United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA738-R-99-EPA Re registration
Eligibility Decision (RED)
Triphenyltin Hydroxide
(TPTH)
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-99-014
November 1999
FACTS
Triphenyltin Hydroxide
Pesticide All pesticides sold or distributed in the United States must be registered by
Registration Abased on scientific studies showing that they can be used without posing
™«*^ritotoj^
knowledge, the law requires that pesticides which were first registered before
November 1,1984, be reregistered to ensure that they meet todays 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 ofthe Food
Q^^^on Act of 1996, EPA considers the special sensitivity of infents and
children to pesticides, as well as aggregate exposure of the public to pesticide
residues fiom all sources, and the cumulative effects of pesticides and other
compounds with common mechanisms of toxicity. The Agency develops any
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters pesticides that meet the safety standard of
toe 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 basisforits
decision m a Reregistration Eligibility Decision (RED) document This tact sheet
summarizes the information in the RED document for reregistration case0099
tnphenyltin hydroxide (TPTH).
TPTH is a non-systemic foliar fungicide used to control early and late blight
on potatoes; leaf spot on sugar beets; and scab, brown leaf spot and other diseases
onpecans. It is only registered for use on these three crops. Thereareno
residential, public health or other non-food uses of TPTH.
TPTH comes in liquid and wettable powder (in water soluble packaging)
formulatio^anditeuseisresMctedtoceriifiedapplicators. TPTH is applied by
ground equipment, chemigation,airblast spray, and aircraft. TPTH labels require
mechanical transfer for liquids, and a closed mixing^oading system for aerial
applications. Handlers are required to wear coveralls, waterproof gloves, chemical
resistant footwear, protective eyewear, chemical resistant headgear for overhead
exposure, and chemical resistant arm)n whai cleanmg equipment, mixing or
Use Profile
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Regulatory
History
Human Health
Assessment
loading. These protective measures may be reduced or modified as specified by
the Worker Protection Standard (WPS) when closed systems or enclosed cabs are
used.
TPTH was first registered as a pesticide in the U.S. in 1971. EPA issued a
Registration Standard for TPTH in September, 1984 (PB85248797) that classified
TPTH as a restricted use pesticide (RUP) due to acute and developmental toxicity
concerns; imposed label warnings regarding developmental toxicity and potential
adverse ecological effects; established a 24-hour reentry period; required additional
data; and announced Ihe Agency's intent to initiate a Special Review of TPTH. In
January 1985, the Agency issued a Position Document (PD 1) initiating the Special
Review of TPTH, based on potential developmental toxicity risks to mixers, loaders
and applicators. In 1988, EPA issued a Data Call-In for studies on
immunotoxicity, reproductive and inhalation toxicity, and carcinogenicity. EPA also
issued a Reregistration Standard Update in 1992 to require additional data for
reregistration purposes. In March 1992, TPTH was classified as a 62 carcinogen
(probable human carcinogen).
Currently, there are 16 TPTH products registered to four companies; There
are also 10 Special Local Needs (or FDFRA section 24(c) registrations) for
products containing TPTH.
Toxicity
In studies using laboratory animals, TPTH generally has been shown to have
high acute oral, dermal and inhalation toxicity. It is an irritant to the eye and is not a
skin sensitizer. Toxicity Categories, which range from 1 (most toxic) to 4 (least
toxic), were n (oral), n (dermal), and I (inhalation).
TPTH belongs to a class of chemicals (organotins) known to be
immunotoxic. TPTH is considered to be a developmental toxicant, although it is not
considered to have mutagenic/genetic toxicity properties. It is carcinogenic both in
the rat (inducing pituitary and testicular tumors) and in the mouse (inducing liver
tumors), and is classified as a BE, possible human carcinogen by all routes of
exposure (oral, dermal and inhalation).
Dietary Exposure
People may be exposed to residues of TPTH through the diet Tolerances or
maximum residue limits have been established for TPTH (please see 40 CFR
180236). EPA has reassessed the TPTH tolerances and found that most are
acceptable, one must be reassigned, and new tolerances must be established for
sugar beet tops and livestock commodities.
Currently there are no Codex Maximum Residue Limits (MRLs) established
tor residues of TPTH in/on plant or animal commodities.
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EPA has assessed the dietary risk posed by TFIH.
_ For females 13+ years old, the population of concern for acute dietary
risk assessment, ensure fiom all cunent TPTH tolerances represents less than
35 /i of the acute PAD (population adjusted dose, or the acute Reference Dose
(RfD), the amount believed not to cause adverse effects fiom one day consumption,
adjusted to reflect a 3x FQPA Safety Factor). The exposure level of the^T
highly exposed subgroup, females 20+ years old, not nursing or pregnant
represents 34o/o of the acute PAD. Therefore, it appears that acuteSetary risk is
not of concern.
For the general US. population and four subgroups, exposure from all
current TFTH tolerances represent less than 5% of the chronic PAD (population
adjusted, dose, or the chronic Reference Dose (RfD), the amount believed not to
i H levd °f ** US- P^0"- Deluding
in^andcMdten,iepresents2o/oofthechronicPAD. Therefore, it appears that
chronic non-cancer dietary risk is minimal
F«rthegeneralU.S.Population,however,itappearschronic cancer
S V 00n001L F°r ±e US' P°pulation> based on exP°^ to aU
TPTH tolerances, the chronic cancer dietary risk estimate is l.Oxl ^ from
food alone (generally, cancer dietary risk estimates that include food a«J drinking
waterexposureslessthanLOxl^arenotof concern). However, the cancsT
dietary nsk estimate is primarily driven by sugar beet tops (the main feed item of the
t^leg^^^)'md*ei^feg^itetod^m^^drnilk. Since
there » a feeding restriction on TPTH products, the dietary risk assessment is likely
to overestimate actual exposure from sugar beet tops.
Based on the Agency's modeling estimates, potential exposure to TPTH
indues m drinking water derived from surface water (through spray drift or run-
ofi) results in aggregate, dietary risk (food and drinking water exposures) that
exceeds the Agency's levels of concern for both chronic non-cancer and chronic
cancer dietary risk.
Occupational and Residential Exposure
There are no residential or other non-occupational uses of TPTH currently
registered, so only occupational exposures were assessed. Based on current use
patterns, handlers (mixers, loaders, and applicators) may be exposed to TPTH
during and after normal use. Since 1985, the TPTH labels have been modified to
mclude engineering controls (mechanical tramfersysternsforrnixing^c^dingU^^
formulations, closed systems for aerial applications, and water soluble packaging)
and^rsonal protective equipment (respirators and chemical resistant proSve
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Despite these protective measures, margins of exposure (MOEs) and cancer
risk estimates remain unacceptable, primarily for mixers/loaders of the wettable
powder formulation (in water soluble bags), and pecan harvesters who reenter
treated fields.
Human Risk Assessment
TPTH generally is of high acute toxiciry, causes developmental effects in
animal studies and has been classified as a Group Bz, probable human carcinogea
Only three food crop uses (pecans, potatoes, sugar beets) are registered Non-
cancer dietary risk from exposure to TPTH residues in foods is low. However, the
cancer risk posed to the general population may pose concerns, especially when
aggregated with surface water source drinking water exposures; modeling estimates
of TPTH concentrations in surface water exceed Drinking Water Levels of Concern
(DWLOCs). Because of TPTH's soil binding qualities, however, and buffer zones
implemented to mitigate ecological risks (discussed below), EPA does not believe
TPTH residues will concentrate in water at levels of dietary concern. The Agency
is calling in additional fate data to verify its conclusion; based on these studies, EPA
will determined whether water monitoring is warranted In addition, since there is
an enforceable feeding restriction on TPTH labels against feeding sugar beet tops to
livestock, it is likely that the Agency's estimates of dietary exposure from sugar beet
tops overestimate potential risk.
Of greater concern is the risk posed to TPTH handlers, particularly
mkers/toaders/applicators, and field workers who corne into contact with treated
crops following application of this pesticide. Exposure and risk to workers will be
mitigated by the use of personal protective equipment (PPE) required by the
Worker Protection Standard (WPS) and prior measures as a result of TPTH
Special Review negotiations, supplemented by closed cab application as required
by this RED. Post-application reentry workers on pecan fields will be required to
observe a 30-day pre-harvest interval.
Based on this assessment, the wettable powder formulation poses
unreasonable risk However, the results of the Agency's occupational (non-cancer
and cancer) risk assessment for this formulation are not consistent with the
Agency's experience that water soluble packaging results in exposures comparable
to the use of other engineering controls such as closed mixing/loading systems for
liquid formulations. The Agency believes that the significant discrepancy observed
between exposure from liquid formulations in closed systems and water soluble
bags for this chemical are due to the failure of the TPTH water soluble bag study to
replicate actual use patterns (acres treated) on all three registered crop sites.
Therefore, to support this formulation and to refine the risk estimates for wettable
powder in water soluble bags for groundboom and aerial/chemigation application
on the larger acreages representative of actual use, the Agency will callin a new,
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"^H__
^nfinmtoryexposuiestudyonthewettablepowderformulatioa TheAgency
believes that«inew worker exposure study based on a larger treated acreage will
demonstrate that the MOEs for the water' soluble bag formulation are a^aST
In addition, for workers, cancer risk estimates are in the 10-5to 10'6 range
?n1rCTTtote0fWn^md^Myexa^^^^^range0fl0^to
10 to seek ways of reducing risks prior to reregistration. For most worker
scenarios, cancerrisks cannot be feasibly mitigatedto 10* short of cancellatioa
Based on a benefits assessment conducted for the TPTH Special Review the
Agency has determined that TFTH's continuing role as a resistance management
fun" tidT^'P°1atoeSmd^bCetSV'VamntSC°ntinUedavaaabffityofthe
reductions in^the total amount of 1PTH that cante used in a give^^son ^^
(implemented to mitigate ecological risks) will ensure that woiker exposures will not
increase beyond current levels.
FQPA Considerations
™ tJ°!^r^*^e^mtemdd^^sP^^mtheI^dcx^ent
m^ttheFQPAsafetystandardforthegen^populatioa EPA'swater modeling
indicates potential dietary concerns from residues in drinking water (surface water
source). However, because of TFIH'ssoil. binding qualities, and buffer zones that
will be required on TFIH labels, the Agency does not believe TFTHw^h
water *.levels of dietary concern. The Agency is requiring additional data to verify
^conclusronibasedonthesestudie^EPAwffldetetminlwh^ ^
monitoring is required
Aggregate risk assessment for TPTH considered risks from TPTH treated
assessed.
so only dretary (food and drinking water)riskwas
For risk assessment purposes, the Agency has not assumed that TPTHhasa
commonmechanismoftoxidtywi1hanyoth3rdiemical(s).
Environmental Environmental Fate
Assessment Datasubmitted for reregistration show that TPTH binds strongly to soil is
S!^^^^ Becauseof
1 is not expected to leach to groundwater. ]
the TPTH parent compound and its degradates are uncertain, as data is lacking on
important fate qualities of these metabolites. ™ ' g
anaerobic aquatic metabolism studies, a field dissipation
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metabolism study, and batch equilibrium studies so that the Agency can better
evaluate the fate of TPTH and its degradates in soil and water. In addition, buffer
zones from water bodies will minimize the opportunity for spray drift and run-off
into water.
Risk Mitigation
Ecological Effects
TPTH is moderately toxic to avian and mammalian species and exceeds
acute and chronic LOCs. For a single application of TPTH, acute avian LOCs
were exceeded for endangered species for all crops. The avian chronic level of
concern is exceeded at all registered maximum application rates.
For multiple broadcast applications of liquid products, mammalian acute
levels of concern are not exceeded at maximum application rates for any crop.
However, the mammalian chronic LOG is exceeded at all registered maximum
application rates for all food uses.
TPTH is very highly toxic to freshwater and marine/estuarine organisms.
Exposure assessments were conducted using Tier n level modeling with
PRZM/EXAMS. The RQs calculated from the modeling results show that acute
and chronic LOCs for freshwater fish are exceeded.
High acute and chronic LOCs for freshwater invertebrates are exceeded for
the pecan use pattern. Also, acute restricted use, endangered species and chronic
LOCs for freshwater invertebrates were exceeded for the potato and sugar beet
use patterns.
High acute risk LOCs for estuarine/marine fish are exceeded for the pecan
use pattern. Also, endangered species LOCs for estuarine/marine fish were
exceeded for the potato and sugar beet use patterns. High acute, restricted use and
endangered species LOCs for estuarine/marine invertebrates are exceeded for all
use patterns.
The exposure and risk to these nontarget species will be mitigated by
reductions in the maximum seasonal use amounts currently allowed on TPTH labels.
The registrants have agreed to reduce the maximum seasonal use rates on all three
crop sites, which will reduce exposure to nontarget organisms. In addition, the
addition of buffer zones to labels will protect aquatic species.
Since the initiation of the TPTH Special Review in 1985, the registrants have
voluntarily taken actions to reduce worker exposures to TPTH. These actions
include deletion of TPTH use on carrots, peanuts and tobacco; requiring closed
mixing/loading systems for aerial applications; requiring use of closed cab tractors
by applicators of the flowable concentrate formulation; addition of protective
clothing requirements to labels; adoption of mechanical transfer systems for liquid
formulations; and packaging of the wettable powder in water soluble bags.
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TFTH Rr «*»»«* identified in the
OTH RED, EPA is requiring the Mowing additional risk mitigation measurcs-
. In all other areas and slates (east of Interstate 35)
^
all
° lbels will
gan.
Additional Data EPA is requiring the Mowing additional generic studies for TPHI to confirm
Required lts regulatory assessments and conclusions: nioconnrm
0 81-8: Acute neurotoxicity/rat
0 82-7: Subchronic neurotoxicity/rat
0 S^StafrDwdopmentf m
0 171-4: Independent laboratory validation (for animal method) and radio
validation (plant and animal method) ^metnoa; and radio
0 171-4m: Multiresidue testing
0 171-4e: Storage stability
° 231 and232: Dermal and inhalation exposure; wettab ^le powder (in water
soluble bags) formulation
o 72-4a: Fish early life stage toxicitytest(sheepshead minnow)
0 72-4b: Acpiatic invertebrate life cycle (mysid)
0 122-2: Aquatic plant growth
o 163-1: Seclimentandsoilabsorption/^sorptionforparmtanddegradate
0 164-1: Freld dissipation study
0 162-1: Aerobic soil metabolism
0 162-4: Aerobic aquatic metabolism
0 162-3: Anaerobic aquatic metabolism
for reregistratioa
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Product Labeling
Changes
Required
Regulatory
Conclusion
For More
Information
All TPTH end-use products must comply with EPA's current pesticide
product labeling requirements and with the following measures. For a
comprehensive list of labeling requirements, please see Ihe TPTH RED document
° Applicators (ground and aerial) will be in enclosed cabs.
o The pre-harvest interval (PHI) for pecan use will be 30 days.
° The maximum seasonal use on pecans may not exceed 24 ounces ai/acre in areas
and states that are west of Interstate 35 (e.g., Arizona, New Mexico, and some
areas of Oklahoma and Texas). In all other areas and states (east of Interstate 35)
the maximum seasonal use on pecans may not exceed 36 ounces ai/acre.
o The maximum seasonal use on potatoes must be reduced to 9 ounces ai/acre in
all states.
o The maximum seasonal use on sugar beets must be reduced to 8 ounces ai/acre in
all states EXCEPT Minnesota, North Dakota, and Michigan.
° A buffer zone of 100 feet from water bodies is required for ground applications.
o A buffer zone of 300 feet from water bodies is required for aerial applications.
The use of currently registered products containing TPTH in accordance with
approved labeling will not pose unreasonable risks or adverse effects to humans or
the environment Therefore, all uses of these products are eligible for reregislration.
The registrants have agreed to amend labels reflecting worker and
environmental risk mitigation measures for use in the 2000 growing season.
However, full re-registeration of products containing TPTH will not be completed
until the required product-specific data and revised Confidential Statements of
Formula are received and accepted by EPA.
EPA is requesting public comments on the Reregislration Eligibility Decision
(RED) document for TPTH during a 90-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 Morrnation 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 htto://www.epa,gov/REDs.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box
42419, Cincinnati, OH 45242-2419, telephone (800) 490-9198; fax
(513)489-8695.
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Following the comment period, the TPTH RED document will also be
available fiom foe National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA 22161, telephone (800) 553-6847, or (703) 605-6000.
For more information about EPA's pesticide reregistration program, the
TPTH RED, or reregistration of individual products containing TPTH, please
contact the Special Review and Reregistration Division (7508C), 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
(800) 858-7378, fiom 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm
Eastern Standard Time, seven days a week The NPTN internet address is
ace.orstedu/info/nptn.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFTRn MATT
NOV ] 7 1339
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
'ISdf't°^b^r reVleW and deClSi0nS °n ** P68*^6 Chemical «* Which includes *e active
4ZSU
conclusions of the potential human health and environmental risks of the current pSct usesand its
""Sfa^T Tftr^ ^^ ™&S ** Pr0dUCtS ^ ** eligible for ««W«ndfci. The
™^ f ± 1, ^§ requffements for Produ^ for registration. It may also include
nen™* for additional data (generic) on the active ingredients to confirm the risk assessments
°
enclosed document ^led "Summary of
to
v
Ths H U ^ " ««* ^ **y -sponses
The first set of required responses is due 90 days from the receipt of this letter. The second
set of reqmred responses is due 8 months from the date of this letter.
responses wJl avoid the Agency taking the enforcement action of suspension
3 1996 a™H ecame effec*ve on August
RFH , \ < g ^ ^ P6StiCide kW (FIFRA) ^ &e food ^ ^S ^w (FFDCA) •£
RED takes mtc .account, to the extent currently possible, the new safety standard set by FQPA for
e^bhsbng and reassessmg tolerances. However, it should be noted that, in continuing to make
Cation detem^natons during the early stages of FQPA implementation, EPA recognizes that it
w.Ubenecessary to make demons relating to FQPA before the implementation proces^omplete
In malcmg these early case-by-case decisions, EPA does not intend to set broad precedents for L
^-ofFQPA. Rate, these early determinations wm be 1Mde on a case-^tS ^d will
not bmd EPA as * proceeds wA further policy development and any rulemaldng to may be required
If EPA determines, as a result of this later implementation process, that any of the
determHianons 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
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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 Jane Mitchell at
(703) 308-8061. Address any questions on required generic data to the Special Review and
Reregistration Division representative Loan Phan at (703) 308-8008.
Sincerely yoi
Enclosures
Rossi, Directo]
Special Review and
Reregistration Division
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SUMMARY OF INSTRT JCTIONS FOR RESPONDING TO
THE REREGISTRATTON ELIGTRTT .TTV DECISION n?Fn>
data ^ required for
. qure r
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 data exemption (GDE) by EPA, you are being sent only the product specific response forms
(2 forms) with the RED. Registrants responsible for generic data are being sent response forms for
both generic and product specific data requirements (4 forms). You must submit the appropriate
response forms (following the instructions provided) within 90 days of the receipt of this
RED/DCI letter; otherwise, your product may be suspended.
?• TIME EXTENSIONS AND DATA WATVFff PFOTTF§Tj>-No time extension requests will
be granted for the 90-day response. Time extension requests may be submitted only with respect to
actual data submissions. Requests fortune 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 REREGISTRATTON OR ».«L.IWWTIT RESPONSE"- V«n mn«
submit the following items for each product within eight months of the date of this letter (RED
issuance date).
a- Application for Reregistration (EPA Form 8570-1). Use only an original application
form. Mark it "Application for Reregistotion." Send your Application for Reregistration (along with
the other forms listed in b-e below) to the address listed in item 5.
b' Five copies of draft labeling which complies with the RED and current regulations and
requirements. Only make labeling changes which are required by the RED and current regulations (40
CFR 156.10) and policies. Submit any other amendments (such as formulation changes, or labeling
changes not related to reregistration) separately. You may, but are not required to, delete uses which
the RED says are ineligible for reregistration. For further labeling guidance, refer to the labeling section
of the EPA publication "General Information on Applying for Registration in the U.S., Second Edition,
August 1992" (available from the National Technical Information Service, publication #PB92-221811 •'
telenhnrm niirnh<»r 7rn_£n'; ^nnm '
telephone number 703-605-6000).
c.
Generic or Product Specific Data. Submit all date'in a format which complies with PR
Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier (MRED)
numbers. Before citing these studies, you must make sure that ithey meet the Agency's
acceptance criteria (attached to the DCI).
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d- Two copies of the Confidential Statement of Formula (CSF1 for each
alternate fonnulation. The labeling and CSF which you submit for each product must comply with P.R.
Notice 91-2 by declaring the active ingredient as the nominal concentration. You have two options
for submitting a CSF: (1) accept the standard certified limits (see 40 CFR §158.175) or (2) provide
certified limits that are supported by the analysis of five batches. If you choose the second option, you
must submit or cite the data for the five batches along with a certification statement as described in 40
CFR §158.175(e). A copy of the CSF is enclosed; follow the instructions on its back.
e- Certification With Respect to Data Compensation Requirements Complete and sign
EPA form 8570-31 for each product.
4- COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTTrF.-^™™^ j***™,
to the content of the RED may be submitted to the address shown in the Federal Register Notice which
announces the availability of this RED.
5- WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY^ AND
APPLICATIONS FOR REREGISTRATTON rS-MONTH RESPONSES)
Bv U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401M St. S.W.
Washington, D.C. 20460-0001
By express;
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
192i Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVTEWS-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
Triphenyltin Hydroxide (TPTH)
LIST A
CASE 0099
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TABLE OF CONTENTS
TPTH REREGISTRATION ELIGIBILITY DECISION TEAM . i
GLOSSARY OF TERMS AND ABBREVIATIONS iji
ABSTRACT v
I. INTRODUCTION 1
II. CHEMICAL OVERVIEW .. 2
A. Regulatory History 2
B. Chemical Identification 3
C Use Profile 4
D. Estimated Usage of Pesticide 5
HI. SUMMARY OF TPTH RISK ASSESSMENT 6
A. Human Health Risk Assessment 6
1. Hazard Characterization 6
2. Toxicity Doses and Endpoints for Risk Assessment 12
3. Dietary Food Risk Assessment 13
4. Drinking Water Dietary Risk 16
5. Occupational and Residential Risk Assessment 18
6. Aggregate Risk Assessment and Risk Characterization 27
B. Environmental Fate and Effects Risk Assessment 29
1. Environmental Risk Assessment 29
2. Environmental Fate Assessment 34
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 35
A. Determination of Eligibility 35
1. Eligibility Decision 36
2. Eligible and Ineligible Uses 36
B. Regulatory Position 36
1. Food Quality Protection Act Findings 37
2. Tolerance Reassessment Summary 39
3. Human Health Risk Mitigation 41
4. Ecological Risk Mitigation 47
5. Occupational (Worker Protection Standard) Labeling Rationale 48
C. Other Labeling Requirements 50
1. Endangered Species Statement 50
2. Spray Drift Management 50
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V.
ACTIONS REQUIRED OF REGISTRANTS 51
A. Manufacturing-Use Products 51
1. Additional Generic Data Requirements 51
2. Labeling Requirements for Manufacturing-Use Products 52
B. End-Use Products 52
1. Additional Product-Specific Data Requirements 52
2. Labeling Requirements for End-Use Products 52
C. Required Labeling Changes Summary Table 53
VL APPENDICES 63
A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION
65
B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES
USED TO MAKE THE REREGISTRATION DECISION ....". 69
C. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE REREGISTRATION DECISION
(BIBLIOGRAPHY) 81
D. COMBINED GENERIC AND PRODUCT SPECIFIC DATA
CALL-IN 121
1. Chemical Status Sheets 145
2. Combined Generic and Product Specific DCI Response Forms
(Insert A) Plus Instructions 149
3. Generic and Product Specific Requirements Status and
Registrants' Response Forms (Insert B) and Instructions 157
4. EPA's Batching of TPTH Products for Meeting Acute
ToxicityData Requirements for Reregistration 175
5. List of All Registrants Sent This Data Call-In Notice 179
E. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS 181
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TPTH REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Tara Chand.-Goyal
John Faulkner
Biological Analysis Branch
Economic Analysis Branch
Environmental Fate and Effects Risk Assessment
Nicholas Federoff
Dirk Young
Health Effects Risk Assessment
John Doherty
Catherine Eiden
Sarah Levy
Kelly O'Rourke
Environmental Risk Branch IV
Environmental Risk Branch IV
Risk Characterization and Analysis Branch
Chemistry and Exposure Branch
Risk Characterization and Analysis Branch
Toxicology Branch JJ
Registration Support Risk Assessment
Cynthia Giles-Parker
Maria Rodriguez
Risk Management
Loan Kim Phan
Nancy Zahedi
Fungicides Branch
Fungicides Branch
Special Review Branch
Special Review Branch
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ADI
AE
a.i.
ARC
CAS
CI
CNS
CSF
DFR
ORES
DWEL
DWLOC
EEC
EP
EPA
FAO/WHO
FDA
FIFRA
FFDCA
FQPA
FOB
GLC
CM
GRAS
HA
HOT
IR4
T.KT.
