Geometric Mean
Generally Recognized as Safe as Designated by FDA
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.
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.
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Adverse Effect Level
Lowest Observed Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Micrograms Per Gram
Micrograms per liter
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Master Record Identification (number). EPA's system of recording and tracking studies submitted
Not Applicable
No Observed Effect Concentration
National Pollutant Discharge Elimination System
No Observed Effect Level
No Observed Adverse Effect Level
Office of Pesticide Programs
111
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Pa
PAD
PADI
PAM
PHED
PHI
ppb
PPE
ppm
PRN
Q.*
RBC
RED
REI
RfD
RS
RTU
RUP
SLN
TEP
TGAI
TLC
TMRC
torr
WP
WPS
GLOSSARY OF TERMS AND ABBREVIATIONS
pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
Population Adjusted Dose - Reference Dose Adjusted for FQPA Safety Factor
Provisional Acceptable Daily Intake
Pesticide Analytical Method
Pesticide Handler's Exposure Database
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
Red Blood Cell
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Registration Standard
Ready to Use Pesticide
Restricted Use Pesticide
Special Local Need (Registrations Under Section 24c of FIFRA)
Typical End-Use Product
Technical Grade Active Ingredient
Thin Layer Chromatography
Theoretical Maximum Residue Contribution
A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
Wettable Powder
Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U. S. Environmental Protection Agency has completed its reregistration eligibility decision
of the pesticide folpet. The Agency has determined that folpet products, labeled and used as specified
in this Reregistration Eligibility Decision document, will not pose unreasonable risks of adverse effects
to humans or the environment. Therefore, the Agency has determined that all supported folpet
products are eligible for reregistration under the conditions specified in this Reregistration Eligibility
Decision document. Products containing folpet for use on avocados and in coatings and sealants are
eligible for reregistration. The registrants are not supporting other folpet uses and have requested
voluntary cancellation of agricultural, ornamental, and greenhouse registrations (EPA Registration
numbers 66222-8 and 7401-231). These unsupported uses were suspended due to lack of
supporting data and are ineligible for reregistration.
The registrant is supporting import tolerances for the Mowing commodities which are being
canceled in the US: apples, cranberries, cucumbers, grapes, lettuce, melons, onions, strawberries, and
tomatoes. The tolerances are being converted to import tolerances for these commodities. Anew
import tolerance will be established for raisins because residue data show that folpet concentrates in
raisins. For some commodities, the import tolerances will be lower than the old tolerance with a US
registration because the import tolerances are based on different use information than was used
previously.
The Agency has conducted both human health and ecological risk assessments for folpet The
human health risk assessment includes dietary, drinking water, residential, aggregate, and occupational
exposure, as required by FQPA. The acute and chronic dietary risk for folpet are not of concern for
food or water exposure. Aggregate risk from food, water, and residential exposure are not of concern
The cancer risk for folpet is not of concern for food, water, residential, or aggregate exposure
Occupational risks for folpet are of concern only for workers who add folpet to paints and stains during
manufacturing. Ecological risks for folpet are not of concern at this time based on the limited use of
folpet. Only the avocado use might result in releases of folpet to the environment.
To lessen the risks posed by folpet, EPA is requiring the following mitigation measures for
folpet-contaimng products:
Gloves and dust/mist respirator or equivalent engineering controls are required to lessen
the risks to workers adding the wettable powder to paints and stains during the
manufacturing process; and
An Environmental Hazard warning is required to lessen risks to nontarget aquatic
organisms. Specific label language is provided in Section V of the RED.
-------
Before reregistering the products containing folpet, 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 and acute toxicity testing
for all end:use products. The Agency will reregister a product only after reviewing these data and the
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA. Products
containing folpet and other active ingredients will be eligible for reregistration only when the other active
ingredients are determined to be eligible for reregistration.
-------
I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) was amended
to accelerate the ^registration 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 ffflh phase is a review by the
U.S. Environmental Protection Agency (referred to as "The Agency") of all data submitted to support
reregistration. pp
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
Hie 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 human 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.b.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 7 US C
I36etseq. 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 safely standard and how it should
be applied to both food and non-food use pesticides.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of folpet including the risk to infants and children from any potential dietary or drinking
water exposure; occupational risks; risk to homeowners who apply folpet-containing paint and stain-
and risks associated with releases of folpet to the environment. The document consists of six sections
Section I is the introduction. Section n describes folpet, its uses, data requirements and regulatory '
nistory. Section HI discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for folpet. Section V discusses
reregistration requirements for folpet. Finally, Section VI contains the Appendices that support this
Addltional detans
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II. CASE OVERVIEW
Mill' |. ' I, '
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility Decision:
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Molecular Weight:
Folpet
A4(^cWoromethyl)tliio]phthalimide
Dicarboximides or chlorinated organosulfur compounds
133-07-3
081601
296.6
B.
Trade and Other Names: Folpan®
Technical Registrant: Makhteshim-Agan of North America, Inc.
Use Profile
The Mowing is an overview of use information on folpet's currently registered uses. A table
detailing the uses is attached as Appendix A.
Type of Pesticide: fungicide
Mode of Action: Broad spectrum contact protectant, which acts by denaturing fungal
proteins when folpet reacts with thiol groups in proteins
US Use Sites:
Terrestrial Food/Feed Crops
avocados (Florida only), wood protection treatment to forest products
Terrestrial Non-Food
paints, caulking compounds, nonaqueous coatings, stains
4
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Import Tolerances: apples, cranberries, cucumbers, grapes, lettuce, melons, onions,
strawberries, tomatoes
Target Pests:
Formulation Types Registered:
avocado scab (sphaceloma); wood rot fungi; mold/mildew; spoilage
fungi (coating compounds)
Manufacturing Use Products
There are currently four folpet manufacturing-use products (MUPs) registered under
OPP Chemical Code Number 081601. The registered folpet MUPs listed below in Table 1
are subject to this reregistration eligibility decision.
Formulation
88% T
88% T
EPA Reg. No.
10182-294
11678-18
Registrant
Zeneca Ag Products
Makhteshim-Agan North
America
End Use Products
liquid - ready to use 0.3 to 0.7%
wettable powder 44 to 50%
Technical Grade
solid 88%
Method and Rates of Application:
Equipment -
Method -
Rates-
dip tank, airblast sprayer, by hand,
pad, paint brush, paint roller, airless sprayer
dip treatment, foliar treatment, high volume spray,
paint additive; soak, spray, wood surface treatment
Avocados: 3 Ibs a.i./acre at 14-day retreatment intervals,
maximum of 7 applications (21 Ibs ai/year), 7 month
preharvest interval
pre-bloom (bud swell), late bloom, post bloom, foliar, during
manufacture, when needed (for wood treatment)
-------
C. Estimated Usage
This section summarizes the best information available for the pesticidal uses of folpet. 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 different sources.
Relatively minor non-agricultural use of folpet is reported. According to proprietary sources,
folpet has a share of the biocide market for paint additives of less than 5 percent, and a share of the '
biocide market for wood preservatives of less than 1 percent.
Use on avocados is the only domestic food crop currently registered for folpet, and folpet is
labeled for use in Florida only. The 1992 Census of Agriculture lists only Brevard and Dade counties
as having commercial acreage in avocado production. The total 1992 avocado acreage for Brevard
County was 5; the total 1992 avocado acreage for Dade County was 5829. There were 585 avocado
orchards in Dade County. This yields an average avocado orchard size of approximately 10 acres.
However, according to recent information from the Florida Agricultural Extension service, there is no
significant use of folpet on Florida avocados. For the purposes of dietary risk assessment, the Agency
assumes that 1% of all avocados are treated with folpet.
1 : - , . i •, /
Support for registraton of folpet on all the other fruits and vegetables grown domestically was
dropped by the registrant in 1987, and US registrations were voluntarily canceled for all US crops
except for avocados. The registrant is currently supporting folpet tolerances for nine imported fruits
and vegetables: apples, cranberries, cucumbers, grapes (table and wine), lettuce, melons, dry bulb
onions, strawberries, and tomatoes. Less than 25% of the total US consumption of these crops is
imported, according to public data from USDA. Data submitted by the registrant indicate that 1
percent or less of commodities with import tolerances consumed in the U.S. is expected to be treated
with folpet
D. Data Requirements
The1987 Registration Standard for folpet required Part 158 generic data and product specific
data. These data were required to support the uses listed in the Registration Standard. An additional
data call in (DO) was issued in January 1993. Appendix B summarizes all data requirements identified
by the Agency for currently registered uses and the data submitted to support reregistration
-------
E. Regulatory History
Folpet is the common name of the pesticide chemical N-[(trichloromethyl)thio] phthalimide
This chemical was first registered in the US in 1948 as a fungicide, insecticide and miticide on roses and
other ornamental plants. There have been over 200 products registered containing folpet. The majority
of the products were canceled voluntarily in response to the Agency's 1987 Registration Standard
because the registrants did not want to support continued registration of the products Folpet is
currently registered as a wood preservative, an additive to coatings and sealants (such as paint and
caulk), a fungicide for Florida avocados, and as a manufacturing use product As mentioned above
folpet is registered for other food uses overseas for which the Agency has established import
tolerances, i.e., tolerances without a US registration.
Two folpet products were suspended in 1987 because the registrants did not submit the data
required for the registration. After this suspension, use on avocados was the only remaining agricultural
use for folpet. The technical registrant, Makhteshim-Agan, kept the suspended registration active to
allow the accompanying tolerances for overseas commodities to continue. During this time EPA and
Makhteshim-Agan reached an agreement about the residue data required to support the import
tolerances. Concurrently, the Agency also established a policy to clarify data requirements to support
an import tolerance (i.e., a tolerance without a US registration)1. In 1999, the registrants requested
voluntary cancellation of the suspended products, which is currently being processed The proposed
canceU
1999 fora 180 day comment
period. The Agency's Reregistration Decision for folpet assumes that these uses will be canceled in the
near futur
i
See Stasikowski M. Draft Import Tolerance Guidelines. December 8,1998. USEPA Office of Pesticide
Programs, Health Effects Division.
2 Federal Register Vol. 64, No. 149, Wednesday, August 4,1999. [OPP-66269; FRL 6092-6]
7
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III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
1. Description of Chemical
Folpet [A^-[(1ricMoromethyl)thio]phthalimide] has an empirical formula of
molecular weight of 296.6. The chemical structure is given below:
and a
—>
ecu
Folpet
2. Identification of Active Ingredient
Pure folpet is a white crystalline solid with a melting point of 177° C. Technical folpet is an off-
white to tan powder with a melting point of 169-177° C. Folpet has low solubility in water at room
temperature (1 mg/L), has very low solubility in aliphatic hydrocarbon solvents, and has low solubility in
aromatic, polar, oxygenated, and hydrocarbon solvents. Folpet is stable in dry conditions at ambient or
elevated temperatures, but is not stable under alkaline conditions at high temperatures.
B. Human Health Risk Assessment
The Agency has conducted a human health risk assessment for the active ingredient folpet (N-
[(tnchloromethyl)thio]phthalirnide) for the purposes of making a reregistration eligibility decision In
conducting its assessment, the Agency evaluated the toxicological, residue chemistry, and exposure
data bases for folpet and determined that the data are adequate to support a reregistration eligibility
decision. The Agency assessed acute and chronic dietary risks, occupational risks, and risks to
homeowner^ from the use of folpet. The Agency also evaluated aggregate risks associated with
simultaneous residential and dietary exposures, including potential exposure from drinking water
-------
1. Toxicology Assessment
The toxicological data base on the active ingredient folpet is substantially complete and
adequate to support a reregistration eligibility decision. The required Subdivision F Toxicology
Guideline requirements specified in 40 CFR Part 158 for a food use chemical are complete for folpet
technical For a detailed discussion of the toxicology data supporting reregistration, see the Agency's
Human Health Risk Assessment for folpet.
a. Hazard Profile for Folpet
Folpet is a member of the N-trihalomethylthio group of compounds which are highly reactive
with biological tissues. The labile N-trichloromethylthio (S-CQ) side chain is the reactive portion of
fee molecule and degrades rapidly under neutral/alkaline conditions in the presence of tissue or blood
thiols (such as cysteine and glutathione) to form a key short-lived intermediate, thiophosgene.
Thiophosgene is highly reactive and severely irritating to tissues. Thiophosgene causes irritation
to mucus membranes and is a skin irritant and sensitizer. The thiophosgene moiety is most likely
responsible for folpet's activity as a surface fungicide and is responsible for the predominant toxicity in
mammals, although the rest of the molecule (i.e., phthalimide, phthalamic acid) may also contribute to
folpet s toxicity.
Subchronic studies in rats demonstrated that the critical systemic toxic effect was acanthosis
and hyperkeratosis and/or ulceration/erosion of the stomach following high oral doses of folpet In a 21-
day dermal toxiciry study, rats treated with folpet at dose levels as low as 1 mg/kg developed '
treatment-related skin damage which consisted of acanthosis and exudate; the higher doses produced
skin ulcers (MRID 40750802). In both the oral and dermal studies, rats showed Idose related
decrease in body weight gain. The local irritating effect to mucus membranes may be responsible in
part, for secondary toxic effects such as decreased body weight gain in adult animals.
The Agency has reviewed the available developmental toxicity data for folpet (MRIDs
00132456; 00132457; 00160432; 00156636; 00151490). Folpet was tested in one strain of rat and two
separate strains of rabbits. Folpet caused an increase in the incidence of hydrocephaly in fetuses with
associated domed skull and irregularly-shaped fontanelles in New Zealand White rabbits in the
presence of maternal toxicity. Both fetal and litter incidences of this malformation were increased
There was also evidence of fetal effects (delayed ossification of the stemebrae) in HY/CR rabbits at a
ower dose than that causing maternal toxicity. Delayed ossification is not considered a permanent or
hfe-threatemng adverse effect. There is no indication of increased sensitivity in a prenatal
developmental toxicity study in rats Mowing in utero exposure or in either of the two-generation
reproduction studies in rats (MRIDs 00151489; 40051401; 40135901).
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!!•• t
Folpet is classified as a Group B2, probable human, carcinogen based on the increased
incidences of adenomas and carcinomas in the duodenum of male and female mice in two strains (CD-I
andB6C3Fl; MRIDs 00125718 and 00151075). The cancer potency value, or Q,*, is 1.86 x 10'3
(mg/kg/day)'1. The increase in the incidence of duodenal adenocarcinqmas in the CD-I mouse study
Occlr:ifd SiT«?^ely his*1 dose,s- A similar response was observed in a 2-year feeding study with
^^^1 m*ce; J^16 ki§kfy reac^ve thiophosgp116 is most likely the metabolite responsible for duodenal
tumor formation in mice. In rats, folpet was classified as a carcinogen in males only based on an
increase in the incidences of C-cell adenomas and carcinomas of the thyroid as well as interstitial cell
tumors of the testes (MRIDs 00151560,00157493,40682501, and 43640201). There was no evidence of
duodenal tumors in the rat; however, there was a dose related increase in incidence and severity of
hyperkeratosis of the esophagus and stomach which may be due to thiophosgene.
„,; ' Li'"!:?",,'1 *" "i"'1 Ki » • ",' ''"':,'''"' ' ,,i. " , ' '! " ,/ ," • ', ,,n
The Agency has conducted a preliminary review of mechanistic studies on folpet (MRIDs '
44286302,44286303, and 44316502). Both folpet and captan appear to exert toxicity via the
reaction of thiophosgene with the gastrointestinal tract. A more thorough review has been conducted
on ^ m^^a^?tic stlldies submitted for the related fungicide, captan. For captan, the Agency has
concluded that thiophosgene is most likely implicated in the duodenal tumors, although its exact mode
of action is unclear and a genotoxic component cannot be ruled out.
Folpet induces a wide range of genotoxic events in vitro including gene mutations/DNA
damage in bacteria and mammalian cells, chromosomal aberrations in mammalian cells and mitotic
recombination in yeast. Although folpet was active in both the presence and absence of S9 activation,
the response was generally more pronounced without S9 activation (MRIDs 00148625; 00132582;
00143567; 00149489; 00149567; 00160445; 42122014; 00153085; 00162394; 00160435).
An oral metabolism study was conducted in Sprague Dawley rats. Folpet was readily and
extensively absorbed and rapidly excreted in the urine. There was no accumulation of folpet detected
during the 5 days after dosing. The major fecal metabolite was phthalamic acid (MRIDs 42122017 and
42122016)^
In a comparative metabolic fate and biochemical effects study, both rats and mice each
received a single oral gavage dose of 14C-labeled folpet (MRID 42122016). Two hours after dosing,
the majority of the radioactivity in the contents of the gastrointestinal tract at the high dose was in the
stomach as unchanged folpet. No breakdown of the compound by cleavage of the trichloromethylthio
side chain (where the I4"C label was positioned) was apparent in either the rat or mouse. The contents
of sections of the intestinal tract contained primarily reaction products of thiophosgene. Unchanged
folpet was present in the cecum of mice, but not rats, at the highest dose indicating that this dose was
close to the animal's maximum capacity to degrade folpet. The pulse dose passed through the
gastrointestinal tract of the mouse more rapidly than did the dose in rats. The metabolites identified in
the contents of the intestine and in the walls were glutathione conjugates of thiophosgene, partially
degraded derivatives of the conjugate, thiazolidine and a disulfonic acid. Radioactivity was rapidly
excreted by all routes with most of the dose of 14C eliminated within 24 hours.
10
ii.
.£;:•.
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A dermal absorption study in rats indicates folpet is minimally absorbed. An absorption of
2.7% over 72 hours exposure was determined for folpet. Repeated dermal application of folpet caused
hyperkeratosis, acanthosis, exudates and ulcers; however, the systemic effects were limited to reduced
body weight gain in males and females, which indicates that folpet is not absorbed through the skin in
significant amounts. There were no sex related differences in the severity of effects observed (MRID
42122018).
b. Hazard Profile for Folpet Metabolites and Degradates
The following environmental degradates of folpet have been detected: phthalic acid (PAT),
phthalimide (PI), and phthalamic acid (PAM). Phthalimide and pthalic acid are also animal and plant '
metabolites. In addition, a fish bioconcentration study shows that the phthalic anhydride accumulates
and concentrates in fish (MRID 42122029). No human health toxicology data are available for these
degradates or metabolites. However, the Agency has determined that none of these environmental
degradates or metabolites are expected to be of human toxicological concern.
c. Acute Toxicity of Folpet
The acute toxicology database on folpet is adequate and will support the reregistration eligibility
decision. Table 2 summarizes the acute toxicity values and categories for folpet technical.
Table 2. Acute Toxicity of Folpet
Test
Oral LD 50 -Rat
Dermal LD 50 - Rabbit
Inhalation LC50 - Rat
Eye Irritation - Rabbit
Dermal Irritation - Rabbit
Dermal Sensitization -
Guinea Pig
Results
43.8 g/kg(M); 19.5 g/kg(F)
>5.0g/kg
0.34mg/L(M); 1 .OOmg/L(F);0.48mg/L(M+F)
intermediate irritation
no irritation
sensitizing
Toxicity
rv
rv
II
II
IV
- N/A
MRID
00144057
00141728
40592301
00160444
00160430
00160431
d. FQPA Considerations for Folpet
The Food Quality Protection Act of 1996 (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 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
11
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comPleteness of to6 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
sa&ty.for S16 Pesticide resJdue opty if> °" the basis of reliable data, such a margin will be safe for infants
and children."
Ip determining whether an FQPA 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 databases, the nature and severity of the effects observed in pre- and post-natal studies in
two species, and other information, such as epidemiological data. Based on these considerations the
Agency concluded that the FQPA safety factor for folpet should be reduced to 3X. Although there
was no evidence of increased susceptibility in rat developmental and reproduction studies nor in the
devel°Pmental study with % HY7CR rabbit strain, the Agency recommenced a 3X safety factory
because increased susceptibility was observed in the developmental study with the New Zealand strain
of rabblts- The FQPA safety factor is to be applied to the population subgroup of females 13-50 for
those scenarios in which the appropriate endpoint for risk assessment is developmental toxicity.
•' . .1 - *" . ••., • -;.. < • • , - •*'• ','•*" .•, '" i,.:'1 . "• ••-,'••
To address the apparent increased susceptibUity in the rabbit, the Agency is requiring that a
developmental toxicity study be conducted in New Zealand white rabbits, with dosing of test animals on
^y8 6 flwajgh 18, the major organogenesis period for the rabbit. In the existing studies the
researchers failed to dose the animals in a manner adequate to cover the major organogenesis period of
the rabbit.
As mentioned above, the Agency also considers the completeness and adequacy of the
exposure database for a chemical when determining whether an FQPA uncertainty factor should be
applied. For folpet, the dietary exposure assessments are partially refined using anticipated residue
data^and percent crop treated information which results in more realistic estimates of dietary exposure
Modeling data are used for the ground and surface source drinking water exposure assessments for '
folpet, resulting in estimates considered to be reasonable but conservative upper-bound concentrations
When potential for residential exposure to infants and children exists during application of products
containing folpet; conservative methods are used for exposure assessment. Postapplication residential
exposure to folpet is not expected. Therefore, the exposure assessments for folpet do not indicate a
greater concern for potential risk to infants and children than for other population groups.
HP ,,,',' »• • • "
The FQPA Safety Factor will be applied to acute dietary risk assessments for females age 13-
50 years only because the endpoint of concern is developmental malformations (hydrocephaly) An
appropriate endpoint attributable to a single dose was not identified for the general population, including
mfants^and children. The FQPA Safety Factor will not be applied for chronic dietary risk assessment
since the chronic lexicological endpoint is based on non-developmental effects (hyper-
keratosis/acanthosis and ulceration/erosion of the non-glandular stomach) observed in a long-term
study. The FQPA Safely Factor will be applied to residential risk assessments since there is potential
•"'• r " ' 12
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for exposure to females age 13-50 years based on the use pattern (indoor and outdoor paints stains
and wood treatment products).
e.
Endpoint Selection for Risk Assessment
The Agency has evaluated the toxicological database for folpet and selected toxicological
endpoints that are appropriate for acute and chronic dietary, as well as occupational and residential
(dermal and inhalation) risk assessments. In the process of selecting toxicological endpoints for risk
assessment, the Agency has also evaluated the use pattern and exposure profile for folpet The risk
assessment endpoints for folpet are summarized in Table 3 below.
Once fee appropriate toxicological endpoints are selected for risk assessment, the uncertainty
associated wrthlhe study results and the endpoints selected is determined. The No Observed Adverse
Effect Levels (NOAELs), Lowest Observed Adverse Effect Levels (LOAELs), and Uncertainty
Factors are used to establish the "allowable" acute and chronic exposures to a pesticide. The Agency
refers to this allowable" exposure as the reference dose (RfD) or, when an FQPA safety factor is
used Population Adjusted Dose (PAD). These established doses are set as the target dietary exposure
that should not ordinarily be exceeded. The percentages of acute and chronic RfD or PAD are the
used as a measure of risk. A dose resulting in less than 100% of the RfD or PAD is usually not of
concern. For occupational and residential exposure, a dose resulting in a Margin of Exposure (MOE)
less than the uncertainty factor is of concern. For example, an MOE of 150 would be of concern if the
uncertainty factor is 300 but would not be of concern if the uncertainty factor is 100
13
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Table 3. Doses and Endpoints Selected for Folpet Human Health Risk Assessments
Exposure
Scenario
Acute Dietary
Female 13-50
years only
Dose
(mg/kg/day)
Endpoint
Study
Acute PAD=0.03; Acute RfD = 0.1 mg/kg/day
NOAEL=10
UF= 100, with
3xforFQPA
Increased number of fetuses and litters with
hydrocephaly and related skull malformations
at 20 mg/kg
Developmental Toxicity
Study in Rabbits
Chronic PAD = Chronic RfD = 0.09 mg/kg/day
Chronic Dietary
US Population
Carcinogcnicity
(Dietary)
Short- and
Intermediate
Term
(Dermal)
Short - and
Intermediate-
Term
(Inhalation)
Long-Term
(Detmal)
Long-Term
(Inhalation)
NOAEL=9
UF=100
N/A
Oral
NOAEL=10
UF= 100 with
3xforFQPA
Oral
NOAEL=10
UF= 100 with
SxforFQPA
Oral
NOAEL = 9
UF=100
Hyperkeratosis/acanthosis and
ulceration/erosion of non glandular stomach
epithelium in both sexes at 35 mg/kg
Q,*= 1.86 x 10'3 (mg/kg/day)-1 based on
incidence of duodenal tumors
Increased number of fetuses and litters with
hydrocephaly and related skull malformations
at 20 mg/kg
Increased number of fetuses and litters with
hydrocephaly and related skull malformations
at 20 mg/kg
Hyperkeratosis/acanthosis and
ulceration/erosion of non glandular stomach
epithelium in both sexes at 35mg/kg
Chronic Toxicity in Rats
Chronic/Carcinogenicity
Study in Mice
Developmental Toxicity
Study in Rabbits
Developmental Toxicity
Study in Rabbits
Chronic Toxicity in
Rats
The use pattern and exposure scenario does not indicate a need for long term risk assessment
except for the paint manufacturing scenario, which uses oral NOAEL of 9 mg/kg/day from
chronic rat study
UF, uncertainty factor, lOx for intraspecies variability, lOx for interspecies extrapolation; 3x FQPA safety factor is
applied only to females 13-50. Acute PAD applies only to females 13-50 because developmental toxicity is the only
acute effect of concern for folpet.
Correction for dermal route necessary (2.7% dermal absorption factor)
A factor of 100% is used to convert inhalation exposures to oral equivalent doses.
i. Acute Dietary
The Agency is using the NOAEL of 10 mg/kg/day from the oral developmental toxicity study
with New Zealand rabbits for evaluating the acute dietary risk. The following uncertainty factors are
applied to acute endpoints for risk assessment: interspecies variability (10X) and intraspecies variability
(10X). Accordingly, the acute dietary Reference Dose RfD for folpet is 0.1 mg/kg/day. The Acute
Population Adjusted Dose (PAD) for folpet is 0.03 to include the FQPA Safety Factor. This Acute
PAD applies only to females age 13-50 because developmental toxicity is the only acute effect of
concern for folpet as described in the study below.
14
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Folpet (88.6%) was administered by gavage to NeW Zealand White rabbits (20 females/group)
at doses of 0, 10,20 or 60 mg/kg/day during gestations days 6 through 28 (MRID 00160432). there
was little or no effect of treatment on body weight gain at various intervals throughout gestation. Food
consumption was below the control values during the latter portion of the study in the 20 and 60
mg/kg/day groups. One fetus from the 20 mg/kg/day dose and three fetuses from two litters of the 60
mg/kg/day had "domed head," which was considered to have been treatment related and correlated
with the incidence of hydrocephalus. The historical control fetal and litter incidences of this external
malformation were reported to be 5/2,160 (0.2%) and 5/285 (1.8%), respectively. The percent values
in the current study were 4.1 for fetuses and 16.7 for litters at 60 mg/kg/day. Soft tissue examination
revealed that one fetus from the 20 mg/kg/day dose group and 4 fetuses from the 60 mg/kg/day dose
group had hydrocephalus (20 mg/kg/day, one fetus also had a cleft palate). Historical control fetal and
litter data for hydrocephalus were 3/2,160 (0.1%) and 3/285 (1.0%), respectively. The percent values
in the current study were 5.5 for fetuses and 25.0 for litters. Enlarged or irregularly-shaped fontanelles
were present in all hydrocephalic fetuses. The maternal NOAEL was 10 mg/kg/day. The maternal
LOAEL was 20 mg/kg/day based on a decrease in food consumption. The developmental NOAEL
was 10 mg/kg/day. The developmental LOAEL was 20 mg/kg/day based on a dose-related increase
in hydrocephalus and related skull malformations (MRID 00160432, also see 00151490). Similar
effects were seen in another developmental toxicity study in New Zealand White rabbits. However a
NOAEL/LOAEL could not be established in this second study because only a single dose (60
mg/kg/day) was tested (MRID 00151490).
ii. Chronic Dietary
The Agency is using the NOAEL of 9 mg/kg/day from a two-year feeding study in rats for
assessing the chronic noncancer dietary risk. The following uncertainty factors are applied to the
chronic endpoint for risk assessment: interspecies variability (10X) and intraspecies variability (10X)
Accordingly, the chronic dietary Reference Dose is 0.09 mg/kg/day. The FQPA Safety Factor applied
to females 13-50 years for the acute dietary risk assessment is not applied for the chronic dietary risk
assessment because the FQPA factor is based on developmental effects which are presumed to occur
from a single dose and are not relevant to the chronic endpoint described below.
Folpet (89.5%) was administered by dietary admix to Sprague Dawley rats (60/sex/group with
10/sex/group sacrificed after 52 weeks) at doses of 0,200, 800 or 3,200 ppm (approximately 0 9 35
or 145 mg/kg/day for males and 0, 11,45 and 180 mg/kg/day for females) for up to 104 weeks '
There were no effects on survival, body weights/gains, food consumption, hematology parameters
climcal chemistry values, urinalysis parameters or ophthalmic findings. Various non-neoplastic
parameters had higher incidences in treated animals than in controls (out of 60/sex/group, 0,200 800
and 3,200 ppm). These effects included hyperkeratosis/acanthosis, submucosal edema and
submucosal inflammation of the stomach; ulceration/erosion of non-glandular stomach; spongiosis
hepatis; focal hepatic necrosis; and ovarian medullary tubule hyperplasia. Neoplastic incidences
included: thyroid C-cell hyperplasia, thyroid C-cell adenoma, C-cell carcinoma, combined thyroid C-
15
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cell adenomas and carcinomas, testicular interstitial cell hyperplasia, and testicular interstitial cell tumor.
For cbroaictpxicity, the NOAEL was 200 ppm (9 mg/kg/day) and the LOAEL was 800 ppm (35
rog/kg'day) based on hyperkeratosis/acanthosis and ulceration/erosion of the non-glandular stomach in
niales and females (MRID 00151560).
Ifa Agency evaluated the carcinogenicity studies in rats and mice to determine the carcinogenic
P°tential of foip?1- A carcinogenicity study in CD-I mice showed a statistically significant, dose-related
increase in the incidence of duodenal adenocarcinomas with an increase of about 50% at the highest
dose tested (1429 mg/kg/day) that was not observed in any controls (MRID 00125718). A similar
response was observed in a 2-year feeding study with B6C3F1 mice in which animals were exposed to
UP to 1000 mg/kg/day; the incidence was about 50% at this dose and was not observed in controls
(M1^ P°151075). The Agency has concluded that folpet is carcinogenic in rats and mice and has
classified it as a Group B2, probable human carcinogen, based on the increased incidences of
duod;eni adenoma? ^
-------
respective controls (74-100% compared with 0% for controls and 10-25% at 1,000 ppm). The
highest dose tested (7,000 ppm) in this study was considered adequate to assess the carcinogenic
potential in mice. The chronic toxicity NOAEL was not established because effects were noted at
1,000 ppm, the lowest dose tested. The chronic toxicity LOAEL was 1,000 ppm (107 and 118
mg/kg/day for males and females, respectively) based on increased incidences of hyperplasia of the
duodenum and hyperkeratosis of the esophagus and stomach (MRID 00151075).
Folpet (89.5%) was administered by dietary admix to Sprague Dawley rats (60/sex/group with
10/sex/group sacrificed after 52 weeks) at doses of 0, 200, 800 or 3,200 ppm (approximately 0 9 35
or 145 mg/kg/day for males and 0, 11,45 and 180 mg/kg/day for females) for up to 104 weeks.'
There were no effects on survival, body weights/gains, food consumption, hematology parameters,
clinical chemistry values, urinalysis parameters or ophthalmic findings. For chronic toxicity, the
NOAEL was 200 ppm (9 mg/kg/day) and the LOAEL was 800 ppm (35 mg/kg/day) based on
hyperkeratosis/acanthosis and ulceration/erosion of the non-glandular stomach in males and females.
Folpet was classified as a carcinogen in males only based on an increase in the incidences of C-cell
adenomas and carcinomas of the thyroid as well as interstitial cell tumors of the testes The highest
dose tested in this study (3,200 ppm) was considered adequate to assess the carcinogenic potential of
Folpet in rats (MRID 00151560). •
In another chronic toxicity study in Fischer 344 rats (20/sex/dose), Folpet (91.1%) was
administered by dietary admix at doses of 0, 250, 1,500 or 5,000 ppm (equal to 0 12 81 or 291
mg/kg/day in males and 0, 15, 100 or 351 mg/kg/day in females) for 24 months. There was no
evidence of carcinogenicity in this study. The following parameters were effected: a decrease in body
weight gain for both sexes at 5,000 ppm; a decrease in food consumption for both sexes at 5 000 ppm-
a decrease in water consumption at 5,000 ppm (10-20% throughout the study) especially during week'
one (30%) for both sexes; esophageal effects (increase in the incidence and severity of diffuse
hyperkeratosis) in both sexes at 5,000 ppm; and an increase in the incidence and severity of diffuse
hyperkeratosis of the nonglandular epithelium of the stomach of both sexes at 1 500 and 5 000 ppm
For chronic toxicity the NOAEL was 250 ppm (12 and 15 mg/kg/day, males and females'
respectively), and the LOAEL was 1,500 ppm (81 and 100 mg/kg/day, males and females
respectively) based on an increase in incidence and severity of hyperkeratosis of the esophagus and
nonglandular epithelium of the stomach (MRID 43640201).
In a carcinogenicity study in Fischer 344 rats (60/sex/group), Folpet (89.5-91 1%) was
administered as a dietary admix at doses of 0, 500, 1,000 or 2,000 ppm (approximately 0 25 50 or
100 mg/kg/day) for 24 months. The Agency concluded that 2,000 ppm caused an increase' over control
values in thyroid C-cell adenomas and mammary benign fibroepithelial tumors in females only The
highest dose tested (2,000 ppm) in this study was considered adequate to assess the carcinogenic
potential in rats. For chronic toxicity the NOAEL was 500 ppm (25 mg/kg/day) and the LOAEL was
1,000 ppm (50 mg/kg/day) based on an increased incidence of hyperkeratosis of the nonglandular
mucosa of the stomach in both sexes (at 2,000 ppm or 100 mg/kg/day, there was an increase in the
17
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incidence of hyperkeratosis in the esophagus of males and females as well as basophilic cell type foci in
the liver of males only at these doses) (MRID 00157493,40682501).
iii. Route to Route Extrapolation
To evaluate dermal risks, a dermal absorption factor of 2.7% is used to convert dermal
exposures to oral equivalent doses, which are then compared with a NOAEL from an oral study. A
factor of 100% is used to convert inhalation exposures to oral equivalent doses.
iv. Short and Intermediate Term Dermal
The Agency is also using the NOAEL from the New Zealand White rabbit study to serve as the
basis for evaluation of short and intermediate term occupational and residential risks. This study
showed a NOAEL of 10 mg/kg based on the increased in number of fetuses and litters with
hydrocephalus with associated skull malformations (irregular shaped interparietal fontanelles and domed
head) at the developmental LOAEL of 20 mg/kg/day. The Agency selected the oral NOAEL because
of the lack of an appropriate dermal toxicity study. In a dermal toxicity study (MRE) 40750802), rats
were dermally treated with folpet at 0,1, 10 and 30 mg/kg for a total of 21 applications over a 4-week
period. All folpet treated rats developed pronounced dermal irritation in a dose-related manner.
Systemic toxicity was defined as decreased body weight gain in male and female rats in rats given 10
and 30 mg/kg, but the critical effect could not be unequivocally separated from a response to severe
skin damage.
v. Long Term Dermal
i . • ' " • ' '.' '.'• ' 'f:i:!'!' ', ' '' . " :
The use pattern and exposure scenario do not indicate a need for long-term risk assessment
except for the paint manufacturing scenario. Folpet is only used in a small fraction of paints and stains.
The Agency is using a NOAEL of 9 mg/kg/day from a chronic dietary study in rats for risk assessment
for long-term dermal exposures. The chronic rat study is the same study used to establish the chronic
RfDandis described in section ii, Chronic Dietary (MRID 00151560),
vi. Short and Intermediate Term Inhalation
The Agency is using the 10 mg/kg/day NOAEL from the New Zealand rabbit oral
developmental toxicity study to serve as the basis for evaluation of short and intermediate term
occupational and residential inhalation risks (MRID 00160432). As mentioned previously, a factor of
100% is used to convert inhalation exposures to oral equivalent doses.
vii. Long Term Inhalation
The use pattern and exposure scenario do not indicate a need for long term risk assessment
18
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except for the paint manufacturing scenario. The Agency is using the oral NOAEL of 9 mg/kg/day
from the chronic rat study for this single long term inhalation risk assessment (MRID 00151560).
f. 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 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 with implementation of this program, further testing of folpet and end-use
products for endocrine effects may be required.
2. Exposure Assessment
a. Summary of Registered Uses
Folpet formulated as a wettable powder (Folpet 50 WP) is applied to avocados with airblast
sprayers. Single application rates for avocados vary from 1.5 to 3.0 pounds active ingredient per acre
(Ib ai/A) or 3 to 6 Ibs formulated product (50% ai). Folpet application to avocados begins at bud swell
and continues through late bloom. Folpet can be applied up to seven times a season at 2-week
retreatment intervals with a seasonal maximum of 21 Ib ai/A or 42 Ibs formulated product A 7-month
preharvest interval (PHI) is specified along with a 24-hour restricted-entry interval (REI).
Folpet, formulated as a solid powder, is added to paint, stains, and caulking compounds in
manufacturing settings using a variety of techniques, such as open pouring and pump-metering Folpet-
contaming paint is subsequently applied with handheld painting equipment (e.g., paint brush, roUer
compressed-air sprayer, or airless sprayer).
Folpet, formulated as a ready-to-use house/deck stain, is applied with handheld painting
equipment (e.g., paint brush, roller, compressed air sprayer, or airless sprayer). At this time products
containing folpet are available for use both occupationaUy and by Hie homeowner.
b. Dietary Exposure (Food Sources)
As mentioned previously, folpet is registered in the U.S. for use on Florida avocados Folpet
also has a number of tolerances to allow apples, cranberries, cucumbers, grapes, lettuce melons
onions, strawberries, and tomatoes which have been treated with folpet outside the US to be imported.
19
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In addition, a new tolerance will be established for imported raisins because folpet residues concentrate
in raisins. These commodities must therefore also be considered in the evaluation of dietary exposure in
the US. The dietary exposure analysis for folpet considers folpet residues in/on the following
commodities and dietary consumption of avocados, apples, cranberries, cucumbers, grapes, lettuce,
melons, onions, raisins, strawberries, and tomatoes.
Results of the residue chemistry data for folpet are summarized below. The residue chemistry
database for folpet is substantially complete, and the data are adequate to assess dietary exposure and
reassess tolerances. However, additional storage stability data are required to confirm the Agency's
analysis. Once these data are received, the Agency will re-evaluate the affected tolerances.
i. Residue Chemistry Data
Nature of the Residue
Plants. The qualitative nature of the residue of folpet in plants is adequately understood based
upon acceptable avocado, grape, and wheat metabolism studies. The Agency has concluded that the
residue of concern in plants is folpet per se. The metabolites phthalimide and phthalic acid are not of
toxicological concern and will not be regulated.
Animals. For purposes of reregistration, ruminant and poultry metabolism studies are not
required because there are no animal feed items associated with avocados, which is the only food/feed
1156 currendy being supported in the U.S. A ruminant oral metabolism study was submitted to support
the import tolerance on apples. A ruminant feeding study is still required to determine the magnitude of
the residue in livestock receiving folpet residues in feed (apple pomace) and to determine if meat/milk
tolerances are necessary. Also, an analytical method will be required for any residues of concern that
are identified in the ruminant feeding study. Wet apple pomace may be used as an animal feed in
countries which export livestock commodities into the U.S. and where folpet is used on apples.
':,, .
-------
radiolabeled carbon becomes incorporated into thiazolidine and natural products. The remaining phenyl
labeled part of the molecule is mostly metabolized to phthalimide and phthalamic acid.
Magnitude of the Residue
Plants. The registrant conducted a single residue study in Dade County, Florida, which is
representative of avocado growing regions in Florida. Five foliar applications of folpet (50 WP) at 3 Ib
ai/acre/apphcation were applied to avocados. Following the final application, triplicate samples of
avocados were collected at 1, 3, 7, 14, and 28 days post treatment. Folpet residues at day 1 were
0.101 - 0.183 ppm and declined to <0.05 - 0.066 ppm by day 28. The maximum folpet residue (0 356
ppm) was found in the day 3 sample.
Adequate crop field trial data have been submitted in support of import tolerances for onions
cranberries, grapes, lettuce, strawberries, apples, and tomatoes. Additional storage stability data are'
required to supporfimport tolerances for melons and cucumbers.
Animals. No animal feed items are currently associated with avocados, the only use of folpet
registered in the U.S. However, livestock feeding studies are required as a result of the import
tolerance on apples. The livestock metabolism study is summarized above; a feeding study is still
required. No metabolites of concern were identified in the ruminant metabolism study.
• Processed food/feed. Registration requirements for magnitude of the residue in processed
food/feed commodities are fulfilled as there are no processed commodities associated with avocados
Adequate processing data have been submitted to support import tolerances on apples, grapes and '
tomatoes. Although concentration of folpet residues was observed in wet apple pomace, a tolerance is
not required because it is unlikely that apples imported into the U.S. will be processed and wet apple
pomace is not imported into the U.S.
Storage Stability Data. Requirements for storage stability data are outstanding Results of
previously submitted storage stability data on residues of folpet in avocados have been variable
Analyses of fortified avocados stored at -10° C showed an initial decline in folpet residues after 14
days, however, folpet residues appeared stable after 60 days of storage. The registrant must conduct a
14- day refrigeration storage stability study to support the residue values in the field trial study These
data are confirmatory.
Sufficient storage stability information has been submitted to support the import tolerances on
onions, cranberries, apples, grapes, lettuce, and tomatoes. Additional storage stability data are
required for melons and cucumbers.
Residue Analytical Method and Multiresidue Method: An adequate GC analytical
method is available for enforcing tolerances of folpet in/on plant commodities and is listed as Method I
21
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method is for the analysis of captan, folpet, and difolatan in plants. However the
enforcement methodologies described in PAM, VoL H for folpet (Methods Ha, lib, and A) are based
on colonmetricdetection of folpet residues, and are no longer considered suitable for tolerance
enforcement.
Two new enforcement GC/ECD methods, one for oily crops (Method 568W-1) and the other
for non-oily crops (Method FP/15/91), have undergone successful method validation by the Agency
"^g avo™*os, lettuce, onions, and tomatoes. These methods are available for enforcement purposes
P16 a(k
-------
estimate the anticipated residue contribution for the general U.S. population and 22 subgroups
Exposure was then compared to the chronic RfD.
The results of the chronic (non-cancer) analysis indicate that the chronic (non-cancer) dietary
nsk estimates associated with the folpet uses supported through ^registration are below the HED's
level of concern (<100% RfD) for the U.S. Population.. These results are presented in Table 5.
Fable S. Chronic (Non-Cancert Dietary Exposure Results for Folpet ( Chronic RfD = Q.Q9 mg/kg/davl
Subgroups
U.S. Population (48 states)
""^^•"^^^^^™^^^^™^»
Children (1-6 yrs)
———^—^——__
Children (7-12 yrs)
—•—•—^—
Females (13-50 nursing)
Chronic (Non-Cancer) Exposure (average field trial residue)
<1 % (0.000053 mg/kg body wt/day)
<1% (0.00008 Img/kg body wt/day)
<1 % (0.000071 mg/kg body wt/day)
^^^^^^"^^"^^"^^^^^""^^"•^^^•^^•^^^^""^•^•^•^••••M
<1 % (0.000084 mg/kg body wt/day)
iv. Dietary Cancer Risk Assessment
Based on a Q,* of0.00186(mg/kg/day)-', the upper bound cancer risk was calculated to be 1 2
x 10 , contributed by all the published uses of folpet at tolerance levels. Incorporating processing factors
from submitted studies and percent crop treated data with average field trail residues, risk was calculated
to be 9.8 x 10 .The upper bound cancer risk is less than the Agency's level of concern of 1 x 10'6 for
dietary cancer nsk. However, if new uses are added in the future, the carcinogenic dietary risk from folpet
treated commodities will require revaluation.
v.
Dietary Exposure (Drinking Water Source)
^^^Agencybegir^toconductadrirJdngwateramlysis^TierlscreeningmodelorTiern
refined screening model is used to provide conservative estimates of concentrations of pesticides in surface
or ground water. These model estimates are then compared against "DWLOC"
(Drinking Water Level Of Concentration Level) values.
ADW^OCismeconcenrrationofapesncideindii^^
in light of total aggregate exposure to the pesticide in food, water, and through home uses A DWLOC
wiUvary depending ontiie toxic endpoint, and with drinking water consumption patterns and body weights
Different subpopulations will have different DWLOCs. wcigms.
The: Agency uses the DWLOC values as a surrogate measure of risk. Because current screening
models for dnnkmg water are very conservative, the Agency does not use concentration estimates from
these models to quantify nsk as %Rffl, %PAD, or MOE. The Agency will instead compare these modd
estates to DWLOC values. If the model estimate is less than the DWLOC, there is no driZg wate
23
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nil!;, i;.'
it";! iva,;1 jr..
concern. If model estimates are greater than the DWLOC, refined estimates of drinking water
concentrations are needed. The Agency tries to use any available ground and surface water monitoring
data. This comparison provides a semi-quantitative risk assessment for drinking water until monitoring data
can be obtained.
The potential for folpet contamination of ground and surface water is expected to be minimal.
Folpet use is currently limited to two counties in Florida and additionally folpet degrades rapidly in the
aquatic envkonment No ground or surface water monitoring data are available, so models were used to
predict environmental concentrations of folpet. The SCI-GROW model predicts that groundwater is not
likely to exceed 0.06 ppb (ng/L). The Generic Expected Environmental Concentration (GENEEC) model
predicts that surface water concentrations resulting from use on avocados will range from 156 ppb at peak
exposure to 2 - 3 ppb at 56 days (Table 26). Currently, Agency drinking water SOPs divide this 56 day
number by a factor of 3 prior to comparison with the DWLOCchronic and DWLOC^,.. The GENEEC
model estimated maximum concentration is compared directly to the DWLOCacute.
vi. DWLOCs for Acute Exposure
i!1 "'.' .'• " !' ""' , "; ''•"" . :" ,, ' '";!!!'i :, ' ' ' '
-Acute DWLOCs for folpet were calculated based on the acute dietary (food) exposure and default
body weights and water consumption figures. The Agency's default body weights and water consumption
values used to calculate DWLOCs are as follows: 70kg/2L (adult male), 60 kg/2L (adult female), and 10
kg/L (child). To calculate the acute DWLOC, the acute dietary food exposure was subtracted from the
acute PAD using the following equation:
DWLOC,,
Where
f acute water exposure fmg/kg/dav^ x body weight ( kell
[consumption (L) x 10'3
acute water exposure (mg/kg/day) = [acute PAD (mg/kg/day) - acute food
(mg/kg/day)].
As shown in Table 6, the drinking water estimated concentrations in ground water (0.06 /j.gfL or
ppb) and surface water (159 Mg/L or ppb) are below the Agency's DWLOCacute (673 Mg/L or ppb) for
folpet for females 13-50. The Agency concludes that based on the available information, modeled residues
in drinking water do not indicate an unacceptable contribution to acute dietary exposure at this time.
Table 6. Drinking Water Levels of Comparison for Acute Dietary Exposure
Population
Subgroup
Females 13-50
Food Exposure
(mg/kg/day)
0.007578
Water Exposure
(mg/kg/day)
0.022422
DWLOCmcule
0*g/L)
673
GENEEC
Gtg/L)
159
SCI-GROW
(*«g/L)
0.06
The acute PAD is 0.03 mg/kg/day.
24
i,,iii , Hi MI,!,,, 'lilnlliiiJI!,,..
-------
vii. DWLOCs for Chronic (Non-Cancer) Exposure
Chronic drinking water levels of comparison (DWLOCs) were calculated based on the chronic
6XPOSUre ^ ^^ b°dy WdghtS ^ Water consu«iption figures. To calculate the
chronic, the chronic dietary food exposure was subtracted from the chronic PAD using the formula
given above for the acute DWLOC, substituting the chronic PAD for the acute PAD.
DWLOCchronic
[chronic water exposure (me/ke/dw) x Cbod
[consumption (L) x 10'3 mg/^g]
where chronic water exposure (mg/kg/day) = [chronic PAD - (chronic food (mg/kg/day)]
As shown in Table 7, the drinking water estimated concentrations in ground water (0.06Me/L) and
surface water (3 ^) are all below the Agency' s DWLOCchronic for folpet for all population subgroups
Based on the available information, residues of folpet in drinking water do not result in an unacceptable
contribution to chronic dietary exposure at this time.
Table?. Drir
Population
Subgroup
US
Population
Children 1-6
(Highest
Exposure)
king Water Levels of Comparison for Chronic Dietarv Kmmnn.
Food Exposure
(mg/kg/day)
0.00005
0.00008
Max. Water Exposure
(mg/kg/day)
0.08995
0.08992
DWLOC^
fcg/L)
3148
899
GENEEC
0*g/L)
1
1
SCI-GROW
G*g/L)
0.06
0.06
viii. DWLOCs for Chronic (Cancer) Endpoint
CancerDWLOCswerecalculatedbaSedonthecancerdietary(food)exPoSureanddefaultbody
weight and water consumption figures as follows:
DWLOC.
DWLOCc
[IxlO-6-
Q,* (mg/kg/day)-1
L.anceJx 70kg/2L x
1.86 xlO-3 (mg/kg/day)-1
x 70kg/2L x 103ug/mg = l?Ug/L or ppb
1 PP
i^evoconi^^
number values generated for chronic scenarios for both ground and surface water (0 06 and 1 ppb
respectively.) Based on the conservative nature of available information, modeled residues in drinking
water do not indicate an unacceptable contribution to dietary cancer risk at this time
25
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c.
Occupational Exposure
There is a potential for both agricultural and industrial workers to be exposed to folpet. Agricultural
workers may be exposed to folpet from application and postapplication activities associated with use of
folpet on avocados in Florida. Industrial workers may be exposed from addition of folpet to paints, stains,
and other products during manufacturing. Occupational exposure may also occur during application of
folpet-containing paints and sprays. Exposure duration is unlikely to exceed several months for any of the
occupational scenarios except to workers adding folpet to paints as an in-can preservative.
Occupational exposure to folpet residues via dermal and inhalation routes can occur during
handling, mixing, loading, and applying as well as during postapplication activities such as harvesting
avocados. The Agency identified seven handler scenarios for folpet that warranted assessment.
. _ Postapplication exposure to folpet is limited to the avocado use. Postapplication exposures from
painting/staining uses in occupational and/or residential settings are expected to be minimal because (1)
folpet was not detected in a chemical-specific post application exposure monitoring study and (2) folpet
has ane*fmelylow vaporpressure ofLfixlQ-7 mmHgat25°C. Therefore, the Agency did not conduct
a PostaPPhcation exposure assessment for painting or staining exposure scenarios.
- ""'" , ' !' ' ' ! . ' "' "j. ; "'''" if ' ' '!". ' ' '. '
i. Occupational Handler Exposure Scenarios
§Sen handler scenarios were identified for folpet use including: (Scenario 1) adding powder to
paint during the manufacturing process, (Scenario 2) loading wettable powder for airblast applications to
avocados, (Scenario 3) applying sprays using an airblast sprayer to avocados, (Scenario 4) applying
folpet-containing paint with a paint brush, (Scenario 5) applying folpet-containing house stain using an
airless sprayer, (Scenario 6) applying folpet-containing paint with a paint roller, and (Scenario 7) applying
a ^y-tc?;use fQnTlulation ^ an pn-site wood dip treatment. No data are available to assess Scenarios
6 and 7. Data for the other painting scenarios are sufficient surrogates to estimate worst case exposure
for the Paint roller scenario (Scenario 6) and the on-site wood dip treatment (Scenario 7).
7116:36 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 on the frequency of exposure. Application of folpet-containing paints and stains is
not considered to be long-term exposure because only a small fraction of paints and stains contain folpet.
Long-term exposure (greater than 6 months duration) is only expected for the addition of folpet to paints
3X1(1 stains ??.!» w^an preservative. The estimated exposures in this assessment considered baseline
protection (long pants, long-sleeved shirt, shoes, socks, no gloves, and an open cab tractor), as well as
additional personal protective equipment (PPE), which also includes chemical resistant gloves and a
dust/mist respirator.
"', M •! * ... • i .. „, „ .
26
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ii.
Occupational Handler Data Sources and Assumptions
An exposure assessment for each folpet use scenario was developed using chemical-specific data
and surrogate data from the Pesticide Handlers Exposure Database (PHED) Version 1.1. PHED is a
software system consisting of two parts - a database containing measured exposure values for workers
involved in the handling of pesticides under actual field conditions and a set of computer algorithms used
to subset and statistically summarize the selected data. PHED was developed by Health Canada, the
American Crop Protection Association, and EPA and 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. The
Agency considers use of surrogate or generic data appropriate because the physical parameters of the
handling and application process (e.g., the type of formulation used, the method of application, and the type
of clothing worn), rather than the chemical properties of the pesticide, determine 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 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, without using chemical-resistant gloves or a respirator. If the level of concern is met or
exceeded, then increasing levels of risk mitigation, such as PPE and engineering controls, are used to
recalculate the MOEs until exposure is sufficiently reduced to achieve an MOE that is not of concern.
Folpet-specific passive dosimetry exposure monitoring studies were also used in the occupational
exposure assessment. The first study (MRID 41411801) monitored exposures resulting from the use of
apaint brush; the second study (MRID 41411802) monitored exposures resulting from the use of an airless
sprayer for house stain. In the paintbrush study, folpet-containing paint was applied by non-professional
painters using 2 and 4-inch paint brushes to interior bathroom walls. The one percent by weight folpet was
packaged as a ready-to-use product. In the sprayer study, folpet-containing stain was applied to the
exterior of a house using a commercial airless sprayer from five gallon ready-to-use containers.
Paint Brush Study. This study monitored 15 exposure replicates of non-professional painters
painting interior bathroom walls. Painting was conducted with 2 and 4-inch paint brushes. The paint
contained folpet at a concentration of one percent by weight. Technical grade folpet was added to the paint
by the researchers prior to the study to ensure stability. Because folpet containing paint is packaged as a
ready-to-use product, the absence of monitoring the act of mixing folpet into the paint is acceptable The
painters applied the paint at a rate of 500 to 550 ft2 per gallon and applied approximately one-half gallon
of paint per replicate. Application duration ranged from 34 to 94 minutes per replicate. The amount of
active ingredient (a.i.) handled per replicate ranged from 0.0253 to 0.051 Ib a.i. (MRID 41411801)
27
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^mai exP°sure was monitored with multi-layered patches simulating normal work clothing (i.e.,
long pants and long sleeved shirt) and the hands were monitored with cotton gloves over latex gloves.