LOAEC
LOAEL
LOC
LOD
LOEL
MATC
MCLG
"g/g
ug/L
GLOSSARY OF TERMS AND ABBREVIATIONS
Acceptable Daily Intake. A now defunct term for reference dose (RfD).
Acid Equivalent
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Cation
Central Nervous System
Confidential Statement of Formula
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
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
Functional Observation Battery
Gas Liquid Chromatography
Geometric Mean
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur
Highest Dose Tested
Interregional Research Project No. 4
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/lcg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
50/o 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.
Lethal Dose-low. Lowest Dose at which lethality occurs.
Lowest Effect Level
Lowest Observed Adverse Effect Concentration
Lowest Observed Adverse Effect Level
Level of Concern
Limit of Detection
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
in
-------
mg/L
MOE
MP
MPI
MRID
N/A
NOAEC
NOAEL
NOEC
NPDES
NOEL
NOAEL
OP
OPP
Pa
PAD!
PAG
PAM
PHED
PHI
ppb
PPE
ppm
PRN
Q',
RBC
RED
REI
RfD
RS
RUP
SLN
TC
TD
TEP
TGAI
TLC
tMRC
torr
WP
WPS
GLOSSARY OF TERMS AND ABBREVIATIONS
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Not Applicable
No Observed Adverse Effect Concentration
No Observed Adverse Effect Level
No Observable Effect Concentration
National Pollutant Discharge Elimination System
No Observed Effect Level
No Observed Adverse Effect Level
Organophosphate
Office of Pesticide Programs
pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Pesticide Handler's Exposure Data
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
Restricted Use Pesticide
Special Local Need (Registrations Under Section 24 © of FIFRA)
Toxic Concentration. The concentration at which a substance produces a toxic effect.
Toxic Dose. The dose at which a substance produces a toxic effect.
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
-------
ABSTRACT
The U. S. Environmental Protection Agency has completed its reregistration eligibility decision
of the pesticide triphenyltin hydroxide (TPTH). This decision includes a comprehensive reassessment
of the required target data and the use patterns of currently registered products. TPTH is an organotin
fungicide used on pecans, potatoes, and sugar beets. The Agency has concluded that all uses, as
prescribed in this document, will not cause unreasonable risks to humans or the environment and
therefore, all products are eligible for reregistration. To mitigate risks of potential developmental
toxicity and carcinogenicity to workers the Agency is requiring, among other changes, that a pre-
harvest interval of 30 days be established for pecan harvesters, and that the registrant conduct new
worker exposure studies for ground and aerial/chemigation application of the wettable powder (water
soluble packaging) formulation of TPTH. Also, buffer zones from water bodies and reductions in use
are being implemented to reduce the potential for TPTH to enter (drinking water and to reduce
environmental risks to fish, birds, and water resources. Additional data on human health and the
environment are being required to confirm the Agency's dietary (drinking water), occupational, and
aggregate risk assessment and conclusions.
The registrants have agreed to amend labels reflecting worker and environmental risk mitigation
measures for use in the 2000 growing season. However, before fully re-registering the products
containing TPTH, the Agency is requiring that product specific data, and revised Confidential
Statements of Formula (CSF) be submitted within eight months of the issuance of this document. These
data include product chemistry for each registration and acute toxicity testing. After reviewing these
data and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will
reregister TPTH products. Those products that contain other active ingredients will be eligible for
reregistration only when the other active ingredients are determined to be eligible for reregistration.
-------
VI
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I.
INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregistration of products with active ingredients registered prior to November 1, 1984.
The amended Act provides a schedule for the reregistration process to be completed in nine years.
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 submission of data to fulfill the requirements. The fifth phase is a review by the U.S. Environmental
Protection Agency (referred to as "the Agency") of all data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Aclrninistrator shall determine whether
pesticides containing such active ingredient are eligible for reregistration" before calling in data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregistration involves a thorough review of the scientific data base underlying a pesticide's registration.
The purpose of the Agency's review is to reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for additional data on health and environmental
effects; and to determine whether the pesticide meets the "no unreasonable adverse effects" criterion of
FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of triphenyltin hydroxide (TPTH). The document consists of six sections. Section I is the
introduction. Section E describes TPTH, its uses, data requirements and regulatory history. Section m
discusses the human health and environmental assessment based on the data available to the Agency.
Section IV presents the reregistration decision for TPTH. Section V discusses the reregistration
requirements for TPTH. Finally, Section VI includes the Appendices that support this Reregistration
Eligibility Decision. Additional details concerning the Agency's review of applicable data are available
on request.
-------
II. CHEMICAL OVERVIEW
A. Regulatory History
Triphenyltin hydroxide (TPTH) was registered in the United States in 1971 for use as a
fungicide. The 1984 Registration Standard classified TPTH as a Restricted Use Pesticide based on
acute and developmental toxicity concerns; imposed label warnings regarding developmental toxicity
and potential adverse ecological effects; established a 24 hour re-entry period; required additional data;
and announced the Agency's intent to initiate a Special Review of TPTH. In 1985, the Agency issued
a Position Document 1 (PD 1) initiating the Special Review of TPTH, based on potential developmental
toxicity risk to mixers, loaders and applicators. In 1988, EPA issued a Data Call-In for studies on
irnmunotoxicity, reproductive and inhalation toxicity, and carcinogenicity. EPA also issued a
Reregistration Standard Update in 1992 to require additional data for reregistration purposes. The
Carcinogenicity Peer Review Committee classified TPTH as a Group Bj carcinogen (probable human
carcinogen) in March, 1992.
Since the initiation of the TPTH Special Review, the registrants have voluntarily taken actions to
reduce worker exposure to TPTH. These actions include deletion of TPTH use on carrots, peanuts
and-tobacco; requiring closed mixing/loading systems for aerial applications; requiring use of closed cab
tractors by applicators of the flowable concentrate formulation; addition of protective clothing
requirements to labels; adoption of mechanical transfer systems for liquid formulations; and packaging
of the wettable powder formulation in water soluble bags. The registrant also submitted additional data,
including a dermal developmental toxicity study and an occupational exposure monitoring study for
pecan mixer/loaders and pecan harvesters.
Issues identified in the TPTH Special Review will be resolved in conjunction with this
Reregistration Eligibility Decision (RED). Due to voluntary actions by the registrants reducing worker
exposure to TPTH, as well as additional data that refine the risk assessment, EPA has determined that
the risks of using TPTH are substantially lower than when the Special Review was initiated in 1985.
Cancer risks, however, remain, as well as risk to non-target organisms. These remaining risk concerns
are addressed in this RED. The RED reflects a reassessment of the current data and use patterns
associated with TPTH, and explains further mitigation and data requirements necessary to the
determination that current uses of TPTH are eligible for reregistration. Following the TPTH
reregistration eligibility decision, the Agency will publish a PD 2 proposing to terminate the TPTH
Special Review, based on the conclusions and mitigation outlined in this RED.
-------
B. Chemical Identification
The Mowing active ingredient is covered by this Reregistration Eligibility Decision:
Triphenyltin hydroxide
Sn-OH
TPTH is a fine white powder with a melting point of 118-120 C, bulk density of 0.2758 g/mL at 25 C,
octanol/water partition coefficient (log K^) of 3.268, and vapor pressure of < IxlO'7 torr at 25 C.
TPTH is practically insoluble in water (0.008 g/L), and is moderately soluble in most organic solvents
(acetone 70 g/L; benzene 41 g/L; 1,2-dichloromethane 74 g/L; ether 28 g/L; ethanol 10 g/L; and
methylene chloride 171 g/L).
Common Name:
TPTH
Chemical Name:
Chemical Family:
Triphenyltin hydroxide
Organotin
CAS Registry Number: 76-87-9
OPP Chemical Code:
083601
Empirical Formula:
Trade and Other Names: SuperTin®, Pro-Tex®, Photon®, Brestan H®
3
-------
• Basic Manufacturer:
C Use Profile
AgrEvo; Elf Atochem; Griffin; Agtrol
The following is information on the currently registered uses with an overview of use sites and
application methods. A detailed table of these uses of TPTH is in Appendix A.
ForTPTH:
Type of Pesticide: Fungicide (non-systemic foliar); Restricted Use Pesticide
Use Sites:
Pecans, Potatoes, Sugar beets. No residential, public health,
or other non-food uses.
Target Pests: Early and late blight on potatoes, and Colorado potato beetle;
leaf spot on sugar beets; scab, brown leaf spot and other
diseases on pecans.
Formulation Types Registered: Wettable powder in water-soluble pack;
flowable concentrate.
Method and Rates of Application:
Equipment - Ground; aerial; chemigation systems; airblast.
-------
Rates and Timing of Applications:
Crop
Pecans
Potatoes
Sugar beets
Maximum
Application Rate
(oz ai/acre)
6
3
4
Maximum
Applied per
Season
(oz ai/acre/year)
60
12
12
Maximum
number of
applications*
10
6
4
Application
Intervals
(days)
14-28
7
10-14
Maximum number of applications cannot be applied at maximum application rate for potatoes and sugar
beets.
Use Practice Limitations: TPTH is a restricted use pesticide (RUP).
D. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of TPTH. These
estimates are derived from a variety of published and proprietary sources available to the Agency. The
data reported on an aggregate and site (crop) basis, reflect annual fluctuations in use patterns as well as
the variability in using data from various information sources.
The Agency estimates total usage of TPTH in the U.S. is approximately 570,000 pounds of
active ingredient (a.i.) per year. The highest crop uses in terms of weight and percent crop treated are
on pecans (260,000 Ibs a.i., 35% crop treated) and sugar beets (240,000 Ibs a.i., 35% crop treated).
The table below summarizes the pesticide's use by site.
Site
Pecans
Potatoes
Acres
Grown
(000)
490
1410
Acres
Treated
(000)
Wtd
Avg
169
185
Est
Max
275
320
% of Crop
Treated
Wtd
Avg
35%
13%
Est
Max
56%
23%
LB AI Applied
(000)
Wtd
Avg
262
66
Est
Max
373
112
Average Application Rate
(ounces ai)
02 ai/
acre/yr
24
6.4
#appl
/yr
4.5
2.3
ozai/
A/appl
5.4
2.4
States of
Most Usage
GAALTX
MS
CONE ID ND
AL WA WI
MN
-------
Site
••••^••••i
Sugar
beets
Total
Acres
Growi
(000)
•IMBMMH
1477
3377
Acres
Treated
(000)
Wtd
Avg
513
867
Est
Max
646
1241
% of Crop
Treated
Wtd
Avg
35%
Est
Max
44%
LB AI Applied
(000)
Wtd
Avg
==
241
569
Est
Max
==
330
815
Average Application Rate
(ounces ai)
ozai/
acre/yr
===
8
#appl
/yr
=====
22
ozai/
A/appl
3.4
States of
Most Usage
MNND
COLUMN HEAIMNfiS
Wtd Avg = Weighted average-the most recent years and more reliable data are weighted more heavily.
Est Max - Estimated maximum, which is estimated from available data.
Average application rates are calculated from the weighted averages.
NOTES ON TABLE DATA
Calculations of the above numbers may not appear to agree because they are displayed as rounded to
- the nearest 1000 for acres treated or Ib. a.i.
- to the nearest whole percentage point for % of crop treated.
SOURCES: EPA data (1988-98), USDA (1990-97), and National Center for Food and Agricultural Policy (1992 & 95 data)
HI. SUMMARY OF TPTH RISK ASSESSMENT
A. Human Health Risk Assessment (see HED revised chapter, September 21,1999
and attachments)
,j
The Agency conducted a human health risk assessment for the active ingredient TPTH
(triphenyltin hydroxide) 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
TPTH and determined that the data are adequate to support a reregistration eligibility decision. The
Agency assessed acute and chronic (non-cancer and cancer) dietary risks, and occupational (non-
cancer and cancer) risks from the use of TPTH. The Agency also evaluated aggregate risks
associated with dietary exposures through food and drinking water.
1. Hazard Characterization
The acute toxiciry database indicates that TPTH is moderately to highly toxic via the oral,
dermal, and inhalation routes (Toxicity Categories H, H, and I respectively).
-------
Acute Toxicity of Triphenyltin Hydroxide
Guideline
No.
81-1
81-2
81-3
81-4
81-5
81-6
Study Tvoe
Acute Oral-rat
Acute Dermal-rat
Acute Inhalation-rat
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
MRID #CS)
071364
252512
071364
071364
071364
071364
Several
Studies
Results
LD50=165mg/kgcr
156mg/kg¥
LD50 = 1600mg/kg
LC,n =60.3 Mg/L
Corrosive
Mild Irritant
Not sensitized in the Buehlei
assay.
'T' • *. /"'« +
II
II
I
I
m
Not considered a
sensitizer.
Toxicity Profile of Triphenyltin Hydroxide1
Study Type
21 -day dermal - rats
(1985)
Subchronic feeding -
rats (1986)
Subchronic feeding -
mouse (1986)
Subchronic feeding -
guinea pig (1960)
Subchronic feeding
-dog
Subchronic inhalation -
rats
(1989)
Chronic feeding - dog
(1987)
MRID No.:
00142880
258230
(Accession
Number)
00157771
261754
(Accession
Number)
00157952
261753
(Accession
Number)
00086467
41017701
40285501
Results
S^stemjc:
NOAEL > 20 mg/kg/day. No systemic effects at highest dose tested.
Dermal:
NOAEL < 5 mg/kg/day. Local irritation.
NOAEL < 0.33 mg/kg/day: decreased IgG antibodies. At 7.63
mg/kg/day: decreased body weight and gain and food consumption.
< 0.75 mg/kg/day (lowest dose tested): decreases in IgA and IgM
antibodies. At 3.78 mg/kg/day: decreased adrenal weight and at 19.46
mg/kg/day: decreased ovary v/eight and increased liver weight.
NOAEL < 2.5 ppm (estimated 0.1 mg/kg/day) (lowest dose tested):
decreased leucocyte counts.
No valid study. Refer to chronic feeding study below.
NOAEL = 0.00034 mg/L. LOAEL = 0.002 mg/L: deaths and lung and
respiratory irritation and edema.
NOAEL and LOAEL > 0.562
-------
!l :• •
Study Type | MRID No.: |
Results
Chronic feeding - rat
(1970)
00080390
099050
(Accession
Number)
NOAEL = 0.1 mg/kg/day; LOAEL = 0.25 mg/kg/day: decreased
leucocyte counts.
Chronic/carcinogenicity
-rat(1989) .
41085702
NOAEL < 0.3 mg/kg/day (lowest dose tested) in 6" and 0.4 in ?
mg/kg/day: deaths in females and decreases in immunoglobulin.
Positive for pituitary and testicuiar tumors. Dose levels considered
adequate.
Carcinogenicity -mouse
(1989)
41087501
NOAEL < 0.85 mg/kg/day (lowest dose tested) based on decreased in
immunoglobulins. Particularly IgA and IgM in either males or females.
Positive for hepatocellular adenomas and carcinomas. Dose levels
considered adequate.
Developmental toxicity -
(1985) rat representative
study, one of several
studies
257402
(Accession
number)
Maternal toxicitv:
NOAEL = 1 mg/kg/day; LOAEL = 2.8 mg/kg/day: decreased body
weight and food consumption.
Developmental toxicitv:
NOAEL = 2.8 mg/kg/day; LOAEL = 8 mg/kg/day: decreased fetal
weight and increased sternebrae unossified. (Typical response at this
dose level.) At 8 mg/kg/day may have smaller litter size and less viable
fetuses in other studies or poor pup survival.
Developmental toxicity •
rabbit/oral
(1987)
40104801
Maternal toxicitv:
NOAEL = 0.1 mg/kg/day; LOAEL = 0.3 mg/kg/day: decreased body
weight gain.
Developmental toxicitv:
NOAEL = 0.3 mg/kg/day; LOAEL = 0.9 mg/kg/day: lower fetal body
weight and increased incidents of hyoid body and/or arches
unossified.
Developmental toxicity -
rabbit/dermal (1993)
(dermal)
42909101
Maternal and developmental toxicitv:
NOAEL and LOAEL > 3 mg/kg/day. No effects at highest dose tested.
Reproductive toxicity -
rat (1.986)
264667to
264676
(Accession
number)
Parental toxicitv:
NOAEL = 0.925 mg/kg/day; LOAEL = 2.5 mg/kg/day decreased body
weight.
Developmental toxicity:
NOAEL = 0.25 mg/kg/day; LOAEL = 0.925 mg/kg/day: decreased litter
size, liver and spleen weights.
Gene Mutation- Ames
test (1981)
00125264
Notmutagenic in S. tymphimuriumoiE. Co//± metabolic activation.
Borderline positive in the presence of S-9 mix but negative in absence
ofS-9.
Mouse Ivmphoma assay
(1985)
00152226
-------
Study Type
Cytogenetics - human
chromosome aberrations
(1985)
Recombinant assay
(Convers) (1985)
Bone marrow cells in
vivo (1987)
Micronucleus assay
in vivo (1985)
Dominant lethal assay
(1978)
Gene mutation (1985)
Unscheduled DNA
synthesis (1985)
General metabolism
(several studies 1986 to
1989)
MRID No.:
00152223
00155521
40377102
00152225
00125265
00152224
00155522
41309102
40029406
40029405
40029407
41387201
41309101
Results
Positive for inducing chromosome aberrations in presence of metabolic
activation (± S-9). Study demonstrates clastogenic property of TPTH.
Negative mSacc. Cerevisiae ± S-9 metabolic activation.
No effect on bone marrow cells.
Negative at 140 mg/kg but study did not demonstrate that TPTH went
to the bone marrow.
Negative at up to 38 mg/kg/day. At 150 mg/kg/day, high rate of
deaths.
Not mutagenic ± metabolic activation in Schizosaccharomyces
Negative up to cytotoxic dose levels.
The contributions from six studies combine to meet the general
metabolism requirement for TPTH. The I4C studies are confounded by
the fact that the labeled phenyl group splits off and the fate of the
parent compound is not followed. Thus, the labeled phenyl may be
excreted in the urine but this does not represent excretion of intact
TPTH. The 113Sn labeled TPTH studies follow the fate of the tin
although this may be as triphenyl, diphenyl or monopheny] or as tin
itself. The biliary route is the most important in excretion of 113Sn from
TPTH. Most of the label (80-100% in several studies) is recovered in
the feces. Little remains in tissues (for example, 0.5%). After 24 hours,
the kidneys, liver epididymis and brain had the most label. After 7
days, little remained in the tissues.
-------
Study Type
MRIDNo.:
Results
Dermal penetration (1986
and 1987)
00156684
40198301
40073001
Studies demonstrate that TPTH adheres to the skin and only a small
percentage (<1%) is absorbed in 10 hours. The TPTH remaining on the
skin can potentially be absorbed over time. Because of complications
involved with adherence to the skin, a dermal absorption factor of 10%
was derived by comparing the oral and dermal developmental toxicity
studies.
Special Immunotoxicity
(Several studies 1982 to
1990
41518200
40303701
00124218
00124217
00141313
InratsJ415182(Xr):
NOAEL = 1.82 mg/kg/day; LOAEL = 3.4 mg/kg/day: decreases in IgG.
At higher doses: decreased spleen weight and white blood cells and
circulating lymphocytes.
Inmice('415182QO'):
NOAEL = 0.23 mg/kg/day, LOAEL =1.15 mg/kg/day: decreased spleen
weight absolute and relative. At higher doses: decreased IgM, WBC,
neutrophils and circulating lymphocytes.
Immunosuppression: (40303701'):
No evidence of increased susceptibility to trichinella spiralia at 2.5
mg/kg/day.
1. All studies classified as acceptable or otherwise determined to contain useful data.
i "" .1 . '",„,, ,i I ,
Developmental toxicity. In developmental toxicity studies, TPTH causes resorptions in
pregnant rabbits at dose levels only slightly higher than it caused maternal effects on body weight.
There was no evidence of increased susceptibility to fetuses noted in the available rat or rabbit
developmental toxicity studies. The slope of the dose response curve in the rabbit developmental
toxicity study is considered steep. In the rat multi-generation reproductive toxicity study increased
susceptibility to the offspring (based on offspring toxicity [decreased litter size, liver and spleen weight]
was seen at a dose lower than parental toxicity [decreased body weight gain]). Because of the
immunotoxic potential of TPTH, a special study for developmental immunotoxicity (consult with Agency
on protocol) will be required.
Immunotoxicity. TPTH belongs to a class of chemicals (organotins) known to be
immunotoxic. The primary treatment related effects via oral exposures are immunotoxicity as indicated
by decreases in lymphocytes and immunoglobulins in rats and mice, Mowing both sub-chronic and
chronic exposures.
Endocrine disruption. There are several indications that imply that TPTH may cause
endocrine disruption. In rats, testicular and pituitary tumors were a marked feature in the
carcinogenicity study. In the mouse there were changes in adrenal and ovary weights. There were no
specific assays for blood levels of hormones in the studies submitted to further assess for possible
endocrine disruption.
Carcinogenicity. TPTH is classified as a B2: probable human carcinogen based on evidence
of carcinogenicity in mice (liver tumors) and rats (pituitary and testicular tumors) at dose levels that
were adequate for assessment of carcinogenicity. The low dose linear approach (Q,*) was used for
10
-------
human characterization and was based on the pituitary tumors observed in rats. The Q,* is 1.83x10
(mg/kg/day)-1. In accordance with Agency policy, this Q, * will be used for assessing cancer risk for all
routes of exposure (oral, dermal and inhalation), and as a default for the dermal and inhalation routes.
Mutagenicity. TPTH is not considered to have a mutagenicity/genetic toxicity concern. Most
studies are negative for mutagenic/genetic toxicity effects. Although there were some apparent positive
responses, other tests, particularly in vivo, conducted to verify the significance of the apparent positive
studies in vitro were negative.
General metabolism. There are several studies which define the metabolism of TPTH using
either 14C or 1I3Sn labeled TPTH. The contributions from six studies combined to meet the general
metabolism requirement for TPTH. The 14C studies are confounded by the fact that the labeled phenyl
groups split off and the fate of the parent compound is not followed. Thus, the labeled phenyl may be
excreted in the urine but this does not represent the excretion on intact TPTH. The 113Sn labeled TPTH
studies follow the fate of the tin although this may be as triphenyl, diphenyl or monophenyl or tin itself.
The biliary route is important in excretion of' 13Sn. Most of the label (80-100% in several studies) is
recovered in the feces. Little remains in the tissues (for example, 0.5%). After 24 hours, the kidneys,
liver, epididymis and brain had the most label. After 7 days, very little labeled chemical remained in the
tissues.
Metabolites. TPTH is serially metabolized to diphenyl and monophenyl tin and excreted. It
appears that all plant metabolites are also animal metabolites. Both diphenyl and monophenyl tin
metabolites are of lexicological concern.
Dermal absorption. There are several studies to assess for dermal absorption. However, the
high affinity that TPTH has for the skin confounds assessing for the potential for TPTH to be absorbed
dermally. A dermal absorption factor of 10% was extrapolated based on the comparison of the
LOAELs of the oral and dermal developmental toxicity studies in rabbits.
a. Application of the FQPA lOx Safety Factor
The FQPA Safety Factor Committee recommended two different safety factors for acute and
chronic dietary risk assessment. The FQPA Safety Factor was reduced to 3x for acute dietary risk
assessment, while the lOx FQPA Safety Factor for chronic dietary risk assessment was retained. The
Committee made these recommendations for TPTH because:
1. There was evidence of increased susceptibility to the offspring following pre- and/or
postnatal exposure in the two-generation reproduction study in rats.
2. TPTH is considered to affect the endocrine system and there is concern for the possible
relationship between TPTH, hormonal effects, and the development of pituitary and
testicular tumors.
11
-------
3. TPTH is considered as an agent that may cause immunotoxicily. The chronic dietary
RfD is based on decreases in white blood cells and both the rat and mouse chronic
feeding and/or oncogenicity studies indicate decreases in immunoglobulins.
4. The Hazard Identification Assessment Review Committee (HIARC) required a
developmental toxicity study that evaluates immunotoxicity, a potential toxic effect of
TPTH to which fetuses and neonates may be especially susceptible, in place of a
developmental neurotoxicity study.
At the time of the FQPA Safety Factor Committee Meeting for TPTH, EFED screening models
(Tier 1) were used for drinking water risk assessment; the acute dietary assessment was unrefined
(TMRC - Tier 1); and the chronic dietary assessment was refined using percent crop treated data from
BEAD and anticipated residues from field trial data. Thus, the exposure assessments will not
underestimate the potential dietary (food and water) exposures for infants and children from the use of
TPTH and currently, no non-dietary (residential) exposures are expected.
The Committee determined that the FQPA Safety Factor can be reduced to 3x for acute
dietary risk assessment for the subpopulation, Females 13 years or older, because the increased
susceptibility was seen only in the offspring of parental animals receiving repeated oral exposures (two-
generation reproduction toxicity study) and not seen following in utero exposures (developmental
studies). For chronic dietary risk assessment, the Committee determined that the 1 Ox Safety Factor
should be retained for all populations (including infants and children) because increased susceptibility to
the offspring was seen following repeated oral exposures in the two generation reproduction study in
rats.
2. Toxicity Doses and Endpoints for Risk Assessment
A summary of the toxicologjcal endpoints used in the human health risk assessment is presented
in the table below. A detailed description of the rationale for selection of the selected doses and
endpoints can be found in section 3 of the HED chapter.
Summary of Toxicological Endpoints for Use in Human Health Risk Assessment
EXPOSURE
SCENARIO
Acute Dietary
DOSE
(mg/kg/day)
NOAEL =
0.3 mg/kg/day
(100 UF)
(3xFQPA)
ENDPOINT
Increased incidents of hyoid body
and/or arches unossified in rabbit
fetuses.
STUDY
Oral Developmental
toxicity -Rabbit
(MRID No.: 40104801)
Acute PAD = 0.001 rag/kg for Females 13+
No acute oral endpoint identified for general population; risk assessment not required.
12
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EXPOSURE
SCENARIO
Chronic Dietary
Carcinogenicity
(oral/dermal/
inhalation)
Short-Term
(Dermal)
Intermediate-Term
(Dermal)
Long-Term
Non-cancer
(Dermal)
Inhalation
(Any Time Period)
DOSE
(mg/kg/day)
NOAEL =
0.1 mg/kg/day
(300 UF)*
(lOxFQPA)
ENDPO1NT
Decreased white blood cells.
STUDY
Chronic feeding study -
Rat
(Accession No.: 099050)
Chronic PAD = 0.00003 mg/kg/day
Risk assessment required for general population including infants and children.
OralQl*
1.83x10
(mg/kg/day)'1
Dermal NOAEL =
3 mg/kg/day
(MOE: 100)'
Dermal NOAEL =
3 mg/kg/day
(MOE: 100)'
None
0.00034 mg/L
(100 UF)
(MOE: 100)'
(NOAEL = 0.092
mg/kg/day)2
TPTH is classified as a B2 Carcinogen - probable human
carcinogen based on pituitary and testicular tumors in rats and
liver tumors in mice. A dermal absorption of 10% should be
used for this risk assessment. An inhalation absorption of
100% should be used for this risk assessment.
No effects at the highest dose
tested.
No effects at the highest dose
tested.
Dermal Developmental
toxicity - Rabbit (MRJD
No.: 42909101)
Dermal Developmental
toxicity - Rabbit (MRID
No.: 42909101)
Use pattern does not indicate exposure will be for this interval.
Lung lesions seen in animals that
died at the next highest dose.
Subchronic Inhalation
toxicity -Rat
(MRID No.: 41017701)
lOx for intraspecies variability, lOx for interspecies extrapolation, 3x for instability of test material in the diet and
potential for increased mortality near the LOAEL.
MOE is only for occupational exposure; there is no residential exposure.
2 Inhalation dose in mg/L was converted to mg/kg/day using the following equation:
Dose (mg/kg/day) = (NOAEL (0.00034 mg/L) * Respiration rate of a young adult Wistar rat (8.46 L/hr) *
Study daily exposure duration (6 hr/day)) / Body weight of a young adult Wistar rat (0.187 kg)
3.
Dietary Food Risk Assessment
a. Dietary Exposure Assumptions (See section 4.3 of revised HED
chapter)
The Reference Dose (RfD) for evaluating dietary risk is derived from an exposure level at
which there are no statistically or biologically significant increases in the frequency or severity of adverse
effects between the exposed population and its appropriate control, along with the application of
13
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uncertainty factors. The percent of the RfD is calculated as the ratio of the exposure value to the RfD
(exposure/RfD x 100 = % RED). The population adjusted dose (PAD) is the adjusted RfD reflecting
the retention or reduction of the FQPA safety factor for all populations which include infants and
children. For TPTH, the population adjusted doses (PAD) pertaining to acute and chronic dietary
exposure are 0.001 mg/kg/day (acute PAD) and 0.00003 mg/kg/day (chronic PAD), respectively.
The acute and chronic (non-cancer and cancer) dietary exposure assessments were conducted
using the Dietary Exposure and Evaluation Model (DEEM™) system. DEEM™ can be used to
estimate exP°sure from constituents in foods comprising the diets of the U.S. population, including all
population subgroups. The software contains food consumption data generated in USDA's Continuing
Survey of Food Intake by Individuals (CFSH) from 1989-1992.
TPTH inputs to the DEEM™ for refined acute and chronic analysis included anticipated
residues (ARs) from field trials (based on Vs. the sum of LOQs for each metabolite (TPTH and is
degradates, di-phenlytin hydroxid and mono-phenyltin hydroxide) for samples with non-detectable
residues; all three crops had non-detectable residues); processing factors (where applicable); and
P610611* c!°p treated (°/°CT) information for pecans, potatoes, sugar beets, milk and meat. Dietary
refinements, such as ARs, are a way to estimate actual exposures, as opposed to high-end estimates
(see Table 7 in HED chapter). No monitoring data for TPTH were available from USDA's POP or
FDA's Surveillance Monitoring Program.
The Agency has recently conducted revised acute and chronic (non-cancer and cancer) dietary
exposure estimates in concurrence with,a review and evaluation of the registrants' submission of acute
and chronic dietary exposure and risk analyses. In addition, the Agency has revised the Residue
Chemistry Chapter (August 25,1999), in which new acute and chronic ARs, processing factors and
%CT information for meat and milk were given.
For purposes of comparing dietary exposure and the associated resulting risks, the Agency
conducted analyses of three acute and chronic (non-cancer and cancer) dietary exposure scenarios:
(1) Dietary analyses including all currently registered crops (pecans, sugar beets, potatoes),
meat and milk (included because sugar beet tops are the main livestock feed item of the three crops,
and sugar beet tops were found to have detectable residues);
(2) Dietary analyses including only meat and milk (i.e., sugar beets, pecans, and potatoes were
assumed to have zero residues, in accordance with the TRAC policy paper, "Assigning Values to
Non-detec,ted/Non-quantifiedPesticide Residues in Human Health Dietary Exposure
Assessments", 11/7/97); and
(3) Dietary analyses including only pecans and potatoes (i.e., sugar beets, meat, and milk were
excluded).
14
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b. Dietary (Food) Risk Characterization
Generally, a dietary risk estimate that is less than 100% of the acute or chronic Population
Adjusted Dose (aPAD or cPAD) does not exceed the Agency's risk concerns. The Population
Adjusted Dose (which is the Reference Dose adjusted to reflect the FQPA Safety Factor) is defined as
the dose at which an individual could be exposed on any given day (acute PAD) or over the course of a
lifetime (chronic PAD) and no adverse health effects would be expected. The acute PAD for TPTH is
0.001 mg/kg/day, and the chronic PAD is 0.00003 mg/kg/day for all three scenarios. For the cancer
endpoint, a dietary risk estimate that is less than 1.0 x 10'6 does not exceed the Agency's level of
concern.
The TPTH acute dietary risk from food is below the Agency's level of concern for all three
scenarios - that is, less than 100% of the aPAD is utilized. For example, at the 99.9'th percentile of
exposure, for the most highly exposed subgroup within the female 13 + subpopulation - i.e.,. the
subpopulation of concern for acute dietary risk (females 20+ years old, not pregnant or nursing) - the
% aPAD value is 34% for Scenario 1. Therefore, acute dietary exposure and risk associated with
TPTH-treated foods is not of concern. The following table summarizes the acute dietary exposure
results of all three scenarios, for the most highly exposed population subgroup.
Subgroups
Females (20+ years/not
pregnant/not nursing)
Females (13-19 years/not
pregnant/not nursing
Females (13+ years/
pregnant/not nursing)
Females (13+
years/nursing)
Females (13-50 years)
99.9th percentile
exposure (% aPAD)
Scenario 1 '
0.000339
(33.9 %)
0.000127
(12.7%)
0.000225
(22.5 %)
0.000230
(23.0%)
0.000194
(19.4%)
99.9th percentile
exposure (% aPAD)
Scenario 22
0.000337
(33.7%)
0.000126
(12.6%)
0.000224
(22.4%)
0.000230
(23.0%)
0.000193
(19.3%)
99.9th percentile
exposure (% aPAD)
Scenario 33
0.000002
(0.24 %)
0.000006
(0.61 %)
0.000001
(0.12%)
0.000002
(0.16%)
0.000003
(0.34%)
2 Scenario 2: includes only meat and milk (pecans, potatoes, sugar beets assumed to have zero residues).
3 Scenario 3: includes only pecans and potatoes (sugar beets, meat and milk not included).
Similarly, the TPTH chronic (non-cancer) dietary risk from food alone is well below the
Agency's level of concern. For the U.S. population and all population subgroups, for all three dietary
analyses scenarios, the % cPAD values are all less than 5%.
15
-------
For chronic cancer dietary risk from food alone, based on a Q, * of 1.83x10 (mg/kg/day)-',
the carcinogenic risk estimate for Scenario 1 (all registered crops + meat and milk) is 1.1 x 10"6 for the
general U.S. population. For Scenario 2 (meat and milk only), the carcinogenic risk estimate is 9.4 x
10~? for the general U.S. population. For Scenario 3 (pecans + potatoes, no sugar beets or meat and
milk), the carcinogenic risk estimate is 8.7 x 10~8 for the general U.S. population.
Although the Agency has assumed that sugar beet tops are fed to livestock in its risk
assessment for Scenarios 1 and 2, it should be noted that the TPTH labels cany a legally enforceable
feeding restriction, prohibiting the feeding of TPTH treated sugar beet tops to livestock. Despite the
feeding restriction on the label, the Agency has determined that such restriction could pose an economic
hardship to farmers and that there remains the possibility that sugar beet tops could be fed to livestock.
The Agency has thus based its assessment on the possibility that farmers might still feed sugar beet tops,
as it cannot ignore the possible worst case scenario. However, feeding of TPTH treated sugar beet
tops under labeled conditions would be a violation and the Agency believes that this will deter most
farmers from violating the label. Therefore, the Agency's risk estimates that assume TPTH residues in
meat and milk are likely to reflect an over-estimate of actual dietary risk, in light of the feeding
restriction.
4.
Drinking Water Dietary Risk
I>rinking water exposure to pesticides can occur through ground water and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and
uses either modeling or actual monitoring data, if available, to estimate those risks. Drinking water
exposure is aggregated with exposures from food and residential uses to determine aggregate risk {see
Section IILA6 below), as mandated by FQPA.
Based on environmental fate data, TPTH will partition to a high degree to soils and is not
expected to leach to ground water at significant concentrations. The primary means of transport of
TPTH to surface water is by spray drift and soil erosion.
To determine the maximum allowable contribution of treated water allowed in the diet, EPA
first looks at how much of the overall allowable risk is contributed by food, then determines a "drinking
water level of comparison" (DWLOC). The DWLOC is the concentration of TPTH and its
metabolites in drinking water which does not exceed a level of concern when considered together with
i' i,; • ' HI „ . ;i nl i|i i,', i ;, ,,,i 'Bui!' - !i' ,:i •
dietary exposure from food alone. The DWLOC value for each dietary assessment (acute, chronic, or
cancer) is compared with estimated environmental concentrations (EECs) of TPTH and its metabolites
in surface and ground water. If the DWLOC value is greater than the estimated surface and ground
water estimated concentrations, then the Agency would believe there is no drinking water concern for
aggregate risk assessment purposes.
Water monitoring data for TPTH were not available, so water quality models were used to
assess risks from drinking water sources. Ground water modeling with SCI-GROW (Tier I) and
16
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surface water modeling with PRZM-EXAMS (Tier II) were used to calculate drinking water EECs.
Inputs for both models are based on the crop with the highest allowed application rate (pecans). SCI-
GROW estimates ground water concentrations for pesticides applied at the maximum allowable rate in
areas where ground water is vulnerable to contamination, while PRZM-EXAMS estimates surface
water concentrations. Surface water EECs represent water concentrations that may result from the
maximum allowable aerial application of TPTH to pecans under a standard environmental scenario,
because the use pattern for pecans represent the worst-case concentrations. However, the estimated
concentrations for water from modeling are conservative and are higher than expected to be actually
found in drinking water.
a. Comparison of DWLOC's to EECs in Drinking Water
The estimated environmental concentrations were then compared to the DWLOCs for TPTH.
The acute DWLOC for females 20+ not pregnant, not nursing (the most exposed female population
subgroup) is 20 ppb. The chronic (non-cancer) DWLOC for children is 0.3 ppb, 0.9 ppb for adult
females, and 1.1 ppb for adult males. The cancer DWLOC is 0.002 ppb (based on scenario 2 - meat
and milk only, all crops assumed to have zero residues) for the U.S. population. These values are
compared to TPTH estimated concentrations in ground water (0.03 ppb) and surface water (13.7
ppb). The following table summarizes these numbers.
Subpopulation
of Concern
Females 20+
Children
Adult females
Adult males
U.S. Population
Acute
DWLOC
20 ppb
Chronic
DWLOC
N/A
0.3 ppb
0.9 ppb
1.1 ppb
Cancer
DWLOC
0.002 ppb
Ground water
EEC
(Tier I)
0.03 ppb
Surface water EEC
(Tierll)
Acute
13.7 ppb
Chronic
3.6 ppb
For acute risk, potential exposure to drinking water derived from either ground water or
surface water (0.03 ppb, or 13.7 ppb, respectively) results in exposure that is below the Agency's level
of concern for females (20 ppb), the most exposed population subgroup.
For chronic (non-cancer) risk, potential exposure to drinking water derived from ground
water (0.03 ppb) results in exposure that is below the Agency's levels of concern for children (0.3 ppb)
and adults (0.9 ppb and 1.1 ppb). However, potential exposure derived from surface water (3.6 ppb)
would exceed the Agency's levels of concern for children (0.3 ppb) and adults (0.9 ppb and 1.1 ppb).
17
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For chronic (cancer) risk, potential exposure to drinking water derived from either ground
water or surface water (0.03 ppb, or 3.6 ppb, respectively) results in exposure that exceeds the
Agency's level of concern for the U.S. population (0.002 ppb). For informational purposes, even if
there were no exposure from residues in food, the cancer DWLOC for the U.S. population would be
0.02 ppb; both ground water and surface water EECs exceed that value. This means that even if there
are no exposures from food, total dietary risk (defined to include both food and water) could still be of
concern, as a result of potential drinking water exposure estimated for the worst case scenario: aerial
application to pecans under currently labeled maximum use rates. Generally, for the U.S. population,
cancer risk estimates that are less than 1.0 x 10'6 do not represent a risk concern to the Agency -
which is essentially the risk estimate for Scenario 1. Any additional exposure through drinking water
would lead to risk estimates that further exceed the Agency's level of concern for dietary exposure.
5. Occupational and Residential Risk Assessment (See HED Chapter,
9/21/99)
There are no registered residential uses of TPTH, so only non-dietary, occupational exposures
are assessed.
Occupational (or worker) exposure to TPTH residues via dermal and inhalation routes can
occur during handling, mixing, loading, applying, and reentry activities. Based on toxicological criteria
and potential for exposure, the Agency has conducted dermal and inhalation exposure assessments for
the occupational handler and post-application worker. Because different endpoint effects were
selected for the assessment of dermal and inhalation risks, separate risk assessments were conducted
for dermal and inhalation exposures. Exposures were evaluated for both commercial applicators and
private growers using TPTH. Private growers are expected to have short-term exposure (i.e., it is
assumed that they treat only their own field), while commercial applicators are likely to have both short-
and intermediate-term exposure to TPTH (i.e., it is assumed that several fields are treated).
The cancer risk assessment for occupational handlers was conducted using the sum of dermal
and inhalation exposures combined with an oral Q, *. Separate cancer risks were calculated, where
applicable, for commercial applicators and private growers because, in several cases, the number of
days these two types of workers are exposed is significantly different.
The endpoints used in assessing occupational handler risks from TPTH are presented again in
the following table.
18
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Endpoints fo
Exposure
Routes
Dermal
Dermal
Inhalation
Dermal &
Inhalation
r Assessing Occupational and Residential Risks for TPTH1
Exposure
Duration
Short-term
(1-7 days)
Intermediate-
term
(1 week to
several mos)
Anytime
period
Any time
period
Dose
(mg/kg/day)
NOAEL
3.0
NOAEL
3.0
NOAEL
0.092"
Oral
Q.*
1.83x10
(mg/kg/day)-1
Effect
No effect
observed
at the
highest
dose
tested
No effect
observed
at the
highest
dose
tested
Lung
lesions
seen in
animals
that died at
the next
highest
dose.
Probable
human
carcinogen
(pituitary,
testicular,
and liver
tumors)
Study
Dermal
developmental
toxicity
(rabbit)
Dermal
developmental
toxicity
(rabbit)
Subchronic
inhalation
study (rat)
Oral
Cancer
(Rat and
mouse)
Uncertainty
Factor
100
100
100
NA
Comment
Route-specific
study; MOE based
on UF for inter-
species (1 Ox)
extrapolation and
intra-species
variability(10x)
Route-specific
study; MOE based
on UF for inter-
species (lOx)
extrapolation and
intra-species
variability(lOx)
Route-specific
study; MOE based
on UF for inter-
species (lOx)
extrapolation, intra-
species
variability(lOx)
A dermal
absorption of 10%
should be used.
Based on
comparison
between rabbit oral
and dermal
developmental
studies. Inhalation
absorption
assumed to be
100%.
Dose (mg/kg/day) = (NOAEL (0.00034 mg/L) * Respiration rate of a young adult Wistar rat (8.46 L/hr)
daily exposure duration (6 hr/day)) / Body weight of a young adult Wistar rat (0.187 kg)
Study
19
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a. Factors Forming the Basis for Occupational & Residential
Handler Risk Assessments
Two studies containing chemical-specific data for assessing human exposure during pesticide
handling activities, were submitted in support of the reregistration of TPTH. The first study monitored
mixers/loaders of the wettable powder formulation (in water soluble bags) of TPTH in three pecan
groves. The second study monitored applicators of the liquid formulation by groundboom sprayer,
aircraft, and to pecans by airblast sprayer; the Agency determined that only the data for airblast sprayer
exposure from enclosed cab application was valid for risk assessment purposes.
It is the policy of EPA to combine submitted chemical-specific data, when possible, with that
from the Pesticide Handlers Exposure Database (PHED) to assess handler exposures for regulatory
action (OPP Science Advisory Council on Exposure, policy paper, "Use of Values from the PHED
Surrogate Exposure Guide and from Analyses of Individual PHED Data Sets," March 11,1999).
Accordingly, the data from the exposure study for wettable powder in water-soluble bags were
combined with PHED data for that particular handler scenario. Similarly, the .airblast sprayer exposure
data were combined with PHED data for the enclosed cab application scenario.
For occupational handler scenarios that do not have chemical-specific data, it is the Agency's
policy to use data from PHED to assess handler exposures for regulatory action.
PHED was designed by a task force of representatives from the U.S. EPA, Health Canada, the
California Department of Pesticide Regulation, and member companies of the American Crop Protection
Association. PHED is a software system consisting of two parts - a database of 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. Currently, the database
contains values for over 1,700 monitored individuals (i.e., replicates).
PHED's algorithms (or evaluations of different exposure scenarios to yield unit exposure values)
are based on the central assumption that the magnitude of handler exposures to pesticides are primarily a
function of activity (e.g., mixing/loading, applying); formulation type (e.g., wettable powders, granulars);
application method (e.g., aerial, groundboom); and clothing scenarios (e.g., gloves, double layer of
clothing).
In addition to the unit exposure values calculated by PHED, other factors such as standard
assumptions about average body weight, work day, daily acres treated, volume of pesticide used, are
also used to calculate risk estimates. When available, chemical-specific information about use patterns
are incorporated into the assessment For example, the Agency incorporated information on typical daily
acres treated, and typical application rates, into the handler assessments for TPTH.
In addition, occupational handler exposure assessments are conducted by the Agency using
different levels of risk mitigation. The Agency typically evaluates all exposures with minimal protection
and then adds additional protective measures using a tiered approach to obtain an appropriate MOE for
20
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non-cancer risk (i.e., an MOE exceeding 100) or cancer risk (i.e., a cancer risk betweenl.O x 10'6 and
1.0 x 10"4; see Section IV below). The lowest tier is represented by the baseline exposure scenario,
followed by, if required (e.g., MOEs are less than 100), increasing levels of risk mitigation (personal
protective equipment (PPE) and engineering controls (EC)). The level of protection at baseline usually
involves a handler wearing long pants and a long-sleeved shirt, without chemical resistant-gloves or
respiratory protection. Additional PPE may include an additional layer of clothing, chemical-resistant
gloves, and/or a dust/mist respirator). Finally, appropriate engineering controls may be employed in an
effort to reduce or eliminate the potential for exposure. Examples of engineering controls include closed
tractor cabs, closed mixing/loading/transfer systems, and water-soluble packets.
The current label for TPTH requires occupational handlers to wear coveralls over long-sleeved
shirt and long pants, water-proof gloves, chemical-resistant footwear plus socks, protective eyewear,
chemical-resistant headgear for overhead exposure, and chemical-resistant apron when cleaning
equipment or mixing/loading, and a dust/mist respirator. Closed cab is required for ground applications
to all three crops. Mechanical transfer systems are required for mixing/loading liquid formulations; in
addition, a closed system is required for aerial applications. Flaggers are also required to be in enclosed
cabs.
b. Occupational Handler Exposure Scenarios
The Agency has identified 10 major exposure scenarios for which there is potential for
occupational handler exposure during mixing, loading, and applying products containing TPTH to pecans,
potatoes, and sugar beets. These occupational scenarios reflect mixing/loading and the use of aircraft (for
pecans, potatoes, and sugar beets), groundboom sprayer (potatoes and sugar beets), airblast sprayer
(pecans only), and chemigation (potatoes only) for application. The scenarios are described below; note
that the numbers given to each scenario correlate to the scenarios detailed in the HED chapter and
referenced Appendices.
(la) mixing/loading (M/L) liquids for aerial/chemigation application;
(Ib) M/L liquids for groundboom application;
(Ic) M/L liquids for orchard airblast sprayer applications;
(2a) M/L wettable powder in water-soluble bags (WSB) for aerial/chemigation application;
(2b) M/L wettable powder in WSB for groundboom application;
(2c) M/L wettable powder in WSB for orchard airblast sprayer application;
(3) applying (A/) sprays with fixed-wing aircraft;
(4) A/ sprays using a groundboom sprayer;
(5) A/ to orchards with an airblast sprayer;
(6) mixing/loading liquid and applying (M/L/A) with a groundboom sprayer,
(7) M/L/A liquid to orchards with an airblast sprayer;
(8) M/L/A wettable powder in WSB with a groundboom sprayer;
(9) M/L/A wettable powder in WSB to orchards with an airblast sprayer;
(10) flagging during aerial spray application.
21
-------
Seven of these scenarios (labc, 2abc, 3, 6, 7,8,9) required engineering controls by default
because unit exposure data for baseline and PPE levels of protection are either not applicable (because
engineering controls are required by label) or not available. This occurred for scenarios 1 and 2 because
both types of formuktions of TPTH have inherent engineering controls for mixing/loading (i.e., the
flpwable concentrate is to be used with a mechanical transfer or closed system, and the wettable powder
is only available in water-soluble bags). Scenarios 6 through § are affected for the same reason; unit
exposures are nof applicable for the mixing/loading portion of the equation. For scenario 3, no data are
available for open cockpit during aerial application. The scenarios were classified as short-term (1-7
days) and intermediate-term (1 week to several months) based primarily on the frequency of exposure.
A long term exposure duration is not expected.
c. Occupational Handler Risk Characterization
' i. Non-Cancer Handler Risk: Summary of Risk Concerns
, . " ... ,| .v • - ,
Generally, non-cancer handler risk is measured by a Margin of Exposure (MOE) that
determines how close the occupational handler exposure comes to a No Observed Adverse Effect Level
(NOAEL). Both short-term and intermediate-term MOEs for occupational handlers were derived based
upon comparison of dermal exposure estimates against a NOAEL of 3.0 mg/kg/day; inhalation MOEs
were derived based upon comparison of inhalation exposure estimates against a NOAEL of 0.092
mg/kg/day. Generally, MOEs greater than 100 do not exceed the Agency's risk concern.
For short- and intermediate-term dermal risks at baseline. MOEs are greater than 100 for all
the assessed exposure scenarios except scenario (5) application of sprays to pecan orchards with an
airblast sprayer at maximum and typical rates (MOEs = 33 at max rate; 50 at typical rate). When
additional PPE (personal protective equipment) is applied, the dermal MOEs are still less than 100 for
this scenario (MOEs = 55 and 82). Using engineering controls (i.e., enclosed cab) mitigates dermal risks
to MOEs of greater than 100 (MOEs = 630 and 950).