Inhalation monitoring was performed using personal air monitoring pumps with polyurethane foam filters.
Although the study is acceptable, the Agency identified a number of deficiencies: paint rollers
fhpuld. have been used in the study instead of paint brushes for potentially higher exposure results; an
insuffif ^ nuinber of replicates were used in the laboratory and field recovery experiments for the cotton
gloves and the foam filters; and a range of fortification levels for the field recovery experiments would have
been more appropriate.
'" i'1' ' ' ';, ;? ""::.' " • " r ' , "I1 • ' ' ''• i •" , " • '
, . , , ,„ , . , ,
^Praver studv- This study monitored 15 exposure replicates of workers using a
commercial airless sprayer. The stain used in the study, packaged in ready-to-use 5 gallon containers,
contained 0-5 percent folpet by weight. The amount of a.i. used per replicate was calculated by using the
percent folpet and assuming a stain density of 0.8 g/mL or 0. 1667 Ibs a.i. per replicate (i.e., 5-gallon stain
buck^)- FolPet was used at a rate of 75° to !'250 ft2 Per 5-gaUons. Application duration ranged from
1 1 to 27 minutes per replicate (MRID 4141 1 802).
Dennal exposure was monitored with multi-layered patches simulating normal work clothing (i.e.,
long pants and long sleeved shirt) and the hands were monitored with cotton gloves over latex gloves!
Inhalation monitoring was performed using personal air monitoring pumps with polyurethane foam filters.
The patch and glove residue values were corrected for field recoveries.
Although the study is acceptable, the Agency identified a number of deficiencies in the study: an
insufficient number of replicates were used in the laboratory and field recovery experiments for the cotton
gloves and the foam filters; and a range of fortification levels for the field recovery experiments would have
been more appropriate.
The Mowing assumptions were used in the occupational exposure and risk
assessment as appropriate:
The Agency uses 60 kg as the average body weight of an adult handler for the short-term and
"ltermediate'term derm?l ^d inhalation exposure and 70 kg as the average body weight for the
cancer assessments. The Agency typically uses a 60 kg body weight for adult females is used when
developmental toxicity is the risk assessment endpoint.
10 Acres of avocados are treated per day.
4>°0° Gallons of paint are treated per day during the manufacturing process.
28
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PHED surrogate information for wettable powder is used to estimate exposure to the solid powder
used in the paint manufacturing process. PHED is also used for estimating exposure to folpet for
the avocado use.
A painter could paint up to 5 gallons of paint with a brush at residential site and stain up to 2 houses
in a day. A typical house dimension is assumed to be 30 ft x 40 ft x 20 ft (2,400 ft2 living area or
2,800 ft2 outdoor surface area to be treated).
For Scenario 4, application with a paint brush, the maximum application rate for paint and stain
products (0.088 Ib a.i./gal) is used for the short and intermediate term assessments. A typical rate
of 0.044 Ib a.i./gal is used in the cancer assessment.
The exposure data presented in Scenario 5 for airless sprayers is assumed to be higher than that
for compressed-air type paint/stain sprayers. Therefore, the airless sprayer is a reasonable worse-
case representative for all other types of paint/stain sprayers.
iii. Occupational Handler Risk Characterization
The same toxicological endpoint was selected for risk assessment for short- and intermediate-term
dermaland inhalation exposures (i.e., NOAEL of 10 mg/kg/day froman oral developmental toxicity study
discussed earlier). Because the endpoints are derived from oral studies, the absorbed daily dose for each
route of exposure 1S converted to an equivalent oral dose using a dermal absorption rate of 2.7 percent
an inhalation absorption rate of 100 percent, according to the Mowing formula:
or
Absorbed Daily Dose \ —22£_J = Daily Exposure
( Kg/Day} ^ Day,
Body Weight (Kg)
• Percent Absorption
The absorbed daily dose of folpet for short-term and intermediate-term exposures is calculated
usrng a 60 kg body weight representing adults females because a developmental toxicity endpoint is used
for risk assessment.
Worker MOEs are derived from a comparison of the total oral equivalent dose (corrected for
inhalation and dermal absorption) with the NOAEL of 10 mg/kg/day for short- and intermediate-term
duration, according to the following formula:
NOAEL
MOE =
Absorbed Daily Dose I mg \
( kg/day)
Folpet is classified as a Group B2, probable human, carcinogen with a cancer potency value (Q,*)
29
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from a 2 year feeding study in mice of 1.86 x lO'3 (mg/kg/day)-'. Estimated worker cancer risk is
calculated using the following formula:
Estimated Risk = LADD (mg/kg/day) * Q,' (mg/kg/day)-1
where Lifetime Average Daily Dose, or LADD is calculated as
LADD (mg/kg/day) =
Daily Total Dose (mg/kg/day} * (days worked/365 days/yr) * (35 years worked/70 vr
lifetime).
Corker MOEs greater than 100 are not of concern. Worker cancer risks less than 1 x 10'6 are
not of concern. The Agency policy for worker risk states that risks shall be as close to negligible (1X10'6)
as possible. Worker risks in the range of 10'4 are acceptable when risks have been mitigated to the
maximum extent feasible with practical measures and when benefits outweigh the risks.
A summary of the short- and intermediate-term, and chronic MOEs, and lifetime cancer risk
estimates are given in Table 8. Risk values are given for baseline and baseline with additional mitigation.
Baseline represents long pants, long sleeved shirt, no gloves, open mixing/loading, and open cab tractor
used in au-blast application. Additional PPE includes chemical resistant gloves and a dust/mist respirator
(5-fold protection factor).
Occupational exposures reflecting baseline protective clothing (i.e., long pants, long sleeved shirt
no gloves, and open systems) result in MOEs and cancer risks that do not exceed the Agency's level of
concern forall scenarios but one. For this one scenario (Scenario /), loading a powder formulation to paint
at the manufacturing process, additional PPE (i.e., use of chemical resistant gloves and a dust/mist
respirator or in-lieu of PPE, the use of engineering controls) are required to mitigate exposure/risk
Provided that folpet exposures are mitigated for the above specified exposure scenario with PPE (or
engineering controls), MOEs and cancer risk for total exposure/risk do not exceed the Agency's level of
concern.
30
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TableS. Summary of Occupational Risks for Folpet
Exposure Scenario
Manufacture of Paints
and Stains
M/L for Avocados
Applicator for
Avocados
Scenarios 4-7:
Application of Paints
and Stains
Postapplication Scenario'.
Avocado Harvesters (1
dayREI)
Exposure
Duration
Short and
Intermediate Term
Chronic
Short and
Intermediate Term
Short and
Intermediate Term
Short and
Intermediate Term
Short Term
Margin of Exposure (MOE)
Baseline*
MOE
17
15
140
1400 to
3300
212 to 260
100
Additional PPE **
130
120
>100
N/A
N/A
N/A
1 Baselme retlects use ot long-sleeved shirt, long pants, shoes, and socks.
PPE includes haselinp nine ^ViRmi^ol i-AeiWr.*** r»in.>An 1 _ j *./„ • *
Acceptable
Value
100
100
100
100
100
100
Cancer Risk at
Baseline***
9.1 X lO'5
4.5 X10's
Ito 2.2 X10-"
1.1 tol.9X10-7
4.3to5.6X10'6
6.5 XIO'6
with Prearet 1 x ffl™ *" C°nsideKd accePtabIe' *> cancer risks with PPE are not presented here, although risks
iv. Incident Reports
No serious illnesses associated with folpet exposure have been reported in the data sources
available to the Agency. The scientific literature suggests folpet may contribute to allergic contact
dermatitis and irritant effects to the skin. The Agency has reviewed the OPP Incident Data System (IDS)
the P01son Control Center, the California Department of Food and Agriculture (Department of Pesticide
Regulation), and the National Pesticide Telecommunications Network (NPTN) data bases for reported
incident information for folpet. Of the 11 cases submitted to the California Pesticide Illness Surveillance
Program (1982-1995), 3 involved use of folpet alone, and it was determined to be responsible for the
health effects. Eye and skin irritation were the only reported effects. Based on these few reports under
some circumstances exposure to folpet can lead to skin and eye irritation, such as skin rashes and
conjunctivitis.
v.
Occupational Postapplication Exposure
The Agency has assessed postapplication exposures for both the avocado and paint uses of folpet
For paints, postapplication inhalation exposures are expected to be substantially lower than those
experienced by occupational handlers. Monitoring in the 14 days following application of folpet-containing
paint in a residential setting showed negligible exposure potential (MRTD 41411801). Moreover the
31
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vapor pressure of folpet is negligible, 1 .6x1 0'7 mmHg at 25 ° C. Although no post-application monitoring
data are available for the use of folpet-containing stains and wood treatment products, negligible exposure
potential is expected. The worst case exposure potential, which is experienced by commercial painters
using folpet-containing paints and stains, results in acceptable risk (MOEs >100).
Post-Application Exposures to Workers in Folpet-treated Avocado Orchards. EPA has
some chemical-specific data upon which to assess the exposure of workers entering avocado orchards to
perform tasks, such as harvesting, following applications of folpet. Dislodgeable foliar residue (DFR)
studies and concurrent worker exposure studies were conducted for folpet in avocado orchards (MRIDs
42122019 and 42122020). However, the study is based on a single application of folpet even though 7
applications are permitted annually at a minimum interval of 14 days separating each application. The
worfcer ^°^on of to® studv had t*16 following deficiencies: the quantification limit was not provided or
described; the study did not indicate the number of field fortifications per monitoring period; and workers
wore an optional outer garment over the tee-shirt dosimeter, specific clothing attire and material type was
not reported. Therefore, the available data do not represent a worst-case characterization of exposures
to workers.
me DFR study and the worker exposure study, approximately 3.0 Ibs a.i./acre of folpet
50WP, the maximum labeled rate (e.g., 47.6% a.L, formulated as a wettable powder), was applied to
avocado trees once using an airblast spray system (MRIDs 42122019 and 42122020). Four different
sprayers placed on trailers were each hitched to 4 different tractors in order to spray 47.5 acres of avocado
trees (i.e., the total acres for the three different sites) located at Goulds, Florida. Applications were made
on November 4, 1989. Rainfall was measured as a "trace" amount on November 6, 0.24 inches on
November 8, and intermittently throughout the study (trace to 0.44 inches per event).
Dislodgeable Foliar Residue (DFR) Study. For the DFR study, six samples (e.g., each sample
consisting of 50 leaf discs measuring 10 cm2) were taken at each sampling interval from each site. Three
of the samples were used for measuring folpet dislodgeable foliar residues, and three samples were used
for measuring total residues. The leaf disc samples were collected from the trees at the height of six feet.
The DFR discs were dislodged using a detergent solution (an aqueous dilution of Aerosol OT-75). Foliage
samples were collected at 0, 1, 3, 7, 9, 13, 21, 28, and 35 days after treatment (DAT).
Avocado Harvester Study. For the worker exposure study, thirty workers were monitored while
harvesting avocados from trees that had been treated once with folpet. Ten volunteers worked in each
grove. Thus, the study contained a total of 1 0 replicate measurements for calculating folpet inhalation and
dermal exposure at three sampling intervals. The sampling interval was different at each site.
Two harvesting techniques were monitored in this study. The first harvesting exposure scenario
involved workers who used a machine similar to a "cherry picker". In this type of harvesting, a worker
stands on a platform which is raised and lowered by the "cherry picker" so that a worker can pick
avocados at different heights of the tree. The platform contains a bucket where the avocados are stored.
32
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When the bucket becomes full, the "cheny picker" lowers the platform so that the worker can empty the
bucket of avocados into a set of wooden crates placed in a tractor drawn trailer. The second harvesting
scenario involves workers picking avocados from the ground or picking up avocados dropped on the
ground by workers in the harvesting machine,and then driving the trucks containing the crates of avocados.
TransferCoefficient. The average dissipation of folpet residues on avocado was calculated using
measured DFR data from 3 sites, correcting the data for a field recovery of 63.5 percent and averaging
the results of the three sites together. Table 6 also provides an MOE assessment based on an average
transfer coefficient (Tc) of 30,015 cnrYhr. The average transfer coefficient is based on the average
exposure of cherry picker harvesters at three different sites, which ranges from 13,359 to 42,237 cnfVhr.
The transfer coefficient for the cherry picker harvesters were used in the risk assessment instead
of the harvesters working on the ground or tractors because the cherry picker scenario represents a
reasonable worst case exposure. The transfer coefficients are calculated as follows-
Transfer Coefficient (cm2/hr)=
Total Dermal Residue fug/day)
Time(4 hr/day) X DFR (jug/cm-)
vi. Postapplication Risk Estimates
As previously mentioned, the toxicology endpoint for short and intermediate term exposures is the
NOAEL of 10 mg/kg/day from an oral developmental toxicity study. Because the endpoint is derived from
an oral study, the absorbed daily dose for each route of exposure is converted to an equivalent oral dose
using a dermal absorption rate of 2.7 percent or an inhalation absorption rate of 100 percent Potential
average daily exposure (ADE) is calculated as Mows:
Potential ADE = DFR (us/cm2) x Transfer Coefficient flO.Ofincm2/hr) x Work r>nv (ft h,
Unit Adjustment from fig to mg (1,000/j.g)
The ADE is corrected for percent absorption to convert it to average daily dose, which is then used to
calculate post-application MOEs using the following formula:
= NOAEL (mg/kg/day)/Dose (mg/kg/day)
Postapplication cancer risks were calculated using the following formulas:
Estimated Risk = LADD (mg/kg/day) * folpet Q, of 1.86'3 (mg/kg/day)-1
where LADD (mg/kg/day) = Daily Absorbed Dermal Dose (mg/kg/day) * (30 days worked/365
days/yr) * (35 years worked/70 year lifetime).
33
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The nsk assessment indicates that the MOEs for short- and intermediate-term exposures exceed
Jay .1 ^er treatment. Cancer risks are 6,9 x 10'6 on the day of treatment after sprays have dried
SdUexceed !'° X ^ on ^ 40 following treatment. EPA believes this represents a potential
of P°st-aRplication risks to avocado workers following folpet applications because of the
data deficiencies noted above.
Table 9. Summary of Avo ado Worker Post-Application Exposure anri Ri«k
Days
After
Treatment
••••••••MMRMBMMB
0
"•"••™*™«W»«W»B™
1
Best Fit
Average DFR
(ug/cm2)'
0.97
0.93
Daily Dermal
Exposure
(mg/day)b
232.9
223.3
Daily Absorbed
Dermal Dose
(mg/kg/day)
0.105
0.100
Dermal
MOB
95
100
Dermal LADD
(mg/kg/day)
3.7E-3
3.5E-3
Cancer
Risk
6.9E-6
6.5E-6
™f av5[aSe dislodgeable foliar residues from the avocado study MRID No. 42 1 220- 1 9 DFR
*™ ~J W dataCaveragedDFRdatafromthethreesitesandcorre
l then ™nin * linear regression equation to estimate the dissipation over
Thepostapplication data used in this assessment are based on a single application of folpet, while
a*5 ma*y ^ 7 applications per year, with a minimum interval of 14 days separating
label
d. Residential Exposure
There are four major folpet exposure scenarios for homeowner handlers using folpet containing
paints and stains labeled for pesticidal use: (Scenario 4) applying ready-to-use formulation with a paint
brush, (Scenario 5) applying ready-to-use stain formulation with an airless sprayer, (Scenario 6) applying
^-^efoimulanon^
f e J** Wfjf?^- fa Edition, homepwnprs may also handle paint and stain products to which folpet
has been added, but not labeled. There are three major folpet exposure scenarios for homeowners using
folpet- containing products not labeled for pesticide use: ^Scenario 4) applying paint with a brush!
(Scenario 5) applying stain with an airless sprayer, and (Scenario 6) applying paint with a roller.
L Residential Handler Exposure Scenarios, Data Sources,
'i||fl " '„, "''! •'" , _ ', and Assumptions
; ^Ag^y^nductedresidentialhandlerexposureassessmentsforpainting/sta^
tial ^^ CXP°sures m based on homeowners wearing long pants, long sleeved shirt, and no
reSid?tial aSS6SSment ^ based on data from two folpet-specific passive
34
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dosimetry monitoring studies using either a paintbrush (MRED 41411801) or an airless sprayer (MRID
41411802). In the paintbrush study, a folpet-containing paint was applied by non-professional painters
using 2 and 4-inch paint brushes to interior bathroom walls. The 1 percent by weight folpet was packaged
as a ready-to-use product. In the airless sprayer study, a folpet-containing stain was applied to the exterior
of a house using a commercial airless sprayer from 5 gallon ready-to-use containers.
Assumptions: The Agency made assumptions regarding body weight, toxicology endpoints,
application rate, area treated, and frequency and duration of exposure similar to those used in the
occupational exposure and risk assessment. The Agency also made the Mowing assumptions regarding
residential exposure:
Area treated in each scenario: 2 gallons of paint for a homeowner, a homeowner would treat one
typical house with stain. A typical house dimension is assumed to be 30 ft x 40 ft x 20 ft (2,400
ft2 living area or 2,800 ft2 outdoor surface area to be treated).
The airless sprayer is a reasonable worse-case representative for all other types of paint/stain
sprayers. Also, the maximum application rate for ready to use stain products is used and is
expressed in Ib a.i7ft2 covered. This product is expected to be used primarily for residential
application and not for large scale commercial structures.
The number of treatment days per year for the cancer assessment are assumed to be as follows:
4 days of painting for homeowners and 1 day for staining for homeowners (house treatment once
per year).
These residential exposure scenarios reflect a broad range of application equipment, application
methods, and use sites. The exposure scenarios were classified as short- and intermediate-term based
primarily on the frequency of exposure. A long-term exposure duration is not expected because
homeowners are not expected to use paint for more than 6 months.
ii. Residential Handler Risk Characterization
MOEs and cancer risks are calculated in the same manner as occupational handlers. However, for
homeowners MOEs greater than 300 are not of concern. This reflects the application of the 3X FQPA
safety factor to homeowners. Cancer risks for homeowners less than lO'6 are not of concern.
A summary of the short-term hazard and risk estimates for residential handlers is presented in Table
10. The estimates for short-term dermal and inhalation hazards and risks are combined because dermal
and inhalation endpoint effects are the same. Exposures were estimated assuming that residents would stain
the house once a year, apply folpet-containing paint 4 times per year, and paint up to 2 gallons per use.
Residential exposures result in MOEs and cancer risks that are below the Agency's level of concern.
35
-------
If I I i
iii. Residential PostappHcation Exposures and Risks
^ st?*Bd Previously> Postapplication exposures are considered to be negligible for persons in or
:;! n?lV,area|;whgre (1) folpet ready-to-use products are being or have recently been applied with brushes,
rollers, or sprayers, or as a dip; and (2) paints containing folpet are being or have recently been applied.
Therefore, postapplication exposure and risk estimates are not presented here. Residential
postapplication exposures and risks are also not of concern.
e. Summaryof Occupational Risk Estimates
>• Short-and Intermediate-term Dermal Risk
The calculations of short-term and intermediate-term dermal risk indicate that the MOE is less than
100 with baseline PPE for Scenario 1, adding the wettable powder formulation to paint at the manufacturing
process. However, the MOE is greater than 100 with the addition of chemical resistant gloves. Therefore,
chemical-resistant gloves are required for workers adding folpet to paints during manufacture.
ii. Short and Intermediate Term Inhalation Risk
Inhalation exposure is expected only for workers adding wettable powder to paint during the
manufacturingprocess (scenario /). The calculation of short- and intermediate term inhalation risk for this
scenario gives an MOE of 40 with baseline PPE and an MOE of 200 with the addition of a dust/mist
respirator. Therefore, a dust/mist respirator is required for workers adding folpet to paints during
manufacture. Inhalation exposure and risk are expected to be negligible for all other occupational exposure
scenarios.
iii- Total Noncancer Risk from Handler Exposure
1116 calculations of total short-term and intermediate-term risk indicate that th:e MOEs are more
than 100 with additional PPE (chemical resistant gloves and dust/mist respirator) for Scenario I, adding
wettable powder formulation to paint during the manufacturing process. Total risk reflects risk from
combined inhalation and dermal exposure.
iy.f Cancer Risk From Handler Exposure
Cancer risk estimates are between 1 x 1(T* and IxlO'5 at baseline for Scenario 1, adding wettable
P°wder to paint during manufacturing. However, with mitigation (chemical-resistant gloves and dust/mist
respirator) risk for Scenario 1 is 4.5 X 10"5.
36
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-------
f. Aggregate Risk
,1 ",1'lHiii ' ' ii ' Kill: ii'1!, , ' 'I! i .1.1' '!' ,!ili !'"' in,""!, '" II 1, .11 ' ' ' i '"i "' ' iiii,. ',ii' ii ' , , " •,' v A !
In establishing or reassessing tolerances, the Food Quality Protection Act (FQPA) requires the
Agency to consider aggregate exposures to pesticide residues, including all anticipated dietary exposures
and other exposures for which there is reliable information, as well as the potential for cumulative effects
from a pesticide and other compounds with a common mode of toxicity. The Act further directs the
Agency to consider the potential for increased susceptibility of infants and children to the toxic effects of
pesticide residue.
Sste^^dcapta^ Other
chemicals may share thiophosgene as a common intermediate. The generation of thiophosgene may need
to be considered in an aggregate assessment. In general, after EPA develops a methodology for applying
cornmonmechanism of toxicity issues to risk assessments, the Agency will develop a process (either as part
of the periodic review of pesticides or otherwise) to reexamine those tolerance decisions made earlier
where appropriate.
In examining aggregate risk, FQPA also directs.EPA to take into account available information
concemWS exppsures fr°rn 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 Pesti5de8 u868 ^ and f0™:11^ to hpme> and exposure in non-residential settings, such as parks and
schools. For folpet, EPA has included exposure from food, water, and residential exposure in the
aggregate risk assessment, as appropriate.
i. Acute Aggregate Risk
Acute aggregate risk estimates for folpet do not exceed the Agency's level of concern. The
aggregate acute dietary risk estimates include exposure to folpet residues in food and water. Exposure
(food only) to combined residues of folpet based on a refined analysis using field trial data and percent of
crop treated, represents 25% of the acute PAD for females 13-50, the population subgroup of concern
for acute effects. Using conservative screening-level models, the estimated maximum peak concentrations
.of folpet in ground water is 0.06 ppb and in surface water is 159 ppb. This estimated peak concentration
is.Iess *%*?Agency's Drinking Water Level of Comparison (DWLOC) for exposure to folpet in
drinking water as a contribution to aggregate acute dietary risk. Based on the available information, the
Agency concludes with reasonable certainty that no harm to any population will result from acute aggregate
dietary exposure to folpet.
>" „•• , -ir ,,, i. - "7"J !'i\..& •, Sh9r*- ?nd Intermediate-Term Aggregate Risks
Short and intermediate term aggregate risk estimates for folpet do not exceed the Agency's level
of concern,,, SJiprt ancl intermediate term aggregate risk estimates considered only two potential
homeowner exposure scenarios: application of Ready-to-Use paint or stain with either a paint brush or an
40
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antes sprayer The highest exposure, from the airless sprayer, represents a short-term MOE of 407 when
dermal _and mhalation exposures are added. The chronic dietary exposure from folpet represents less than
56 dlr'p^pr T .^^^^-tennDWLOCof 90 ppb available for water. The modeled
56-day GENEEC value is 1 ppb, and the modeled concentration of folpet in groundwater is 0 06 ppb
Because the short-term DWLOC is greater than the modeled concentrations of folpet in surface or
groundwateiv the short-term aggregate risk is not of concern. Therefore, the registered uses of folpet do
not exceed the Agency's level of concern when short-term residential exposures are added to the chronic
dietary exposure from currently registered food uses.
iii. Chronic (Non-Cancer) Aggregate Risk
Chronic (non-cancer) aggregate risk estimates for folpet do not exceed the Agency's level of
concera The aggregate chronic dietary risk estimates include exposure to folpet residues in food and
water. No chronic residential use scenarios were identified. Exposure to folpet residues in food, based
on a assessment using average field trail residues and percent of crop treated data, represents less than 1 %
of the chronic PAD for the most highly exposed population subgroup (non nursing infants less than 1)
SlTdTl 0thtrgrTrePreSentSleSSthan 1%ofthechr°nicPAD. Using conservative screening-
levelmodelsme estimated concentration offolpet in ground water is6ppb and in surface water is 1 ppb
Thrs estimated average concentration is less than the Agency's drinking water level of comparison for
exposure to folpet in drinking water as a contribution to aggregate chronic dietary risk. Based on the
avadable information, the Agency concludes with reasonable certainty that no harm to any population will
result from chronic dietary exposure to folpet.
iv. Cancer Aggregate Risk
. Cancer aggregate risk estimates for folpet do not exceed the Agency's level of concern Lifetime
eerrerate sfr*:^f^water^^^
estimates of aggregate r*k. The dietary food and water exposure "numbers are considered conservative
The dietary portion is refined through percent crop treated and field trial residues. The residential exposure
number was derived from a chemical-specific monitoring study submitted by the registrant The modeled
--trationof folpet^in ground water is 6 ppb and in surface water is Ippb. T^is estimaJd^f
concentration is less than the Agency's DWLOCcancer for exposure to folpet in drinking water as a
contention to aggregate chronic dietary risk. Aggregate lifetime exposure from food? water and
residential use does not pose a cancer risk of concern to the Agency.
v.
Cancer Aggregate Risk for Captan and Folpet
Captan and folpet share a common metabolite, thiophosgene, which is believed to be responsible
SSTr°fr,f t °f ta C°mPOUndS- ™°Phos^e is • ^y -ctive, short-lived'pTct
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 showed
41
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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 (DWLOQ.^) based on this total cancer risk estimate is 11
ppb, using the captan Q,* of 2.4 x 10"3. The estimated environmental concentration (EECs) for folpet are
1 ppb for surface water and less than 1 ppb for ground water. The EECs for captan are 4 ppb for surface
water and less than 1 ppb for ground water. 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 ffi the Ql tract (duodenum/jejunum-ileum) as a result of oral dosing. The relevance of dermal
exPosure to a..pl tract tumor is unknown at this time. Thus, the Agency concludes that an aggregate cancer
risk e?tim?te considering dietary exposure (food and water) 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
commonmechanisms 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 other substances, EPA does not at this time have
the methodologies to resolve the complex scientific issues concerning common mechanism of toxicity ina
meaningful way.
has beg"11 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 ffiderstanding 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.
A! ^s time' ^ 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
42
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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).
In the case of folpet, the Agency is aware of a proposed common mechanism of carcinogenicity
with captan, via the common metabolite thiophosgene. This thiophosgene moiety is thought to be
responsible for many of the toxic effects observed with both compounds. However, Ihiophosgene is a highly
reactive moiety whose residues are not found because it is transient and not readily measurable. Without
measurable residues of the thiophosgene common metabolite, it is difficult at this time to relate exposures
of folpet to those of captan because the rate of thiophosgene formation may be different for each
compound. Other chemicals may also share a common mode of toxicity with thiophosgene or have
thiophosgene as a reactive intermediate. In general, after EPA develops a methodology for applying
corrrnionmechanism of toxicity issues to risk assessments, the Agency will develop a process (either as part
of the periodic review of pesticides or otherwise) to reexamine those tolerance decisions made earlier In
die meantime, the Agency has determined that it should proceed with reregistration and reassessment of
folpet tolerances independent of a cumulative risk assessment
C. Environmental Assessment
Theenviromnentalassessmentforfolpetcor^istsoffivesections:EcologicalToxicity,Environmental
Fate and Transport, Water Resources Assessment, Ecological Exposure and Risk Assessment and
Environmental Risk Characterization. The first and third sections report the ecological toxicity data from
laboratory studies, estimate the ecological exposure and assess the effects to nontarget terrestrial and
aquatic organisms. The second section depicts the environmental fate and transport data from field and
laboratory studies and analyzes the impact to water resources. The section on environmental risk
characterization integrates the exposure and effects assessments to determine the extent and potential for
risk to the environment.