Assessments for scenarios labc, 2abc, 3,6,7, 8, and 9 incorporated engineering controls.
Dermal MOEs are more than 100 for all scenarios except two scenarios. The engineering control
scenario (2aj mixing/loading wettable powder in WSB for aerial/chemigation application to all crops
yielded MOEs that range from 65 to 82 even when typical application rates, rather than maximum rates,
were used. The engineering control scenario (la) mixing/loading liquids for aerial application to sugar;
beets has ah MOE of 84 when the maximum application rate is used. This MOE is mitigated to 170 with
the use of the typical application rate.
, ii" ' . ' , • | . . '. ii! ' • ,
'i , . , if « , .. J
However, for scenario (2a), engineering controls (and chemical-resistant gloves) in conjunction
with the use of typical application rates, rather than maximum rates, are not adequate to mitigate dermal
risks to an MOE of lOO or more. Therefore, this scenario remains a concern to the Agency.
22
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Summary of Dermal Risks that Remain a Concern
Scenario
(5) Applying sprays to
orchards with airblast sprayer
Engineering Control
Scenarios
(la) M/L liquids for aerial
application
(2a) M/L wettable powder
(WSB) for aerial/chemigation
application
Crop
pecans
Crop
sugar
beets
pecans
potatoes
sugar
beets
Rate (max or
typical)
Ib ai/acre
max = 0.375
typ = 0.25
Rate
max = 0.25
t\m — O 1O^
max =0.375
typ = 0.25
max =0.1875
typ = 0.125
max = 0.25
typ = 0.125
Baseline
MOE
max = 33
typ = 50
N/A
N/A
N/A
N/A
N/A
w/,PPEf
max = 55
typ = 82
N/A
N/A
N/A
N/A
N/A
w/
Engineering
max=630 •
typ = 950t
Engineering
Controls
max = 84
typ =170 '"'-
max = 55
typ = 82
max = 44
typ = 65
max = 33
typ = 65
—j — _. _ _..v...*«»£2 u»u U4*u*iiivai A^oiDLallL KIUVCS.
Engineering controls include closed mixing/loading or water-soluble bag, single layer of clothing, chemical resistant
gloves, enclosed cab, enclosed cockpit, or enclosed truck.
Gray, shaded areas indicate mitigation measures that would reduce risks to a level that would not represent a concern
to the Agency (i.e., MOE of above 100). E.g., for scenario (la), using the typical rate (*) would mitigate risks to an
MOE of 170.
For short- and intermediate-term inhalation risks, MOEs are greater than 100 at baseline for all
the assessed exposure scenarios except scenario (5) applying sprays to pecan orchards with an airblast
sprayer at the maximum application rate (MOE = 95). This risk estimate is mitigated to an MOE of 140
with the use of the typical application rate, and an MOE of 480 with PPE.
For the assessments incorporating engineering controls, scenarios labc, 2abc, 3, and 6 through 9
all inhalation MOEs are greater than 100.
23
-------
Scenario
(5) Applying sprays to
orchards with airblast sprayer
Crop
pecans
Rate (max or
typical)
Ib ai/acre
max = 0.375
typ - 0.25
Baseline
MOE
max = 95
typ =140
w/ PPE'
max=480
typ = 720
w/
Engineering
Controls2
max=950
typ=vl,400
Engineering controls: enclosed cab.
Gray, shaded areas indicate mitigation measures that would reduce risks to a level that would not represent a concern
to the Agency (i.e., MOE of above 100).
ii- Cancer Handler Risk: Summary of Risk Concerns
Thecancer risk assessment used an oral Q,*; a 10 percent dernial absorption value; and a 100
percent inhalation absorption value. The dermal and inhalation exposures were summed to calculate a
total exposure, which was combined with the Q, * to estimate cancer risk. Generally, cancer risk
estimates greater than 1.0 x 10"4 would represent a risk concern for the Agency. As well, cancer risk
estimates that are less than 1.0 x 10"4 but greater than 1.0 x 10'6 would raise concerns that may require
further mitigation and risk-benefit balancing for risk management purposes (see Section IV below).
Risk estimates indicate that cancer risks at baseline are greater than 1.0 x 10"4 for scenario (4)
commercial application of sprays with a groundboom sprayer to potatoes (1.4 x 10"4). For the private
grower foe cancer risk is 4.3 x 10'6. With PPE, risks are 8.1 x 10'5 for commercial applicators, and 2.5
x 10-6 for private growers. As mentioned previously, seven scenarios (labc, 2abc, 3, 6, 7, 8,9)
incorporated engineering controls. Of these, scenarios (2ab) mixing/loading wettable powder in WSB for
aerial/chemigation application and for groundboom application, yielded cancer risk estimates ranging from
8.1 x 1Q-6 (pecans; not captured in table below because not a concern) to 1.5 x lO^4 (potatoes) for the
commercial applicator. For the private grower, the cancer risk estimates for these same scenarios ranged
from 3.6 x 106 to 9.1 x 10'5.
For scenario (2ab), engineering controls (and chemical-resistant gloves) in conjunction with the
use of typical application rates are not adequate to mitigate cancer risk estimates to below 1.0 x 10"4 for
commercial treatment of potatoes.
Risk estimates incorporating engineering controls are in the range of 1.0 x 10"4 to 1.0 x 10"6 for
all other scenarios, except the flagging scenario, which has risks that are less than 1.0 x 10"6:
24
-------
Summary of Cancer Risks Exceeding 1.0 x 10"4 (all scenarios used typical rates & typical number of
Scenario
(4) A/ sprays with a
groundboom sprayer*
Engineering Control
Scenarios
(2a) M/L wettable powder
(WSB) for aerial/chemigation*
(2b) M/L wettable powder
(WSB) for groundboom*
Crop
potatoes
Crop
potatoes
potatoes
Rate (typical
only)
Ib ai/acre
0.125
Rate
0.125
0.125
Baseline
1.4 xlO"4
N/A
N/A
N/A
w/PPE
8.1 x 10-5
N/A
N/A
N/A
vf
Engineering
(Controls
3.5 xl(T5
Engineering
Controls
1.5 xlO"
1.5 xHT1
Summary of Cancer Risks in the 1.0 x 10'6 to 1.0 x 10-" Range (all scenarios used typical application
Scenario
(4) A/ sprays with a groundboom sprayer*
(5) A/ sprays to orchards with airblast
sprayer
(10) Flagging spray applications
Engineering Control Scenarios
(la) M/L liquids for aerial/chemigation*
(Ib) M/L liquids for groundboom
application*
(2a) M/L wettable powder (WSB) for
aerial/chemigation application
Crop
sugar beets
pecans
potatoes
sugar beets
Crop
potatoes
sugar beets
potatoes
sugar beets
sugar beets
Baseline
83 x 1C'5
4.4 xlO'5
3.4 x 1CT5
2.0 xlO-5
N/A
N/A
N/A
N/A
N/A
N/A
w/PPE
4.9 xlO-5
2.5 xlO"5
2.5 xlO-5
1.5 x ID"5
N/A
N/A
N/A
N/A
N/A
N/A
W
Engineering
(Controls
2.1 x 10-5
2.5 x ID"6
6.8 xlO"7
4.1 x ID"7
Engineering
Controls
63 xlO-5
3.8 xlO"5
6.1 x 10-5
3.7 xlO"5
9.1 x lO"5
25
-------
Scenario
(2b) MIL wettable powder (WSB) for
groundboom*
(3) A/ sprays w/ fixed wing aircraft
Crop
sugar beets
potatoes
sugar beets
Baseline
N/A
N/A
N/A
w/PPE
I
N/A
N/A
N/A •
w/
Engineering
Controls
8.8 x ias
3.8 xlO"5
23 x 10"5
'commercial applications only
d. Incident Reports
The Agency has reviewed the OPP Incident Data Systems (IDS), the Poison Control Center
(PCC), the California Department of Pesticide Regulation (CA-DPR), and the National Pesticide
Telecommunications Network (NPTN) databases for reported incident information for TPTH. No data
were reported from PCC or CA-DPR. From the NPTN, TPTH was not reported to be involved in
human incidents out of the list of the top 200 chemicals for which NPTN received calls from 1984 to
1991. Seven cases were submitted to the IDS; however, the cases from the IDS dp not have
documentation confirming exposure or health effects unless otherwise noted. The Agency concludes that
relatively few incidents of illness from exposure to TPTH have been reported. No recommendations can
be made based on the few incident reports available.
• ' .,' , • •; • ' ' ,r«;:. . ' . ' .'j ^
e. Occupational Post-Application Exposure
' . '' , ,. '. '. .'' '.: , j:.. '• ' '•
EPA has determined that there are potential post-application exposures to individuals entering
treated areas for purposes of:
• harvesting pecans (although this is done mechanically, it is a very dusty operation);
• Scouting and moving hand-set irrigation pipes for potatoes and sugar beets; and
• harvesting, sorting/packing, and brushing/washing potatoes and sugar beets. Although this is
usually done mechanically for potatoes, there may be some farms at which these activities are
performed by hand. For sugar beets, these activities are done almost exclusively by mechanical
means and, therefore, were not assessed. However, in the case that hand methods are used for
sugar beet harvesting, the exposures are not expected to exceed those encountered during
potato-harvesting activities.
None of these crop activities have been identified as scenarios yielding potential chronic exposure (i.e.,
greater than or equal to 180 days of exposure/year) concern.
26
-------
i- Data and Assumptions for Post-application Exposure
Assessment
The TPTH Taskforce submitted a reentry study of pecan workers operating windrowing
equipment as part of pecan harvesting activities in Georgia and Texas. Both dermal and inhalation
exposure monitoring were conducted. In addition, soil and thatch samples were collected from the
dripline beneath the pecan trees. The Agency used both the monitoring data and the soil/thatch residue
levels in assessing post-application risk.
The Taskforce also submitted soil and foliar dissipation data collected following applications of
TPTH to potatoes and peanuts (although peanuts is no longer a registered use, so only potato data were
used). The Agency determined the data acceptable and found the potato data also useful for the sugar
beets assessment because both crops have similar application rates and cultural practices.
Agency assumptions about application rates, transfer coefficients (where applicable), work day,
average body weight, exposure duration and frequency factored into the calculations of post-application
risk. Otherwise, the chemical-specific and transferable residue data described above were used to
complete this assessment. For assessing maintenance activities, the non-cancer calculations were
completed using the maximum application rates for specific crops recommended by TPTH labels.
Typical application rates were used in calculations for the cancer assessment.
11.
Occupational Post-application Risk Characterization (see
Appendices 5 through 7 of revised HED chapter for more detail.)
Post-application risk estimates indicate that for pecan harvesting. MOEs exceed 100 (i.e., are
not a concern) on day zero after application. Cancer risk estimates are greater than 1.0 x 10"4 (i.e.,
are a concern), however, until 7 days after the last application at the Georgia site, and are greater than
1.0 x lO"4 until some time between 21 and 30 days after the last application at the Texas site. MOEs for
potato maintenance activities are greater than or equal to 100 on day zero after application; MOEs for
sugar beet maintenance activities are greater than or equal to 100 on the second day after application.
The cancer risk estimate for maintenance activities are less than 1.0 x 10"4 on the second day after
application for both potatoes and sugar beets. The MOE and cancer risk estimate for potato harvesting
are below the Agency's levels of concern on any day after application.
The current reentry interval (REI) is 48 hours for all crops. TPTH has the potential to be a
primary eye irritant (toxicity category I), which triggers the worker protection standard's (WPS) default
REI of 48 hours.
6. Aggregate Risk Assessment and Risk Characterization
In establishing or reassessing tolerances, the Food Quality Protection Act (FQPA) requires EPA
to consider aggregate exposures to pesticide residues, including all anticipated dietary exposures and
27
-------
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 mechanism of toxicity. Dietary exposures include those
from food and drinking water sources. Exposures from residential or other non-occupational uses are
also aggregated; however, for TPTH, there are no registered residential uses, so these types of exposures
are not expected. For the risk assessment of TPTH, the Agency has not assumed that TPTH has a
common mechanism of toxicity with any other chemicals. Therefore, for assessing aggregate risk from
TPTH use,,the Agency has evaluated only dietary exposure through food and drinking water.
a. Acute Aggregate Risk
The acute aggregate risk assessment for TPTH is defined to include risk estimates associated with
dietary exposure through food and drinking water only. As previously described, based on a refined
analysis using exposure data that incorporated anticipated residues, percent crop treated data, and
processing factors, acute dietary risk estimates for food alone are all below the Agency's level of concern
(i.e., less than 100% of aPAD is consumed). For the most highly exposed female population subgroup,
females 20+ years old, not pregnant, not nursing, 34% of the acute PAD is occupied at the 99.9th
percentile of exposure. In addition, drinking water EECs for both ground and surface water (acute EEC
= 13'7) <% n9l exceed toe acute DWLOC value. Therefore, acute aggregate risk from food and drinking
water exposures do not represent a concern to the Agency.
b. Short-and Intermediate-term Aggregate Risk
Short- and Intermediate-term aggregate risk estimates, defined to include exposures from food,
water, and residential uses, are not required for TPTH because there are no residential uses.
,,,"" ,,,, '. "v, • • '! iiili',; : " | ' >. •• . . • I ;I ' |
c. Chronic (Non-Cancer) Aggregate Risk
The chronic aggregate risk assessment for TPTH includes risk estimates associated with chronic
dietary exposure through food and water. As previously described, refined chronic dietary risk estimates
for food alone are below the Agency's level of concern (i.e., less than 100% of the cPAD is consumed).
For the most highly exposed population, children 1-6 years old, 4% of the chronic PAD is occupied.
However, potential exposure derived from surface water (chronic EEC = 3.6 ppb) would exceed the
Agency's level of concern for children (0.3 ppb) and adults (0.9 ppb for females, 1.1 ppb for males) -
therefore, chronic aggregate risk from dietary exposure could exceed the Agency's level of concern (i.e.,
could exceed 100% of cPAD).
d. Chronic (Cancer) Aggregate Risk
The cancer aggregate risk assessment for TPTH includes risk estimates associated with dietary
exposure through food and water only, as there are no registered residential uses of TPTH. As
previously described, exposure to TPTH from food sources alone exceed the Agency's level of concern
for cancer dietary risk estimates. Based on a Q, * approach for cancer risk estimate, the cancer dietary
28
-------
risk estimate for Scenario 1 (all crops + meat and milk), which comprises only food exposure, is 1.1 x
ID'6 - this risk estimate contributes to the entire allocation of risk for dietary exposure (which includes
food and drinking water). Generally, for the U.S. population, cancer risk estimates that are less than 1.0
x 10'6 do not represent a risk concern to the Agency - the risk estimate for Scenario 1 slightly exceeds
that allocation. Therefore, any additional exposure through drinking water would lead to risk estimates
that further exceed the Agency's level of concern for dietary exposure.
With dietary exposure refinements reflected in Scenarios 2 (only meat and milk; all crops
assumed to have zero residues) and 3 (pecans + potatoes only; sugar beets, meat and milk excluded),
risk estimates for food exposure alone are less than 1.0 x 10'6 - risk estimates are lowered to 9.4 x 10'7
and 8.7 x 10'8, respectively. However, as related above, cancer risk estimates for potential exposure to
drinking water derived from either ground water or surface water (0.03 ppb, or 13.7 and 3.6 ppb,
respectively) exceed the Agency's level of concern for the U.S. population (0.002 ppb). Also, even if
there are no residues from food, the cancer DWLOC value for the U.S. population is 0.02 ppb, and
estimated concentrations in water would still exceed mat DWLOC. Therefore, cancer risk from drinking
water exposures based on water modeling causes dietary risk estimates (defined to include food and
drinking water) for all three dietary scenarios to exceed the Agency's level of concern for dietary
exposure.
B. Environmental Fate and Effects Risk Assessment (for details on risk assessment,
see EFED chapter, June 8, 1999)
1. Environmental Risk Assessment
Risk assessment of a pesticide's ecological effects integrates the results of exposure and eco
toxicity data to evaluate the likelihood of adverse ecological effects on a non-target species. The means
of integrating these exposure factors is the risk quotient (RQ) method. Risk quotients are calculated by
dividing estimated environmental concentrations (EECs) of the pesticide by acute and chronic eco toxicity
values. EECs are based on the maximum application rates for that pesticide.
Risk quotients are then compared to the Agency's levels of concern (LOCs). These LOCs are
used to analyze potential risk to non-target organisms and the need to consider regulatory action. The
criteria are used to indicate when a pesticide used as directed has the potential to cause adverse effects
on non-target organisms. LOCs currently address the following risk presumption categories: (1) acute
high: potential for acute risk is high and regulatory action may be warranted in addition to restricted use
classification; (2) acute restricted use: the potential for acute risk is high, but may be mitigated through
restricted use classification; (3) acute endangered species: endangered species may be adversely affected
by use; and (4) chronic risk: the potential for chronic risk is high, regulatory action may be warranted.
Currently, the Agency does not perform assessments for chronic risk to plants, acute or chronic risks to
non-target insects, or chronic risk from granular/bait formulations to birds or mammals.
29
-------
Risk presumptions, along with the corresponding RQs and LOCs are tabulated below.
' ' '
Risk Presumptions for Terrestrial Animals
Risk Presumption
RO
LOG
Avian
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEC1/LC50 or LD50/sqft2 or LD50/day3
EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)
EEC/LC50 or LD50/sqft or LD50/day
EEC/NOEC
0.5
0.2
0.1
1
Wild Mammals
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEC/LC50 orLD50/sqft or LD50/day
EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)
EEC/LC50 or LD50/sqft or LD50/day
EEC/NOEC
0.5
0.2
0.1
1
1 abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items
2 mg/ft2 3 mg of toxicant consumed/day
LD50 * wt. of bird LD50 * wt. of bird
Risk Presumptions for Aquatic Animals
Risk Presumption
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
RO
EECl/LC50orEC50
EEC/LC50orEC50
EEC/LC50orEC50
EEC/MATC or NOEC
LOG
0.5
0.1
0.05
1
1 EEC = (ppm or ppb) in water
30
-------
Risk Presumptions for Plants
Risk Presumotion
Terrestrial and Semi-Aquatic Plants
Acute High Risk
Acute Endangered Species
Aquatic Plants
Acute High Risk
Acute Endangered Species
RQ
EEC1/EC25
EEC/EC05orNOEC
EEC/EC05 orNOEC
LOG
1
2 EEC = (ppb/ppm) in water
In addition, the Agency considers any incident data that is submitted concerning adverse effects
on non-target species; for TPTH, no incident data have been submitted.
a. Risk to Nontarget Terrestrial Organisms
TPTH is moderately toxic to avian and mammalian species and exceeds acute and chronic
LOCs. For a single application of TPTH, acute avian LOCs were exceeded for endangered species for
all crops (RQ range 0.01 - 0.40). In addition, the restricted use LOG is exceeded for pecans (short
range grass) and beets (short range grass) (RQ range 0.20 - 0.40). The avian chronic level of concern is
exceeded at all registered maximum application rates (RQ range 1.3 - 30).
For multiple applications avian acute high levels of concern are exceeded for short range grass at
the maximum allowable application rate for all uses (RQs = 0.6) and in pecans for all feed items except
seeds (RQ range 0.7 - 1.24). Restricted use and endangered species levels of concern are exceeded for
all maximum application rates except seeds (RQ range 0.3 - 0.60). Avian chronic LOCs are exceeded
for all food items at all registered maximum application rates (RQ range 3.0 - 104).
For multiple broadcast applications of liquid products, mammalian acute levels of concern are not
exceeded at maximum application rates for any crop. However, the mammalian chronic LOC is
exceeded at all registered maximum application rates for all food uses (RQ range 2.0 - 63).
The tables below summarize the avian and mammalian exposure assessments.
31
-------
Avian exposure assessment for TPTH use. "X" indicates that the RQ exceeds the LOG.
Crop
Potatoes
Pecans
Sugar
beets
Food Item
Short grass
Tall grass
Broadleaf
plants/Insect
s
Seeds
Short grass
Tall grass
Broadleaf
slants/Insect
s
Seeds
Short grass
Tall grass
Broadleaf
jiants/lnsect
s
Seeds
Single Application
acute
RQ
0.18
0.08
0.1
0.01
0.4
0.16
0.2
0.02
0.24
0.11
0.13
0.02
chronic
RQ
15
7
8.3
1
30
13.7
17
2
20
9.3
11.3
1.3
acute
high
risk
acute
restricted
use
X
X
endangered
species
X
X
X
X
X
X
X
X
X
X
X
chronic
risk
X
X
X
X
X
X
X
X
X
X
X
Multiple Applications
acute
RQ
0.60
0.30
0.30
0.04
1.24
0.60
0.70
0.08
0.60
0.30
0.32
0.04
chronic
RQ
48
22
27
3.
104
48
59
7
48
22
27
3
acute
high
risk
X
X
X
X
X
acute
restricted
use
X
X
X
X
X
X
X
X
X
endangered
species
X
X
X
X
X
X
X
X
X
chronic
risk
X
X
X
X
X
X
X
X
X
X
X
X
Mammalian exposure assessment for TPTH use "X" indicates that the RQ exceeds the LOG.
Crop
Potatoes
Pecans
Food Item
Short grass
Tall grass
Broadleaf
plants/Insect
s
Seeds
Short grass
Tall grass
Broadleaf
plants/Insect
s
Seeds
Single Application
acute
RQ
0.01
0.00
0.00
0.00
0.03
0.01
0.02
0.00
chronic
RQ
9.0
4.2
5.0
0.6
18
8.2
10
1.2
acute
high
risk
acute
restricted
use
endangered
species
chronic
risk
X
X
X
X
X
X
X
Multiple Applications
acute
RQ
0.04
0.02
0.03
0.00
0.10
0.04
0.05
0.00
chronic
RQ
29
13
16
2.0
63
29
35
4.0
acute
high
risk
acute
restricted
use
endangered
species
chronic
risk
X
X
X
X
X
X
X
X
32
-------
Crop
Sugar
Food Item
Short grass
slants/Insect
s
RQ
0.02
RQ
12
high
risk
.acute
restricted
use
endangered
species
chronic
risk
X
X
Multiple Applications
acute
RQ
0.05
0.02'
<>
-------
The table below summarizes the aquatic exposure assessment.
Aquatic exposure assessment for TPTH use. "X" indicates that the RQ exceeds the LOG.
Organism
Freshwater
Fish
Freshwater
Invertebrates
Sstuarine and
Marine Fish
Scenario
. potato
pecan
sugar beets
potato
pecan
sugar beets
potato
pecan
sugar beets
acute
RQ
0.07
0.7
O.OS
0.14
1.37
0.2
0.05
0.06
0.54
chronic
RQ
9.2
102
10.8
1.17
10.8
1.3
no data
no data
no data
icute high
risk
X
X
X
acute
restricted
use
X
X
X
X
acute
endangered
species
X
X
X
X
X
X
X
X
chronic
risk
X
X
X
X
X
X
X
c. Risk to Endangered Species
Endangered and threatened avian species may be at acute and chronic risk from applications of
TPTH. There were no acute risks to endangered and threatened mammalian species associated with
single applications of TPTH but risks from multiple applications were associated with the pecan use.
Endangered and threatened mammalian species may be at chronic risk from most single and all multiple
applications of TPTH. Endangered and threatened freshwater fish, freshwater invertebrates,
estuarine/marine fish and especially mollusks may be at acute risk from TPTH. Also, endangered and
threatened freshwater fish and invertebrates may be at chronic risk from TPTH. Chronic risk to
endangered and threatened estuarine/marine fish and invertebrates is unknown due to a lack of data,
although risk would likely be present due to high toxicity of the compound to aquatic organisms in general
and extrapolation from freshwater data.
2.
Environmental Fate Assessment
TPTH is hydrophobic (log K<,w = 3.1), and although there is some uncertainty with regard to
measured values of K^ values, indications are that TPTH partitions very strongly to soils, with K^
possibly ranging from 1900 mL/g to greater than 54000 mL/g. Based on submitted data, TPTH is
resistant to photo degradation and hydrolysis. Data also indicate that TPTH degrades in aerobic soil with
a half life of 21 days, although open literature indicates that the half life may be as high as 140 days.
TPTH half life under anaerobic soil conditions is 36 days, according to submitted reports. Based on its
high KO,. and comparatively short soil half life (from submitted data), TPTH is not expected to reach
groundwater at significant concentrations. However, if the half-life of TPTH is closer to reported
literature values, TPTH could reach groundwater in concentrations higher than previously predicted.
TPTH that reaches the ground after field application will be strongly sorbed; thus the major transport
mechanism to surface water bodies will be by spray drift and soil erosion. Once in surface water bodies,
34
-------
studies indicate that TPTH will accumulate in tissues offish by factors of 2900,4900,3700X for the
edible tissue, nonedible tissue, and in the whole fish, respectively.
There remains uncertainty, however, about the persistence of TPTH in water and the possible
toxicity to aquatic invertebrates. This uncertainty is compounded by a lack of appropriate data (e.g.,
aerobic and anaerobic aquatic metabolism studies). Also, more data is needed to characterize the fate of
TPTH degradates of toxicological concern, mono-phenyltin and. di-phenyltin, in soil and aquatic systems.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissions of relevant
data concerning an active ingredient, whether products containing the active ingredients are eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e., an
active ingredient specific) data required to support reregistration of products containing triphenyltin '
hydroxide or TPTH active ingredients. 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 TPTH for
use on pecans, potatoes, and sugar beets. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregistration eligibility of TPTH, and lists the submitted
studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the registered
uses of TPTH. The Agency determined that TPTH products, when used as specified in this document
(i.e., with the mitigation measures outlined in this section), can bs used on currently registered crop sites
without resulting in unreasonable adverse effects to humans and the environment. The Agency therefore
finds that all products containing TPTH as the active ingredient, for use on pecans, potatoes, and sugar
beets are eligible for reregistration. The reregistration of particular products is addressed in Section V of
this document.
The Agency made its reregistration eligibility determination based upon the target data base
required for reregistration, the current guidelines for conducting acceptable studies to generate such data,
published scientific literature, and the data identified in Appendix B. Although the Agency has found that
all uses of TPTH 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 TPTH, if new information comes to foe Agencys attention or if the data
requirements for registration (or the guidelines for generating such data) change.
35
-------
1.
Eligibility Decision
Based on the reviews of the generic data for the active ingredient TPTH, the Agency has
sufficient information on the health effects of TPTH and on its potential for causing adverse effects in fish
and wildlife and the environment. The Agency has determined that TPTH products, labeled and used as
specified in this Reregistration Eligibility Decision, will not cause unreasonable adverse effects to humans
or the environment. Therefore, the Agency concludes that products containing TPTH for use on pecans,
potatoes, and sugar beets are eligible for reregislration.
2. Eligible and Ineligible Uses
T:
The Agency has determined that use of TPTH on all currently registered crop sites (pecans,
potatoes, sugar beets) are eligible for reregistration under the conditions specified in this Reregistration
Eligibility Decision.
J r' H; ', '',,„!, ,', ' .in
B. Regulatory Position
The registrants of TPTH have agreed to amend current labels to prevent TPTH from reaching
drinking water sources, add protective measures for pecan harvesters, mitigate risks to non-target species
and aquatic ecosystems, and conduct confirmatory studies to refine the Agency's worker, drinking water,
and aggregate risk assessments. The Agency has determined that these measures will reduce risks such
that the benefits of TPTH use presently outweigh the risks, and that unreasonable adverse effects will not
result from such use. The Agency thus finds that all currently registered uses of TPTH are eligible for
reregistratipn, with the following risk mitigation measures incorporated into amended labels for TPTH-
containing products in the 2000 use season.
I
For all crops:
— A buffer zone of 100 feet from water bodies for ground applications.
- A buffer zone of 300 feet from water bodies for aerial applications.
— Enclosed cabs for all applicators and flaggers.
-r. Conduct a new worker exposure study on mixing and loading of wettable powder in water
soluble packaging for groundboom and aerial/chemigation application.
For pecans:
— In areas and states that are west of Interstate 35 (e.g., Arizona, New Mexico, and some areas
of Oklahoma and Texas), the maximum seasonal use will not exceed 24 ounces ai/acre.
- In all other areas and states (east of Interstate 35) the maximum seasonal use will not exceed
36 ounces ai/acre.
- A pre-harvest interval (PHI) of 30 days after the last application.
For potatoes:
— The maximum seasonal use will not exceed 9 ounces ai/acre.
36
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For sugar beets:
- In all states EXCEPT Minnesota, North Dakota, and Michigan (where the maximum seasonal
use will remain unchanged), the maximum seasonal use will not exceed 8 ounces ai/acre.
The following is a summary of the regulatory positions and rationales for managing risks
associated with the use of TPTH. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Food Quality Protection Act Findings
a. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for TPTH, with the amendments and changes
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(D) of the FFDCA, that there is a reasonable certainty of no harm for the general population.
In reaching this determination, EPA has considered the available information on the toxicity, use practices
and scenarios, and the environmental behavior of TPTH.
There are no TPTH products registered for home or other non-occupational use; therefore there
is no residential exposure considered in the aggregate risk assessment. The Agency has concluded that
for acute-non-cancer dietary risk from food, estimates for the subpopulation of concern, females 13+
years, are less than 34% of the aPAD, and therefore is below the Agency's level of concern. For chronic
non-cancer dietary risk from food, estimates for all U.S. populations are less than 5% of the cPAD, and
therefore is below the Agency's level of concern. For chronic cancer dietary risk from food, based on
Scenario 1 (all registered crops, meat and milk), the estimate for the U.S. population, including infants
and children, is essentially 1.0 x 10"6 (1.1 x 10"6). Thus, exposure from food alone exhausts the entire
allocation for dietary risk, such that if drinking water exposures occur, this could result in potential dietary
risk.
Based on the Agency's water modeling assessment, chronic (non-cancer and cancer) drinking
water levels of concern are exceeded. Water modeling estimates indicate that potential drinking water
contributions from surface water sources result in chronic (non-cancer and cancer) dietary risk that
exceeds the Agency's level of concern, when combined with food exposures. The Agency's modeling
estimates are expected to be higher than actual concentrations, due to assumptions built into the model,
and the Agency would normally require a water monitoring study to better refine the expected dietary
contribution from water. However, given that available information indicates that TPTH binds strongly to
soil, and that the registrants have agreed to impose buffer zones to prevent run-off and spray drift,
through which TPTH could otherwise reach surface water, at this time EPA believes that water
monitoring in not necessary. If TPTH does reach aquatic systems, it will partition to the sediment,
thereby reducing TPTH concentrations in overlying water. In the present case, since the Agency has only
limited data on the fate of TPTH's degradates in the environment, rather than requiring a water monitoring
study, the Agency is requiring a field dissipation study, aerobic and anaerobic aquatic metabolism, and
37
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aerobic soil metabolism studies to verify its conclusion that TPTH and its degradates will not be present in
water at levels of concern. The Agency's requirement of additional data will allow it to better evaluate
the fate characteristics of TPTH and its degradates in water and soil. Based on these studies, the Agency
, will determine whether water monitoring is warranted.
b. Determination of Safety for Infants and Children
.' ;; . ' • ,„ , ' , j,
. , ,| , , .
EPA has determined that the established tolerances for TPTH, 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 TPTH residues in this population subgroup.
In, determining whether or not infants and children are particularly susceptible to toxic effects from
TPTH 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, TPTH has a substantially complete database for
developmental and reproductive toxicity. Studies cited earlier in this document indicate evidence of
increased susceptibility of offspring following pre- and post-natal exposure in a two-generation
reproduction study in rats. Based on these and other findings (see section IE above), the Agency
retained the FQPA lOx Safety Factor for chronic dietary risk assessment of all populations, including
infants and children.
All doses for risk assessment purposes were assessed using the conventional safety factors of lOx
for interspeciesextrapolation and lOx for intraspecies variability. In addition, the FQPA lOx Safety
Factor was retained for chronic dietary risk assessment of all populations, including infants and children,
because increased susceptibility of the offspring was seen following repeated oral exposures in a two-
generation reproduction toxicity study. For acute dietary risk assessment, the FQPA Safety Factor was
reduced to 3x for the subpopulation Females 13+ (13-50 years, i.e., females of childbearing age).
Although increased susceptibility was not seen following in utero exposures (developmental studies), the
Agency is concerned about potential immunotoxic effects, and is requiring developmental neurotoxicity
studies, including one that tests for immunotoxicity (see Section V).
As discussed earlier, the chronic non-cancer dietary risk estimates for food alone is less than 5%
of the cPAD for the U.S. population, including infants and children. Acute dietary risk from food alone
occupies 34% of the aPAD for all females 13+, the subpopulation of concern for acute dietary risk
assessment At these levels of contribution from food, the Agency is generally not concerned about
potential drinking water dietary contribution from ground water sources, because EECs do not exceed
38
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the DWLOC values for these risk assessments, and fate data suggests that TPTH will not reach ground
water at significant concentrations. .
However, potential contribution from surface water sources may pose concerns. The chronic
cancer dietary risk estimate for food exposure alone is 1.0 x 10'6, and potential drinking water
contributions from surface water sources, based on modeling data, would exceed the Agency's level of
concern. At this time, however, as explained above, the Agency believes the buffer zones and TPTH's
soil binding properties will prevent TFTH from reaching surface water and is requiring additional
confirmatory fate studies to demonstrate that TPTH will not reach drinking water sources at significant
concentrations.
c. Endocrine Disrupter Effects
FQPA requires EPA to develop a screening program to determine whether certain substances
(including all pesticides and inerts) "may have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or such other endocrine effect..." EPA has been working with interested
stakeholders, including other government agencies, public interest 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 TPTH and end-use products for endocrine effects
may be required.
2. Tolerance Reassessment Summary
Tolerances for residues of TPTH are currently expressed in terms of TPTH per se (40 CFR
§180.236). TPTH residues of concern in plant and animal commodities have been determined to include
TPTH and its metabolites, MFTH and DPTH. Accordingly, the tolerance definition for TPTH residues
should also be changed to read as follows:
'Tolerances are established for the combined residues of the fungicide triphenyltin hydroxide and
its monophenyltin (MPTH) and diphenyltin (DPTH) hydroxide and oxide metabolites, expressed
in terms of parent TPTH, in/on the following raw agricultural commodities:"
A summary of the TPTH tolerance reassessment for the animal and crop commodities and
recommended modifications in commodity definitions are presented in Table 6 of the HED chapter
(replicated below).
39
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Tolerances Listed Under 40 CFR S180.236:
Sufficient data are available to reassess tolerances for the combined residues of TPTH in/on
pecans, potatoes, sugar beets, and livestock commodities.
The available residue data indicate that the established tolerances for TPTH residues in/on
pecans, potatoes and sugar beet roots are adequate provided that use directions are amended as
required, and the storage stability data are provided for residues in pecans and confirmatory storage
stability data for sugar beet tops. The existing tolerance for sugar beet root is adequate to cover residues
in refined sugar, molasses, and dehydrated pulp from sugar beet processing. The existing tolerance for
potato is adequate to cover residues in potato processed commodities.
The available data indicate that the established tolerances for residues of TPTH in the kidney and
liver of cattle, goats, horses, and sheep (0.05 ppm each) are lower than necessary to protect human
health and the environment These tolerances should be revised, in terms of the combined residues of
TPTH, to 4.0 ppm in liver and 2.0 ppm in kidney of cattle, goats, horses, and sheep.
1 i ,:i , • , ' " • ill'1', •• '''..i,'1. i| • ,'i' i. '" ,1
,,,,, i , i , •, i i,, 'i i ,,;,. , ,,1111 , jj, , IM M | , , • „;, |
Residue data indicate that tolerances for residues of TPTH in hog kidney and liver should be
reassigned by establishing a separate tolerance of 0.3 ppm for residues in hog meat byproducts.
Tolerances to be Established Under 40 CFR §180.236:
Based on the available residue data, a tolerance of 10.0 ppm should be established for TPTH
residues in/on sugar beet tops.
I ' I 1 , ' '» ; ,»'! j , "' ' ' t ' ,1
For livestock commodities, new tolerances for the combined residues of TPTH in cattle, goat,
horse, and sheep commodities should be established at 0.5 ppm in meat, 0.2 ppm in fat, and 0.06 ppm in
milk. New tolerances are needed for residues in hog meat and fat (at 0.06 and 0.3 ppm, respectively).
In addition, the separate tolerances for residues in hog kidney and liver should be reassigned by
establishing a separate tolerance for residues in hog meat byproducts at 0.3 ppm..
Tolerance Reassessment Summary for Triphenyltin Hydroxide (TPTH) (Table 6 from HED chapter).
Commodity
Current
Tolerance
(ppm)"
Tolerance
Reassessment
(ppm) b
Comment/Correct Commodity
Definition
Tolerances listed under 40 CFR §180.236:
Pecans
Potatoes
Sugar beet, roots
0.05
0.05
' 0.05
0.05
0.05
0.05
Pecan
Potato
Beets, sugar, roots
40
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Commodity
Liver and kidney of cattle, goats,
horses, and sheep
Liver and kidney of hogs
Current
Tolerance
0~05
Tolerance
Reassessment
4.0
2.0
Reassigned
Comment/Correc/ Commodity
The available data from the ruminant
feeding study support increasing the
tolerance on liver.
The available data from the ruminant
feeding study support increasing the
tolerance on kidney.
The tolerance should be reassigned
by establishing a separate 0.3 ppm
tolerance for residues in meat
Tolerances to be established under 40 CFR §180.236:
sheep
Fat of cattle, goats, horses, and
sheep
Hog, fat
Hog, meat
Hog, meat byproducts
Milk
None
None
None
None
None
None
None
10.0
0.5
0.2
0.3
0.06
03
0.06
Based on the available field trial data
on sugar beet tops.
Based on data from the ruminant
feeding study.
A tolerance of 0.3 ppm for residues in
mbyp should be established to
replace separate tolerances for
Based on non-detectable residues
and a LOQ of 0.02 ppm for each
Expressed in terms of the combined residues of TPTH, and its metabolites MPTH and DPTH.
CODEX HARMONIZATION
There are currently no Codex Maximum Residue Limits (MRLs) established for residues of
TPTH in/on plant or animal commodities.
3. Human Health Risk Mitigation
a. Acute Dietary Risk Mitigation
Acute dietary exposure is below the Agency's level of concern for the subpopulation of concern
(females 13+ years old). The 99.9th percentile of acute exposure through food to this subpopulation
occupies 34% of the acute PAD. As noted above, potential drinking water exposure from either ground
or surface water sources (i.e., EECs) do not exceed the acute DWLOC value, and would not be a
41
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concern to the Agency. Therefore, no mitigation measures are necessary to address acute dietary risks
from food and water.
b. Chronic (Non-Cancer) Dietary Risk Mitigation
j
•Chronic non-cancer dietary risk from TPTH treated food is below the Agency's level of concern.
For the U.S..population and all population subgroups, the % cPAD values are ail less than 5%.
Therefore, no mitigation measures are necessary to address chronic (non-cancer) dietary risks from food.
As noted above, potential drinking water exposure from ground water sources (i.e., EECs) do not
exceed the chronic DWLOd value, and would not be a concern to the Agency. However, potential
exposure from surface water sources would exceed the Agency's level of concern. Therefore, mitigation
measures and confirmatory data are necessary to resolve potential chronic risk from surface water source
drinking water exposure - these are discussed in conjunction with remaining chronic cancer dietary risks
below.
c. Chronic (Cancer) Dietary Risk Mitigation
Generally, for the U.S. population, cancer dietary (food and water) risk estimates that are less
than 1.0 x 10 6 do not represent a risk concern to the Agency. The carcinogenic risk estimate for all three
crops plus meat and milk (i.e., Scenario 1), is 1.1 x lO'6. This risk estimate contributes to the entire
allocation of risk for dietary exposure, which includes exposures from food and drinking water.
When aggregated with estimated concentrations of TPTH in drinking water sources (based on
modeling), the carcinogenic risk from dietary exposures exceeds the Agency's level of concern. As
noted above in the aggregate risk discussion, even if there are no residues from food, the cancer
DWLOC value for the U.S. population is 0.02 ppb, and drinking water EECs would still exceed that
DWLOC.
Ijnder Jhe Agency's 1997 policy, "Interim Approach for Addressing Drinking Water
Exposure " (S. Johnson memo, 11/17/97), EPA believes it is not appropriate to require elimination of
uses/crops based on dietary exceedence from water modeling alone. Instead, the Agency's policy is to
require surface water monitoring to refine the water residue estimates calculated by the PRZM/EXAMS
model. At this time, however, EPA will not require surface water monitoring because the Agency
believes the following measures will mitigate potential drinking water and food exposures from TPTH:
• j
• Labels will be revised to establish 100 foot (ground) and 300 foot (aerial) buffer zones from
water (outlined in the ecological risk mitigation section). These buffer zones will reduce the potential for
TPTH residues to reach surface water resources.
• The registrants will conduct a field dissipation study (of pecans and sugar beets); anaerobic and
aerobic aquatic metabolism studies; an aerobic soil metabolism study; and batch equilibrium studies.
•These studies are being conducted so that the Agency can confirm that the TPTH parent compound and
42
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its degradates are unlikely to reach drinking water sources at significant concentrations or at levels that
will pose dietary nsk. Based on available but limited fate data, TPTH binds strongly to soil, and is
expected to partition to the sediment in aquatic systems. These studies will confirm the fate of both the
parent compound and degradates in soil and aquatic systems, allowing the Agency to refine its
environmental fate assessment of TPTH.
• Lower seasonal use rates (as outlined in ecological risk mitigation section) may further reduce
the likelihood'that residues of TPTH and its degradates will reach surface water resources.
d. Occupational Risk Mitigation
Non-cancer Occupational Ri^g
To address dermal and inhalation risk from airblast spray applications (scenario 5), enclosed
cabs for applicators are required Dermal and inhalation MOEs are mitigated to greater than 600 with
such engineering controls as enclosed cab application. Enclosed cabs are currently required for ground
applications; amended labels will require enclosed cab for all applicators using ground or aerial
equipment.
MOEs for rnixing/loading wettable powder (WSB) for aerial/chemigation application (scenario
2a) remain of concern: MOEs for pecans range from 55 (maximum application rate) to 82 (typical rate)-
MOEs for potatoes range from 44 to 65; MOEs for sugar beets range from 33 to 65. Based on this '
assessment, the wettable powder (WSB) formulation for aerial/chemigation application poses
unreasonable risk However, based on a number of factors, the Agency believes that the MOEs for the
water soluble bag formulation are acceptable. First, the results of the Agency's non-cancer occupational
nsk assessment for this formulation, and similar results in the occupational cancer risk assessment
(discussed below), are not consistent with the Agency's experience; that water soluble packaging results
in exposures comparable to the use of other engineering controls such as closed mixing/loading systems
for liquid formulations, and is therefore a protective measure the Agency generally promotes. Second,
the Agency believes that the significant discrepancy observed between exposure from liquid formulations
in closed systems and water soluble bags for this chemical are due to the failure of the TPTH water
soluble bag study to replicate actual use patterns on all three registered crop sites - i e the study
monitored workers who handled only enough active ingredient to treat 5 acres, modeling an airblast
application scenario for pecan orchards which are 40 acres, rather than the 1,200 acres for aerial
application to sugar beets and potatoes. Results of the worker exposure study were thus, of necessity
extrapolated to calculate risks from handling enough active ingredient to evaluate larger acreages resulting
in potential overestimates of worker exposure, since the Agency does not believe, under the
circumstances present, that a linear extrapolation of exposure from 5 acres to 1,200 acres is appropriate
Consequently, although the Agency believes that the study is appropriate to estimate exposures based on
treatment of 40 acres, it does not believe that it is appropriate to use this same study to estimate
exposures based on treatment of 1,200 acres. Based on the above, the Agency believes that a new
exposure study based on a larger treated acreage will demonstrate that the MOEs for the water soluble
43
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•fl"
..i !'.
formulation are acceptable. The Agency believes an eligibility finding is supported in this instance
since it is reasonable to expect that a two- to three-fold reduction in exposure can be demonstrated in a
new study, based on the level of exposure reduction expected through water soluble bag technologies,
which would be sufficient to bring MOEs to an acceptable level. Furthermore, the regulatory endpoint
for non-cancer occupational risk was based on no-observable adverse effects at the highest dose tested,
which may thereby provide an additional margin of protection and/or be a potential source of
overestimating risk.
"• »•• » l-- 1 ' ' ' ' ' " ' i" , "' '"'"'"i" :i"! ' ' ,. : 1 1 l[l" !' ' ' '
Therefore, to support this formulation and to refine the risk estimates for wettable powder in
water soluble bags for groundboom and aerial/chernigation application on the larger acreages
representative of actual use, the Agency will call in a new, confirmatory exposure study on the
wettable powder formulation. If this study does not confirm the Agency's belief that the MOEs are
acceptable, the Agency would consider appropriate regulatory action. Alternatively, the registrants may
cancel this use rather than generate the data.
Cancer Occuational Risks
.• .»;J:!
, EPA considers worker cancer risks of 1Q'6 and below not of
%! Pk nianagement purposes, and would not typically pursue risk reduction measures for such
"risks.
None of the occupational handler scenarios assessed for TPTH have risk estimates that are less
than 1.0 x IP'6 at baseline. However, for scenario (10) flagging spray applications, engineering controls
reduce risks to belowlO-6. Current labels require human naggers to be in enclosed cabs, so further
mitigation is not necessary.
;," i1'
Rl?i£S greater than Iff4. Generally, EPA will not allow the continued registrations of existing
uses that have worker cancer risks greater than 10"4, because such risks typically outweigh the benefits of
use, and thus will cause unreasonable adverse effects. If risk reduction measures do not reduce the risk
below the Agency's level of concern, EPA may take regulatory action.
Mixing/loading of wettable powder uses: As described in section m, based on this
assessment both the engineering control scenarios (2a) and (2V), mixing/loading wettable powder (WSB)
for aerial/chemigation or groundboom sprayer commercial application to potatoes result in cancer risk
estimates greater than ICr4; furthermore, MOEs for these scenarios are also of concern. Even though
these scenarios have incorporated engineering controls (i.e., water soluble bags), and the Agency
incorporated results from a chemical-specific worker exposures study, cancer risk estimates continue to
exceed 1.0 x 10"4, and MOEs are below 60. EPA believes that these results are related to flaws in the
TPTH water soluble bag study such that worker exposure from these handling scenarios were not
adequately replicated. As discussed above, the Agency believes that the results of the new worker
exposure study for the wettable powder (WSB) formulation will demonstrate that worker exposures have
been overestimated for these use scenarios and that worker risks are below 1.0 x 10"4. Therefore, the
44
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Agency is requiring a new exposure study for aerial application of the water soluble bag formulation to
support this use.
Application with groundboom sprayer: The cancer risk estimate for applying sprays with a
groundboom sprayer for commercial application to potatoes (scenario 4) is greater than W4 at baseline
An enclosed cab requirement for applicators on all crop sites mitigates risks to the Itf5 range
Current TPTH labels require all ground applicators to be in enclosed cabs; however labels must be
amended to require enclosed cabs for all application methods, including ground and aerial applications.
Risk between HT6 and KT4. The Agency's goal is to reduce worker cancer risks to 10'6 or
less, although risks somewhat higher than 10* will be considered acceptable if measures to mitigate these
risks are not available and benefits of continuing use are demonstrated. Thus, for risks that are greater
ton ^0-and Jess than 10< the Agency carefully examines risks in this range including the benefifofuse,
availability of alternatives, number of workers at risk, and will sesk ways to farther mitigate these risks
nVTn-^^* ^ T°rlT SCenari°S deSCribed * SeCti°n m lttm cancer ** esti™tes * the ™ge
of 10 tolO , EPA considered whether additional worker mitigation measures were available and
examined the benefits of TPTH use on pecans, sugar beets, and potatoes.
Based on a benefits assessment developed as part of the TPTH Special Review (updated in
August, 1999, attached), and recent Agency discussions with and submissions by pecan, potato and
sugar beet growers (see revised benefits assessment, October, 1999), the Agency found that there are
several effective, registered alternatives available to control disease on all three crops, as well as pending
J^SS? ?phcationS f°r Several actives, including reduced risk pesticides. EPA has determined
that TPTH plays an important role in managing resistance within an Integrated Pest Management (IPM)
program. The benefits of TPTH in resistance management programs are highest for pecans, followed by
sugar beets, and are lowest for potatoes.
•
On pecans TPTH controls scab disease, the most significant fungal disease, as well as a broad
;" • - • P°weiy """. sooty
leaf blotch). Although several alternative fungicides are registered for pecans, none of the alternative
fungicides control all of the diseases controlled by TPTH. Also, the alternatives fenbuconazole and
propiconazole are more expensive, which will increase the economic burden on many small pecan
growers. More importantly, because these, alternatives have similar modes of action, if TPTH were not
avadable for use with these alternatives, this could lead to earlier development of resistance in the pest to
fenbuconazole and propiconazole (if used exclusively for two to three years).
TPTR disease. Several registered alternatives to
TPTH are available (copper fungicides, mancozeb, benomyl, thiabendazole, thiophanate-methvl and
tetmconazole (under a section 18 to Minnesota and North Dakota)). Copper fungicides, however, have
lost their efficacy in controlling the disease, and the pest has developed resistance against the
benzimidazole fungicides in most states. Sugar beet growers minimize their use of mancozeb a B2
carcinogen, because of its lower efficacy and need for more irequent application timings relative to TPTH
45
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1 'S"! I1'"'
i
, - • •
(7-10 day intervals for mancozeb, 12-16 day intervals for TPTH), resulting in a higher level of
environmental loading of pesticides for similar levels of control. Although the pest has developed
tolerance against TPTH in Minnesota and North Dakota, it is still effective in controlling disease at
maximum labeled application rates. Minnesota and North Dakota growers currently use TPTH (at
maximum labeled rate) and tetraconazole in alternation to control leaf spot disease. Growers in these
states believe that the pathogen may soon develop resistance against tetraconazole if it is not applied in
alternation with a protectant fungicide like TPTH. Sugar beet growers in other states can still use
benzimidazole and TPTH at moderate labeled rates to control the disease because the resistance to
benz"nidazole and tolerance ,to TPTH is not as severe as m Minnesota, and North Dakota. Therefore,
TPTH still plays an important role in pest resistance management programs for sugar beets.