1. Ecological Toxicity Data
The Agency has sufficient data to assess the acute and chronic hazard of folpet to nontarget species
for reregistering the existing folpet uses on avocados and in paint. However, additional data would be
required if folpet were registered for new food uses or for if the geographic area for use on avocados were
to expand.
The Ecological Effects Database for folpet is substantially complete for the current use pattern
There is a data gap for Guideline 850.4400, Daphnia chronic (life cycle) toxicity testing. These data are
considered to be confirmatory and are not expected to alter the conclusions of the risk assessment As
43
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mention^ above, the Agency would require additional data with any expansion of folpet use; these data
would include the Mowing: (1) Guideline 850.5400, Tier 2 toxicity testing on 5 species of algae; (2)
Guideline 850.1075, testing of the PAI degradate on bluegill sunfish; and (3) Guideline 850.1010, testing
of the 50% WP formulation on Daphnia magna.
a. Toxicity to Terrestrial Animals
i. Birds, Acute and Subacute
IS ^M^80 t*16 tc>xicity of folpet to birds, the following tests were required and performed using
the technical grade material: one avian single-dose oral (LD50) study on one species (mallard duck or
bobwhite quail); two subacute dietary studies (LC50) on one species of waterfowl (mallard duck); and one
species of upland game bird (bobwhite quail). Test results indicate that the folpet test material ranges from
slightly toxic to practically non-toxic. The Acute and Subacute Toxicity data requirements (Guidelines 71-
l(a), 7i-l(b), yi-lfo, ^ 71:?(b)> are fulfilled for reregistration (MRIDs 00112793, 00112794,
00112795, and 00160000). No additional acute or subacute toxicity data for birds are required. Study
results are summarized in Tables 13 and 14 below.
Species
Northern bobwhite quail
Mallard duck
Japanese quail
Green finch
%
a.i.
92.5
92.4
87.5
87.5
U>so
mg/kg
>2510
>2000
2440
1340
Citation
(MRID)
00112793
00160000
00137698
00137698
Toxicity Category
practically nontoxic
practically nontoxic
practically nontoxic
practically nontoxic
Fulfills
Guideline
Requirement*
Yes
Yes
No
(Supplemental*)
No
•Supplemental Study provided useful information but Guideline was not satisfied.
Species
Northern
bobwhite
quail
Mallard duck
% a.i.
92.5
92.5
LCsoPpm
>5000
>5000
Citation
(MRID)
0012794
0012795
Toxicity Category
practically nontoxic
practically nontoxic
Fulfills
Guideline
Requirement
Yes
Yes
44
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ii. Birds, Chronic
Avianreproduction studies are required when birds may be exposed repeatedly, or continuously
throughpersistence, bioaccumulation, or multiple applications, or if mammalian reproduction tests indicate
reproductive hazard. The folpet end use label allows multiple applications per growing season therefore
avian reproduction studies were required. The avian reproduction studies indicate that exposure up to
1000 ppm in the diet does not appear to affect reproduction. Folpet residues at the maximum label
application rate for avocados in Florida are not expected to exceed 800 ppm on foliage. The guideline
requirements are fulfilled for the current folpet registrations (MRID 00098004, 00098005).
ill. Mammals
Data from available mammalian studies which are used for human health risk assessment were used
to estimate the toxicity of folpet to wild mammals. Wild mammal testing is required on a case-by-case
basis, depending on the results of such lower tier studies as acute and subacute testing, intended use
pattern, and pertinent environmental fate characteristics.
An acute oral toxicity study in rats shows that folpet is practically non-toxic (MRID 001434057)
Hie rat acute oral LD50 for folpet is 19,500 mg/kg. Chronic effects data are addressed in a two-year
chronic feeding study in rats (MRID 00151560). The NOEL in the rat chronic study was 200 ppm- the
LOEL was 800 ppm. Effects included hyperkeratosis/acanthosis and ulceration/erosion of the non-
glandular stomach. However, exposure of nontarget animals for 2 years is unlikely in actual field exposure
scenarios. Therefore, wild mammal toxicity testing is not required.
iv. Insects
A honey bee acute contact LD50 study is required if the proposed use will result in honey bee
exposure. Theacute LD50 in honeybees is 12.1 ug/bee.This is sufficient information to characterize folpet
050^991^ n°ntOX1C t0 h0neybeeS' Th& &***** requirement is fulfilled (MRIDs 00113613 and
b. Toxicity to Aquatic Animals
i. Freshwater Fish
(1) Acute Toxicity
Joestobh'shrnetoxicityofapesticidetofreshwaterf^^
grade of the active ingredient are two freshwater fish toxicity studies. One study should use a coldwater
species (preferably the rainbow trout), and the other should use a warmwater species (preferably the
bluegill sunfish).
45
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TablelS. Freshwater Fish Acute Toxicity Findings
Species
Bluegill sunfish
(warmwater)
Bluegill sunfish
Rainbow trout
(coldwater)
Rainbow trout
Brown trout
Brown trout
Channel catfish
Coho salmon
Lake trout
Lake trout
Smallmouth
bass
Yellow perch
% a.i.
90.3
88
90.3
88
88
88
88
88
88
88
88
88 .
96-hr. LC50
(ppb a.i.)
47
72
15
52.1
29
66
108
106
24
87
91
177
Citation (MRID)
40818804
40094602
40818803
40098001
40098001
40094602
40094602.
40094602
40098001
40094602
40094602
40094602
Toxicity
Category
very highly toxic
very highly toxic
very highly toxic
very highly toxic
very highly toxic
very highly toxic
highly toxic
highly toxic
very highly toxic
very highly toxic
very highly toxic
highly toxic
Fulfills
Guideline
Requirement
Yes
Supplemental*
Yes
Supplemental*
Supplemental*
Supplemental*
Supplemental*
Supplemental*
Supplemental*
Supplemental*
Supplemental*
Supplemental*
*Supplemental study provided useful information but guideline was not satisfied.
ft£ resets of the 96-hour acute toxicity studies in both cold and warm water species indicate that
folpet is highly toxic to very highly toxic to fish. The guideline requirements are fulfilled for testing with
technical material (MRIDs 40818803 and 41818804). The results of the 96-hour acute toxicity studies
indicate that folpet end-use formulations are highly toxic to very highly toxic to fish. This is supported by
10 studies using an 88% formulation that shows a range of LC50 values from 24 to 177 ppb.
Additionally, when the technical LC5q is less than or equal to either the maximum expected
environmental concentration or the estimated environmental concentration when the end-use pesticide is
used according to the label, then acute formulated product testing with a typical end-use product is
required. The folpet LC50 of 15 ppb in rainbow trout is less than the estimated environmental
concentration of 159 ng/L, which triggers the requirement for testing with a typical end use product. For
folpet, various formulations have been tested.
One of the formulations tested, Fungitrol 11-50,44% a.i., is not a typical end use product (TEP)
for use on avocados. Data from two other formulations, 50 and 75% wettable powder (50 and 75WP),
indicate that the wettable powder end use products are less toxic than the technical grade material but are
still very highly toxic to fish. The three supplemental wettable powder studies taken together satisfy the
guideline requirement for TEP testing with freshwater fish.
46
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Table 16. Freshwater Fish Acute Toxicity Findings
V ~ ™cuauic puwder Studies to«ether satisfy the guideline requirement for a typical end use nroduct Oth.r
supplemental stud.es provided useful information although the guideline was not satisfied ?
Degradate testing can be required when the parent compound is short-lived and the major
degradateOO are beheved to be stable and exist at concentrations greater than 10% of applied parent
Folpet is short hved, wA a half life of 2.5 days based on the results of the aerobic soil metaboHsmsm^
Degradates include phthahmide (PI), phthalic acid (PAT), and phthalamic acid (PAM) Of these PI and
i-Al are the are major degradates; however, none of the degradates are of toxicological concern although
Table 17. Freshwater Fish Acute Toxicitv Findin for Foloet
Bluegill sunfish
^««^-«M«^B«l^
Rainbow trout
(2) Chronic Toxicity
Data from fish early life-stage tests are required when the product is expected to be transported
to water fromthe mtendeduse sites, when the fish acute LC50 values are less than 1 mg^ iHen 1
St ^Ind8 ^ ? °/ff?^-0'01 ofanyacuteEC50 or LC50 value, T^e study .suits ££
^«f?lt^r^f ^^^^^areaffectedbetweenS.Sl and 17.7ppb. The study NOEL
was 8.8 Ippb. The guideline requirement is fulfilled (MRID 43786301).
47
-------
;f
•I!1!!!" I1!1"!!!!1: i! In,"
A fish foil life-cycle study is designed to evaluate risk from chronic pesticide exposure to fish
reproduction and other life stages. This study is required when the end-use product is intended to be
aPP}ied^^yto water or is expected to transport to water from the intended use site if the estimated
environmental concentration is equal to or greater than one-tenth of the NOEL in the fish early life-stage
Or kve^rat<: ,,P«ycle test. The 56 day anticipated EECs for folpet in water, following single or repeat
terrestnal aPPhcations of the product to avocado at the maximum label rates, are I 22 and 2 85 ppb
respectively. This represents 18.4 and 32.3% of the NOEL reported in the fish early life cycle study'
However, the Agency believes mat the limited use of folpet on avocados in a regionally defined area in
Dade *"& P16!3"1 Counties? Florida, will not result in residue levels in excess of 10% of the NOEL for the
fish early life study. No further testing is required to support the current use pattern.
u- Freshwater Invertebrates
The minimum testing required to assess the hazard of a pesticide to freshwater invertebrates is a
fieshwater aquaue invertebrate toxicity test, preferably using first instar Daphnia magna or early instar
amphipods, stoneflies, mayflies, or midges. Table 18 lists the results of toxicity tests of folpet on freshwater
invertebrates.
Table 18. Acute T<
Species
Daphnia magna
Daphnia magna
Gammarusfasciatus
jxicity of Folpet to Aquatic Invertebrates
Formulation
90.3
88.6
87.5
Tech
48-hr. ECM
(PPb)
20
>1500
85
(24 hr.)
2500
(96 hour)
Citation
(MRID)
40844491
00070507
00137697
40094602
Toxicity
Category
very highly toxic
moderately toxic
very highly toxic
moderately toxic
Supplemental Study provided useful information but Guideline was not satisfied:
Fulfills Guideline
Requirement
Yes
Supplemental*
Supplemental*
Supplemental*
7116 results ?f t*16 48-hour acute toxicity studies indicate that folpet ranged from moderately toxic
to very highly toxic to freshwater invertebrates. The guideline requirements are fulfilled for testing with
technical material (MRID 40844491).
A^Hte toxicity testing with a typical end use product (TEP) is triggered when the LC50 is less than
or equal to either the maximum expected environmental concentration or the estimated environmental
C0ncentratlon when to end-Vse pesticide is used according to the label. Any use resulting in an acute
aquatic nsk quotient equal to or greater that 1.0 triggers the requirement. For folpet, the 48 hour EC50
^?°PP^*h?slowerthMtheestirnatedEECofl59PPb. Therefore, acute invertebrate toxicity testing
with tlje typical end use product is required.
' . '. ': >..."''. " .' . : .. ' . 48
' , dul ,,K ill '•; ,|i', ill1'1 :'!i,
-------
A formulation with 44% active ingredient was tested on aquatic invertebrates. The results of the
96-hour acute toxicity study in Daphnia magna indicates that the 44% formulation is highly toxic to
freshwater invertebrates, with a 96-hour LC50 of 600 ppb (MRID 0007408). Although the 44%
formulation is not a typical end-use product for folpet on avocados. This data satisfies the requirement for
Guideline 72-2B (OPPTS Guideline 850.1010), the toxicity of a typical end use product to freshwater
invertebrates, for the purposes of the RED due to the limited use. However, additional data would be
required if any additional uses are requested for folpet.
The Agency may require degradate testing when the parent compound is short-lived and the major
degradate(s) are believed to be stable and exist at concentrations greater than 10% Two of the major
degradates, phthalimide (PI) and phthalic acid (PAI), meet these criteria. A 48-hour acute toxicity study
in Daphnia magna using PI showed an LC50 of 39 ppm (MRID 42122005) characterizing the PI
degradate as practically non-toxic to Daphnia magna. The guideline requirement for PI is fulfilled (MRID
42122005). No further testing on PAI is required at this time due to folpet's limited use. Additional data
would be required with any expansion of folpet use.
Aquatic invertebrate life-cycle testing is required since folpet is applied repeatedly by air blast and
may contaminate waterways via drift. A life cycle study in Daphnia magna showed a NOEL greater than
L88ppm(MRlD42122013);effectsincludedreducedlengthandnumberofyoungproduced. Theresults
of this flow-through study are inconclusive because measured concentrations at all test levels varied
substantially during the test. Therefore, the actual chronic levels to which the test organisms were exposed
are unknown. The Agency considers this study unacceptable. Guideline 72-4B (OPPTS Guideline
850.4400), Chronic Daphnia Toxicity, is a data gap. These data are considered to be confirmatory and
are not expected to alter the conclusions of the RED.
iii. Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine organisms is required when an end-use product is
expected to reach the estuarine environment in significant concentrations. The current location of the
avocado growing region in Florida is unlikely to present a nontarget exposure scenario for estuarine and
marine organisms. Therefore, these data are not required to maintain the current folpet registration Some
estuanne and marine toxicity data have been submitted; these data are presented in the supporting
Environmental Fate and Effects Division RED chapter.
49
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c. Toxicity to Plants
i Terrestrial
Terrestrial plant testing (seedling emergence and vegetative vigor) is not required for folpet. There
^ Cither phytotoxicity label statements or reports of nontarget phytotoxic effects, so there is no reason
to test the toxicity of folpet on terrestrial plants.
i, . 1" ! ,,, ' , , :„ ' J | ,'''!' I'" ' ' '' ' ' ''•,:'
ii. Aquatic Plant Growth
Agency would tyPicaNy. require aquatic plant testing for folpet since it has outdoor non-
resident!a^ tenistrial uses ^it: may move off-site during application by drift (e.g., it has aerial and air blast
applications). The typical application scenario for applying folpet to avocados is by airblast. There is also
a study demonstrating phytotoxic effects of folpet on a species of alga (Scenedesmus subspicatus). The
results of this toxicity test indicate that this particular algae species experienced a 50% inhibition in growth
at less than 1 ppm; the ECSO in the study was 0.1 ppm (MRID 00137693). However, the Agency is not
requinng f^tosc testing on either the parent folpet or its degradates at this time due to folpet's limited use.
Additiqna] dag would be required with any expansion of folpet use. The required data would include
OPPTS Guideline 850-54°P (°pP Guideline 123-2), Tier 2 aquatic plant growth, which would further
characteri?e tos toxicity of folpet to aquatic plants in the case of expanded use. Testing would be required
on five aquatic species: Selenastrum capricornutum, Lemnagibba, Skeletonema costatum, Anabaena
flosaquae, and a freshwater diatom).
2. Environmental Fate and Transport Data
tfie environmental fate and transport databases are adequate to support reregistration of folpet.
To summarize, folpet dissipation appears to be dependent on abiotic hydrolysis and microbial-mediated
degradation. Folpet degrades rapidly (half life, t,/2, of 2.6 hours to 2 days) in aquatic and terrestrial
cnyirofflpents, and its degradates contain either the trichloromethyl moiety of folpet or the phenyl-ring of
folpet (i.e., phthalimide (PI), phthalarnic acid (PAM), or phthalic acid (PAI)).
ill -it'll ,. ' : ''l.'x' ',: ,,i . J1 , " ' , ,'• .• • ' .I1'11' ! I!-",;.1'" ii!'1 ! "i1 ' '' '. ', ' ' : .. ••'I,'"!"'•' V ', ' '"E ' ,
„ "„,, ,£,;;; ""„ a.' ,' Degradation
' " - •„' „ ''.in.1 - ' '.'' „; .v ' ," ' 'i.- ,. ., .I-1 • „ •" " i""'" '. ' .>"«„'' , ' • ' i"':
,!' I
i. Hydrolysis
RadiolabeledfolPet5at 1 to 1.2ppm,hasahalf-Ufeof2.6hoursinpH5buffer, 1.1 hours inpH
7 buffer, and 67 seconds in pH 9 buffer (MRID 40818801). Hydrolysis products were PI, PAM, and
PAI.
7116 tncWoromethyl moiety of folpet appears to hydrolyze rapidly in pH 5,7, and 9 buffer solutions
(MRID ^5-?)1)> Potential ^^y818 Products of $* ^cWoromethy moiety of folpet are
:' ' ' " " 50
-------
trichloromethylmercaptan)thiophosgene,C02,H2S,andCOS.Tliehydrolysisdatarequirement(Guideline
161-1) is fulfilled for reregistration. No additional hydrolysis data are required at this time.
ii. Photodegradation in Water
Radiolabeled folpet, at 0.96 ppm, in pH 3 buffer degraded in less than 8 hours at rates similar to
the dark controls when irradiated with UV light for 8 hours. Phthalimide was detected in irradiated and
dark controls. These data show that folpet degradation in water is governed by hydrolysis and does not
appear to be dependent on photodegradative processes. The data requirement for photodegradation in
water (Guideline 161-2) is fulfilled for reregistration. No additional photolysis in water data are needed
at this time.
iii. Photodegradation on Soil
Existing data show that radiolabeled folpet had longer half-lives in irradiated treatments (17 and
68 days) when compared with dark controls (7.3 and 42.8 days) (MRID 42122026). These data suggest
that photodegradation on soil is not a major route of dissipation for folpet. However, the existing data do
not meet FIFRA guideline requirements. This study cannot be upgraded because of inherent technical
difficulties associated with material balance and degradate identification. Additionally, the study results on
the persistence of folpet in soil under irradiated conditions contradict the low folpet persistence observed
in the aerobic soil metabolism study (MRID 42122022) and field dissipation studies (MRIDs 4212207 and
42122028). The photodegradation on soil study does not need to be repeated to support folpet use on
avocados because the data suggest that photodegradation on soil is not an important route of dissipation
for folpet. Further, the localized use of folpet on avocados in Florida limits the need for extensive
environmental fate data.
iv. Photodegradation in Air
The data requirement for a photodegradation in air study (Guideline 161-4) is waived Folpet has
a low vapor pressure (<1 x 10'5 mmHg) obviating the need for these data.
v.
Aerobic Soil Metabolism
Radiolabeled folpet, 10 ug/g, has a first-order half-life of 75.4 days in Georgia sandy loam soil
(MRID 42122022). Since the degradation pattern for folpet is biphasic, the registrant estimated two half-
lives to reflect distinct differences in degradation rates. The estimated half-life of folpet is 4 3 days from
0 to 14 days post-treatment and 164.5 days from 14 to 365 days post-treatment. The Agency estimated
an integrated first-order half-life of 2.55 days from non-transformed data using non-linear regression The
integrated first-order half-life provides the most reliable description of folpet degradation without censoring
the original data. Non-volatile soil degradates of folpet were PI and PAL The Agency calculated first-
order half-life of PI is 17.2 days. The major volatile degradate (cumulative concentration 69.8%) was
51
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CO2.
In another older aerobic soil metabolism study, carbonyl-labeled folpet at 5.92 ppm had a half-life
of 2.4 days in a sandy loam soil (MRID 00160422, 42122022). Formation of radiolabeled carbon
dioxide was rapid; 74% of applied radioactivity was measured as I4CO2 at 7 days post-
treatment.
data requirement for aerobic soil metabolism (Guideline 162-1) is fulfilled. No additional
aerobic soil metabolism data are required at this time.
vi. Anaerobic Soil Metabolism
Radiolabeled folpet, at 10 ppm, has an estimated anaerobic soil half-life of 14.6 days in anoxic
Georgia sandy loam soil (MRID 42122023). Non-volatile degradates of folpet are PI and PAL The
major volatile degradate was CO2.
In an earlier anaerobic soil metabolism study, researchers found carbonyl-labeled folpet at 5.33
ppm had a half-life < 7 days in anaerobic loamy sand (MRIDs 0160422 through 0160428). PAI and
PAM ^ a combined maximum concentration of 44.6% of applied folpet at 1 12 day post-treatment and
declined to 1 8 % of applied folpet at 365 days post-treatment. Carbon dioxide was a major volatile
degradate (80% of applied radioactivity).
data requirement for anaerobic soil metabolism (Guideline 162-1 ) is fulfilled. No additional
data are required at this time.
viL Aerobic and Anaerobic Aquatic Metabolism
Aerobic and anaerobic aquatic metabolism data are not needed because folpet is not directly
applied to aquatic environments. Because all wood and paint preservative uses are restricted to terrestrial
environments, the Agency believes that direct impacts to aquatic environments are not likely. The Aerobic
and Anaerobic Aquatic Metabolism (162-3 and 162-4) data requirements are waived for current uses of
folpet. No additional data are required at this time.
-
b. Mobility
Leaching and Adsorption/Desorption
S!?dies submitted to the Agency indicate that folpet residues are mobile, as indicated by low
soil/water partitioning coefficients. The Freundlich adsorption coefficients for folpet range from 0.13 to
0.22 rnL/g, and desorption coefficients ranged from 0.04 to 0.12 mL/g. Corresponding K_ values ranged
from 7.47 to 21.87 mL/g.
52
-------
The un-aged batch equilibrium data are non-upgradable, supplemental, studies because of problems
withidentification of specific folpet residues, sterilization of soil, and discrepancies between adsorption and
desorption coefficients (MRID 42122025). Since radiolabeled residues were not identified and folpet
hydrolyzes rapidly in water, the Freundlich partitioning coefficients are only representative of total folpet
residues (parent and degradates) and not folpet alone. Further, the use of sterile soils is discouraged
because it can alter the physicochemical properties of soils which may alter the batch equilibrium
coefficients.
The aged residues mobility portion of the batch equilibrium/soil column study do not fulfill the data
requirement for Guideline 163-1. Aged soil column data are unacceptable because of inadequate
identification of residues, inadequate residue aging period, and low material balances. Low material
balances prevent confirmation of experimental and analytical methodologies. Because folpet has a relatively
short half-life in soil, a 30 day pre-incubation period is too long to assess mobility of folpet degradates
(e.g., PI and PAI).
Although the studies have numerous scientific deficiencies which limit data interpretation, the
Agency believes that additional batch equilibrium studies (Guideline 163-1) are not needed since folpet
residues (including folpet, phthalimide, phthalimic acid, phthalic acid) have a low soil water partitioning
coefficients, indicating high mobility. The Agency assumes that all folpet residues are highly mobile in
terrestrial and aquatic environments.
The batch equihbrium/soil column leaching (Guideline 163-1) data are adequate for reregistration
of the avocado use of folpet. Batch equilibrium data on soil cannot be used to support paint uses of folpet.
Partitioning of folpet from paint coatings is expected to be different than soil/water partitioning.
ii. Volatility
The Laboratory Volatility (163-2) data requirement is waived because folpet has a low vapor
pressure(
-------
residues are rapidly eliminated (greater than 93%) over a 7 day depuration period. PAI and phthalic
anhydride are major metabolites (i.e., greater thanlO% of accumulated residues) in fish fillet and viscera
ffhthahc anhydride was not identified in other fate studies, and is not of toxicological concern to the
Agency.) Folpet, PI, and PAM are minor constituents (less than 10% of accumulated residues) in fish
tissues.
, . . J •-•-J for folPet are based solely on total radiolabeled residues and not specific
folpet residues. Further analysis of radiolabeled residues in both water and fish tissues indicates that folpet
was not stable during study. More importantly, PAI is a major degradate in the aquarium water as well
as in fish fillets and viscera. These data suggest that folpet should not bioconcentrate in fish because it
rapidly hydrolyzes in water. Independent laboratory environmental fate data substantiate that folpet does
nptpersistinsoilandaquaticenvironments. Also, the data suggest that phthalic acid should not accumulate
in fish tissues. The data requirement for the bioaccumulation in fish study (Guidelinel 65-4) is fulfilled No
additional data are needed at this time.
: i'i ' „ ill •' • , ' " ''!" ,' '
iv. Field Dissipation
^ Supplemental terrestrial field dissipation studies on citrus in Florida provide limited confirmation on
•T f°*es °Cdlss?Pation for folPet (MRIDs 42122027 and 42122028). Folpet, at 18 Ibs a.i /A has a 50%
dissipation time of less than 1 week when applied to oranges in central Florida. Although the field
dissipation (Guideline 164-1) data requirement is not fulfilled, additional field studies are not needed
because of limited folpet use.
v. Spray Drift
Droplet size spectrum (Guideline 201-1) and drift field evaluation (Guideline 202-1) studies were
required due to airblast application to orchards, which raise a concern for potential risk to nontarget
aquatic organisms. However, to satisfy these requirements the registrant in conjunction with registrants of
other pesticide active ingredients formed the Spray Drift Task Force (SDTF). The SDTF has completed
and submitted to the Agency a series of studies which are intended to characterize spray droplet drift
potential due to various factors, including application methods, application equipment, meteorological
conditions, crop geometry, and droplet characteristics. The Agency plans to complete its evaluation of
S'ffC§^ ^T"" ^ ^ ^ lnterim ** f°r ** RED' ** Agency is KlV°£ on Previously
subrnittedsp^ Theratesare 1% of the applied
spray volume from ground applications and 5% from aerial and orchard air blast applications at 100 feet
downwind. After its review of the new studies, the Agency will determine whether a reassessment of the
potential risks to nontarget organisms is warranted.
• i ;•! . • „, ' • • HI " ' , .- •: ;!'':;;"fir • , ^,i - „ , "• i '„(", " PI, •• i • - ,, •
54
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3. Water Resources Assessment
The Agency has conducted a Tier I water resources assessment for folpet. This assessment is
limited because of deficiencies with the environmental fate data. Monitoring data are not available at
present, thus this assessment of potential ground and surface water exposure is based on screening models
Tier 1 surfacewatermodelingindicatesmaximumacuteconcentrationsoffolpetof 159ug/L Themodeled
maximum 56 day average annual chronic concentration of folpet is 2.6 ug/L. Tier 1 surface water modeling
the maximum acute and chronic concentration for PI is 219 ug/L.
Because folpet exhibits a clear biphasic degradation pattern in an aerobic soil metabolism study
(MRID 42122010), the Agency estimated a new half-life of 2.55 days using an integrated first-order
degradation model fit to non-transformed data. This half-life provides a better description of folpet
degradation without censoring data.
The potential for folpet contamination in ground and surface waters is expected to be limited
because of the environmental fate behavior of folpet, limited use area, and foliar dissipation. Since folpet
degrades rapidly in aquatic and terrestrial environments, folpet is not expected to pose a threat to ground
and surface waters. Additionally, most folpet use on avocados occurs in single county in Florida which has
extensive areas of surface water (e.g., Everglades) and shallow ground water levels. Based on geographic
site analysis, the registrant stated the folpet use area is approximately 3 miles from the Everglades This
information suggests that direct folpet movement into the Everglades would be dependent on long-range
spray drift. Since folpet is a foliar-applied fungicide and hence is likely to have indirect impact to terrestrial
environments, there is limited potential for ground water contamination because of foliar interception and
dissipation processes. It is reasonable to assume that foliar interception will reduce the environmental
loading of folpet. The magnitude of the load reduction cannot be quantified at this time.