On Potatoes, TPTH controls early and late blight. There are at least six registered alternative
%Wcidesj wi* diff616^ mod,es of action, available for use on potatoes to control these blights. These
alternatives effectively control these diseases. However, TPTH remains an important tool in preventing
development of resistance, particularly for early and late blight, which have become more problematic in
the past year.
• •_ • • • ........ •! ...... ' ......... ;
EPA has determined that further viable mitigation measures to mitigate worker cancer risks to
10'6 were not available short of cancellation of the current uses. Because of its continuing role as a
resistance management tool for all three crop uses, the benefits of TPTH warrant continued availability of
the fungicide, but only to the extent consistent with the minimum amount required to manage resistance
w^hin an : E*M Prog13111- The Agency believes that the reduction in the total ampunt of TPTH that can be
Nl h a; .iPi^ P635011 (described below for ecological risk mitigation) will allow farmers to manage
resistance within an IPM program, until more effective and reduced risk alternatives become available.
EPA recognizes that the benefit of TPTH for resistance management may decrease for particular crops as
more alternatives become available.
'. ' ...... ' '. ^ "' ' ' .: ...... :. "'. '". , ........ , ".•:'..: "', . ''.'. 1, ;, ,: . . V
Additionally, these use reductions will help ensure that worker cancer and non-cancer risks will
not increase. The Agency assessed worker cancer risks using typical rates and typical numbers of
applications for each handler scenario. By limiting the amount of seasonal use on all three crops, the
Agency ensures that worker exposures will not increase beyond these current levels, particularly as
^^^JS-.HTM^y610)??.^*' on sugar beets), requiring growers to apply higher rates to achieve
similar levels of control if they choose to rely on TPTH ralher than other alternatives.
i . '
Post-Application Worker Risk to Pecan Harvesters
on a study that monitored exposure from TPTH use on pecans at maximum labeled rates
and numbers of applications, post-application cancer risk estimates for pecan harvesters are greater than
1 -° x JP"4 ."P^ll days after the last application at the Georgia site, and are greater than 1 .0 x 10"4 until
some time between 21 and 30 days after the last application at the Texas site. To address pecan
harvester worker risk, registrants will amend labels to require a pre-harvest interval (PHI) for pecans
of 30 days. Since harvesting activities do not generally begin until at least 21 days after the last pesticide
application, this PHI will have minimal impact on a farmer's ability to harvest pecans. EPA has
46
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determinesI that further mitigation of pecan harvester risks are not feasible short of cancellation of this use
Given the benefits of TPTH for pecan use, however, and the lower exposures that will result from
reduced seasonal use rates, the Agency has determined that the pecan harvester risks are acceptable.
Although cancer risk estimates for pecan harvesters remain greater than 10'6 (i e are in the 10'5
range) after 30 days after the last application, these risks cannot be mitigated to the Agency's goal of 10'6
- however, as the Agency has determined that the benefits of use outweigh remaining worker and handler
risks, the Agency is accepting the 30-day PHI as the best mitigation measure available.
4. Ecological Risk Mitigation
Mammalian and Avian Risk Mitigation
Risk to terrestrial ecosystems is expected based on both acute and chronic effects to birds and
mammals, especially from use of maximum application rates, and multiple applications of TPTH For
example, at currently labeled use, the avian acute RQ exceeds the LOG value by a factor of 2 5 and it
exceeds the restricted use LOG by a factor of up to six. Also, for avian species, chronic RQs are as high
as 104, and endangered species LOCs are exceeded by factors as high as 12.4. For mammalian
species, acute LOCs are not exceeded, but chronic LOCs are exceeded by factors as high as 63 The
pecan use, because of its higher application rates and frequency of applications relative to potatoes and
sugar beets, poses the greatest risk to these non-target species.
To address mammalim and a
labels to limit the maximum seasonal use on all three crop sites in the following manner:
(1) On pecans, the current label allows a maximum seasonal use of 60 ounces ai/acre in all states.
The maximum seasonal use on pecans will be revised to 24 ounces ai/acre in areas and states to
are west of Interstate 35 (e.g., Arizona, New Mexico, Oklahoma and some areas of Texas) In all other
areas andstates (east of Interstate 35) the maximum seasonal use on pecans will not exceed 36 ounces
ai/acre. These new limits reflect a 40 and 60% reduction in use in areas east and west of Interstate 35
respectively. Of the total national pecan acreage, 30% of the acreage will be limited to the lower '
seasonal rate (24 ounces ai/acre) and 70% will be limited to the higher rate (36 ounces ai/acre). The total
reduction is 46% overall. High humidity, east of Interstate 35, favors disease development, requiring
higher numbers of sprays to control the disease. These reductions also address the higher risks
associated with pecan use due to the higher application rates and frequency of applications for pecans
relative to potatoes and sugar beets.
(2) On potatoes, the current label allows a maximum seasonal use of 12 ounces ai/acre.
The maximum seasonal use on potatoes will be revised to 9 ounces ai/acre in all states.
47
-------
'Ill
The new limit reflects a 25% reduction in use in all potato growing areas. This limit will be sufficient to
control the disease in areas with high disease pressure because many other registered alternatives are
available.
(3) On sugar beets, the current label allows a maximum seasonal use of 12 ounces ai/acre in all states.
The maximum seasonal use on sugar beets will be revised to 8 ounces ai/acre in all states
EXCEPT Minn^sota' N?*11 P^013! a*"1 Michigan. The new limit reflects a 33% reduction in use in all
states except Minnesota^ North Dakota and Michigan. These states need to retain the current labeled
^mit for effective disease suppression. The pest has developed tolerance to TPTH and lower numbers of
sprays or lower use rates may not provide adequate disease control. Sixty percent of the total U.S. sugar
beet acreage are in these three states.
Aouatic Risk Mitigation
(3lroi"c a*"1 acute LPCs are exceeded for all freshwater fish and invertebrates, and are
esPeda%higIlfor freshwater;fish at the maximum apph'cation rate for pecans. Chronic LOCs are as high
35 102 %lhe I60311 VSG- Acute high risk, restricted use, and endangered species LOCs are exceeded
by factors as high as 2.7,13.7, and 27, respectively.
! ";" 'il'" '':„' •• '"'!, 1'I; ' . ' , '" '';.|ji 'l|1' • • i " : | .''l|11'" ' ' , "
Reductions in seasonal use rates on the three crops will help mitigate aquatic risks. Also, since
risk to aquatic ecosystems results primarily from ground and aerial spray drift and from runoff, buffer
zones will reduce the potential for exposure to aquatic ecosystems. Therefore, the registrants'have
agreed to amend product labels to require a buffer zone of 100 feet from water bodies for ground
applications, and 300 from water bodies for aerial applications.
Although the mitigation measures developed to address ecological risks do not reduce all RQs to
an acceptable level, based on a qualitative examination of benefits, the Agency has determined that
unreasonable adverse effects on the environment will not result from TPTH use as amended by the above
use reductions and addition of buffer zones.
5. Occupational (Worker Protection Standard) Labeling Rationale
During the reregistration process, EPA considers all relevant generic and product-specific
information to decide what protections and risk mitigation is needed for all products. Products may
contain various types of occupational uses, which may or may not be covered by the Worker Protection
Standard (WPS).
111 • " i
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
agricultural plants (including food, feed, and fiber plants, trees, turf grass, flowers, shrubs, ornamentals,
48
-------
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 (RED, and notification are interim. These requirements are to
be reviewed and revised, as appropriate, during reregistration and other Agency review processes.
At this time, all products containing TPTH are intended primarily for occupational use (i e mixed,
loaded, and applied by commercial applicators. All of these uses are covered by the WPS.
Personal Protective Equipment for Handlers (Mixers. Lnafors, Applicators, etc ^
Personal protective equipment requirements usually are set by specifying one or more pre-
estabhshed 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
(tor 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
earlier, 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
fl^Jf6 P^' A* dfacu«5d * *e risk mitigation section above, the additional PPE is needed due
to TPTHs high acute toxicity, developmental, cancer, dermal and inhalation effects.
Post-Application/Entty Restrictions
Under the Worker Protection Standard (WPS), interim restricted-enny 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 thres 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 H, 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. In addition, the WPS specifically retains two types of REI's established by the
Agency prior to the promulgation of the WPS: (1) product-specific REI's established on the basis of
adequate data, and (2) interim REI's that are longer than those that would be established under the WPS.
The WPS prohibits routine entry to perform hand labor tasks during the REI and requires PPE to
be worn for other early-entry tasks that require contact with treated surfaces. Under the WPS these
personal protective equipment requirements for persons who must enter areas that remain under a
restricted-entry interval are based on the acute toxicity category of the active ingredient.
49
-------
A has determined that no regulatory action is needed as the result of acute or other
adverse effects of the active ingredient. The early-entry PPE requirements will be established on the basis
of the acute dermal toxicity category, skin irritation potential category, and eye irritation potential category
of the end-use products.
1 . ,i ,!!!!•", ' "!i, , IM • "' 1i ,11 ' " '„„ !l , ', ,i " *.
C Other Labeling Requirements
The Agency is also requiring other use and safety information to be placed on the labeling of all
end-use products containing TPTH. For the specific labeling statements, refer to Section V of this
document.
:"' , ,, , ' „ ' „ ,! !. ' III!1 ll
1. Endangered Species Statement
Qirrently, the Agency is developing a program ("The Endangered Species Protection Program")
to identify all pesticides whose use may cause adverse impacts on endangered and threatened species
and to implement mitigation measures that will eliminate the adverse impacts. The program would require
use restrictions to protect endangered and threatened species at the county level. Consultations with the
Fish and Wildlife Service may be necessary to assess risks to newly listed species or from proposed new
uses. In the future, the Agency plans to publish a description of Hie Endangered Species Program in the
Federal Register and have available voluntary county-specific bulletins. Because the Agency is taking this
approach for protecting endangered and threatened species, it is not imposing label modifications at this
time through the RED.
In the future, the Agency plans to publish a description of the Endangered Species Program in the
Federal Register. EPA is in the process of developing county-specific bulletins that specify measures to
protect endangered and threatened species. Although bulletins have not yet been developed for all
ties where they will be needed, EPA has completed and distributed over 300 county bulletins.
2. Spray Drift Management
% ASencv has J56611 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; ^f^ments 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
"^"^ fftaS6'^ ?P% rM?5 ^sociated 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:
, ' ,;ii; ' " ,:» ''I'- ,' ' ! I, • 1*1! , ,i i , „ ' •! , ,.;" i1 , i, ' ' •". i ii. ,"• ', ' ,„;„ ; "r!"|, |. "•'" ' • , •';••
."Do not allow this product to drift"
: ' ' •' "50
-------
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses 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 TPTH for the above eligible uses has been
reviewed and determined to be substantially complete. The Mo-wing data gaps remain and data are still
required for confirmatory purposes:
Guideline#
830.7050
870.6200(81-8)
870.6200 (82-7)
Special Study
860.1340 (171-4c and d)
860.1360 (171-4m)
860.1380 (171-4e)
860.1500 (171-4k)
23 land 232
72-4a
72-4b
850.4400 (122-2)
835.1230(163-1)
835.6100 (164-1)
835.4100 (162-1)
835.4300 (162-4)
835.4400 (162-3)
Study
UV/Visible Absorption
Acute neurotoxicity/rat
Subchronic neurotoxicity/rat
Developmental immunotoxicology neurotoxicity study (consult with
Agency on protocol)
Independent laboratory validation (for animal method) and radio
validation (plant and animal methods)
Multiresidue testing
Storage stability
Crop field trials-beets, sugar
Worker exposure, wettable powder in water soluble bag, mixing/loading
enough quantities to treat large acreages with groundboom (150 acres) or
aerial/chemigation (1,000 acres) equipment
Fish early life stage toxicity test (sheepshead minnow)
Aquatic invertebrate life cycle (mysid)
Aquatic plant growth
Sediment and soil absorption/desorption for parent and degradates
Field dissipation study
Aerobic soil metabolism
Aerobic aquatic metabolism
Anaerobic aquatic metabolism
Specific product and residue chemistry data requirements remain unfulfilled for the
following registered 96% T/TGAIs
830.1550, 1700, 1750, 1800, 6314, 6316, and 7370.
830.1550
830.1550,1750, 6314, 6316, 6317, and 6320.
51
Elf Atochem 96% Technical
AgrEvo 96% Technical
Agtrol 96% Technical
-------
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MUP) labeling must be revised
to comply with all current EPA regulations, PR Notices and applicable policies. The MP labeling must
bear the labeling contained Table 5 at the end of this section.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must review
previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to
conduct new studies.'' If a registrant believes that previously submitted data meet current testing
standards, then study MRID numbers should be cited according to the instructions in the Requirement
Status and Registrants Response Form provided for each product.
2. Labeling Requirements for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above. Specific
language to implement these changes is specified in Table 5 at the end of this section.
: I Xli,
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52
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that are being supported by MP registrant}. "This product may only be used to formulate
products labeled for use in closed systems only, and wettable powder end-use products thi
in water-soluble packets."
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This pestic,de is toxic to fish and wildlife. Do not discharge effluent containing this produ,
streams, ponds estuaries, oceans or other waters unless in accordance with the requirement-
Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has be<
writing pnor to discharge. Do not discharge effluent containing this product to sewer syste,
previously notifying the local sewage treatment plant authority. For guidance contact your
Board or Regional Office of the EPA."
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RESTRICTED USE PESTICIDE due to carcinogenicity, potential for affecting fetal develop,
acute toxicity to humans. For retail sale to and use by Certified Applicators or persons unde,
supervision, and only for those uses covered by the Certified Applicators certification "
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hot water. Keep and wash PP
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52
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Table 5: Summary of Required Labeling Changes for Triphenyltin Hydroxide (TPTH
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"Engineering Controls"
"Mixers and loaders supporting aerial and chemigation applications must use a closed mixing and loading
system that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural
pesticides [40 CFR 170.240(d)(4)] for providing both dermal and inhalation protection. The system must
include a mechanism for removing the pesticide from the shipping container, rinsing the container, and
transferring the pesticide and rinsate into mixing tanks and/or application equipment. At any disconnect
point, the system must be equipped with a dry disconnect or dry couple shut-of device that is warranted
the manufacturer to minimize drippage to not more than 2 ml. per disconnect point.
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Mixers and loaders supporting ground applications must use a mechanical transfer system that meets the
requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR
170.240(d)(4)] for providing dermal protection. The system must be capable of removing the pesticide froi
the shipping container and transferring it into mixing tanks and/or application equipment. At any disconn
point, the system must be equipped with a dry disconnect or dry couple shut-of device that is warranted 1
the manufacturer to minimize drippage to not more than 2 ml. per disconnect point.
Pilots must use an enclosed cockpit that meets the requirements listed in the Worker Protection Standard
(WPS) for agricultural pesticides [40 CFR 1 70.240(d)(6)].
f*
Ground-equipment applicators and flaggers must use an enclosed cab that meets the requirements listed ii
the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 1 70.240(d)(5)].
-
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All mixers, loaders, applicators, and flaggers must wear the personal protective equipment specified above
for the task they are performing and all (except aerial applicators) must be provided and must have
immediately available for use in an emergency, such as a spill or equipment failure, the PPE specified abovi
for handlers not using engineering controls."
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"Engineering Controls"
"Mixers and loaders using intact water-soluble packaging are us
meets the requirements listed in the Worker Protection Standard
170.240(d)(4)].
Pilots must use an enclosed cockpit that meets the requirements
(WPS) for agricultural pesticides [40 CFR 1 70.240(d)(6)].
Ground-equipment applicators and flaggers must use an enclose:
the Worker Protection Standard (WPS) for agricultural pesticides
All mixers, loaders, applicators, and flaggers must wear the persi
for the task they are performing and all (except aerial applicators
immediately available for use in an emergency, such as a spill or i
for handlers not using engineering controls."
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"Users should wash hands before eating, drinking, chewing gum
"Users should remove clothing/PPE immediately if pesticide get
clean clothing."
"Users should remove PPE immediately after handling this prodi
removing. As soon as possible, wash thoroughly and change int
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"Environmental Hazards:
This pesticide is toxic to fish and wildlife. Do not apply directl;
present, or to intertidal areas below the mean high water mark.
apply with aircraft within 300 feet of any waterbed including, bi
and reservoirs. Do not apply with aircraft when wind speed is {
groundboom equipment within 100 feet of any waterbed includ
lakes and reservoirs. Apply this pesticide only as specified on t
cleaning equipment or disposing of equipment washwaters."
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for all crops."
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that involves contact with anything that has been treated, such
- coveralls
- chemical resistant gloves such as any waterproof mat
- shoes and socks
- protective eyewear"
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drift. Only protected handlers may be in the area during applical
"Do not allow this product to drift."
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Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND
STUDIES USED TO MAKE THE REREGISTRATION
DECISION
GUIDE TO APPENDnr R
Appendix B contains listings of data requirements which support the reregistation for active ingredients within
case 0099 (TPTH) covered by this Registration Eligibility Decision Document. It contains generic data
requirements that apply to TPTH in all products, including data requirements for which a "typical formulation"
is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear in 40
CFR Part 158. the reference numbers accompanying each test refer to the testprotocols set in the Pesticide
Assessment Guidelines, which are available from the National Technical Information Service 5285 Port Roval
Road, Springfield, VA 22161 (703) 605-6000.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements apply.
The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column lists the
identifying number of each study. This normally is the Master Record Identification (MRID) number, but may
be a "GS" number if no MRID number has been assigned. Refer to the Bibliography appendix for a complete
citation of the study.
69
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Appendix C. CITATIONS CONSIDERED TO BE PART OF THE DATA
BASE SUPPORTING THE REREGISTRATION DECISION
(BIBLIOGRAPHY)
GUIDE TO APPENDIX C
3.
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.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The Agency
has also attempted to unite basic documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION 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.
4. 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.
a Author. Whenever the author could confidently be identified, the Agency has chosen to show a
personal author. When no individual was identified, the Agency has shown an identifiable
laboratory or testing facility as the author. When no author or laboratory could be identified, the
Agency has shown the first submitter as the author.
81
-------
b. Document date. The date of the study is taken directly from the document. When the date is
followed by a question mark, the bibliographer has deduced the date from the evidence contained
in the document. When the date appears as (19??), the Agency was unable to determine or
estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or enhance a
document title. Any such editorial insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency'in the:past, the traUing 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
administrativenumber associated wi& the earUest 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
sfiidy appears. The six-digit accession number follows thei symbol "CDL," which stands
for "Company Data Library." This accession number is in turn followed by an alphabetic
suffix which shows the rehtive position of the ^dy within uie volume.
pi . , i,, ,''"., ':4L; i' • :• ','<", • • -1 ' ;v"'; ." '""' ¥;, • •• -?i ;«::»! ";,i s <\:-' •• „. , vi - i: ;
"''.'• ' I,, • ;ii ,,,;?i ' , .•'.. ' ' i ,...'••'• -, • . \ <••", • ', Si •<,(. , ;i; , .. >:",;"- '^ ••
82
ml lill i l( i I ill iiii
-------
BIBLIOGRAPHY
MRID
CITATION
TOUOT
TOUOT04
TOUOT05
TOUOT06
00009181
00009378
00137668
00018842
See MRIDs 125275 and 125276
See MRID 125267
See MRID 125270
See MRID 125273
Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969). Effect of Pesticides on
Apiculture: Project No. 1499. (Unpublished study received Jul 29, 1976 under
352-342; prepared by Univ. of California-Riverside, Dept. of Entomology, submitted
by E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:224800-C)
E.I. du Pont de Nemours and Company (1976). Data Supporting Use of Lannate(R)
D Methomyl Insecticide and Lannate(R) 5-D Methomyl Insecticide on Cotton.
Summary of studies 226190-B through 226190-W. (Unpublished study received Sep
28, 1976 under 352- 380; CDL:226190-A)
M & T Chemicals, Inc. (1984). General Chemistry Data for Triphenyltin Hydroxide.
(Unpublished study received Feb 29,1984 under 5204-69; CDL:252557-A)
Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969). Effect of Pesticides on
Apiculture: Project No. 1499. (Unpublished study received Jul 29,1976 under
352-342; prepared by Univ. of California-Riverside, Dept of Entomology, submitted
by E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:224800-C). Duplicate of
MRID #00009181.
00029834
Cannizzaro, R.D. (1979). Determination of Triphenyltin hydroxide Residues in Rough
Rice by Gas Chromatography/Mass Spectrometry Promim. Method no. 28 dated
Feb 26,1979. (Unpublished study received Mar 28,1980 under OF2340; submitted
by Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099345-B)
83
-------
i! 'v (,;« ;:"r
ail It .,' ' I!.,!!! I, ';„!' Ill'* 'I'M! , III',",-IT:.,-1,,"! J,
'nil 'I IIIUi .Pi' 'ill"1"
i.i. ,; „ iiii in , ,! Jill, i," i,; ;'", i. 1"
,i It!'1
::: MRID
CITATION
I :•,;
00029835 Cannizzaro, R.D. (1979). Determination of Triphenyltin Hydroxide Residues in Rice
Process Fractions (Brown Rice, White Rice, Hulls, Bran, Polishings, and Straw) by
„", I 'jlilliiill1 "III-!',,1' J'!1'1 •; "Til'li "III ':,!' * ,1 , '-""Illill S lid!"! ' ',„, , • ; '',;„ ', ,1 -1,1,1:1, j ',','« • 7.' Jlli,! ,: Pi... i , • •!,', i,-:,;,- ../•»/ .
Gas Chromatography/Mass Spectrometry Promim. Method no. 31 dated Feb 28,
1979. (Unpublished study received Mar 28, 1980 under OF2340; submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099345-C)
00030250
00030251
Ackerman, M.E.; Granata, S.V.; Tapprich, B. (1976). The Determination of
Carbon-14 Labeled Residues Due to TPTH following Oral Administration of Rice
Foliage Containing Residues from the labeled Fungicide to Lactating Goats: ADC
Project #270. (Unpublished study received Mar 2§"," 1980 imcjer 6F234b; prepared
by Analytical Development Corp., submitted by Thompson-Hayward Chemical Co.,
Kansas City, Kans.; CDL:099343-A)
Moring, S.; Nye, D. (1978) Identification of 14C-TPTH Residues in Weathered
Rice Folage and Their Bioavailability to Rats via Single Oral Dose: Project 780316.
Final rept. (Unpublished! study received Mar 28, 1980 under OF2340; prepared by
Stoner Laboratories^ Inc., submitted by Thompson-Hayward Chemical Co., Kansas
City, Kans.rCDL:b993i3-B) "'"" ' " '"' ""'' '"" " " '
00030252 Granata, S.V.; Mulkey, N.S. (1976). Metabolism and Residue Method Development
for TPTH in Rice and Soybeans: ADC Project # 221. (Unpublished study received
Mar 28,1980 under OF2340; prepared by Analytical Development Corp., submitted
by Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099343-C)
';
00030253 Wargo, J.P., Jr.; Wilkes, L.C.; Mulkey, N.S. (1977). Fate of 14C- Triphenyltin
hydroxide (Du-ter) following Application to Rice ADC Project # 221. Includes
methods dated Jun 27, 1977. (Unpublisfied study received Mar 28,1980 under
OF2340; prepared by Analytical Development Corp., submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099343-D)
00030254 Danhaus, R.G. (1976). Field Metabolism and Environmental (Rice Treated with
14C-TPTH): ADC Project #278. (Unpublished study received Mar 28,1980 under
OF2340; prepared by Analytical Development Corp., submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099343-E)
j
84
-------
BIBLIOGRAPHY
MRID
CITATION
00030259
00030272
00030309
00030310
00030311
Thompson-Hayward Chemical Company (1970). Fentin acetate; Fentin chloride;
Fentin hydroxide. (Unpublished study received Mar 28, 1980 under OF2340;
prepared in cooperation with Farbwerke Hoechst, A.G., N.V. Philips-Duphar and
National Institute Public Health, Plant Protection Service; CDL:099342-A)
Cannizzaro, RD. (1979). Determination of Triphenyltin hydroxide Residues in
Irrigational Crops (Wheat, Barley, Kidney Beans, Radish Tops, Beet Tops, Swiss
Chard, Radishes) by Gas Chromatogaphy/Mass Spectrometry Promim. Method No.