Based on limited environmental fate data, phenyl ring degradates of folpet have sufficient mobility
and persistence for potential movement in ground and surface waters. The rapid hydrolysis of the
tnchloromethyl moiety of folpet is expected to limit persistence in ground and surface waters A possible
degradateofthetnchloromethylmoiety is thiophosgene. The fateoflhiophosgene appears to be dependent
on volatilization. However, thiophosgene was not detected as a volatile component in any of the submitted
laboratory studies. Therefore, based on data submitted to the Agency, the amount of thiophosgene formed
by folpet degradation cannot be quantified. For this reason, and because the Agency currently has no
methods for estimating exposure to vapor-phase residues, the risk posed by folpet-derived thiophosgene
to non-target organisms cannot be calculated.
The registrant states that thiophosgene is not likely to enter the environment via volatilization
because it will instantaneously react with most compounds containing -OH, -NH2, and -SH groups To
document this claim, the registrant provided literature citations on the reactivity of thiophosgene with
ammonia, amines, thiols, epoxides, ketones, and phenols. Degradation products include ammonium
thiocyanate, thioureas, thiocarbonates, HC1, H2O, and CO2. Furthermore, thiophosgene has an estimated
55
-------
vapor pressure of 29.7 mmHg and an estimated Henry's constant of 0.00586 atm-rriVmole.
In summary, thiophosgene is not expected to be a drinking water concern, due to dissipation either
by volatilization or reaction with compounds on leaf surfaces or in the soil. Thiophosgene can degrade to
fomj ammonium thiocyanate, a potentially toxic degradate. However, the extent to which this compound
is formed by degradation of thiophosgene cannot be quantified, since the amount of thiophosgene formed
in the environment is not known, and because ammonium thiocyanate is only one of several possible
degradates of thiophosgene.
a. Ground Water
No ground water monitoring data are available for folpet. Therefore, potential maximum folpet
concentrations in groundwater were estimated using the SCI-GROW screening level model. The SCI-
GROW mSdeI predicts that groundwater concentrations of total folpet residues (folpet + PI) of 5.8 ppb.
Re-§ult5? fr°m SCI-GROW are based on the fate properties of the pesticide, the application rate,
and ±e e^stinS j^y of d313 from small-scale ground water monitoring studies. The model assumes that
the pesticide is applied at its maximum rate in areas where the groundwater is particularly vulnerable to
con^amir¥%P- Jl°fw^ver' a c°9fdera;ble portion of any use area will have groundwater that is less
vulnerable to contamination thaii the areas used to derive the SCI-GROW estimates. As such, the
estimatediQaxMuni .concentration derived using SCI-GROW should be considered a high-end to bounding
6511111316 4acul6 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
exposuresi
% *® screei1 inc¥4ed tye maximum application rate of 2 1 Ibs a.i./A/year for folpet and
calculated maximum application rate of 1 1 .55 Ibs a.i./A/ year for PI. The application rate for PI is a source
of significant uncertainty in this assessment. This rate was derived by multiplying the maximum annual rate
of 21 lb a-i/A of folpet by 0.55, the maximum amount of PI detected in any laboratory study as a
percentage of applied folpet. The Agency used an aerobic soil metabolism half life of 2.5 days for parent
folpet (17.2 days for PI), and a median K^ for folpet of 17 mL/g (7.1 mL/g for PI).
Compound
Folpet
PI
Total Folpet Residues (Folpet + PI)
Groundwater Concentration
(ppb folpet equivalents)
0.06
5.7
5.8
The potential for folpet contamination of groundwater is expected to be limited because of the
56
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environmental fate of folpet, the limited use area, and foliar dissipation. Folpet degrades rapidly in aquatic
and terrestrial environments, and so is not expected to pose a threat to ground water. Folpet use is also
currently limited to a single county in Florida. Also, folpet is a foliarly applied fungicide so the
environmental loading should be reduced by foliar interception and dissipation.
b. Surface Water
Tier 1 surface water modeling indicates the maximum acute concentration of folpet is not likely to
exceed 159 ug/L. The GENEEC model predicts a 56 day average annual chronic concentration of folpet
of 2.6 ug/L. Tier 1 surface water modeling predicts that the maximum acute and chronic concentrations
are PI equal to 219 ug/L.
The following data were used for input into the GENEEC modeling for folpet:
Parameter
soil Koc
Aerobic soil half-life
Aerobic aquatic half-life
Photolysis Half-life (pH 7) Stable
Hydrolysis (pH 7)
Water Solubility
Value Reference
7.4 mL/g MRIDs 42122022
2.55 days MRTD 42122021
Stable Assumption
MRIDs 42122021
0.05 days MRID 40818801
1.3 mg/L Assumption
Annual Application Rate
(Ibs a.i./A)
3 (single application)
21 (seven applications)
Peak
91
159
4 Days
23
40
21 Days
4
8
56 Days
2
3
GENEEC EECs are based on e,ther a single application of 3.0 Ibs a.:./A or seven applications of 3.0 Ibs a i /A at 14-dav
application intervals (Folpet 50 W label, EPA Reg. No. 66222-7). Y
i vr Water assessment for PI is based on the following assumptions: (1) the K, and
solubility ofPI are equivalent to parent folpet; (2) the aerobic soil metabolism half-life was estimated from
the aerobic soil metabolism data (MRID 42122021); (3) the batch equilibrium coefficient for folpet was
used as a surrogate value; and 4) the application rate of PI is assumed to be 55% of the folpet application
rate based on mass conversion efficiency in the aerobic soil metabolism study (MRID 42122021)
57
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The following data were used for input into the GENEEC modeling for PI:
i f
I!"1"!!"
Parameter
Soil K,,,
Aerobic soil half-life
Aerobic aquatic half-life
Photolysis Half-life (pH 7) Stable
Hydrolysis (pH 7) Stable
Water Solubility
Value
7.4mlUg
„ 17.2 days
Stable
Reference
MRID 42122025
MRID 42122022
Assumption
Assumption
Assumption
1.3mg/l Assumption
Table 21. GENEEC EECs(ug/L) for PI Use on Avocados
Annual Application Rate (Ibs a.i./A)
21*
Peak
219
I Days
219
21 Day;
219
56 Day:
219
* Application rate of PI is based on 55% conversion efficiency from parent folpet. This conversion efficiency is based
on the maximum concentration (expressed as percent of folpet) found in the aerobic soil metabolism study (MRID
42122021).
n£ folPet exhib,its aa clear biphasic degradation pattern in an aerobic soil metabolism study
(MRP 42122021), the Agency estimated a new half-life of 2.55 days utilizing an integrated first-order
degradation model fit to nqn:transfomied data. This halfeUfe provides a better description of folpet
degradation without censoring the data. The surface water assessment for PI is based on the same
assumptions.
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4. Ecological Exposure and Risk Characterization
a. Explanation of the Risk Quotient (RQ) and the Level of Concern
(LOC)
The Agency characterizes the ecological risks of a pesticide by assessing the acute and chronic
toxicity to four nontarget faunal groups and acute toxicity for each of two nontarget floral groups.
Acute toxicity is expressed as follows:
-EC25 (terrestrial plants),
-EC 50 (aquatic plants and invertebrates),
-LC50 (fish and birds), and
-LD50 (birds and mammals)
Chronic toxicity is expressed 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.
A risk quotient is then 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. The risk
quotient is then compared with an appropriate level of concern (LOC), which is a criterion used to indicate
the level at which significant adverse effects may be expected to nontarget organisms. The LOC indicates
whether a chemical, when used as directed, has the potential to cause undesirable effects on nontarget
organisms. 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.
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Table 22, Levels of Concern (LOG) and associated Risk Presumption
IF...
THEN the Agency presumes...
Mammals and Birds
The acute RQ > LOG of 0.5,
The acute RQ >LOC of 0.2,
The acute RQ > LOG of 0.1,
The chronic RQ > LOG 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 > LOG of 0.5
The acute RQ > LOG of 0. 1
The acute RQ >LOC of 0.05
The chronic RQ > LOG of I
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
TheRQ>LOCofl
The RQ > LOG of 1
High risk
Endangered plants may be affected
b. Exposure and Risk to Nontarget Terrestrial Animals
: 1( >,!'" ' • ' - " i. Birds
Residues fpundpn dietary food items following folpet application may be compared to LC50 values
to predict hazard. The maximum concentrations of residues of folpet which may be expected to occur on
selected avjan or mammalian dietary food items following both single and multiple foliar application rates
are provided in the tables below. Residues per pound of active ingredient 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. The
majdmum rec°!!ded values fof a*1 application rate of 1 Ib/al/acre reported in these studies are: short grass
(240 ppm), long grass (110 ppm), broadleaf (135 ppm), and fruits (15 ppm).
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There are no definitive risk quotients for acute risk because definitive LC50s are not available for
the core avian studies. However, folpet applied at the highest label rate is not expected to exceed the
maximum doses at whichavian species were tested. 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 dietarv
exposure.
For multiple applications of a pesticide, the terrestrial exposure model FATE is used to estimate
residues based on accumulation from repeat applications at a given interval and degradation rate due to
estimated foliar dissipation. Because actual foliar half-life data are not available, the dissipation half-life of
2.55 days is estimated by the Agency based on data submitted by the registrant. Maximum initial residue
values are used, as described in Fletcher (1994). Folpet concentrations are expressed as EEC maximum
and average maximum. The model assumes that folpet is applied to avocados grown in an orchard with an
understory and between row vegetation of short grass. The Agency assumes an initial foliar residue of 720
ppm Mowing 7 applications with a 14 day interval between applications and a half life of 2 55 days
When the model simulation is run for a time duration of 100 days, the model predicts maximum residue of
736 ppm and average residue of 210 ppm.
Table 23. Terrestrial Estimated Environmental Concentrations (EECs) for Folpet
Use Site
Avocados
App. rate
(Ibs a.i./A)
No. of
applications
Application
interval
(days)
Single Application
3
Avocados
3
1
N/A
Multiple Applications
7
21
Food item
short grass
long grass
broadleafplants/
insects
seeds
short erass
long grass
broadleafplants/
insects
seeds
EEC
(ppm)
maximum
720
330
405
45
736
338
414
46
EEC
(ppm)
average
mean
N/A
N/A
N/A
N/A
209
96
118
13
Based on a review of the data, it appears that folpet applied to avocados in Florida, at maximum
label rates, would provide minimal acute or chronic exposure risks to avian species
Estimated maximum residues resulting from multiple applications at the maximum rates and minimum
61
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intervals are below the no-mortality level in all avian LC50 test data. Therefore, it appears unlikely that these
dietary residues would result in avian mortality. Avian reproduction testing was conducted up to 1000
ppm, with no effects reported. Use of folpet on avocado at the maximum label rate of 3 lbs/a.i./A,
maximum number of applications and minimum application interval would result in maximum residues less
than 1000 ppm on all avian food items.
11.
Mammals
Small mjimmal exposure is addressed using the acute oral LDJO values converted to estimate a LC50
value for dietary exposure. The estimated LC50 is derived using the following formula-
': ' .' '• !'!lil' •:'.,: •' • '! .'•" !'" • i-i i ,: . , ., "v ' i "'"' i''"I " v '•, •''' , . . . .,
LC50 = LD5(< x bodv weight (gt
food consumption per day (g)
'"tH
i
Table 24. Small Mammal Food Consumption (Based on an LDSO = 19.5 gm/ks)
Small Mammal
Meadow Vole
Adult Field Mouse
Least Shrew
Body
Weight
(g)
46
13
5
% of Weight
Eaten Per
Day
61
16
110
Food Consumed
Per Day (g)
28.1
2.1
5.5
Estimated LC!0
Per Day (ppm)
31,922
120,714
19,500
Corporation. 1963.
The estimated LC50 is then compared to the residues listed above to calculate a risk quotient
(EEC/LCjo). The estimated LC5<, in these calculations canbe considered as the concentration of toxicant
in the diet fpr one. day that is lethal to 50% of a test population. Table 25 below indicates the risk quotients
for each of the indicated application rates. These risk quotients are based on maximum Fletcher values for
folpet residues.
%d. mod?Is ^.,a?foUows;.me^w vole <»nsuming short grass; adult field
mouse consuming seeds; least shrew consuming forage and small insects. Single applications of folpet at
3 lbs a
-------
1. Maximum residue values are based on direct applications to the target plants. The between
row vegetation in the avocado orchard would be subject to indirect spray.
2. A portion of the airblast spray would be lost to drift.
3. Understory and between-row vegetation in the avocado orchard is likely to consist of mixed
vegetation and not uniform cover of short grass.
At this time, the Agency does not believe that risk to small mammals warrants regulatory action on folpet
given the limited use pattern and the conservatism inherent in the risk assessment.
Table 25. Mammalian Risk Quotients for Folpet Use on Avocados
rate
(Ibs a.i./A)
No. of
applications
Application
interval (days)
Small mammal
Single Application
3
1
1
1
•N/A
N/A
N/A
meadow vole
field mouse
least shrew
Multiple Applications
3
7
14
meadow vole
field mouse
least shrew
Acute Risk
Quotient
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
Chronic
Risk
N/A
N/A
1.05
<1.0
<1.0
iii. Insects
Ecological toxicity data on honey bees indicate that folpet does not appear to pose a risk to honey
bees. No further risk assessment is required at this time.
c. Exposure and Risk to Nontarget Aquatic Animals
Folpet displays high acute toxicity to most aquatic animal species tested. The Agency uses
GENEEC to calculate screening level EECs in water based on drift and runoff from a 10 hectare field to
a 1 hectare wide and 2 meter deep water body. These EECs take into account degradation in the field
prior to a rain event as well as degradation and partitioning in the pond.
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" 11
"I'"!' I '"'iiir .
Table 26. Estimated Environmental Concentrations (EECs) for Folpet applied to Avocados bv
Airblast.
Application
Rate in Ibs a.i./A
(No. of applications.)
3(7)
3(1)
Initial
159.49
90.54
4-day
39.87
22.64
EEC (ppb)
21-day
7.59
4.31
56-day
2.85
1.62
90-day
,
i. Freshwater Fish
^ 1uotients for freshwater fish are given in Table 27 below. Risk quotients for freshwater fish
were calculated according to the following equations:
Acute RQ = initial EEC
: • LC50 ;'' , ' '" , ;
Where the LC50 for rainbow trout, the most sensitive species, is 15 ppb.
Chronic RQ=_
56-davEF.C
Cieom. mean of NOEC and LOEC
,1 "III,,, ,"i , ' ' ' ' 'i' * I '.fi '!, ,M " I, " " " ,"' 'll ' ' ,1',' ' ' I !, "' ' , '• • ' ' , •:'•: , ' ' ' „ ' '
*e geometric mean is of the NOEC from the fish early life-cycle and of the LOEC of 8 1
ppb for the fathead minnow.
,},,, '! I. i - '! ..< ,i; ,,:":• *,": I '• 'i,ul/ II ill III ., i;1 ' ' '.",' I '•. ' ' ''''" ":! " ' •• ' ' • '
Table 27. Risk Quotients (RQs) for Freshwater Fish
Application Rate, Ib a.i./A
Number of applications.
7
1
Acute RQ
10.6
6.0
<1.0
<1.0
Air blast applications of folpet, at the maximum label rates for avocado, are expected to exceed
*te n?k restricted use, and endangered species LOCs for fish. Chronic risk to fish is not expected
based on the MATC (geometric mean of the NOEL and LOEL) for growth effects derived from fathead
minnow fish full life when compared to the EEC averaged over 56 days.
Tests with the PI degradate on freshwater fish reported LD50 values of 49 ppm for rainbow trout
™d™ ppm for blue^ sunfish- No LOC for this degradate would be exceeded with the proposed use
of folpet on avocado in Florida.
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ii. Freshwater Invertebrates
Risk quotients for aquatic invertebrates are given in Table 28 below. Risk quotients for freshwater
invertebrates were calculated according to the following equation:
Acute RQ = initial EEC.
LC50 .
Where the LC50 for D. magna, the most sensitive species, is 20 ppb.
The Chronic RQ was not calculated because the chronic NOEL was not reported.
Table 28. Risk Quotients (RQ) for Freshwater Invertebrates
/ no. of applications.
Acute RQ
8.0
4.5
Chronic RQ
Not calculated, no data available
Not calculated, no data available
Air blast applications of folpet, at the maximum label rates for avocado, are expected to exceed
high acute risk, restricted use, and endangered species LOCs for freshwater invertebrates. Chronic risk
to freshwater invertebrates cannot be calculated from the data submitted.
Tests with the PI degradate onDaphnia magna reported an LD50 value of 39 ppm. No LOG
for this degradate would be exceeded with the current use of folpet on avocado in Florida.
iii. Estuarine and Marine Animals
As described previously in this document, the current location of the avocado growing region in
Florida is unlikely to present a nontarget exposure scenario for estuarine and marine organisms. The risk
assessment for estuarine and marine animals used a conservative model to predict the maximum amount
offolpetthat could occur in surface water foUowing air blast appHcations to avocados at the maximum label
rates. The risk quotients calculated by this method showed apotential concern for acute risks to estuarine
and marine animals and risks to endangered species. However, as stated previously, actual exposure to
estuarine and manne animals is extremely unlikely. If the folpet registration were expanded to include other
use sites, risk to estuarine organisms could be a potential concern.
Tests with the PI degradate on Eastern oyster, Mysid shrimp, and Sheepshead minnow yielded
LC50 values of 12.1, 13.8, and 47.7 ppm, respectively. No LOG for this degradate is likely to be
exceeded with the proposed use of folpet on avocado in Florida.
65
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j, "ililii:",!*' :i""
"Jit
" t
d. Exposure and Risk to Nontarget Plants
There is no risk concern for terrestrial plants. There are neither phytotoxicity label statements or
reports of nontarget phytotoxic effects, so there is no reason to test the toxicity of folpet on terrestrial
plants. Further, exposure terrestrial plants is expected to be extremely limited.
The risk to aquatic plants cannot be determined at this time. Folpet shows high acute toxicity to
the aquatic plant species tested; the EC50 for £ subspicatus, an alga is 0.1 ppm. Comparing this value
to *!?? max!mi™ initial aquatic EECs shown earlier indicates a potential risk concern. However, as stated
Previously, actual exposure to aquatic plants is extremely unlikely given the limited use. If the folpet
registration were expanded to include other use sites, risk to aquatic plants could be a potential concern.
Additional data on aquatic plants would be required to support additional use sites. The Agency typically
requires tests with five aquatic plant species.
e. Endangered Species
The Agency has concerns about the exposure of threatened and endangered species to folpet.
Levels of concern (LOG) are expected to be exceeded for aquatic organisms exposed to single or multiple
applications of this fungicide.
There are a number of endangered species in Bade County, Florida. These include the Everglades
s^ khe, whosejmrnary diet consists of apple snails. Although folpet was considered practically nontoxic
to ayian species, the reported high toxicity of folpet to aquatic invertebrates requires measures to reduce
the risk of folpet reaching bodies of water. These measures would include label advisories concerning drift
potential when adjacent to apple snail habitat.
The Agency has developed a program (The Endangered Species Protection Program) to identify
Pesticides whose use may cause adverse impacts on endangered and threatened species, and to implement
mitigation measures that will eliminate the adverse impacts. At present, the program is being implemented
On ^ "lterim b!J?is ^ described in a Federal Register notice (54 FR 27984-28008, July 3,1989), and is
providing information to pesticide users to help them protect these species on a voluntary basis. As
currently planned, the final program will call for label modifications referring to required limitations on
pesticide uses, typically as depicted in county-specific bulletins or by other site-specific mechanisms as
5)ec^e^ by state P3111161^- A final program, which may be altered from the jnterim program, will be
described in a future Federal Register notice. The Agency 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.
66
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f. Environmental Risk Characterization
Based on analysis of the data submitted, minimal non-target risks are expected by the use of folpet
on avocados in Florida, with the possible exception of the endangered species mentioned above. None
of the levels of concern (LOCs) for avian and mammalian species are expected to be exceeded at the
maxunum label application rates and frequencies. Although folpet is very highly toxic to freshwater fish and
invertebrates, the avocado groves in Florida are spatially removed from water bodies (e g Everglades
other wetlands, and the Atlantic Ocean). Additional uses would require new assessments of anticipated
LOCs and adequacy of ecological toxicity data base. Although folpet residues appear to be mobile folpet
B not persistent in terrestrial or aquatic environments. Rapid degradation of folpet should limit the potential
for off-site movement and accumulation in ground and surface waters.
Major degradates of folpet include PI and PAL The environmental fate data suggest the phenyl-
.nng degradates of folpet are more persistent than parent folpet; the trichloromethyl moiety hydrolyzes
rapidly to potentially form thiophosgene. Mobility of PI and PAI appears to be comparable to parent
folpet. Thiophosgene dissipation is expected to be dependent on reactivity. Toxicity and exposure
modehng indicate PI is orders of magnitude less toxic than parent to non-target animals and would not
exceed LOCs, even for endangered species. No toxicity data are available for PAI.
The water resource assessment is based on the current labels, which restrict agricultural use of
folpet to avocados in Florida. The limited potential use pattern for folpet on avocados in Florida is
documented in the open literature. The 1992 Census of Agriculture lists only Brevard and Dade counties
as having commercial acreage in avocado production. The total acreage for Brevard County is 5- the total
acreage for Dade County is 5829. There were 585 avocado orchards in Dade County. This yields an
average avocado orchard size of approximately 10 acres.
Dietary exposure through drinking water is likely to be greatly limited because of folpet's limited
use area and its environmental fate properties (e.g., rapid hydrolysis). Therefore, Tier 1 modeling for folpet
for the water resource assessment is considered conservative, because the extent of the use pattern and
n°^rffo^^
SCI-GROW groundwater screening model predicts that the maximum acute and chronic concentrations
of folpet are each 0.026 ug/L. Tier 1 surface water modeling predicts that the maximum "acute
concentrations of folpet is 159 ug/L and the maximum 56 average day annual chronic concentration of
folpet is 2.6, ug/L. Tier 1 surface water modeling for the degradate phthalimide.predicts that the maximum
acute and chronic concentrations for phthalimide are both 219 jig/L.
Further characterization of the use area indicates that Dade County has extensive surface water
areas (e.g., Everglades) and shallow ground water. There are no lakes in the avocado growing region The
avocado groves closest to estuarine marine environments are 5 to 6 miles from the coast However the
folpet use area is approximately 3 miles from the Everglades. Because the folpet use area is not directly
adjacent to large surface water bodies, direct deposition of folpet into surface water is expected to be
67
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dependent on long-range spray drift. Because folpet is a foliar-applied fungicide, it is reasonable to assume
that foliar interception will further reduce the environmental loading of folpet. Therefore, the Agency
believes that long range spray drift of folpet is unlikely at this time.
The non-food uses for folpet include incorporation of the fungicide into paints and stains. The
potential of leaching to aquatic systems could be a concern if folpet were used inadvertently in products
designed to protect wood in contact with soil or water. However, folpet undergoes rapid hydrolysis,
making it unsuitable for use in antifoulant paints. Further, there is a label restriction against release to water.
Limited acreage and spatial isolation are two of the mitigating factors limiting the potential risk to
aquatic organism from the use of folpet on avocados in Florida. Agricultural practice may also be a factor.
In.summary, acute and chronic ecological effects are not anticipated from folpet use at this time.
Minimal acute and chronic effects are anticipated from avian and mammalian species exposed to folpet
residues, at the maximum label rates, resulting from the use of this product on avocados in Florida.
Estimated environmental concentrations (FJECs) for this application are below either the no effect levels
(NOELS) or the maximum dosing levels for tested avian and mammalian species. Folpet is also considered
relatively nontoxic to honeybees.
Folpet is acutely toxic to both fish and aquatic invertebrates. Acute LOCs are above the level of
concern for all iquatic animals tested, but chronic LOCs should not be exceeded for both fish and aquatic
invertebrates. Since folpet degrades rapidly, a complete toxicity profile should include an analysis of the
maJ°r, ah"', 'I,:,"'I ' '•: ' ' ,; '
There are a number of endangered species in Dade County, FL. These include the Everglades
Snail KitQ,,,,whose primary diet consists of apple snails, which may be endangered if exposed to folpet
because folpet has been shown to be highly toxic to other aquatic invertebrates. However, the treated
avocado groves are 3 miles from the Everglades. Therefore, the most likely route of exposure to snails
would be long range spray drift, which can not be quantified at this time. The current spray drift label
advisory should be continued. Additional drift mitigation practices may be identified following review of
the Spray Drift Task Force database.
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IV. RISK MANAGEMENT AND REREGISTRAT ION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA caUs for the Agency to detennine, 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 generic (i e active
ingredient specific) data to support reregistration of products containing folpet as an active ingredient The
Agency has completed its review of these generic data, and has determined that the data are sufficient to
support reregistration of all products containing folpet for use on avocados in Florida and in sealants and
coatings (such as caulking, paints, and stains). Appendix B identifies the generic data that the Agency
reviewed as part of its determination of reregistration eligibility of folpet.
These data were also sufficient to allow the Agency to determine that folpet can be used on
avocados in Florida and in sealants and coatings without resulting in unreasonable adverse effects to
humans andmeenvironment. The Agency therefore finds that the products registered for these specific uses
containing folpet as the sole active ingredient are eligible for reregistration. Actions needed to reregister
particular products are addressed in Section V of this document.
The Agency made its reregislration 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 that all uses of folpet 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 folpet
if new information comes to the Agency's attention or if the data requirements for registration (or fee'
guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient folpet, the Agency has sufficient
informationon the health effects of folpet and onits potential for causing adverse effects in fish, wildlife and
fee environment. The Agency has determined that folpet products, labeled and used as specified in this
ReregistrauonEligibiliry Decision Document, willnot pose unreasonable risks of adverse effects to humans
or fee environment. Therefore, fee Agency concludes feat products containing folpet for use on Florida
avocados and for use in sealants and coatings (such as caulking, paints, and stains) are eligible for
reregistration. .
2. Eligible and Ineligible Uses
^eAgencyhasdeteirninedfeatuseoffolpetonFloridaavocadosandincoatingsandsealantsare
eligible for reregistration under fee conditions specified in this Reregistration Eligibility Decision. The
69
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not been fulfilled: apples, cranberries, cucumbers, grapes, lettuce, dry bulb onions, strawberries, tomatoes,
and ornamental plants. Only two folpet products (EPA Reg. Nos. 66222-8 and 7401 -231) are registered
for these ineligible uses. Both of these products have been suspended for several years and the registrants
have recently requested voluntary cancellation of both registrations. The Proposed Notice of Cancellation
was published in the Federal Register on August 4, 1999 [FRL 6092-6; OPP 66269] for a 180 day
comment period. The Agency's Reregistration Decision regarding folpet assumes that these uses will be
canceled in the near future.
C Regulatory Position
To lessen the risks posed by folpet, EPA is requiring the following mitigation measures for folpet-
containing products:
* Gloves and dust/mist respirator to reduce exposure and risk to workers adding me
wettable powder to sealants and coatings during the manufacturing process;
j •;::: , :., . • , , " a,.*1 ; . ,t •• .',•". ' • •,; i, ,•(i""1;1: , *"c n f \ • 'Vr • ;,'•; * • • , •, ,?.
f Protective clothing requirements for ready to use products, including long sleeve shirt, long
pants, shoes, and socks;
'"', !ili". i»"': ,„ • ,j ,', , ni , „ !"„ ,,i,'' 'vi i • , ' '.„ i1 ,'i1'. ,"i'!«i' liii::"," •/ ".„ ' " '•*•,"' , •'»' 1 i>i ,,,:.i,i"i. ' •'!' , i| •
• Labeling changes to lessen risks to nontarget aquatic organisms, as provided in Section V
of this document-and
• User safety requirements and recommendations as well as application restrictions for non-
WPS products.
The following is a summary of the Agency's regulatory position and rationale for managing risks
associated with the use of folpet. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1.
Food Quality Protection Act Findings
•' '" " •'" "{, :•' ' ' i, :' ' •••' '',? ' , i • ., ',-/ ' :,
Determination of Safety for U.S. Population
a.
. established tolerances for folpet, with the amendments and changes
specified in mis document, meet the safety standards under the FQPA amendments to section 408(b)(2)(D)
ofthe 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) ofthe 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 understandingof 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, there are pesticides that are toxicologicaUy 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. There are also 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 observed with both compounds. Thiophosgene is a highly reactive short-lived
species which is produced in the gut and believed to cause tumors through the irritation of the duodeum
Because it is so short lived, its residues cannot be quantified. Without measurable residues of the common
metabolite, it is difficult at this time to relate exposures of captan to those of folpet since the rate of
formationofthiophosgene may be differentfor 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 worse case estimate. When this is done, the risks do not exceed the Agency's level of
concern.
The Agency considers residential postapplication exposure to folpet from its use in sealants and
coatings to be negligible because dermal and inhalation exposures are likely to be minimal Therefore EPA
has considered only residential handler exposure together with dietary and drinking water exposures in its
aggregate risk assessment.
In assessing acute aggregate dietary risk, EPA used a NOAEL of 10 mg/kg/day from a
developmental study in rabbits. Because the selected endpoint is from a developmental toxicity study, the
71
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< 'III'IIL' , .'
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metabolite thiophosgene is appropriate.
b. Determination of Safety for Infants and Children
The Agency has determined that the established tolerances for folpet, 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 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
consumptionpattems of infants and children, as well as the possibility of increased susceptibility to the toxic
effects of folpet residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic effects from
folpet 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, folpet has a complete database for developmental and
reproductive toxicity. Reliable studies cited earlier in this document indicate limited concern for special
sensitivity of young organisms to folpet (see Section fflb). However, the Agency has determined that the
Safety Factor can be reduced to 3X based on the developmental and reproductive toxicity studies available
for folpet, as described previously in Section ffl(B)l(d) of this document. The Agency has retained a 3X
FQPA safety factor to ensure adequate protection of infants and children. This FQPA safety factor applies
only to females 13-50 for acute and acute and short-term exposures. Therefore, the Agency has concluded
that a total uncertainty factor of 300 is adequate to protect infants and children. This uncertainty factor of
300, which includes the FQPA 3X, was incorporated into the acute dietary and short-term residential risk
assessments for females 13-50.
The Agency has not yet made a final decision concerning the possible common mechanism of
toxicity and the potential for cumulative effects of folpet 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 and folpet will be revisited to assess the cumulative effects
ofboth fungicides. Therefore, for the purposes of the tolerance reassessments in this RED document, EPA
has considered the risks of folpet only.
During the early stages of the FQPA implementation process, the Agency recognizes that some
decisions will be made as if FQPA were fully implemented. Decisions made on a case-by-case basis 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 reserves the right to reconsider actions or decisions
described in this RED.
73
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' ii;!!11 IK '' •;! rij iiiiiiHii; m i ill i • i? i: mi!
Hi"!
III1 "I, I,
ll.ll'i,
c. Endocrine Disrupter Effects
FQPA requires EPA to develop a screening program to determine whether certain substances
(including all pesticides and inerts or inactive ingredients) "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 to develop a screening and testing program as well as a priority setting
scheme. As the Agency proceeds withimplementation of this program, further testing of folpet and end-use
products for endocrine effects may be required.
' 2.
'"lliiil 1.-
Tolerance Reassessment
'•"-•.I11!"1!,! I'lll'iil .>!.!!'' 1 'iiii.l • "
i, Jit .
I1!1!;,'!!
As part of EPA's reregistration eligibility decision for folpet, all agricultural (except avocado),
ornamental, and greenhouse registrations will be voluntarily canceled The registrants have requested
voluntary cancellation of EPA Registration 66222-8 and 7401-231, which were suspended due to lack of
supporting data. The following uses will be canceled: apples, cranberries, cucumbers, grapes, raisins,
lettuce, melons, dry bulb onions, strawberries, tomatoes, and ornamental and greenhouse uses. However,
the registrant is supporting import tolerances for these commodities. For some commodities, the import
tolei^n^ •y^r^rlo^^Nfi,^?-0^o^eP?c?Wtn a ^registrationbecause the import tolerances are
based on different use information than was used previously. A new tolerance will be established for
imported raisins because residue data show that folpet concentrates in raisins.
For ""Port tolerances> or tolerances without a US registration, EPA requires the same technical
chemistry and toxicology data as for a domestic tolerance. In addition, EPA requires residue chemistry crop
field trials that are representative of growing conditions in exporting countries. The data required to support
these import tolerances are substantially complete. To support the import uses listed above, the following
additional data are needed: storage stability data on cucumbers, melons, and tomatoes; analytical method
for apples.
for residues of folpet in/on plant raw agricultural commodities (RACs) are currently
expressed in terms of folpet per se [40 CFR §180.191]. No food/feed additive tolerances have been
established for residues of folpet. A summary of the folpet tolerance reassessment and recommended
mqdificatipns in commodity definitions are presented in the following table.
,n i.. 'ill: , '
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74
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Table 29. Tolerance Reassessment Summary for Foloet
Current
Tolerance
Comment/'Correct Commodity Definition
Tolerances listed under 40 CFR §180.191
"^ ~-~— ———^——_
Residue data support lower tolerance.
Import only. No U.S. registrations for
this commodity. Analytical method data
are required.
Regional registration for Florida only.
Storage stability data are required.
Residue data support lower tolerance.
Import only. Storage stability data are
required.
Residue data support higher tolerance.
Import only.
Import only. Storage stability data are
required.
———————^——-
Residue data support lower tolerance.
Import only.
Onions, dry bulb
New tolerance required because residue
data show folpet concentrates in
raisins. Import only
Residue data support lower tolerance,
Tolerances Listed T Jnrier 40 CFR § 1 Sn 101 •
AvocadosistheonlycommoditypresentlybeingsupportedintheU.S. Use of folpet on avocados
bdto^sre^^^
be amended to indzcate that ,t ,s lunited to a regional registration for the state of Florida . As such, fobe
use on avocados will be limited to Florida. Additional data would be required to support foCule on
avocados outszde the state of Florida or use on other agricultural cornmodL
75
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Codex Harmonization
The Codex Alimentarius Commission has established temporary maximum residue limits (TMRLs)
for folpet residues in/on various plant commodities (see Guide to Codex Maximum Limits For Pesticide
^..'fesVH^.EPnJ-l 1997}- The Cpdex residue definition and the y,S, tolerance expression for folpet are
currently compatible, as each includes only the parent, folpet. A comparison of the Codex TMRLs and
the corresponding U.S. tolerances is presented in the table below.
Commodity
(As Defined)
Cucumber
Grapes
Potato
Strawberry
Codex TMRL
(mg/kg)
2
0.5'
2
10*
0.02
20
5'
Reassessed U,S.
Tolerance (ppm)
15
50
None
5
Recommendation and Comments
Storage stability data being generated for
import tolerance
U.S. import tolerance cannot be made
compatible with proposed MRL, based on
residue data submitted to Agency
Proposed modification and import tolerance are
compatible
Proposed amendment to existing limit
The following conclusions can be made regarding efforts to harmonize the U.S. tolerances with the Codex
TMRLs:
0 The reassessed grape tolerance cannot be made compatible with the existing MRL or the
proposed modification because different residue data were used to establish the MRL. the
Agency recommends that the registrant submit the residue data used by the Agency to
establish the grape tolerance to Joint Meeting on Pesticide Residues (JMPR) for further
consideration.
o Additional information on storage stability is required to support an import tolerance for
cucumbers. Compatibility with the Codex MRL will be addressed when a final
recommendation for a U.S. tolerance is made.
76
•:• Hi."
41:1
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3. Human Health Risk Mitigation
a. 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). At the 99.9th percentile, acute exposure through food to females 13-50 years
occupies 25% of the acute PAD. Therefore, no additional mitigation is required.
b. Chronic Dietary Mitigation (non-cancer)
The chronic dietary risk from folpet is below the Agency's level of concern. The most exposed
group is non-nursing infants less than 1 year old. The exposure to this group occupies less than 1% of the
chronic PAD using the reassessed tolerances and occupies 1% of the chronic PAD with the current
tolerances. No additional mitigation is required.
c. Carcinogenic Mitigation
The dietary cancer risk for folpet is below the Agency's level of concern. The upper bound dietary
cancer risk was calculated to be 7 X 10'7 for all registered uses of folpet, assuming residues at the tolerance
level and including refinements such as processing factors and percent crop treated data. No additional
mitigation is required.
d. Worker Mitigation
Adding wettable powder to sealants and coatings during manufacturing process: The
margin of exposure (MOE) to workers involved in the manufacture of folpet-containing sealants and coatings
is of concern. For short-, intermediate-term, and chronic exposure durations, the total MOEs range from
15 to 17 under baseline conditions (long sleeve shirt and longpants). Cancer risk to these workers ranges
from 4.5 to 9.1 X lO'5. These risks can be mitigated to an acceptable level with the addition of chemical
resistant gloves and a dust/mist respirator. Cancer risk after mitigation is 4.5 X 10'5; total MOE ranges from
120 to 130. If available, engineering controls such as closed loading systems are an adequate substitute for
the PPE.
Airblast application: The total MOE to workers mixing/loading/applying wettable powder for
airblast application of folpet to avocados range from 1400 to 3300 under baseline conditions (i.e., long-
sleeved shirt, longpants, shoes, and socks). Estimated cancer risk for these mixer/loaders/applicators range
from 1.9 x 10'7 to 2 x 10'6. Therefore, no additional mitigation is required.
Post-application exposure to avocado harvesters: Since folpet is toxicity category H for
inhalation exposure and eye irritation, a 24-hour restricted entry interval (REI) is required for avocado
harvesters. Early entry PPE is required for any workers who enter treated avocado orchards before the
24-hour REI.
77
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ft' :':*& 'if1.
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iil!JIJH .i1 nil I I ' "if i,'' " , i>: .j" •, '' !»! 4 " " „ .I1 '": '"' •' " i • ', ' ' l,"1'"1' i i:,!;iiii;V , , , , ,"» '|1!".'i i, '""' , •
Applying folpet-containing sealants and coatings: The total MOE for workers applying folpet-
d°ritain^fea!^lts ^d c^1^!s nol°CcPn?em to *? Agency. Of the possible scenarios, the highest
exposure is to workers applying a stain with an airless sprayer, which results in an MOE of 212. The
estimat^d; l^cgr risk to. these wprkers is 6 x 10'6- No additional means of mitigating cancer risks are
practical; therefore, no additional mitigation is required.
The following table summarizes the personal protective equipment (PPE) that are required for
handlers for each use scenario of folpet. These PPE are required either to mitigate a risk that was identified
during the reregistration process, or because the risk assessment supporting reregistration assumed that these
PPE were being used by pesticide handlers or applicators.
Table 31. Summary of Required Handler Personal Protective Equipment
Exposure Scenario
Adding WP to Paint at the
Manufacturing Process
Mixing/Loading WP for
Airblast Application to
Avocados
Applying Liquids with an
Airblast Sprayer to
Avocados
Applying Ready-to-Use
with a Paint Brush
Applying Ready-to-Use
with an Airless Sprayer
Applying Ready-to-Use
with a Paint Roller"
Applying Ready-to-Use
as a Wood Dip
Treatment"
Baseline*
PPE
Required
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Additional PPE Required
Chemical-resistant gloves,
dust/mist respirator
None
None
None
None
None
None
None
Engineering
Controls
None
Yes
None
None
None
None
None
None
Reentry Interval
(REI)
N/A
N/A
N/A
24 Hours
N/A
N/A
N/A
N/A
- —- --- — - ——vu MV»»^ ui w T u ijuii i, iwitg LsaiiLa, oiiuco, allU o' ' :,'!' ',;!!llf I,' : I" " ' , ' '' ,» ' , 'Bill', I'M, „ ' ' :. 'I1,,!1
e.
Residential Mitigation
kesidents (homeowners) may be exposed to folpet in while applying Ready-to-Use sealants and
qoatings containing folpet. The MOE for these homeowners ranges from 407 with application by airless
78
in,;1
-------
sprayer to 700 with application by paint brush. The cancer risk estimates for homeowners are 5 6 X 10'8
for application with an airless sprayer and 1.3 X 10'7 for application with a paintbrush. Risks from
application of folpet-containing paint with rollers are expected to be comparable to risks from application
withapaintbrush. Postapplication risks are expected to be negligible; therefore, nonoccupational residential
risks are not of concern.
f. Drinking Water Mitigation
The Agency's upper bound estimates of acute, chronic, and lifetime (carcinogenic) drinking water
exposure are below the corresponding Drinking Water Level of Comparison (DWLOC) Therefore the
nsk from drinking water is below the Agency's level of concern. No additional mitigation is required.'
g. Aggregate Mitigation
As discussed earlier, aggregate acute or chronic food and drinking water exposures are not
expected to exceed 100% of the acute or chronic PAD, respectively. Likewise, aggregate food, water and
residential exposure over a lifetime are not expected to exceed a total estimated cancer risk of 1 x V6
Therefore, the aggregate cancer risk, including drinking water, is below the Agency's level of concern No
additional mitigation is required.
4. Ecological Risk Mitigation
The ecological risk assessment and risk mitigation recommendations for folpet are based on the
present limited use of folpet. At present, the only potential ecological risks are from the use of folpet on
avocados in Florida. As stated previously, only a very small percentage of Florida avocados are treated
with folpet.
a.
Risk Mitigation for Nontarget Terrestrial Animals
Acute and chronic risks to birds and mammals from folpet are not of concern, even at maximum
label application rates and frequencies. Folpet also does not appear to pose a risk to honeybees or other
insects. Therefore, no additional risk mitigation for nontarget terrestrial animals is required.
b. Risk Mitigation for Nontarget Aquatic Animals
Folpet is highly toxic to most aquatic animal species tested. Based on toxicity test results and results
of conservative modeling of folpet concentrations in water, airblast application of folpet to avocados in
Honda are expected to exceed high acute risk LOCs for all aquatic animals. Because folpet is applied
directly to leaves of avocado trees, only a small amount of folpet will be available for long range sprav drift
to water. Chronic LOCs are not expected to be exceeded for fish or aquatic invertebrates
79
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Folpet degrades rapidly in water to PI and PAL The degradate PI has been shown to be only
slightly toxic to aquatic animals. No toxicity data are available on PAL However, since PAI is not exected
to be lexicologically significant and usage is limited to two counties in Florida, no additional data will be
required at this time. However, if the use pattern changes, the Agency may reconsider this position.
Because of the rapid degradation of folpet in water and the limited folpet use area, the Agency does
not believe that these risks are of concern. No additional mitigation is required.
The current spray drift label advisory should be continued. Additional drift mitigation practices may
be identified following review of the Spray Drift Task Force database.
"c. Risk Mitigation for Nontarget Aquatic Plants
A full plant exposure and risk assessment cannot be done with the existing data. Because of the
limited use area, no additional data pr mitigation are required at this time. However, additional aquatic plant
testing would be required with any expansion of folpet use.
i „,. • niiniii ,; ''ir ' 'i ; 'H'" '",1,1, ill1 i1 j| •, i i . " ' ''"!"' i' '' „ ' '',.!", • . , , • ;
d. Risk Mitigation for Endangered Species
. .. 'I T ;» < ' '" ', ' t I (if . , '" " I < *!!:" ' > | ' ,11.}, v '''•',•'' •',. • ,,' „'" I. ; ; "' '
The Agency has concerns about the exposure of threatened and endangered species to folpet.
Levels of concern (LOG) are expected to be exceeded for aquatic organisms exposed to single or multiple
applications of this fungicide. There are a number of endangered species in avocado growing regions in
Florida. These include the Everglades snail kite, whose primary diet consists of apple snails. Although folpet
is highly toxic to aquatic invertebrates, such as apple snails, the nearest avocado groves are approximately
3 miles from the Everglades. Therefore, the most likely route of exposure to snails would be long range spray
drift, which is unlikely to occur and which can not be quantified at this time. The current spray drift label
advisory should be continued Additional drift mitigation practices may be identified following review of the
Spray Drift Task Force database. After its review of the new studies, the Agency will determine whether
a reassessment of the potential risks to nontarget organisms is warranted.
5. Occupational (both Worker Protection Standard and non-WPS) Labeling Rationale
D^ujng 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 covered by the WPS
include all commercial and research uses on farms, forests, nurseries, and in greenhouses to produce
•.: ,i • - ... :: •. , '80
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agnculturalplants (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 reregistration and other Agency review processes.
At this time, some products containing folpet are intended primarily for occupational use and some
are intended primarily for homeowner use. Of the occupational uses, only the avocado use is covered bv
the WPS. J
a.
PersonaIProtectiveEquipmentforHandlers(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.
b. 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 0, the interim WPS REI is established at 24 hours If none
of the three acute toxicity effects are in category I or H, the interim WPS REI is established at 12 hours A
48-hour REI is mcreased 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 uiose that would be established under the WPS For folpet a24 hour
REI is required because folpet is classified as Toxicology Category n for acute inhalation toxicity and for
81
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eye irritation.
The WPS prohibits routine entry to perform hand labor tasks during the REI and requires PPE to
be wonijor .pjher, early-entrytasks 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.
, ' I"!'!!"1 , "' '" '"! ' i'" . ' ' , . - ' ""- 1 ,, i,r i'i , Isi:' ,'**!' .,:• '«• ' i- l i i. ',. ,•
,'i r ,„ i!"11", *, 'I '' li. • ill. I1 i :' ," ll'v „, i :, : v ,,"'" U'lMi I'1,!1!, i III UN ,: ,"' li'ii i, • .1 *" 'i'T "II! I'll' Ii1'1, ii, "i! Jin ,in
f §f fpjpet. EPA has determined that no regulatory action is needed as the result of acute or other
adverse ejects of the actiyg 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.
c. Other Labeling Requirements
_____ ___ end-
use P"*1"0^ containing folpet. For the specific labeling statements, refer to Section V of this document.
6. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species Protection Program")
t0 identi^ ?U l)esticides vfhose use mav 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. WiIdMfe 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.
Currently, the Agency is developing a crop-based program ("The Endangered Species Protection
1301") for the protection of these species. Limitations in the use of folpet may be required to protect
endangered and threatened species, but these limitations have not been defined and may be specific to the
formulation and use site. EPA anticipates that a consultation with the Fish and Wildlife Service will be
^"du^ted *n I;?00"*31!?6 with the species-based priority approach described in the Program. After
c?mPIetion °f consultation, registrants will be informed if any required label modifications are necessary.
, Such mc^fica!Jon? would most likely consist of the generic label statement referring pesticide users to use
limitations contained in county Bulletins.
fc ft16 frture. 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
82
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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.
7. Spray Drift Management
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 AgDRIFT 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"
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 folpet for the eligible uses has been
reviewed and determined to be substantially complete. However, the Mowing confirmatory data must
be provided to support the continuing registration:
OPPTS Guideline OPP Guideline
830.7050 None
860.1200 171-3
860.1380 171-4(e)
860.1480 171-4Q)
850.1300
870.3700
875.1100/1200
or
875.1300/1400
72-4(b)
83-3(b)
23 land 233
or
232 and 234
Study Title
UV/Visible Absorption for the PAI
Direction for Use
Storage Stability for avocados, cucumber, and melon
Magnitude of the Residue in Meat and Milk
(Ruminant Feeding Study)
Chronic Daphnia Toxicity
Prenatal Developmental Toxicity in the New Zealand
White Rabbit
Exposure Monitoring for application with wood dip and
paint roller
83
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;. I''1! I "• ', ?'..,<;!!' '' I! iiLli. W
. ,:ll • ' ,' • • .'.ill!1 T1 ' IB'illH'!' " '.i
t! i" !£' Ii*'
'ihii '.jJfk
As
conclusions
if, „;!' -:i"' lilt. ;T . i. '" v '"'''"'S ! '• i'-t! IP W, "!."'- • ii! \y., ' '"in "i;
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previously mentioned, these data are confirmatory; i.e., they are not expected to change the
of this RED.
•"'"'2.
Labeling Requirements for Manufacturing-Use Products
Toremain in comph'ance with FffRA, manufacturing use product (MP) labeling must be revised
to comply with all current EPA regulations, PR Notices and applicable policies. The MUP labeling must
^Ung contained in the table at the end of this section,
B. End-Use Products
1- Additional Product-Specific Data Requirements
Secti°n. 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 $*&• submissions to ensure that they meet current EPA acceptance criteria and if not, commit to
c°n£uctnew 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.
fiif w' 2.
Labeling Requirements for End-Use Products
Label changes are necessary to implement mitigation measures outlined in Section IV above.
T11656 changes include planting information for avocados to be consistent with the residue field trial data,
updated PPE restrictions, and ecological restrictions.
3. Required Labeling Changes Summary Table
:,i ' . < ' i , im "',r < !n i'i , •• • < "ilirln, ' i,1' ,'n ' '! „:,' , ' „' ' iSliili ''. ' 'lilniliiiilik
The summary of required labeling changes appears on next page.
i ' : ,
84
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If this product is applied in a closed system designed by the manufacturer to enclose the pesticide
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and is used and maintained in accordance with the manufacturer's written operating instructions, h
need not wear chemical-resistant gloves or a dust-mist-removing respirator, but must wear at least 1
shirt, long pants, socks, and shoes."
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Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.
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clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves befo
removing. As soon as possible wash thoroughly."
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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 permittil
authority has been notified in writing prior to discharge. Do not discharge effluent containing this
sewer systems without previously notifying the local sewage treatment plant authority. For guidan
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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 Reregistration 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.
ITie Agency has determined that registrants may distribute and sell folpet 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.
89
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90
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IV. APPENDICES
91
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.,»:'-: « i -i- '•" 'i "• '• GUIDE TO APPENDIX B
Appendix B contains Ustings of data requirements which support the reregistration for active ingredients
"within the case fplpet covered by this Reregistration Eligibility Decision Document. It contains generic data
requirements that apply to folpet 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
$0 CFR ^ajt ^8i.r.^e.ief^reflcewnumfee^iaccjQ!rnpanying 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) 605-6obo.
'!, ill, ;., ', , " ; ; »?!' . v •' • ;• , ' ' i; •• f fH ,-; "S!" , • a1 •,••*• ' ••'; • •• ' •'• • "=
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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
ill/1!"11 ' i'lll'll mi1" , f, / », :, ' , '»' „ ,', ,' " , , '', ' ' , '!,
H i Greenhouse food , r _ - ni
I Greenhouse non-food
J Forestry
K Residential
"_ L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citatipn (Column 3). If the Agency has acceptable data in its files, this column lists
* ^
nun&er, but .rriay; be a "GS" number if no MRED number has been assigned. Refer to the Bibliography
appendix for a complete citation of the study.
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GUIDE TO APPENDIX C
3.
4.
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
Reregistration 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.
up., : ii ,11111 ih r •
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 tide (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.
EDENTMCATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID 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 MRID entries. This temporary identifying number is also to be
used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), 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.
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 fkcility• as the author. When no author or laboratory could be identified,
the Agency has shown the first submitter as the author.
Document date. The date of the s,tudy 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
: ; ' ; ' ,. 112 :': ::"". ;..;':.; ; ;" ,:i:." .
-------
c.
d.
determine or estimate the date of the document.
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.
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.
113
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ill"
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It" J:!'1!!! I!!1'" 1 ."Jill" Klill!!1 ' !, III,!
!!•: 1 * .ill sSil, ''"
• , it"" ...iTillllIBi! lilt"!!1 <
MRID
BIBLIOGRAPHY
CITATION
y lift''' " '•' '' :. :, i,
00070415
00070507
00074008
00074009
, 1; Moore, IE. (1968) The Water Solubility of Difolatan, Captan and Phalian: File
No. 721.2. (Unpublished study received Nov 26, 1974 under 239-533; submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:120648-C)
Boudreau, P.; Forbis, A.D.; Cranor, W.; et al. (1980) Static Acute Toxicity of Phaltan
i'l?1^1^ <%!49,j° DaPhl!ia magna: ABC Report # 26632. (Unpublished study
received Jan 14, 1981 under 239-1763; prepared by Analytical Bio Chemistry
Laboratories, Inc., submitted by Chevron Chemical Co., Richmond, Calif.- GDI/
244442:A) n ' ' f ' i o ' i
LeBlanc, G.A. (1977) Acute Toxicity of Fungitrol® 11-50: Dispersion to the Water Flea
(PaPhniamaSna)- (Unpublished study received Mar 7,1978 under 1100-70; prepared
:% EG & G, Bionomics, submitted by Tenneco Chemicals, Inc., Piscataway NJ-
CDL:232998-J)
Buccafusco, R.J. (1977) Acute Toxicity of Fungitrol® 11-50: Dispersion to Rainbow
Trout (Salmo gairdneri). (Unpublished study received Mar 7, 1978 under 1100-70;
prepared by EG & G, Bionomics, submitted by Tenneco Chemicals, Inc., Piscataway'
N.J.; CDL:232998-K) " „','/"",, ,. ,,. t, ,
00074010
00096972
Buccafusco, RJ. (1977) Acute Toxicity of Fungitrol® 11-50: Dispersion to Bluegill
(Lepomis macrochirus). (Unpublished study received Mar 7, 1978 under 1 100-70;
prepared by EG & G, Bionomics, submitted by Tenneco Chemicals, Inc., Piscatawav'
N.J.; CDL:232998-L)
Pack' D'E- 11?77) Soi| Mobility of Captan, Folpet and Captafbl As Determined by Soil
Thin-layer Chromatography: File No. 722.0. (Unpublished study received May 30, 1 978
"Pder 239-221 1; submitted by Chevron Chemical Co., Richmond Calif.-
CDL:234046-N)
00098004
Fjnk' R- B:eavers' J-6-; Jpiner, G.; et al. (1982) Final Report: One-generation
Reproduction Study-Bobwhite Quail: Phaltan Technical (SX-1111): Project No.
162"133' ^P??"15118116^ stu,dy receiXSd MF 29,. 1982 under 239-1763; prepared by
Wildlife International Ltd and John's Hopkins Univ., Dept. of Biostatistics, submitted by
Chevrpn Chemical Co., Richmond, Calif.; CDL: 2471 13-B)
114
-------
BIBLIOGRAPHY
MRID
CITATION
00098005
00112793
00112794
00112795
00125718
00132456
00132457
Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1982) Final Report: One-generation
Reproduction Study-Mallard Duck: Phaltan Technical (SX-1111): Project No.
162-134. (Unpublished study received Mar 29, 1982 under 239-1763; prepared by
Wildlife International Ltd. and John's Hopkins Univ., Dept. of Biostatistics, submitted by
Chevron Chemical Co., Richmond, Calif; CDL: 247113-C)
Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) Final Report: Acute Oral LD50~Bobwhite
Quail: [Phaltan Technical (SX-1111)]: Project No. 162-149. (Unpublished study
received Jul 19,1982 under 239-1763; preparedby Wildlife International Ltd., submitted
by Chevron Chemical Co., Richmond, CA; CDL:247887-A)
Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) Final Report: Eight-day Dietary
LC50-Bobwhite Quail: [Phaltan Technical (SX-1111)]: Project No. 162-147.
(Unpublished study received Jul 19, 1982 under 239-1763; prepared by Wildlife
International Ltd., submitted by Chevron Chemical Co., Richmond CA- CDL-
247887-B)
Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) Final Report: Eight-day Dietary
LC50--Mallard Duck: [Phaltan Technical (SX1111)]: Project No. 162-148.