30 dated Feb 28,1979. (Unpublished study received Mar 28,1980 under OF2340;
submitted by Thompson-Hayward Chemical Co., Kansas City Kans •
CDL:099345-E)
Danhaus, R.G. (1976). Field Metabolism and Environmental (Soybeans Treated with
14C-TPTH): ADC Project # 278. (Unpublished study received Mar 28, 1980 under
OF2340; prepared by Analytical Development Corp., submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099344-D)
Danhaus, R.G. (1976). Field Metabolism and Environmental (Soybeans Treated with
113=Sn-TPTH): ADC Project # 290. (Unpublished study received Mar 28,1980
under OF2340; prepared by Analytical Development Corp., submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099344-E)
Danhaus, R.G. (1977). Field Metabolism and Residual Behavior of Radiolabeled
Triphenyltin Hydroxide in Soybeans: ADC Project #278/290. (Unpublished study
received Mar 28,1980 under OF2340; prepared by Analytical Development Corp.,
submitted by Thompson-Hayward Chemical Co., Kansas City Kans •
CDL:099344-F)
00030313
Smith, K.S.; Merricks, DX. (1976). Triphenyl Tin Hydroxide TissueResidue and
Metabolism Study in Poultry. (Unpublished study received Mar 28,1980 under
OF2340; prepared by Cannon Laboratories, Inc., submitted by Thompson-Hayward
Chemical Co., Kansas City, Kans.; CDL:099344-H)
85
-------
I If ' -i I,,,,, ;;:" ill
i! " ft" ri 'i i , BIBLIOGRAPHY
is in „ , L „ ji •; „„ii'! '» "iiii!11'1' 'Mi'y'ii'i1 i'lfi'ii.1 ' ' '"ir''"'' '"'":• „,.:!,'ii ' •' ," ' "i" , ,• ' • i • ,„•„• 'v, '• • ' '.,!-' '!" , " jj ''.,,.' ;il,• /i,"
p.;..•:: ••j;r,M|^..:/;.lc|TAM^ ,..',..'" ', , , ', ,"'.''! ".. !,".", ,
' ' " ' •' ' ' 'I '" "' l I '! ' '"i""'' ' ' '" " ' ' " ' I""' '~ ' "I'1 '" "'' ' '" * '^Tri' . |'|| , ", , ,, ,. „ ,", -. ••••-•; , •—
, ' ' H 'I ,,,,'i' j|, , , " llllli! Ms!' ;'||i,i|'! II mill! fill1! !' . . '"'I „„ i',, ,,.|; . . "ii ' ' , ViliM'illi',,1.'«. i,:,-:':11'' ,• "i >,i!llil|lll|l' 'P i, i MI, , K '• ' '' ' ,i • ', I,: • ,
Qj%3.i(^ii Smith, K.S^; Merricks, D.L. (1977). Triphenyl tin hydroxide Metabolism in Dairy
• Cows. (Unpublished study received Mar 28, 1980 under OF2340; prepared by
Cannon Laboratories, Inc., submitted by Thompson-Hayward Chemical Co., Kansas
City, Kans.; CDL: 099344-J)
1 ;_; (' ' i(ii, ^ _f , ' iriif;';,; ; ,; , ,,M- , ;L1. " ' ' ;" ; i,iqn, ; ; h .„ ,, , ;;., ' ' "
00030316 Mpring, S.; Nye, D.E. (1978). Structure Elucidation of 14C-Labeled Residues in
Tissues of a Cow Exposed to 14C-TPTH for Nine Days: Project # 771672. Final
rept. (Unpublished study received Mar 28,1980 under'bF2340; prepared by Stoner
Laboratories, Inc., submitted by Thompson-Hayward Chemical Co., Kansas City,
'i^":;'' i-, Kans.; CDL:099344-K)
00030381 New Mexico State University, Agricultural Experiment Station (1979). Theoretical
Considerations on the Residues of Ambush (R)ason Rangeland and Range Cattle.
00036021
Thompson-Hayward Chemical Company (1972). Clean-Up Procedure for the
Colorimetric Residue Determination of Triphenyltin Compounds in Rice. Method no.
A-128-A dated Mar 24, 1972. (Unpublished study received May 3,1973 under
3G1393;CDL:095436-J)
00036027 Thompson-Hayward Chemical Company (1973). Clean-Up for the Colorimetric
Residue Determination of Triphenyltin Compounds in Milk, Method no. A-331 dated
Mar1§, 1973. (Unpublished study received May 3, 1973 under 3G1393;
CDL:095436-P)
00036029
00053415
'"„, < i :,i;|l " I'lilir!!;,!.; ' J
i
Thompspn-Hayward Chemical Company (1973). Confirmation of Triphenyltin
Hydroxide in Milk by Thin Layer Chromatography. Method no. A-332 dated Mar
29, 1973. (l^ubHsted study received May 3, 1973 under 3G1393;
CDL:095436-R)
Bruggemann, J.; Earth, K.; Niesar, K.H. (No date). Communication E: Experimental
f1 *Jh,^ "t' , ,i,», ''il >' .JHi' '«' ,' !|! I"..,,!! !",'. 4 ! • 'i vil"". • 'i \f'M*f'f n» ,i, i fl,n „' i m, „ ",i ,' »•/, . i ',,1: "..rii, , , », n i , ,:/», " rm, ,,*T
Studies of the Occurrence of Triphenyltinacetate Residues in Beet Leaves, Beet Leaf
Silage, Animals Fed Therewith and Their Excretion Products. (Unpublished study
„
i-.'j Sf':;
86
"'„ j .iiiii!" '-'IS;
Li fill ' ;,
-------
BIBLIOGRAPHY
MRID
CITATION
received Nov 8, 1965 under unknown admin, no.; submitted by Thompson-Hayward
Chemical Co., Kansas City, Kans.; CDL: 105279-B)
00071364
Shell Chemical Company (1976). Summary of Information Regarding SD 43775 on
Cotton. Summary of studies 099958-E and 099958-F. (Unpublished study received
Feb 1,1976 under 6G1755; CDL: 099958-D)
00080381 Herok, J.; Gotte, H. (No date). Communication HI: Radiometric Metabolic Balance
Studies with Triphenyltin Acetate (TPTA) in the Milk Sheep. (Unpublished study
received Feb 7, 1968 under 8F0700; prepared by Farbwerke Hoechst, AG,
submitted by Thompson-Hayward Chemical Co., Kansas City, Kans.;
CDL:091218-F)
00080387
00080390
00083551
Thompson-Hayward Chemical Company (1968). Detection of Triphenyltin
Comounds in Peanuts by Thin Layer Chromatography. Method no. A-184 dated Jan
24, 1968. (Unpublished study received Feb 7, 1968 under 8F0700; CDL:091218-L)
Til, H.P.; Feron, V.J.; De Groot, A.P. (1970). Chronic Toxicity Study with
Triphenyltinhydroxide in Rats for Two Years: Report Nr. R 3138. (Unpublished study
received on unknown date under 8F0700; prepared by Centraal Instituut voor
Voedingsonderzoek, Netherlands, submitted by Thompson-Hayward Chemical
Co.,Kansas City, Kans.; CDL:091218-O)
Thompson-Hayward Chemical Company (1979). General Chemistry: [Outer (R>
Fungicide]. (Unpublished study received Oct 18,1979 under 148-689;
CDL:099046-A)
00086450
Stewart, T. (1979). Determination of Triphenyltin Hydroxide Residues in Soybeans
and Soybean Foliage by Gas Chromatography/Mass Spectrometry PROMDSf.
(programmable Multiple Ion Monitoring). Analytical method no. 29 dated Sep 5,
1979. (Unpublished study received Oct 18, 1979 under 148-689; submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099056-B)
87
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; ,};:;:::„;,
BIBLIOGRAPHY
MRID
CITATION
OQ086452 Thompson-Hayward Chemical Company ~(1979)T Determination of Triphenyltin
''418''-Hydroxide Residues in Soybean Processe Fractions (Meal, Hulls, Soapstock, Oils) by
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i I , ' : i ,: • i ,!' . ' :"" ; "";,; "'Si" ,"•"" ' ; : ?',",' , r • P:, , ': , .', ' .•': l:" ,>' ':"' .* " .• I1","" ' "" ./•.•• ' i •''""• ''
:"'l\i^''i',S,
, ,
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| iij .n. ii ".. ,,i, ,i ,,! .["i; 'I',1.! iii:!«,,,, 11 in] , "'. ,,"1, ., MIL ".; - , „ • ,i, . i „ .;: ! , ,;; ,, T, •,,.'. .. .j.r.wir ;,,,;ii , • ;,
1". "i ,l!"''"iBI . ' .Si If,,1/ Vi'iY 3II,i,> lkil''''/"T ,,'s,:, '-VF''•'..>• ,!i, , .:•'!,".' „ Iii '.,i :,F.i, i ;;>, „ ,; ,{t! ,":;/' !•. ,,,T iri,
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I!1!1 i,,f i1'111!1" Jill* ,!"!' *"!r'!"!:'l , ] Jili'ilfn,:, MSI! "III! >-, • Yi Jn v, <.\ n ,-a .•. r, i «•,«• , • ,>,", • i „„' , •. i r i, i •,.« c •.
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I Tt ' i;;,,,T', 'mini "i ' '!"!',"t ,st i,, a,, "i! in: i , Jiiii "'H'li'iiit, :., ',v -* ,„ r, • „ ,,,riv-' % ; i, - ~' r. „„ „ „,„„ „
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152952 IM|^ p- (^SS). 13-Week Oral Toxicity (Feeding) Study with TPTH-Technical in
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] lie" , i"ii<,i, ' iiiiiRi i' ' ', 'i," • iBiiiU'i ' ,'mi/anil, ;i 'iii;i" 'ii n , ,,i ,, ^ "
:* lillE :", fiiillP ! :,' JilT'l, ", ,! r: 'iili' J'WI
llEi f iifN :;; ';! • ' .«,f . , " ;/»« "i ': „ ,.'"'' ' : i!" :•
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Ill I 111 III II III Illllllllllllllllll III
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' ! '": ;. „ ,- ,::;jii!!!l: I Jf '•%(• •<.• ' f: ••<:,»,"'»: .•'.• , ' ^> i,,/, Mi" ' ,.•„,. f;i^'..!. ••: ',..«•. ill ;i' : i !!(::! s v •'•! "i! i:"' -S :"'-~ '."W
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I ....... I' : ..... Iii1' ; IHiv'i," ,|l"i||||ll ' |||illil||||||||||lli ..... „, \ 'illllil! niUIIII1!1! ..... 'Dili ..IJI'IIIIB.i. .ai'li'ili'i'lJIIIIIIII Ofi .""IF ..... i/lii"
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in i
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I I IF" „>„ i"! ;li!;;,;; , ,; , -'if:*'! "!',;;'" ' ;" "''.'" ',;)«'' ;|'*'' "•;, „'"• '-* !»; p1', jf/1" '';! ^Tiv^'n ,,. 'il-"'"„;' '....A'' '•' ,'.•_ """j"'1, j. i 'fS. S;;
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" !'l ill!;1111 „ ", Hrilllf ,, 'iinK,!!".: I ,,i „, HI, 'i l:!"i'! i, , !!„ " i, ' ,1 i 'III " .".i,, ,'ii, ., 'i,i I. '1 illpili, i'4, ,'" 1!: i'n J • | J, ' ,'nl! I:i , "III l',''Vi!i '!
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,' i _ ,1' ;ii I ; fi : "" .......
lip T •'> ..... :>' Mil, I'Vii' ....... '
P ..... ii,,,; '' ...... «,;: ',!!'. ,!'"':•
- .
1 .......... ........ T ........ " ...... 2' ...... • ......... JT^va •«'!'' .......... ""! .....
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( I (HI
'F If;:',,!1 ' ,,iiii fi111"1 < liflrhr,,, iij;!!iiiiil!!f
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I r.mij
•i!*'!' ' ' I ill '
iv i1,11 '.,'•
HI';,,,, ' /. ..» , ;
1,1'lWll'" 1" ,„' • '" 'I' IJil,
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_
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Ill
-------
I'm! s ;. ' r n,
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• »,;'- I-!,;,
I :,; ..s..
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BIBLIOGRAPHY
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(I I
1 ,111 I ( 11 Ililli i I 11 i I) i
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I I ,,,!,i, ,i
93 p
"
,,,, , ,, ,
'jltiiii illllli i '/I'm'
..... ,
,'C,1',! l-tljiii ilK ' ...... ' " 'I ......... !
I
'ni'
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^^^^^^^1^
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.......... * '
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' ' ;;: Unpublished study prepared by Case Consulting Labs, Inc. 12 p.
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I ') iliri ''S,j|;
I nil,!::' I-, "nil ri', : in
"""'.iiiiiii M „',;;
i I! 'I J'",, , ti,ll|!i|li'
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-------
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113
-------
Mil • "Ellin" ',,• \f. :< .;»„
laiT" 'iiii''" '''"R in.' " . iii""
|| HI i ,|h' ' 'Ijllli' I
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'!": '""''"if
ill!1",
Ill !l ! *l,l|1; ,..[ I '" lift !
iJi . miir ' iiiiiiik '['MI i,; £111" i 'ill' "
.iJIII i. " :>
nil/1'1,1!"" ./ I !« lilHI i,,!!',1!
"I 'l'"
•SaSfc Pr (I994)- Triphenyltin Hydroxide(TPTH): Acute Toxicity to Eastern Oyster
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114
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115
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' ail i ill!" II"1™ ''ill'1 I Ji!1 1, ,i '
' "
' "I1 1 III' I ' "III1 ' ' If! ""'
'
I If .
'lilt IV II',,,
BIBLIOGRAPHY
,!""!! " 'I1 111',! llll1' ' ill lip".1' '• '
'iMHir'k Jlf HniilF!:
"' ,ll,, I " tlll'T "!,i.'!iiilSi "I "Mlnl'li I
:"• ..'> I, I,' IB, <,'
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lih , ,iiil" I | I r n I
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t ' j jjjj.i.,^ Vi;J!" :„,, Jjjj^ _ '
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;: •' """'' ::" '' '': *$•' ;:'"': '" :";'i '" :: :"""" ' ' :"" :::" ::::"'::" ' '";""'":" ':":'"'';;""""";":" 7::';"";::':: t!'i:: •'•' •::v"1'
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* <.n.»'ii "'» "^.' vsii.11' Sugar Beet Leaves and Roots and Potato l^beK)7 Detennination ^^^
; -';'":::";'; ";; "f •• • :.f ^FentinJIya^xide ^(Triphenyl ^Tin |Hydrpxide, HOE 029_664) ^and ite iMetabpjites in
" "!1|]v \f;: ": ,":"' ; j^ ' ^Sugar'iBeet'LeavesandPotato'TubersrLab Projecti^wti^^6^"-l:567'w.
Unpubh'shed study prepared by PTRL West, Inc. 76 p.
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I, j, of .the Rate, of Hydrolysis: [Translation of Report #31534): Lab Project Number: CM
" '': [ :" ™:'" '"""^ study 'prepared' by HoechstAG"' "l4 p.
43874701 Buerkle, W. (1985). HOE 002782 (Triphenyltin-acetate) (carbon 14): Determination
1 i 'I) r;:;^ : [;:^'t^fjhe R^teofH^^lysis^^^lationofR^rt CM
' :'"'" ' ::"=''''=i:!"p09785: A'326031! Unpubhshed study prepared b^ HoechstAG. 14p.
43874702 Herok, J. (1965). Determination of the Adsorption, Translocation and Storage of
LCetate and triphenyltin Chloride in Potatoes: Lab Project Number:
| A 2923 5j A 42784, ynpubUshed study prepared by Hoechst AG. 16
"• P- ' ., '", ! :
••'' ' ' i
"::' :..;• : •• :: ':'"::: '": • "; 116
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Dionne, E. (1996). Triphenyltin Hydroxide
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(lull in
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444^3201
I1
44413202
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{OPPTS 830.1550, 830.1600, 830.1620, 830.1670}
,f '-"Mi:l!1,," • ';
'1 3 'jiii ii.;:*i:r
Jacobson, S. (1997). Agtrol TPTH Technical-Product Chemistry Volume E:
Preliminary Analysis, Certified Limits and Enforcement Analytical Method: Lab
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Richardson, W. (1998). Final Report: Preliminary Analysis of Triphenyltin Hydroxide
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CHB-EX-004-011-P-1. Unpublished study prepared by Phibro-Tech, Inc. 88 p.
{OPPTS 830.1700}
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Cimaa, R, L. Ballarina, G. Bressab, A. Sabbadina and P. Burighela. 1996. Triphenyltin
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Schaefer, C.H., T. Miura, E. F. Dupras and W.H. Wilder. 1981. Environmental impact of
the fungicide, triphenyltin hydroxide, after application to rice fields. Journal of Economic
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Hunter Jr., M.L., J.W. Witham and H. Dow. 1984. Effects of a carbaryl-induced depression
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1 '''"
I ! '", '" ^ '
in i i™" 14 'I,!.;!,,!,: '„,' ,„ ' iiiiii11;:"'"'1,si,,•",!!, 11,;;:' ";i;i" vigihiiiEliL •• ^'jiiii'::!.!1,,!1!!!111 .ii'irf1",,'1'1"1 "t • *•,n,r , IIL/HI in,;,, s i, "•' • . f 'S . , • „•" r" . •» 'A, ••':',
ihiiiijii Li* hi in n •„ IK n •'";,', vinniiiiii; f! i! :< . ;.,i,i 'Miit •"' 'ainhiiiiiii iiiiiiiiiU'iinii >'«! „:' IIP •„„ ' i/v" '" ,"irn,fi i im i, i " ', ../:.„. - i, '"''I'V'i n« , 'iiiiiiik1 ,. ri:\f* ,
i li;i|ll"|||lii I"!', iiJiliJi ;PI|li Jijjllij!,! ''Itjli" .rllj/'Bi' !|!'!|ii' inljijjli '!",,••• "IBIli ' l^Ai11 ', "V1' '', ¥!' ' " ..,,," Jir '""'niii."!! *''''' / !. "' i » >l , , ^ «!.• . , '"!,H. ''.h'i' l|1'1 : ""Mi','"i|| «' • iiili'. ."'"'ii' .I'lhhiJi / v," '•''||'il'; •" V'1"1 L :,„,•' in'Is at' mr''!, »•
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• bJI:, hllliii. Pllir'ii, T"' • '"' '•,! "• II, " !,„ '• 'i'ln • "IIIFlh !'i.:",,i,":I - i,.!,!'"1!.,,. '»ii|l!!|l"l!!!:, '• , •* '"• "* 1, *'" •»'' ' "'!.,•; ./"'ll'"' ' i ' !" / ,*'"
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QHlii1 liiillilllll '" nil11,,,!11 ',,' ',li'JHi1,i '• M|' ' " "'I ,„ .f 'ill ' ,:
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120
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Appendix D. COMBINED GENERIC AND PRODUCT SPECIFIC DATA
CALL-IN
121
-------
iiiiiin
Ill Ill (I
'1 'I i-1
Ill HIP
111 I II 111 111
111 111
II ill I1
ill ' ,1 1! , i'I II" I'll
122
'"III
'hi 111 i In
111 III
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MATT.
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice, the Data Call-Tn Chemical Status
Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
produces) 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.
How you will comply with the requirements set forth in this Notice and its Attachments 1
through 6; or
Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3 (for both generic and product specific data), the Requirements Status
Registrant's Response Fnrm, (see section HI-B); or
123
-------
ilillSl, ,; lilii,!,1!1"..!."'!,,,!!'1'
Ill
3.
Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section HI-D).
Ill i I in , -p!«,",, :''',<, :.
Ti Milt il1':'!;
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with its
or"ents or should be exempt or excused from doing so, then the reeistration of vour
||||;ill||iii i' , 'Illlliiiilllllllllj ^fllliilll'iiniillli,,!!11" ||, .iil'iii/iiiMlif1!"!!1,':!!,! ll'i,1; iiii" IP ,1111111, ,!'' H1 FiiiKi '"lif""!!, i L':.i it tin I Jlllin1 Jr « ™i| i • ,,. , ,2,,, &^ Vit J ^MA
S? Sut-!ect to this Notice w111 be subJect to suspeBsi03?; We have provided a list of
*ti of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-m Response Forms Also included is a list of all
registrants who were sent this Notice (Attachment 5).
The authority for this Notice is section 3(c)(2)(B) of the Federa]|nsecticide,
Fungicide and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of
this information is authorized under the Paperwork Reduction Act by OMB Approval No 2070-0107
and 2070-0057 (expiration date 3-31-99).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices. The Attachments contain specific
chemical information and instructions. The six sections of the Notice are:
Section I
Section n
Section HI
Section IV
Section V
Sectio
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this Notice
Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 .
2-
3-
4- ;
5-
Data Call-in Chemical Status Sheet
fieneric Data Call-in and Product Specific Data Call-In R^nnn^ TW^
with Instructions
G£Zieiic_Data Call-In and Product Specific Data Call-Tn Reouirements S
Repstrant's Respnse Forms (Insert B) with Instructions
EEA_Batchine of End-Use Products for Meeting Acute Toxicolo^v Data
for Reregistranon
List of Registrants Receiving This Notice
s flnsert A}
tatusand
Eeauiremenl
124
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SECTION I.
WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the data
needed to support continued registration of the subject active ingredient(s). This reevaluation identified
additional data necessary to assess the health and safety of the continued use of products containing this
active ingredients). You have been sent this Notice because you have produces) containing the subject
active ingredients).
SECTION H. DATA REQUIRED BY THIS NOTICE
II-A. DATA REOIJTRRD
The data required by this Notice are specified in the Requirements Status and Registrant's
Response Forms (Insert B) (for both generic and product specific data requirements). Depending on
the results of the studies required in this Notice, additional studies/testing may be required.
H-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in the
Requirements Status and Registrant's Response Forms (Insert B) within the time frames provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service (NTIS),
Attn: Order Desk, 5285 Port Royal Road, Springfield, VA 22161 (Telephone number
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
125
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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).
fi1
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].
II-D: REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY ''" ': "' "''''* "' ' ' ' ""':'
I! i I! II I1 * I1 ',' ?!„;:{.,„; •,::'l»,'"'(;)11<<"!:!!?¥;:'! ""l,»|l',|i""
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Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-Ms), 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
issuancefof a Notice of Intent toi Suspend their affected products.
i ;,,,!','-if" „ Til,,;,.' ,iK^ fl'l ' -Ii;! iL,jliL "' i,'1'?,,(:,,i,il!" 'I I'1 i I ' ill ! i III \ I
SECTION IS. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
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You must use the correct forms and instructions when completing your response to this Notice.
The type of Data Call-in you must comply with (Generic or Product Specific) is specified in item
number 3 on the four Data Call-in forms (Attachments 2 and 3).
ffl-A. SCHEDULE FOR RESPONDING TO THE AGENCY
K;
The appropriate responses initially required by this Notice for generic and product specific data
must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
' ' " ii"lj||i|||ii|" JT' llllW't'l 4!'' liJIIIIIIIIIliillilllllllPl111! !'i°'ill! " SlllillliBiihflflLllb'il'hTi A , , in '\ , v '.• • "'is ""I,,;, 'I1:- .I11?1!"'"':'],!,,"1 '••• •<",•'''[*!>•• Jsilf':;;,': -fif,«,;,'" ' *>" fffii'!''''~, : :•(
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126
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I
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A discussion of how to respond if you choose 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 generic 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.
Two forms apply to generic data requirements, one or both of which must be used in responding
to the Agency, depending upon your response. These two forms are the Data-Call-Tn Response Form
(Insert A), and the Requirements Status and Registrant's Response Fnrm (insert B).
The Beta Call-in Response Forms (Insert A) must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms (insert B) also must be submitted if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation of your
registrations). Please note that the company's authorized representative is required to sign the first
page of both Data Call-in Response Form? (Insert A) and the Requirements Status and Registrant
Response Forms (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(s) identified in Attachment 1.
a. Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of your
produces) containing the active ingredient that is the subject of this Notice. If you wish to voluntarily
cancel your product, you must submit completed Generic and Product Specific Data Call-Tn Response
Forms C1"8^ A)> indicating your election of this option. Voluntary cancellation is item number 5 on
both Dflta Call-In Response Form(s). If you choose this option, these are the only forms that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product after
the effective date of cancellation must be in accordance with the Existing Stocks provisions of this
Notice, which are contained in Section IV-C.
b. 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 Fnrm (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 under item 9 in Ihe instructions for the
Requirements Status and Registrant's Response Forms (Insert B). You must also complete a Data
Call-In Response Form (Insert A) by signing the certification, item number 8. Application forms for
127
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Ill III IMIII 1111 I i i III I i , ii" Hilir ,!•, i:,'"«,' ,"" ',!!'!• ' ' l""lif"1 ; ".,;,", ',i '.'iii1 J. f,1,'" '" '"Will1:",,'! • I",'1;11"1!"'!'!,'
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amending registrations may be obtained from the Registration Support Branch, Registration Division,
Office of Pesticide Programs, EPA, by calling (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, is allowed only if the product bears an amended label.