(Unpublished study received Jul 19, 1982 under 239-1763; prepared by Wildlife
International Ltd., submitted by Chevron Chemical Co., Richmond CA- CDL-
2478S7-C)
Wong, Z.; Eisenlord, G.; MacGregor, J.; et al. (1982) Lifetime Oncogenic Feeding Study
of Phaltan Technical (SX-946) in CD-I (ICR Derived) Mice: SOCAL 1331.
(Unpublished study received Feb 1, 1983 under 239-1763; submitted by Chevron
Chemical Co., Richmond, CA; CDL:249485-A; 249486; 249487- 249488- 249489-
249490; 249491; 249492)
Hoberman, C; Christian, M.; Sica, E.; et al. (1983) Pilot Teratology Study in Rats with
Folpet Technical: Argus Project 303001P. Final rept. (Unpublished study received Oct
24, 1983 under 239-1763; prepared by Argus Research Laboratories, Inc., submitted
by Chevron Chemical Co., Richmond, CA; CDL:251659-A)
Hoberman, A.; Christian, M.; Sica, E.; et al. (1983) Teratology Study in Rats with Folpet
Technical: Argus Research Laboratories Study No. 303-001. Final rept. (Unpublished
115
-------
lii i,'1
MMD
BIBLIOGRAPHY
CITATION
Jil'SIl
tili '" S
00132582
00113613
00137693
00137697
I! Ill
tic ! Ji.' :'>"
i" '" l!'l!!,ll
00137698
00141728
' '.' ' , ' i - : :• •' . :-i , , : ' r • '.: i ••• ;• ,• " ;" • ¥>"<>, "" *',', •' i,'.'1,. ', . ' •'.( • i - ' iii .'SB
study received Oct 24, 1983 under 239-1763; prepared by Argus Research
Laboratories, Inc., submitted by Chevron Chemical Co., Richmond CA"
CDL:251659-B)
Sirnmon, V.; Mitchell, A.; Jqrgenson, T. (1977) Evaluation of Selected Pesticides as
Ph?™c^ Mufcgens: h vitro and in vivo Studies. By Stanford Research Institute.
R;es^h T^S16 Pafk> N9: Health Effects Research Labpratory. (Environmental health
effects research series; EPA-600/1-77-028; contract no. 68-01-2458; available from:
National Technical Information Service, Springfield, VA 22161; also in unpublished
submission received Nov 28, 1980 under unknown admin, no.; submitted by Stauffer
Chemical Co., Richmond, CA; CDL:251563-H)
Atkins, R; 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)
I)k:khaus' S-' Heisler? fi; I!9,8?) Algal Growth Inhibition Test with Folpet: E.H./P,
1-8-152-83 • (Unpublished study received Feb 22,1984 under 11678-18; prepared by
Pharmatox Forschung und Beratung GmbH, W. Ger., submitted by Makhteshim Beer
Sheva Chemical Works Ltd., New York, NY; CDL:252591-A)
Dickhaus, S.; Heisler, E. (1983) Acute lexicological Study of Folpet in Daphnia magna:
Acute Immobilisation Test: EJL/Br. 1-8153-83. (Unpublished study received Feb 22,
1 984 under 1 1 678] 8; prepared by Pharmatox Forschung undBeratung GmbH, W. Ger.'
submitted by Makhteshim Beer Sheya Chemical Works Ltd New York NY-
CDL:252595-A)
. . . .. ,
hE^ S-' H^ler, E. (1983) Acute Tpxicplogical Study of Folpet after Oral
Application to the Greenfinch: E.H./Br. 1-8-11783, (Unpublished study received Feb
22' 1984 under 1 1 678- 18; prepared by Pharmatpx Fprschung und Beratung GmbH, W.
Ger., submitted by Makhteshim Beer Sheva Chemical Works Ltd New York NY-
CDL:252596-A) ,n , ( ........... ...... ........ ipi ^ ..... s _„ / ..... ^ ......... / _ ,'
Korenaga, G. (1982) The Acute Dermal Tpxicity of Chevron Folpet Technical
(SX-1346) in Adult Male and Female Rabbets: S-2152. Unpublished study prepared by
Chevron Environmental Health Center. 10 p.
116
• Ji i
lilt '•!
-------
BIBLIOGRAPHY
MRID
CITATION
00143567
00144057
00144067
00148625
0149489
00149567
00151075
00151489
00151490
Valencia, R. (1981) Mutagenesis Screening of Pesticides Drosophila. Prepared by Warf
Institute, Inc. for the Environmental Protection Agency; available from National Technical
Information Service. 80 p. EPA 600/1/-81/017.
Korenaga, G. (1983) The Acute Oral Toxicity of Chevron Folpet Technical (SX-1346)
in Adult Male and Female Rats: S-2151. Unpublished study prepared by Chevron
Environmental Health Center. 14 p.
Kempf, J. (1984) Eye Irritation Test of Wood Oil Stain & Preservative Clear: Laboratory
N6.:2437. Unpublished study prepared by Applied Biological Sciences Laboratory Inc
13 p. '
Moore, M. (1985) Evaluation of Chevron Folpet Technical in the Mouse Somatic Cell
Mutation Assay: Final Report: Project No. 20994. Unpublished study prepared by Litton
Bionetics, Inc. 117 p.
Machado, M. (1985) Microbial/Mammalian Microsome Mutagenicity Plate Incorporation
Assay: Comparison of Captan Technical (SX-1086), Chevron Folpet Technical
(SX-1388), and Chevron Captafol Technical (SX-945): Report No. SOCAL 2042.
Unpublished study prepared by Chevron Environmental Health Center. 31 p.
Moore, M. (1985) Evaluation of Chevron Folpet Technical in the Mouse Somatic Cell
Mutation Assay: Final Report: Project No. 20994. Unpublished study prepared by Litton
Bionetics, Inc. 156 p.
Rubin, Y. (1985) Folpan: Oncogenicity Study in the Mouse: LSRI Report No.
MAK/015/FOL. Unpublished study prepared by Life Science Research Israel Ltd
1109p.
Hardy, L. (1985) Two Generation (Two Litter) Reproduction Study in Rats with Chevron
Folpet Technical: SOCAL 2140. Unpublished study prepared by Chevron
Environmental Health Center. 3527 p.
Feussner, E. (1985) Teratology Study in Rabbits with Folpet Technical Using a
"Pulse-dosing" Regimen: Argus Research Laboratories, Inc. Project No. 303-004.
Unpublished study prepared Argus Research Labortories, Inc. 222 p.
117
-------
MRID
BIBLIOGRAPHY
CITATION
00151560
00153085
00156636
pQ?c,;:R.(1985) Combined Chronic Oral Tpxicjty/Oncogenicity Study in Rats: Chevron
FoIPet Technical (SX-1388): Final Report: Project No. 2107-109. Unpublished study
preparecl b'y Hazleton Laboratories America, Inc. 3015 p.
Carver, J. (1985) Response by the Chevron Environmental Health Center, Inc. to
Comments from the U.S. Environmental Protection Agency on the in vivo Cytogenetics
StudyihRats: Folpet Technical, SX-1388 (MRI-225-CC-83-21) and Reverse Mutation
in Salmonella (S-1262). Unpublished study prepared by Chevron Chemical Co. 64 p.
'r'i! | ,„!', ! ijiii /'fi i1'"' „" ,„ ' It , ! 1 {' i, "!iu!•...[! PL ..'''!i",' " : ,:'^in.1, !• „•" .»' !" ' ", 'I:1,1 • ii,1!1, 'in „. '.'"l:,'1-'."!!"] "'"^ , ' ' ..'•',!I•" " ' • ''' i • • " *
Rubin, Y. (1985) Folpan: Teratology Study in the Rabbit: LSRI Report No.
MAIC/051/FOL- UnPublished study prepared by Life Science Research Israel Ltd. 120
00157493
00160000
Crown, S. (1985) Folpan: Carcinogenicity Study in the Rat: LSRI Report No.
MAK/022/FOL. Unpublished study prepared by Life Science Research Israel Ltd
1161 p.
* R-; Tucker, R,; Haegele, M. (1984). Handbook of toxicity of pesticides to
wildlife; second edition. U.S. Fish and Wildlife Service: resource publication #1 53 91
P- ........ " " " ...... '"
00160422 Pack, D. (1980) The Anaerobic Soil MetaboUsm of Carbonyl-Carbon-14 Folpet: File
No. 721.14. Unpublished study prepared by Chevron Chemical Co. 27 p.
00160423 Arthur D- Little, Inc. (1975) Initial Scientific and Mini-economic Review of Folpet:
(Section H: Summary): Contract No. 68-012489. Unpublished study. 8 p.
00160424
00160425
Arthur DB L|ttle, Inc. (1975) Folpet: Section HI: Chemistry: Part of'Initial Scientific and
Mini-economic Review of fplpet1: Contract No. 68-01-2489. Unpublished study. 23
P- ,
Arthur D. Little, Inc. (1975) Metabolism, Toxicology and Pharmacology of Folpet:
C§ection IV of'Initial Scientific and Minieconomic Review of Folpet'- Contract No
68:01 -2489). Unpublished study. 19 p.
118
-------
BIBLIOGRAPHY
MRID
CITATION
00160426
00160427
00160428
00160430
00160431
00160432
00160435
00160444
00160445
Arthur D. Little, Inc. (1975) Fate and Significance in the Environment: (Section VI of
'Initial Scientific and Mini-economic Review of Folpet1: Contract No. 68-01-2489).
Unpublished study. 12 p.
Arthur D. Little, Inc. (1975) Mini-economic Reviw: Section VII of'Initial Scientific and
Mini-economic Review of Folpet': Contract No. 68-01-2489. Unpublished study 23
P-
Pack, D. (1976) The Soil Metabolism of Carbonyl-Carbon 14 Folpet Phalatan: File No.
773.21. Unpublished study prepared by Chevron Chemical Co. 33 p.
Bullock, C. (1982) The Four-hour Skin Irritation Potential of Phalatan Tehnical (PN
2623): SOCAL 1908. Unpublished study prepared by Chevron, Environmental Health
& Toxicology. 8 p.
Cavalli, R.; Hallesy, D. (1969) Skin Sensitization Potential of Difolatan H: SOCO
63/11:69. Unpublished study prepared by Standard Oil Co. of California, Industrial
Hygiene & Toxicology. 12 p.
Feussner, E. (1984) Teratology Study in Rabbits with Folpet Technical: Final Report:
Project No. 303-002. Unpublished study prepared by Argus Research Laboratories
Inc. 126 p.
Bullock, C. (1978) S-1261: The Potential of Technical Phalatan (Calhio) and Technical
Phalatan (Port de Bouc) To Mutane TA 100, a Histidine-deficient Strain of Salmonella
typhimurium: SOCAL 1216/32:75. Unpublished study prepared by Standard Oil Co. of
California. 5 p.
Bullock, C. (1982) The Eye* Irritation Potential of Phalatan Technical (PN 2623):
SOCAL 1907. Unpublished study prepared by Chevron, Environmental Health &
Toxicology, lip.
Esber, H. (1983) In vivo Cytogenetics Study in Rats: Folpet Technical (SX-1388)- Final
Report: MRI Report No. MRI-225-CCC-83-32. Unpublished study prepared by
EG&G Mason Research Institute. 84 p.
119
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'W1,!'1"1! ,„: ' , , I
MRID
BIBLIOGRAPHY
CITATION
00162394
05001991
40051401
40094602
40098001
40135901
40592301
40682501
40750801
, M.; Rundle, D.; Mitchell, A. (1980) An Evaluation of Mutagenic Potential of Folpet
the L5178Y TK+/Mouse Lymphoma Assay: Final Report: Project No.
LSU-7558. Unpublished study prepared by Stanford Research Institute. 17 p.
Stevenson, J.H. (1978) The acute toxicity of unformulated pesticides to worker honey
bees (Apis mellifera). Bant Pathology 27(11:38-40.
Tellone, C. (1986) Historical Control Data for the Two Generation (Two Litter)
'V,,^6?10^^?^,8^^,,1!1,.^?!3 with Chevron Folpet Technical: Socal 2140. Unpublished
study prepared by Chevron Environmental Health Center. 3 p.
Johnson, W.; Fiiiley, M. (1980) Handbook of Acute Toxicity of Chemicals to Fish and
Aquatic Invertebrates: Resource Publication 137, U.S. Fish and Wildllife Service,
Washington, D.C. 106 p.
Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and Data
Base for 410 Chemicals and 66 Species of Freshwater Animals, US Fish and Wildlife
Service, Resource Pubiica.tiqn 160, 79 p.
Rubin, R. (1986) Folpan: Two-generation Reproduction Study in the Rat: Project ID:
R-4347. Unpublished study prepared by Life Science Research Israel Ltd. 638 p.
Gil]ey, D.; Griffis, L. (1988) The Acute Inhalation Toxicity of Chevron Folpet Technical
(SX;1388) in Rats: Study No. S-3075: CEHC 2826. Unpublished study prepared by
Chevron Environmental Health Center, Inc. 94 p.
Nyska, A. (1985) Folpan Carcinogenicity Study in the Rat: Supplementary Pathology
Data for Report MAK/022/FOL. Unpublished study prepared by Life Sciences
Research Israel Ltd. 617 p. '
i
Updyke, J. (1988) Analysis and Certification of Product Ingredients: Folpet Technical:
Laboratory Project ED 8812013. Unpublished study prepared by Chevron Chemical Co
:"
40750802
Dougherty, K. (1988) Four-week Repeated-dose Dermal Toxicity Study in Rats with
iii^P61 JS^?™ ^?fM§8); La^oratory Pr°ject ID S:3Q76- Unpublished study
prepared by Chevron Environmental Health Center, 265 p.
120
-------
BIBLIOGRAPHY
MRID
CITATION
40818801
40818803
40818804
41411801
41411802
42122002
42122004
42122005
42122009
42122013
Ruzo, L.; Ewing, A. (1988) Hydrolysis of [Carbon 14]-Folpet: Laboratory Project ID
PTRL 124. Unpublished study prepared by Pharmacology and Toxicology Research
Laboratory. 95 p.
Burgess, D. (1988) Acute Flow-Through Toxicity of Folpet Technical to Daphnia magna:
Final Report No. 36786. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 192 p.
Bowman, J. (1988) Acute Flow-through Toxicity of Folpet Technical to Rainbow Trout
(Salmo gairdneri): Final Report No. 36785. Unpublished study prepared by Analytical
Bio-Chemistry Laboratories, Inc. 223 p.
Merricks, D. (1990) Folpet Worker Exposure Study Using a Paint Containing Folpet
Interior Application in Bathrooms Using a Paint Brush: Lab Project Number: 2206.
Unpublished study prepared by Agrisearch Inc. 95 p.
Merricks, L. (1990) Folpet Worker Exposure Study Using Commercial House Stain
Containing Folpet Exterior Application by Airless Sprayer: Lab Project Number: 2207.
Unpublished study prepared by Agrisearch Inc. 105 p.
Bowman, J. (1989) Acute Toxicity of Phthalimide to Rainbow Trout (Salmo gairdneri):
Lab Project Number: ABC 36789. Unpublished study prepared by ABC Labs, Inc. 22
P-
Bowman, J. (1991) Acute Toxicity of Pthalimide to Bluegill Sunfish (Lepomis
macrochirus) in a Static Renewal System: Lab Project Number: ABC 36788.
Unpublished study prepared by ABC Labs, Inc. 492 p.
Forbis, A. (1989) Acute Toxicity of Pthalimide to Daphnia magna: Lab Project
Number: ABC 36790. Unpublished study prepared by ABC Labs, Inc. 42 p.
Manning, C. (1989) Phthalimide: Acute Toxicity to Mysids (Mysidopsis bahid) Under
Flow-Through Conditions: Lab Project Number: 93019-0500-2130. Unpublished study
prepared by Hunter/ESE, Inc. 32 p.
Burgess, D. (1989) Chronic Toxicity of Folpet Technical to Daphnia magna Under
Flow-Through Test Conditions: Lab Project Number: ABC 37035. Unpublished study
121
-------
MRID
BIBLIOGRAPHY
CITATION
42122014
t
42122016
42122017
42122018
42122019
42122020
42122021
42122022
42122023
42122025
prepared by ABC Labs, Inc. 272 p.
Loveday, K. (1989) In vitro Chromosomal Aberration Assay: Folpet Technical: Lab
Project Number: ADL 61565-00. Unpublished study prepared by Arthur D. Little, Inc.
:s3 1, p.
Chasseaud, L. (1991) Comparative Metabolic Fate and Biochemical Effects of Folpet
in Male Rats and Mice: Lab Project Number: HRC /MBS 32/901 10. Unpublished study
prepared by Huntingdon Research Centre Ltd. 1078 p.
Chasseaud, L.; Wood, K.; Cheng, M.; et al. (1 99 1) Metabolic Fate of Carbon 14-Folpet
in Sprague-Dawley Rats: Lab Project Number: HRC/MBS 41/91499. Unpublished
study prepared by Huntingdon Research Centre Ltd. 124 p.
of Dermal Penetration of Carbon 14-Folpet in the Rat: Lab
Project Number: MAG/l/PH. Unpublished study prepared by Toxicol Labs Inc 207
::p.,v ;: •;•;".• ;; ....... ..... ;:_. ..... . ;•;;__ ;.;; ' ',: ; '" ;; ;;;..._ . ; ,„ ...... , ; ....... .;. - ; ;
Merr!ck£i> D- 11 ??P) FolP£t Disl°dgeable Foliar Residue Study in Avocados: Lab Project
^umbei-: 2802,: UnPublisned study prepared by Agrisearch Inc. 135 p.
Derricks, P- 0990) Folpet: Field Worker Exposure Study in Avocado Harvesting
Operations: Lab Project Number: 2801. Unpublished study prepared by Agrisearch Inc.
179 p.
Ruzo, L. (1989) Pilot Experiment: Aqueous Photolysis of Carbon 14Folpet in Natural
Sunlight and Ulteaviolet Light at pH3: Lab Project Number: 173W. Unpublished study
prepared by Pharmacology Toxicology Research Lab. 36 p.
II II I II I II I II I I I I I
Daly, D. (1991) Aerobic Soil Metabolism of Carbon 14-Folpet: Lab Project Number:
ABC 37 155. Unpublished study prepared by ABC Labs, Inc. 42 p.
Daly, D. (1991) Anaerobic Soil Metabolism of Carbon 14-Folpet: Lab Project Number:
37156. Unpublished study prepared by ABC Labs, Inc. 48 p.
Yer Hev> M- (1989) Environmental Fate Study for Adsorption/Desorption (Kd) of
Folpet: Lab Project Number: MAKHTESHIM 1098. Unpublished study prepared by
122
-------
BIBLIOGRAPHY
MRID
CITATION
42122026
42122027
42122028
42122029
42122030
Colorado Analytical Research & Development Corp. 64 p.
Rhoads, W. (1991) Determination of the Soil Photolysis Characteristics of Folpet Under
Natural and Artificial Light Using Carbon 14-UL-Folpet: Lab Project Number:
MAKHTESfflM 1096. Unpublished study prepared by Colorado Analytical Research
& Development Corp. 85 p.
Creeger, S. (1991) Folpet Field Dissipation Study in Citrus Groves in Polk County,
Florida: Lab Project Number: CO-002A. Unpublished study prepared by Environmental
Chemistry Institute. 203 p.
Creeger, S. (1991) Folpet Field Dissipation Study in Citrus Groves in Seminole County,
Florida: Lab Project Number: CO-002B. Unpublished study prepared by Environmental
Chemistry Institute. 192 p.
Burgess, D. (1989) Uptake, Depuration and Bioconcentration of Carbon 14-Folpet by
Bluegffl Sunfish (Lepomis macrochirus): Lab Project Number: ABC 37036.
Unpublished study prepared by ABC Labs, Inc. 41 p.
Heitkamp, J. (1991) Characterization of Carbon 14-Folpet Residues in Bluegill (Lepomis
macrochirus) Water and Tissues: Lab ProjectNumber: ABC 37037. Unpublishedstudy
prepared by ABC Labs, Inc. 70 p.
42451401
43640201
43786301
Concha, M.; Ruzo, L. (1992) Hydrolysis of [Carbon 14-trichloromethyl] Folpet at pH
5, 7 and 9: Lab Project Number: 371W-1: 371W. Unpublished study prepared by
Makhteshim-Agan of North America Inc. 77 p.
Crown, S.; Nyska, A.; Waner, T. et al. (1989) Folpan: Toxicity by Dietary
Administration to Rats for Two Years: Final Report: Lab Project Number:
MAK/053/FOL. Unpublished study prepared by Life Science Research Israel, Ltd 896
P-
Rhodes, J.; Stuerman, L. (1995) Early Life-Stage Toxicity of Folpet Technical to the
Fathead Minnow (Pimephales promelas) Under Flow-Through Conditions: Final
Report: Lab Project Number: 42578. Unpublished study prepared by ABC Labs, Inc
291 p.
123
-------
MRID
43786301
43814701
44286302
44286303
44316502
BIBLIOGRAPHY
CITATION
Rhodes, J.; Stuerman, L. (1995). Early Life-Stage Toxicity of Folpet Technical to the
Fathead Minnow Under Flow-through Conditions: Final Report: Lab Project Number:
42578. Unpublished study prepared by ABC Labs, Inc. 291 p.
McLane, H. (1995) 0.21% DimensionPlus Fertilizer: (Product Chemistry): Lab Project
Number: EPA\LESCO\D-21-PC1.PM5. Unpublished study prepared by Lesco, Inc.
5 p. ..................................... ...... ^ ...............
Waterson, L. (1994) Folpet: Extended Feasibility/Preliminary Study by Dietary
Administration to Male Mice for 28 Days: Lab Project Number: MBS 43/942343.
UnPubh'shed study prepared by Huntingdon Research Centre Ltd. 270 p.
' J ...... , : Y1, "" ......... i
Waterson, L. (1995) Folpet: Investigation of the Effect on the Duodenum of Male Mice
after Dietary Administration for 28 Days with Recovery: Lab Project Number: MBS
45/943003. Unpublished study prepared by Huntingdon Research Centre Ltd. 292 p.
i^ L. (1994) Fplpet: Feasibility Study by Dietary Administration to Male Mice
for 21 Days: Lab Project Number: MBS 43/942221. Unpublished study prepared by
Huntingdon Research Centre Ltd. 128 p.
124
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X""***,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
GENERIC DATA PALL-IN NOTTriT
OFFICE OF
PREVENTION, PESTICIDES
-o TOX,C SUBSTANCES
CERTIFIED MATT
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active ingredients)
identified in Attachment 1 of this Notice, the Data Call-in Chemical Status ShPPt 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® containing this active ingredients)
Within 90 days after you receive this Notice you must respond as set forth in Section HI below. Your
response must state:
1.
2.
3 .
how you will comply with the requirements set forth in this Notice and its Attachments 1 through
4; or, ^
why you believe you are exempt from the requirements listed in this Notice and in Attachment 3,
Requirements Status and Registrant's Regions* Form, (see section ffl-B); or,
why you believe EPA should not require your submission of data in the manner specified by this
Notice (see section ffl-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 produces)
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).
125
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If I',! ' V
n
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B- SCHEDTJT.F. FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Repistranfs Response Form (Insert B), within the time frames
provided.
C- TESTING PRQTOCOT
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
Date 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
studieswere not conducted in accordance with acceptable standards. The OECD protocols are available
from2001 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)J.
D.
REGISTRANTS RECF.TVTTMG PREVTOTTS SECTION ^n
THE AGF.NCV
NOTI(
Unless otherwise noted herein, this Data CaIMn does not in anv wav an^ ^
requirements of any previous Data raH-Tnfr). or any other agreements entered into with the Agency
pertaining to such pnor 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 REQUTRFMFNTS OF THIS NDTTPF
A- SCHEDIJT.F. FOR RESPONDING TO THE AGENCY
^
days after your receipt of this Notice. Failure to adequately respond to this Notice within 90 days of
127
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i' li, ",: i • J
If'!1,,H
si!, y ;
!l pit, i "
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 F/-B.
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 ffl-C. A discussion of
options relating to requests for data waivers is contained in Section ffl-D.
l
,,,,, , , , , ,, , ,,
' I'l'l Wll,l, i'li , >!!", .1 ,ii ....... I ...... " „ ' , , i" ..... '" V • " ........... ' " „ 1,1, ..... : ...... "i i,ill! ...... ':;l ....... UTI ...... I,,,!1;,, 'Illpi ' "i ...... |, ,!:,,pll:lii ....... II,,,!!11 ........ ,iln ',, mil „ 1 1" , plr ..... ',':! ...... ,
There are two forms that accompany this Notice of which, depending upon your response, one
* nt bj^piUNresponse to the Agency. ........ Thesejorms ..... are the Data-Call-in Response Form
, ....... ^?"*rc™gn^ 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
£oj3TJ (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 CanceJiation - 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
tfjkNgfetfypuwishto 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 itermumber 5 on the Data Call-In Response Form flnsert 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
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Requirements Status and Registrant's Response Form nn*«* m 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.
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 ingredients) if the active ingredients) in the product is derived exclusively from
purchased, registered pesticide products containing the active ingredients). 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, ajl of the Mowing requirements must be met:
a. The active ingredients) in your registered product must be present sojejy 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-Tn
Response Form (Insert A), and all supporting documentation. The Generic Data Exemption is
item number 6a on the Data Call-Tn Response Form (Insert A). If you claim a generic data
exemption you are not required to complete the Requirements Status and R^pkfrqnfs Respnn.^
Form (Insert B). Generic Data Exemption cannot be selected as an option for product specific
data. . r
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 registrants) 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 produces), unless you commit to submit and do submit the required data
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tillil'i, «?•!, i •!' .i",'11'liw1;!,1 "'"''' ,;' ''"'i: ' ,!;i'!' > I,1;') I ijliliSilfiJii1'1'1" , v'^iili/'1., ii*!'!''.w|'jjii;, „ :; j: V\ i "t'il'P1'1 iiiilSf'1"1'''»,!:'
ijiih;*jli|;,, ,,, •,: „; "iji!"",,,. .i,:"!"1:!1" ,"" i|!|||, :|n,:!; ; Si,1;'1,;,,!,!',,,,1 ?!f:'M:». irif^rWiiiii-1 " i',¥';,"' '' tri'iV1'!7' '''Gl'1"1"'1 i,,:1 ^ "•".'''• i ,' i,"'1"1;* "'^ i1' "'"I if'"' • '"»Jiilil. '•'
I am submitting an existing study that has not been submitted previously to the Agency by
anyone (Submitting an Existing Study),
,11 ',..' „ • .y , , „< . , ,r . i, •: , •• PI! ' '»: ' > ii, i ' ,,'i : lu, ,,„!', ' I,,', ,;«i||;i r
•i iif • Illliiii' iiiii iP i,,! 'i 'ii
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Option 1. Developing Data
If you choose to develop the required data it must be in confoimance 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 PR Notice 86-5. In addition, certain studies'require
Agency approval of test protocols in advance of study initiation. Those studies for which a
protocol must be submitted have been identified in the Requirements Status and Registrant-.:
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 H-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 aprotocol not specified in Section H-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 Repistrant's Respon^ TWm (fo^ 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 registrations).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intendtoseekadditional time to meet the requirements), you must submit a request to the Agency
wnichincludes: (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
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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.
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
1 Ill I VC iri'll illlllllllllll M 'I III! LI lIp'L'M, II I II III ',1 , 'i '. II ' I. • »' , '" /' ' ,,,! ^ , hi ., LnlV
IJlKilJ?e 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
„' ', glndjhe .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
f||"!'li :/'% ,f If1 ' 'FIKJI'I "M"l I' ," /'h' »h '!:. '•«! 1H''llll:'li f"|. ..nil I." 1«. :»?..'' r .I.'...'111 I. .'I1:."' *• "i ,,^ ; : , ' 1,','i v ' ",L '. ,,
^l^iFai^ement^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
1 '. •: jr;,existing agreement to meet the requirements of this Notice and have been unsuccessful, you may
j'leqjiSst EPA (by selecting this option) to exercise its discretion not to suspend your registrations),
;j^Ithou^i 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
/i-Jnto 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
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.
m 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 FEFRA
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
'|j;i " I I II ft I III I - :
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a Data Call-Tn Response Form (Insert A) and a Requirements Status and Registrant's
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 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 reqiiired
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 1 60. 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."
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b. Healfe and safety studies completed after May 1984 must also contain all GLP-
requifed 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 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 4Q CJFR ;15JJQ, ;;wMch ...sfeMgg 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.
111 ill II I l I I I I I 1 1 ll II 1 1 II I ill
If you submit an existing study, you must certify that the study meets all
requirements of the criteria outlined above.
I | | (III II I III! Ill I I II1 1 111 111
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
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required to submit new data normally without any time extension. Deficient, but upgradeable
studies wiU 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 aU 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-
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 eachofthose criteria
as well as a certification regarding protocol compliance with Agency requirements.
Option 6. Citing Existing
^ If you choose to cite a study that has been previously submitted to EPA, that study must
have been previously classified by EPAas 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-gmdelme" 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 youare 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 .
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': D.
REQUESTS FOR DATA WAIVERS
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
fbquirenient(s) are inapplicable and do not apply to your product.
||,;,,,,, ; ; 5;. ,;1,|, , Low Vojume/Minor;Use Waiver— Option 8 on the Requirements Status and Registrant's
, „ , •;; ... .-,; ; .RggPgj^ Fg™. finsert_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 foraU pesticide registrantsis 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
S fiom use of the pesticide. If an active ingredient(s) is used for both high volume and low
volume uses, a low volume exemption will not be approved. If all uses of an active ingredient(s)
,„ ,,; , , ,, , ,, „ , : , S. !°S70*SH5 ^^.gpPfcWSfl Klff^g.lor.all.uses.are also, low, then an exemption may be
S^an^d, depending on review of 'pflier ^omratipn ou^ed teitow. An exemption will not be
i '" ,'"', I;,!! :"!Jl1""' '.'I'1'1!!' ^1^1^^ ^y..1?gistrant °£ the active ingredients) elects to conduct .the, testing. Any registrant
: , ;, -,;f ( ,pvj ii,;,,!'!,.' ii ij^jrj^^^I^^Vf116 S^^^^^y^n™^.1!6?^^.^1^ fe^fe f'g111'68 in their forecast
^porting 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, Tpta| company sales (pounds and dollars) of all registered produces) containing
the active mgredient(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 ingredients) 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.
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d. Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredients) by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredients), 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 produces) containing
the active ingredients) (following the parameters in item c above), indirect production
costs of produces) containing the active ingredients) (following the parameters in item
d above), and costs of data development pertaining to the active ingredients).
h. A description of the importance and unique benefits of the active ingredients) to
users. Discuss the use patterns and the effectiveness of the active ingredients) 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 ingredients) 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 ingredients), as opposed to its registered alternatives, (c) information on the
breakdown of the active ingredients) 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
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
137
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li!';,*1 !' ,i " '!' il
IV.
A.
,i, n| N, " 'I "Mil' ; , ' jinlMlL; i,1 .'Hi,*.' ,:' '. ,', .; '! ", ill |. * » ,' '• $, , • „ . ' ; ' „', ' !i •' , ' '!',', '" '». '"'Ill ' >
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,
ifg current copy of your ConfidentialStatement of Formula is not already on file you must submit
a current copy.
!^^|Y^ If the Agency determines that
J|| d||a requirements of this Notice do not apply to your product(s), you will not be required to
supply the data pursuant to section 3(cJ(2)(B). If EPA determines that the data are required for
your prbductfsX vou 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.
CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
NOTICE OF INTENT TO ST JSPRND
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 Cail-In Notice, pursuant to FIFRA section
3(cX2)(B). Events which may be the basis for issuance of a Notice of Intent to Suspend include, but are
riot limited to, the following:
1.
2. "
3,
4.
5.
Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
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.
Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
Failure to submit on the required schedule acceptable data as required by this Notice.
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).
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6. Failure to submit supportable certifications as to the conditions of submitted studies, as
required by Section m-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,
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 SUBMTTTF.D STUDY TS UNACCRPTART .F.
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.
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mil ' :
3< EPA ^l™?116?118 J6!?*1"1? t*16 ^Porting of data, Eluding 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 CANCKLED 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.
i ' " iiiuihiJ ...... U,i:ii| i, i ..... ..... , 111 ,', I' ',, ' '!lil. • : in 'I.'1'! i •' " ............. ,i," • i ''„!' 'l!,i""l"i ' , ; ' '"'i r / '">' ' ' ..... i ...... IIHM ' „ ••• ...... •
•V16 Agency nas determined mat 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,
°f u56 existing stocks of suspended produces) only in exceptional circumstances. If you believe such
disposition of existing stocks of your produces) 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
P^™ssi°n W9^d 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.
^Cy0" !eSP^st a yoJyntary cancellation of your product(s) as a response to this Notice and your
P10^ is in M «>mpHance with all Agency requirements, you will have, under most circumstances, one
y^ fron2 *e ..&*? 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.
», ' 'i, i'i, ' ii < ...... .'""' "" , , " , in ' 1 • ..... ,.• • : . .l ' I I ''' i "
for Y^F^ry canceUation received after the 90 day response period required by this
Notice w§ 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
irare, in fiffl .compliance with all Agency requirements, including the requirements of this Notice. For
example, if vou decide to volunbmlv r.awel vmir r&mctmtinn eiv m^n^Uo u=e^^ „ •» ,MO_ „*,, j.. • __ua^ i A
i ycoi aiuuy is oC/neuuieQ
before EPA will consider granting an existing stocks provision.
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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 NDTTPF
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 S
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 Statm
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 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,
Sis A. Rossi, JSirector
''Special Review and
Reregistration Division
141
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''''ilfi. KI!l!Eli'lhl|!!lltr It iP ,.'
FOLPET DATA CALL-IN CHEMICAL STATUS SHEET
i ii ii mi in , „ !'; ,. • , ,„ , n ''( ' , , • MI
INTRODUCTION
hf^g^n sent tWspepqric Data Call-in Notice because you have produces) containing folpet.
THsGeneric Date Call-in Chemical Status Sheet, contains an overview of data required by this notice,
anflPpi"! ?f c^^ct for inquiries pertaining to the reregistration of folpet). This attachment is to be used
in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic Data Call-In Response Form
.
receiving is De (Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost
Share and Data Compensation Forms in replying to this Folpet 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 folpet are contained in the
strant's 1ResPnnse; Attachment C. The Agency has concluded that additional
.
product chemistry data on folpet are needed. These data are needed to fully complete the reregistration
of all eligible folpet products.
INQUIRIES AND RESPONSES TO THIS NOTTCF.
If you have any questions regarding the generic data requirements and procedures established by this
Notice, please contact Ms. Christina Scheltema at (703) 308-2201.
All responsades to this Notice for the generic data requirements should be submitted to:
111 I I 111 I II I II I i I ''/"I , . "VIS '•!' •>'. .' '..
Ms. Christina Scheltema, Chemical Review Manager
Special Review and Registration Division (7508C)
Office of Pesticide Programs
tJ.S. Environmental Protection Agency
Washington, D.C. 20460
111 RE: Folpet "
142
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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.
143
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Item 6a.
Item 6b.
Item7a.
,. . f? is % 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.
^ f6 ^ib!e 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.
' tf y°u 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.
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 Respnns* Form (insert A) ±at indicates how you
will satisfy those requirements.
use
Check this item if this call-in if a data call-in as indicated in Item 3 for a manufacturing _
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 Regi,
Response Form (Insert A) that indicates how you will satisfy those requirements.
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:e,m if Jhis 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- ,™s certification statement must be signed by an authorized representative of your
'. ^d the person signing must include his/her title. Additional pages used in your
ns? mus^ ** rotated and dated in fee space provided for the certification.
Item 9.
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144
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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 reregistration 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 produces)
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
147
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connection with the study. As noted in Section III of the Data Call-in Notice,
90-day progress reports are required for all studies.
„;,„ !f 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).
Uge pattern of the pesticide. A brief description
i identifies the code
of each code follows:
, A.
B.
c.
E.
F.
" G. "•' " ':'
H.
I. , ••;
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Terrestrial food
Terrestrial feed
Terrestrial non-food
Aquatic food
Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food
indoor non-food
Indoor medical
Indoor residential
Item I: 111 Jt^m ^°^?.tf*e code
description of each code follows.
to the substance that must be used fpi; testing. A brief
EP
ii
MP
MP/TGAI
PAI
PAI/M
P" AI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP_*
TEP/MET
End-Use Product
1 .iini-fin,," i ', , v,, ,,i!,', i, , i, -,; ,-i! '.., • ' ' ,, • i ,, :;,,„
Manufacturing-Use Product
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Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Acti_ye Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient Specified
Typical .End-Use Product and Metabolites
'•':' 148 ""1":::; ' ,ll;;;,"'. '~. ; 1""';:H*"<'"'"'':"1:;", , ':
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Technical Grade Active Ingredient or Pure Active Ingredient
Metabolites
Impurities
Degradates
Item 8. This item identifies the time frame allowed for submission of the study orprotocol 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.
4.
(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.
(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 fee cost of developing data as
outlined in the Data Call-in Notice.
(Offer to Cost Share) I have made an offer to enter into an agreement wife 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.
(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
149
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5.
lull
outlined in the Data Call-In Notice and I have attached the needed supporting information
along with this response.
(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 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 Identificatipn
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;
8.
'I'll Ill'l' ' •""!;':„! 'i1
(Cjting 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.
(Deleting Uses) I am attaching an application for amendment to my registration deleting
the uses for which the data are required.
(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
thanlow 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 iMs 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.
150
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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 HI below. Your response must state:
1.
2.
3.
How you will comply with the requirements set forth in this Notice and its Attachments
1 through 5; or
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
Why you believe EPA should not require your submission of product specific data in
the manner specified by this Notice (see section IH-D).
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'iPllillii!1'!" Pi:-i"'!! Ill II!'":,1,, i,!! "nil,: '"'lilD'IJI1 ' II'VIIIVI''1!.'1!,' IF ',•!M|1" 'I1 '" i: ^TH1'11'!!!1" .I"'1!'!" ^li.l :•" IPltllllHI1" r.i:»". ' IHl'iP iiilM!]1" "IK "1 li',1 .!' It •'''' !' 'Wllill1' 'i'll!, iffl1 " '/,<£ ,'i" "• 'Jililfl '";" .;»,, "'I'1 'if V'W 'SHIiim!!;!*,,'.:!':1]!1!!!!!!!*'. i|liillll!lll|li::»' .i,!!'i'
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).
TJieiHthoriry 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 03-31-99).
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SECTIQg I, _ WHY YOU ARE RECEIVING THIS NOTirF.
The Agency has reviewed existing data for this active ingredient and reevaluated the data
need,ed to ppport continued registration of the subject active ingredient. The Agency has concluded
^ ^ Pity a^tionEd data necessary are product specific data. No additional generic data
re<*uir®ments ^ beinS itnPosed: T91! haYe b.een sent this Notice because you have product(s)
containing the subject active ingredient.
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SECTION II. DATA REQUIRED RV THIS NOTICE
H-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant's Resppnse Form (Insert B). Depending on the results of the studies required in
this Notice, additional testing may be required.
n-B. SCHEDULE FOR SUBMISSION OF T>ATA
You are required to submit the data or otherwise satisfy the data requirements specified in
msert B> Requirements Status and Registrant's Response Form (Insert FU within the time fiames
provided.
H-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 202-785-0350).
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-D. REGISTRANTS RECF.TVTNG PREVIOUS SECTION 3fcM21fBl NOTTCFS
ISSUED BY THE AGENCY "
Unless otherwise noted herein, this Data Call-Tn does not in anv wav superette nr rfump* *»
requirements of any previous Data Ca11-Tn(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.
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""SECTION iff:
I in
OF THIS NOTTPF
III-A. SCHEDULE FOR RESPONDING TO THF A r:yivrv ......................
The appropriate responses initially required by this Notice for product specific data must be
e W •. „ .,„, ,. , ,.., .,
I16, options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree *> satisfy the product specific data requirements imposed by this notice or (c)
request a data waiver(s).
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Ijl'l ' t: , ''ll/ ini!;!™!! ':,:'!:;"I::1!, , ':,! ,'!!!!"'!„„", ':;" , "" "E"!" :TP "" "!' '" .."".' ',, '„;""' " ' !',,'i," ' '»"',!'":!, , '„"'"»!!'"'!!".„:"' ., i'1'!"' ..,,!' ''!,," i „' ,!!'"! '„ i!'!'"!,',' , '"" - '"i"
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
re£luirements ofthis Notice is contained in Section ffl-C. A discussion of options relating to requests
for data waivers is contained in Section m-D.
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two forms that accompany this Notice of which, depending upon your response, one
must b6 "sed in your response to the Agency. These forms are the Data-Call-Tn Respond
ert A), and the Requirements Status and Registrant's Response Fnrm (Insert B). The Data
^^"n^Jy^JPustbg submitted as part of every response to this Notice. In addition one
of the Requirements Status and Registrant's Respon^ Fnr^ (insert B) must be submitted for each
product hsted on the Data Call-Tn Respond Fnrm (insert A) unless the voluntary cancellation option is
selected or unleg tlje 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
t0 ^ *! fe Ea,8e PfttePaft CalllTn Rfispnnse Form (Insert A) and Requirements Sfai™ ^
Registrant's Response Form (Insert B), initial any subsequent pages. The forms contain separate
de^ed^!ffc!iimffifeiffisponse 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.
*• Voluntary Cancellation - You may avoid the requirements of this Notice by
^uesting voluntary cancellation of your product® containing the active ingredient that is the
^J6* of this Notice- ff y°u wish to voluntarily cancel your product, you must submit a
completed Data Call-In Response Form fTnsMt A) ^i^My^^tim ofthi: option
Volun!afy can^llation is ifem number 5 on the Data Call-Tn Response Fnrm (Insert B). If you
chcK)se *Js.0Ptionvthis.is ^ only form that you are required to complete.
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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 foe Existing Stocks provisions of this
Notice which are contained in Section IV-C.
2- Satisfvinp the Product Specific Data Requirements of this Nntit-P There are
various options available to satisfy the product specific data requirements of this Notice These
options are discussed in Section HI-C of this Notice and comprise options 1 through 5 on the
Requirements Status and Registrant's Response FnnWTn^rt A) and item numbers 7a and 7b
on ^ Data Call-Tn Response Form(Insert 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 ffi-D of this Notice and are covered by option 7 on the Requirements
Status and Reg1strant'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.
m-C SATISFYING THE DATA REOTJTRFMENTS OF THIS NQTICF
If you acknowledge on the Data Call-Tn 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 Resnonse 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 Respnn^
Fonn(Insert 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-
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) *
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the Agency
by anyone (Submitting an Existing Study)
I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
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 CFR Part 160), be conducted according to the Pesticide
157
(1)
(2)
(3)
(4)
(5)
(6)
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Ill I Illllll II
Assessment Guidelines(PAG), and be in conformance with the requirements of PR Notice 86-
': 5.
The time fiames 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.tune, 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
cjonrrol 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.
Option 2. Agreement to Share in Cost to Develop Data - Registrants may flnly 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
HBjsi 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; jheiriiiiidirFerences 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
, 158
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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 Hn^rt T^ 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 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
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 he 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
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Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR
160.3(j) " '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(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 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 theregistrant 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 puippse 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 outlinedi 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.""
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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 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 Resnect to Citations of Data Cm PR
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.
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III-D. REQUESTS FOR DATA WAIVERS
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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 trie study in question. Waiver
requests submitted without adequate supporting rationale will be denied and the original due date will
remain in force.
" SECTION IVV CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
; ;, v ;., |IV-A NOTICE OF INTENT TO SUSPEND
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ma}/; 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(cX2)(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
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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
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'", '"''!!',S I' i'l ill1' .1! S'' "1,'!,"! ''• 0'..'J. ::«, i,:',,1!! "',-•"","" fl, !e "i, Ii', ./',''"'MSI't, '.I,,:: ', ;,,';''Si1'''Jl ;;"C.,; It; ;' "!(" ••;. .'.if :,"',":',-f ' .'I
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).
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9.
Failure to submit supportable certifications as to the conditions of submitted studies, as
required by Section III-C of this Notice.
Withdrawal of an offer to share in the cost of developing required data.
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.
b.
c.
inform EPA of intent to develop and submit the data required by this Notice on
a Data Call-Tn Response FnrmrTngPrt A) and a Requirements Status and
Registrant's Response Formflnsert B1:
fulfill the commitment to develop and submit the data as required by this Notice;
or
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.
Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B- BASIS FOR DETERMINATION THAT SUBMITTED STUDY TS
UNACCEPTART.F
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.
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iiJE ' '.. , ,,„!,
C'lriiiii, ' vf! 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
Cf)tnP}y with tote 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.
a v?1"1!!^ cancellation of your product(s) as a response to this Notice and your
product is in mil 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 seU, distribute, or use existing'
^k8- Normally, the Agency will allow persons other than die 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
U1gredient for which ^ Agency has particular risk concerns will be determined on case-by-case basis.
''
^taS cancellation received after, the 90 day response period required by this
Srfe^^ili4 H^ll I? A,iency granting any additional time to sell, distribute, or use existing stocks
J^y°nd a year from the date the 90 day response was due unless you demonstrate to the Agency that
y?u ^ ,m j^i ^SP^ci^Jfe.a!1AHency requirements, including the requirements of this Notice. For
examPle> if you decide to yoluntaiily cancel your registration six months before a 3 year study is
scheduled to be subinitted, 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.
164
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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(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.
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.
A. fiosii, Directc
' Special Review and
Reregistration Division
Attachments
1 -
2 -
3 -
4 -
5 -
Data Call-in Chemical Status Sheet
Product-Specific Data Call-in Response Form (Insert A^
Requirements Status and Registrant's Response Form rinsftrt B)
EPA Batching of End-Use Products for Meeting Acute Toxicology Data Requirements
for Reregistration
List of Registrants Receiving This Notice
165
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FOLPET DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing folpet.
™s Product Specific Data Call-in Chemical Status SWt contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of folpet. 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 Folpet Product Specific Data Call-in (Attachment 7). Instructions and guidance accompany each
form.
DATA REQUIRED BY THIS NOTTCF.
The additional data requirements needed to complete the database for folpet are contained in the
Requirements Status and Registrant's Response, Attachment 3. The Agency has concluded that additional
data on folpet 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 My complete the reregistration of all eligible folpet
products.
INQUIRIES AND RESPONSES TO THIS NOTTPF
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Ms. Moana Appleyard at (703) 308-8175.
All responses to this Notice for the Product Specific data requirements should be submitted to:
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508C
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Folpet
167
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I1 II III
II 111
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 wiU 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.
Item7a.
Item 7b.
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.
168
-------
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
I
I
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item 3.
This n^ber must be used in the transmittal document for any data submissions in
,. : .:.' :.-,'.":"*,. ^'response'to1 tiiis Data Call-In" Notice.
' lllihllll, I1 Hlllll'!'" Jill
Item 4.
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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
ulder 40 CFR 158.155 through 158.180, Subpart C.
Item 5, the study title associated with the guideline reference number is identified.
" rjf'l I" "IS .Itvill'AiS 'lUliA
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.
IF. II:. . lil'ill 'II
Item 8. The due date for submission of each study is identified. It is normally based on 8 months after
issuance of the Registration Eligibility Document unless EPA determines that a longer time
period is necessary.
Item 9. Enteronly one of the following response codesforeach 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, 1certify that I will comply withall 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
no
II I
I
II I
-------
5.
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 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).
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
similarenough to another product to quaHfy for this option. I am submitting evidence that
I have made an offerto 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 ffl-C.l.) 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 theConfidential
Statement of Formula (EPA Form 8570-4).
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 ffl-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).
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 m-C.l.) apply. By the specified due date, I will also
submit. (1) a completed "Certification With Respect To Data Compensation
171
-------
Requirements" form (EPA Form 8570-34) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
If!::1:
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
(Qting 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 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.
1 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"
lifonnprin atSPV, format. By the specified due date, I will also submit: (1) a completed
";i:;;, ! •;;;:! "Ceitifijptipij.^ffiliJRespect To Data Compensation Requirements" form (EPA
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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
tosuppjy the data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies my
ii^^reg"6?*!Imust Choose a method of meeting the data requirements of this Notice
jjpy me 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
subjpssion of datp as specified by the original data call-in notice will not change. By the
itSPJ^ified 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.
I,, V!' • , '"'it;;. ": •,•:. i i . " .j'v • ':jw.; \K\U\I •'•», "^ ' ••••' • v
JVQXE: You may provide additional information that does not fit on this form in a signed letter
&at accompanies this form. For example, you may wish to report that your product has
ateady been transferred to ^pther company or that you have akeady voluntarily canceled
^s P.r?.d.uct F9r these cases, please supply all relevant details so that EPA can ensure
that its records are correct.
'4 '=:•-
172
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EPA'S BATCHING OF FOLPET 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 reregistration of products containing FOLPET as the active ingredient, the Agency
has batched products which can be considered similar for purposes of acute toxicity. Factors considered
m 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 a batch 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 (DCI) 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 eachproduct. 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 Mowing options: Developing Data (Option 1); Submitting an Existing Study (Option 4V
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 3V
or, Citing anExtsting 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
177
-------
does not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option
3) those studies.
EPA Batching of End-Use Products for Folpet
ii'l ' " I ''
Batch
1
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2
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No Batch
EPA Reg. No.
1100-70
10182-294
11678-18
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11678-29
66222-7
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577-538*
577-539*
577-542
1100-78
6557-17
7313-6
8177-32
8177-36
39702-3
Active Ingredients
Folpet 88%
Folpet 88%
Folpet 88%
• • .' '. .-• •••-.'. . :'••'- *?.. :?&::" •:.--• .'!
•' ••' • •' ' ' - '•-"/v.. ."•."•••-W..;V-;**:1i"«
Folpet 50%
Folpet 50%
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-------
composition of which is not known to the reviewer - and the product's mineral spirits, which are
problematic for acute oral toxicity because of a possible aspiration hazard. In addition, the possibility of
synergistic effects between the large quantity of mineral spirits in the 1100-78 product and one or more
other chemicals in the product cannot be ruled out. The inert ingredients composition of 1100-78 differs
significantly from that of the Batch 2 products.
With the exception of EPA Reg. Nos. 1100-78 and 7401-231, the products in the 'No Batch-
group in the table above contain both folpet and bis(tributyltin) oxide (TBTO) as pesticidal active
ingredients. Although this commonality might suggest that some of the No Batch products could be
batched, this is not the case. First, the percentage folpet or TBTO in one product versus the percentage
in another may be significant in several cases. Additionally, most of these products differ in several ways
because of their many other ingredients. These 'inert' ingredients have several functions in the products
They are resins or binders, solvents or thinners, suspension or anti-settling or rheologic agents, fillers
extenders, pigments, tinting aids, wetting agents, de-foaming agents, drying agents, anti-skin agents water
repelling agents, and ultraviolet absorbing agents. Given the number and variety of inert ingredients in the
No Batch products, it is not surprising that the product formulations differ significantly as to both the
ingredients' chemical identities and their concentrations. Also, a given ingredient (such as a resin) may have
its own formulation which differs from the formulation of a similar kind of ingredient in another product
In some cases, one ingredient (such as mineral spirits) in a product or product component may represent
a significant acute hazard by one or more routes of exposure. In other cases, several differences among
several ingredients in a product, each of which is present in a small quantity, may possibly add up to a
significant difference in the acute hazard. Also note that, with so many chemicals present in each product
the possibility of synergistic effects among chemicals should not be ignored
Because of the above considerations, the Agency has no way of knowing whether or not the
studies conducted on one product in the No Batch group would adequately characterize the acute hazards
of another product in the group. A possible exception to this, however, is found in Reg. Nos. 577-538 and
577-539. These two product formulations would appear substantially similar to each other if not for the
differences in their resin components, which constitute a major percentage of the product formulations
These differences may or may not be significant. Therefore, the registrant may wish to submit chemical
composition information and/or other evidence that the resins are similar as to their acute hazards
179
-------
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Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprdOO 1 /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 at williams.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
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
httn://www.ena.pov/onnrd001/forms/8'i70-l pdf
httD://www.eDa.eov/ODDrdOOI/forms/8570-4 nrlf
httr>://www.eDa.L'ov/ODDrd001/forms/8570-5.prif
httD://www.eDa.eov/opDrd001/forms/8570-17.nrif
htto://www.eDa.20v/ODDrdOO! /forms/8570-2'; prif
httn://www.ena.trov/onr>rd001 /forms/8570-77 pdf
httD://www.et)a.eov/oDDrd001/forms/8570-?X PHf
httD://www.eDa.eov/ooDrd001/forms/8570-'!0 prlf
httD://www.eDa.eov/opDrd001/forms/8570-3/> pdf
181
-------
8570-34
8570-35
8570-36
8570-37
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)
httD://www.eDa.20v/ODDnmsdl/PR Notircs/prOK-'; rf|
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http://www.epa.gov/opppinsdl/PR Notices/pr98-5.pd
f.
httn:/,<'www.ena.L'ov/onnnmsdl/'PR Notices/nr98-l pd
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httD://www.ena.!?ov/oDDDmsd1/PR Notices/or98-l nd
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Pesticide Registration Kit
Dear Registrant:
www.epa.gov/pesricides/reiristrationkit/.
^ 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 (pf DCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
3 I3'3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
;;'Vc. 86-5 Standard Format for Data Subrnitted under FIFRA
d- ?7-! Label Improvement Program for Pesticides Applied through Irrigation Systems
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g-
h.
87~6 ^e?frg^?nte in Pesticide Products Policy Statement
90-1 Inert ingredients in Pesticide Products; Revised Policy Statement
95-2 Notifications, Non-notifications, and Minor Formulation Amendments
98-1 Self Certification of Product Chemistry Data with Attachments (This document is in
PDF format and requires the Acrobat reader.)
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Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3: p|||pi<|| ,:,Pffiduc| .Registration Apph'catipn Forms (These. forms are in PDF format and will requi
. ",.tiie. ..... Acrobat
reader.)
IE No; 8570'1' Application for Pesticide Registration/Amendment
.ire
a-
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b.
c.
d.
e.
EPA Form No. 8570-4, Confidential Statement of Formula
EPA Form No. 8570-27, Formulator's Exemption Statement
EPA Form No. 8570-34, Certification with Respect to Citations of Data
EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and wiU require the Acrobat
reader.)
Registration Division Personnel Contact List
Biopesticides and Pollution Prevention Division (BPPD) Contacts
Antimicrobials Division Organizational Structure/Contact List
53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
40 CFR Part 158, Data Requirements for Registration (PDF format)
50 E.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
a.
c.
d.
e.
f.
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 (he United States",
PB92-221811, available through the National Technical Information Service (NTIS) the
following address:
National Technical Information Service (NTIS)
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
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Ill 111
submission a stamped, self-addressed postcard. The postcard must contain the following entries to be
completed by OPP:
Dafe 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 jor 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
gned 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.
I
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.
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2.Detailed Label Usage Information System (LUIS) Report.
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