I ' " '"
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is exempt from
the requirement to submit or cite generic data concerning an active ingredient if the active ingredient in
the product is derived exclusively from purchased, registered pesticide products containing the active
ingredient. 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, |]J of the following requirements must be met:
• ' " ii
• ' '" ' ' ' " i ' ; , ' " '
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient and is
purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your product subject to
nil.j II'I,II' ,, i i , in, I ,,j I,, ' mi',, I' i ,",,„, "", ' ,,,'„ , i ,,l"il'H Ml,,, ,I,',|S ,T -t' ff , ,,
ffjF^^ij1"1 ' '' iii .'' ji'i; ',. ff fe;PS SCS^i^E^'^ilS^SB3^,?11
I |T Ii;.|!i ,,y 1' j, - if I *!^ !!i" i"1' flftcc^ljance; and
(iii). You must have provided to EPA an accurate and current "Confidential Statement of
iii | ?i \"": I tf ' J'; i,,;'- i '. J3" 'Formula" for each of your products to which this Notice applies.
K" *'• 'W1: ' *!:: * ;*yTo jippfy for the Generic Data Exemption you must submit a compJet^ Data Call-in Response
F_QJHJ (Insert A), Attachment 2 and all supporting documentation. The Generic Data Exemption is item
number, ,<5a .on . J3he. Data Call-In Response Form (Insert A). If you claim a generic data exemption you
are not rejuired to complete the Requirements Status and Registrant's Response Form (Insert A).
Generic Data Exemption cannot be selected as an option for responding to product specific data
'"- " requirements.
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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
I1"!'1,Ill,';]' i' ,"" " i|f|i||i|'i'li:: ',! ,' 73i ilii'1*1'1' 'HIIii1 JPil, ill I iiBllllliii, ' '1, .iliiLiiiin",, ,lLi,!!i"i!!'il"! ililillliiiliinlli'iinlllliilJiliillllliPlli1 jiiiUillPllllillililllllllliiiiiill'illi, ipi'.iilil!1 inlllnii p ' ii ilhi, , «m\\r 'inn mi1,,' ,,,,h' iw \ ,;<\\\,' ,ii»:iPui' n mi1 ,n 1,1 nnn'i nii';,i:,, nii'iiii'i'' hniii'hiiiiiiiiiiiniiiiiiiip'i'iii'iiiP11,! • 'Biiiiiiii TS« ,i, , „ , ,
required data fail to take appropriate steps to meet requirements or are no longer in compliance with
this Data gall-In Notice, the Agency will consider that both they and you are not compliance and will
NllliiHI i| ii},!,,;, , iirii||lii,,fl " "||, J, |,| I' jni/'if'''!!!''!!!'!!''|,*, :i,»ii 8''. ' ' '»,„'' '' '' ,« ''»' ,,,'»i''!, ''" , ,'' ''i'i" " »:, ", '" ''ill1' "" ''"& '» » ^'
normally initiate proceedings to suspend the registrations of both your and their produces), unless you
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'ill
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commit to submit and do submit the required data within the specified time. In such cases the Agency
generally will not grant a time extension for submitting the data.
d.
Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this Notice. These
options are discussed in Section IH-C.l. of this Notice and comprise options 1 through 6 of item 9 in
the instructions for the Requirements Status and Registrant's Response Form (Insert B) and item 6b on
the Data Call-In Response Form (Insert A). If you choose item 6b (agree to satisfy the generic data
requirements), you must submit the Data Call-In Response Form (Insert A) and the Requirements
Status and Registrant's Response Form (Insert B) as well as any other information/data pertaining to the
option chosen to address the data requirement. Your response must be on the forms marked
"GENERIC" in item number 3.
e.
Request for Generic Data Waivers.
Waivers for generic data are discussed in Section HI-D.l. of this Notice and are covered by
options 8 and 9 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form (Insert B). If you choose one of these options, you must submit both forms as well as any other
information/data pertaining to the option chosen to address the data requirement.
2.
Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice or (c)
request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option is presented
below. A discussion of the various options available for satisfying the product specific data
requirements of this Notice is contained in Section ni-C.2. A discussion of options relating to requests
for data waivers is contained in Section ni-D.2.
Two forms apply to the product specific data requirements one or both of which must be used in
responding to the Agency, depending upon your response. These forms are the Data-Call-in
Response Form (Insert A), and the Requirements Status and Registrant's Response Form (Insert B),
for product specific data. The Data Call-In Response Form (Insert A) must be submitted as part of
every response to this Notice. In addition, one copy of the Requirements Status and Registrant's
Response Form (Insert B) also must be submitted for each product listed on the Data Call-In Response
Form (Insert A) unless the voluntary cancellation option is selected. Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form (Insert A)
129
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31101 Rgcmirgments Status and Registrant's Response Form (Insert B) (if this form js required) and initial
any subsequent pages. The forms contain separate detailed instructions on the response options. Do
hot alter the printed material. If you have questions or need assistance in preparing your response, call
or write the gQntact person(s) identified in Attachment 1.
Voluntary Cancellation
inn •
'»i •» • I
You may avoid the requirements of this Notice by requesting voluntary cancellation of your
product® containing the active ingredient that is the subject of this Notice. If you wish to voluntarily
cancel your product, you must submit a completed Data Call-in Response Form (Insert A), indicating
your election of this option. Voluntary cancellation is item number 5 on both the Generic and Product
Specific Dafi Call-in Response Forms (Insert B). If you choose this option, you must complete both
Data Call-in response forms. These are the only forrns ^ you ^g require^ 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.
b.
Satisfying the Product Specific Date Requirements of this Notice.
'i »
F • •'
There are various options available to satisfy the product specific data requirements of tiiis
Notice. These options are discussed in Section IH-C. of this Notice and comprise options 1 through 6
of item 9 in the instructions for the product specific Requirements Status and Registrant's Response
£oun (Insert B) and item numbers 7a and 7b (agree to satisfy the product specific data requirements
for an MUP or EUP as appjicable) on the product specific Data Call-in Response Form (Insert A).
Note that the options availabje for addressing product specific data requirements differ slightly from
those options .forfWfflJjf^ generic data requirements. Deletion of a use
-------
HI-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTTrF.
1.
Generic Data
If you acknowledge on the Generic Data Call-In Response Form (Insert A) that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select one of the
six options on the Generic Requirements Status and Registrant's Response Form (Insert B) related to
data production for each data requirement. Your option selection should be entered under item number
9, "Registrant Response." The six options related to data production are the first six options discussed
under item 9 in the instructions for completing the Requirements Status and Registrant's Response
Form. These six options are listed immediately below with information in parentheses to guide you to
additional instructions provided in this Sectioa The options are:
(1) I will generate and submit data within the specified timeframe (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the Agency
by anyone (Submitting an Existing Study)
(5). I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and ungradable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing study
that has been submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency guidelines
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's Response Form (Insert B) and/or footnotes to the form. If
you wish to use a protocol which differs from the options discussed in Section tt-C of this Notice, you
must submit a detailed description of the proposed protocol and your reason for wishing to use it. The
Agency may choose to reject a protocol not specified in Section 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
131
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Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an existing
agreement to meet the requirements of this Notice and have been unsuccessful, you may request EPA
(by selecting this option) to exercise its discretion not to suspend your registration(s), although you did
not comply with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept the 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 Certification with Respect to Citations of
Data (in PR Notice 98-5) (EPA Form 8570-34). 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 to 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 Recmiremente Stati,* ^ Registrant's
Response Form (Insert B) committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer to share
in the burden 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
normally will be subject to initiation of suspension proceedings, imless 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 tune extension for submitting the data.
Option 4. Submittinp 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). J'
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.
133
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, IIHII ' ,•"! 'VI ''" illllPill'iii'ii, •..,:,;"l!!!|j,i!»! |i,« : ,,:l \ i, >,„, i.lii'KJ „,'•,;" 'if ,"»':!'••'• „;' •:" il, " i' V ,,'''lil"'1 n,!!1 1!!,, 'I,. !„ i , ,;„,,:' !„„"", '„":,'!,:',;;,' !,;, , , I1" „;::":'"!„, „, ,,!
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To meet the requirements of the DCl Notice for submitting an existing study, all of the following
three criteria must be clearly met:
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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,
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 riecessary for the reconstruction and evaluation of the report of that study, in the
:-: 'i1;,,!'^!!!" ' ,, ' ,,, , , i r , rf
,^1^.. iiipyilflljillPMHSl SSS^PPt? °?,ra,w ^.^^X6,, I3??11 PreHarec^ (e-§-' tapes which have
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|_^lficlude photographs, microfilm or microfiche copies, computer printouts, magnetic
'^'Tjriedia,including dictated observations, and.recorded data.from automated instruments."
_ ...i ,,„:' Tis; ra-She term, "specimens'1, according to 40 CFR 160.3, means "any material derived from a
test system for examination or analysis."
I III1!"!!, :' I!" I'"" i,,"!' II!,',
,,, •; .b. _ ]M Health,and safety studies completed after May^^984^must ds^co^
2 .quiality. assurance and quality control rnformation pursuant to the requirements of 40
;;: -' '."'i' .< "i'Ii:iii"i'>' ILCFR Part 160. Registrants also must certify at the time of submission of the existing
study that such GLP information is available for post May 1984 studies by including an
appropriate: statement on or atoclwd to the study signed by an autliorized official or
representative of the registrant.
c.
i (
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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 documents available from
NTIS). A study not conducted according to the PAG may be submitted to the Agency
for consideration if the registrant believes that the study clearly meets the purpose of the
PAG. The registrant is referred to 40 CFR 158.70 which states the Agency's policy
regarding acceptable protocols, ff vpu wish to subnut 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 p^ose of the PAG and[that
necessary raw data usually are 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.
1 mi , .I ii 1 i hi • ' i1 1,11 " U1 i r
134
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If EPA has previously reviewed a protocol for a study you are submitting, you must identify any
action taken by the Agency on the protocol and must indicate, as-part of your certification, the manner
in which all Agency comments, concerns, or issues were addressed in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not meet the
criteria outlined above but does contain factual information regarding unreasonable adverse effects, you
must notify Ihe Agency of such a study. If such a study is in the Agency's files, you need only cite it
along with the notification. If not in the Agency's files, you must submit a summary and copies as
required by PR Notice 86-5 entitled "Standard Format for Data Submitted under FIFRA".
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 £ind 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 g& 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 entitled "Standard Format for Data Submitted under FIFRA."
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 also should 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.
135
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.Option 2. Agree to Share in Cost to Develop Data - If you enter into an agreement to cost share, the
same requirements apply to product specific data as to generic data (see Section III.C.1, Option 2)
However, registrants may anjv. 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 numhgr of the product for which data M be
submitted mug be noted in the agreement to cost share by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development -The same requirements for generic data
(Section m.C.L, Option 3) apply to this option. This option only applies to acute toxicity and certain
efficacy data as described in option 2 above.
Option 4, Submitting an Fasting Study - The same requirements described for generic data (see
Section ffl.C. 1 ., Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study - The same requirements described for generic data (see Section
m.C.l., Option 5) apply to this option for product specific data.
Option fr Citing Existing Studies - The same requirements described for generic data (see Section
HI.C.l., Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements described in
the instructions for completing the Data Call-Tr. Resprm^ Fo^ (insert A) and the Requirement. S
and Registrant's Response Form (Insert B), and in the generic data requirements section (ffl C n as
appropriate. ' ' 'h
REQUESTS FOR DATA WATVFRg
1.
Generic Data
There are two types of data waiver responses to this Notice. The first is a request for a low
volume/minor use waiver and the second is a waiver request based on your belief that the data
requirement(s) are not appropriate for your product.
a. Low Volume/Minor I Jse Waiver
Option 8 under item 9 on the Requirements Status ™A T^gjstrant's Response Form
(Insert B). Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of
requiring data for low volume/minor use pesticides. In implementing this provision, EPA
137
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considers low volume pesticides to be only those active ingredients whose total production
volume for all pesticide registrants is small. In determining whether to grant a low volume, minor
use" waiver, the Agency will consider the extent, pattern and volume of use, the economic
incentive to conduct the testing, the importance of the pesticide, and the exposure and risk from
use of fee pesticide. If an active ingredient is used for both high volume and low volume uses, a
low .volume exemption will not be approved. If all vises of an active ingredient are low volume
and the combined volumes for all uses are also low, then an exemption may be granted,
depending on review of other information outlined below. An exemption will not be granted if
any registrant of the active ingredient elects to conduct the testing. Any registrant receiving a low
Yolumgminpr use waiver mu§tiremain,„within the sales figures in their forecast supporting the
waiver request in order to remain qualified for such waiver. If granted a waiver, a registrant will
be required, as a condition of the waiver, to submit annual sales reports. The Agency will
respond to requests for waivers in writing
To apply for a low volume/minor use waiver, you must submit the following information, as
applicable to your produces), as part of your 90-day response to this Notice:
(i). Total company sales (pounds and dollars) of ail registered produces) containing the
active ingredient If applicable to the active ingredient, 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
i« ''"'i ",'!l'"ii,,' ,: '4llil » ' .r'H ,"' !,t, ,!•, I,, "i''!ii! ill , I" . !• ',"l' •' • ,i ' '. V - ' illlBn!"1: r .|,l,li',!>ii' ,llr i, " I I'ill ,, |MI'!!i«;,,L. ' „' ilJV'i „». •, - • .."nr
years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active ingredient for
each major use site. Present the above information by year for each of the past five years.
I! I" !,,> ! "H
(iii) Total direct production cost of produces) containing the active ingredient 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.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and equipment)
charged to produces) containing the active ingredient by year for the past five years. Exclude all
non-recurring costs that were directly related to the active ingredient, such as costs of initial
registration and any data development.
(v) 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.
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(vi) 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.
(vii) For each of the next ten years, a year-by-year forecast of company sales (pounds
and dollars) of the active ingredient, direct production costs of produces) containing the active
ingredient (following the parameters in item 2 above), indirect production costs of product(s)
containing the active ingredient (Mowing the parameters in item 3 above), and costs of data
development pertaining to the active ingredient.
(viii) A description of the importance and unique benefits of the active ingredient to
users. Discuss the use patterns and the effectiveness of the active ingredient relative to registered
alternative chemicals and non-chemical control strategies. Focus on benefits unique to the active
ingredient, providing information that is as quantitative as possible. If you do not have
quantitative data upon which to base your estimates, then present the reasoning used to derive
your estimates. To assist the Agency in determining the degree of importance of the active
ingredient in terms of its benefits, you should provide information on any of the following factors,
as applicable to your produces): (a) documentation of the usefulness of the active ingredient in '
Integrated Pest Management, (b) description of the beneficial impacts on the environment of use
of the active ingredient, as opposed to its registered alternatives, (c) information on the
breakdown of the active ingredient 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.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements States and Registrant's Response Form.
This option may be used if you believe that a particular data requirement should not apply
because the requirement is inappropriate. You must submit a rationale explaining why you
believe the data requirements should not apply. You also must submit the current label(s) of your
produces) and, if a current copy of your Confidential Statement of Formula is not already on file
you must submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency determines that
the data requirements of this Notice are not appropriate to your produces), you will not be
required to supply the data pursuant to section 3(c)(2)(B). If EPA determines that the data are
required for your productfsl vou must choose a method of meeting the requirements of this
Notice within the time frame provided bv this Notice. Within 30 days of your receipt of the
139
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Ill III ill I
Agency's written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.
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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
^^'.j'l^j^ic^to^relevant EPA regulations, guidelines or policies. (Note: any supplemental data must
|p Sifefnjlted in me 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
IJIIiiilJU'liik ill UHli! iliillHIi „ 'i|illll,Li:"!,!ilillll,ii!,.i''i' ^liiilUf iJ'r'ira^ 'JIli!:!1 t";/ ..UIW"11 >' ii Uirili, Ml " .I.ITTI'K nniiiPiiriii' I1* a' „,• .in'i'mi *i • :• < „ •,. , pi i iO, »• a /HI it
FIFRA. Jf 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 in<^te_suad_subrmt the option chosen on the product specific Requirements Status and
Registrant's Response Form (Insert B). Pjoduct specific data requirements for product
'.£fySHS$ry> acute toxicity and efficacy (where appropriate) are required for ail products and the
^
| • ,|||j''jj'l|ljl lilll'i'igillllligiigilllHi'' '• iiiiiiiiirii1: ' i"i n ' ft J n/11!" i A » " tn i« v n..11,!!1'!' r ' i: r, ''iihi1 A , ,
aware that submitting a waiver request will not automatically extend the due date for the study in
"Ill ii:|j,i'"!"l • '''^lii'i'liiiiiniiliiiJII''''!!!!!!:!!!!!; Vli'^P'''*'*!, llf'BiiihHMiii,!1 ITIK: »a;iiin": .'n \ \w<" »in ii'UniiiiniiihU IIIPI r* "i iHwrifJUii iiy HIII hiii-, !',ni i , „ >, -\ • h,.i.;i 'i :;.« .< - "«:/ r
question. Waiver requests submitted without adequate supporting rationale will be denied and
the original due date will remain in force.
'•;' 'SECTION"IV. "' ' ' CONSEOUENCJES OF FAILURJE TO COMPLY''wiTH THIS NOTICE
IV-A: NOTICE OF INTENT TO SUSPEND
Irf:'; ,,*; '.:"'': ,';;'- '|:;: ,,;::":. :|The, Agency^may issue a'Notice'of fcte^t| to ^Sus^
• |,fe^mS l>y a registrant to comply with the requirements of this Data Call-in'Notice, pursuant to FIFRA
^Jf^ctjionj 3(c)0(F). iEventSii|Which may te the basis for issuance of a Notice of Intent to iSuspend
include, but are not limited to, fee following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
7"' .'"*. ';! !'!! Notice.
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illi11,! '' ,',"'!,: 'I', I ,'il'ii: "'''I |!.' > "I'l,.'1!,! i , Ill I I!'1 1 Mil1 , hr'ii'illi L Illlii,,! ' :!:„ ,:"!lll!liii 'I'!"!!:!!' lii " lillll'l ,. ' ''ril "I i n,i, i " i 'it
2. Failure to submit on the required schedule an acceptable proposed or final protocol
•• 5" "\ T.'"i': ;;;|':i ;' S|gti.^§Hch,;is rjquired^ to be ''submitted to tBie ^Agency for review.
IRS' i,KJ«i" p is '; IIP' "ail""• ii f',": ';'"Siif i if!'; i; -!",s j ii::: i,!:,i•,"? *'i+iiis in. \ «•;iini• •. ai '.•iiv*^Mpn.1?!! -! • • -i ,i i
"Vila I , '''!''' 'IP,,, Ill '11111;' I"': Mlllllin Ill1 'P'llll I : i liELii'illi llilP ''I MP plli":1!"!!" "I EIPIIIIILI 'Pi' 'illllli, „ nil ill, I1 ii ,il' IP ' i|lll|!.;!!,.,' '"IIL «i ill! ' " ,!!, I'm 111 f''! 'i', f full "!J',:'["'.,; ni'l .IP!'! I yii KB I •iiO-i! ''HIK 'I
3. Failure to submit on the required[schedule an adequate progress report on a study as
required by this Notice.
140
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4.
5.
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).
6.
Failure to submit supportable certifications as to the conditions of submitted studies, as
required by Section Itl-C of this Notice.
7.
8.
9.
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. 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).
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 fiame.
Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
141
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IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY TS
UNACCEPTABLE
I ij i i,., i iijii, i siiy i i n i i II i i in i 11 i 11 lip i| l |i H i 11 ' i
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
Giideliijes, and Genetox Health Effects Test Guidelines) regarding the design, conduct, and
, 1". ," , ^.^rjepohing of required studies. Suc^requir^ents^ those, relating to
,„ ,„,,, sir •' i,i! i;v,,:,'.; i IE, ls,lS§HiL te?f procedures, selection of species, number of animals, sex and distribution of
: [^ ' ;-;-;• :!;'^ duration of test, jind, as applicable,
,,:}•:,, " :;;i ..i v-yr..!.., ; •,"," Good j^bgrjatpiy Practices.
iJiJji iLh ti;'"!'. V. iiiil '(', ifSif '"lliiii;*i;v:'"«V.'Srk^ltVv "i'l,' t'.i-. ',* . >t&W:-.'i- ^.'i^.^flv' ''.('^.f^Cfft''1 ;'• • ;*" . i '••$''•: ii III
:.ijij,j:,,; . i, i^;_, '• -'•",,,,:, iany changes required by the Agency following review.
'Iff? |j« i ii ji« {,)}" i"ip/'ip>" • jJij,,;,.• Iii';>;,' ft"'**!',: 7":"" liii' ijiilK' ».,i: ~i »\$,.&i • "t'!';," tfjtfl.' ;I ji'jliti»'''! 5-iff "s,;*? jiii >| i:• j«ir 7 .••'"'jti'- l'"JMif'1ikii,<: liiiiiiH& ;~ Irjwii-'jtriiiiMwis.'.v*:^1 .•»L *•'"'! "iifl'iiS;' :'Mk h*i'iJ',j!iisiHi ii;! "s 'i!~"'::rt.' '.• I'1™,*is;,,": iiii:"",,;v "ij' ''"i .iVi1' tdBfisiii
3) EPA requirements regarding the reporting of data, including the manner of reporting, the
i ^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.
1 AH studies must be submitted in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement
'-"r : ' " , „: ' '
| '"-i".,,:; ii "K;: ,;; 'ijii*:! ii; nu ( in » i I i I i II I II i II
, EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
IIP1'11'lljll M,iilll|l|lH'J "ilr llMn ilh|, i llllllllllii" Iii1 '! || , „ !.
EPA has statutory authority to permit continued sale, distribution and use of existing stocks of a
Pesticide product which has been suspended or cancelled if doing so would be consistent with the
i • , , i •• -purposes of'the Act.
• jii' .I!;-!;,;;,,,;, s,. .11;,, }„,[; t j-,,, ^^4gt'vjl^^>§^cy^h^deteimined that such disposition by registrants of existing stocks for a
istration when.a section 3(c)(2)CB) data request is outstandmg generally would not be
,- —-s-"i si—a ^ Acfs purposes. Accordingly, the Agency anticipates granting registrants permission
' to sell, distribute, or use existing stocks of suspended product(s) only in exceptional circumstances. If
|ou believe such disposition of existing; stocks of your produces) which may be suspe^
comply with this Notice should be permitted, you have the burden of clearly demonstrating to EPA that
granting such permission would be consistent with the Act. You also must explain why an "existing
?^M! PI2Y?5!0? Ji?;,ne.ce.s?a!I? including a statement of the quantity of existing stocks and your estimate
of &e time required^for their sale, distribution, and use. Unless you meet to burden, the Agency will
. I' lILiliiii'iJIi' ."liilh .i>:''IE! '4li .i' III1:!!' In I'lllIU ^rVlllUll I, 1 ' 'H ' I'hi 'J , " " MI!" ' "'" < "''. :"!,„,II',,! Mi"1! il " "« II•. ' 'V " ' .n, < ' .'. , :,i, I .H.Vili
142
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not consider any request pertaining to the continued sale, distribution, or use of your existing stocks
after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and your
product is in full compliance with all Agency requirements, you will have, under most circumstances
one year from the date your 90 day response to this Notice is due, to sell, distribute, or use existing'
stocks. Normally, the Agency will allow persons other than the registrant such as independent
distributors, retailers and end users to sell, distribute or use such existing stocks until the stocks are
exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products containing an active
ingredient for which the Agency has particular risk concerns will be determined on a case-by-case
basis.
Requests for voluntary cancellation received afigr. the 90 day response period required by this
Notice will not result in the agency granting any additional time to sell, distribute, or use existing stocks
beyond a year from the date the 90 day response was due, unless you demonstrate to the Agency that
you are in full compliance with all Agency requirements, including the requirements of this Notice. For
example, if you decide to voluntarily cancel your registration six months before a 3-year study is
scheduled to be submitted, all progress reports and other information necessary to establish that you
have been conducting the study in an acceptable and good faith manner must have been submitted to
the Agency, before EPA will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBTJOATTON TO PFPQRT PQSSTRT F
UNREASON ART .E ADVERSF FFFTTTTS
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 VL INQUIRIES AND RESPONSES Tn TTTTS ^r>Tir*T
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
All responses to this Notice must include completed Data Call-in Response Forms (Insert A)
and completed Requirements Status and Repistranfa Rgspnm* TW^C 0^ B)> for ^^ (generic gnd
143
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1. Chemical Status Sheets
145
-------
TPTH DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing TPTH.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data required
B'liL '••: I,!,! B BUI |, ,;ii,|,, >, ,«;, i,,,, ^ f: , iin 1111,11,;iiiiiiii™iiBiiiiiii*iiiiiiiBH~iii;lisiiii ii,F'isiiii,'"'i,iPiiiBinsi MINUS,:B»lii' r im ninnii iL I «-. ,- -..r.u. ^ ^ ^
by this notice, and point of contact for inquiries pertaining to the reregistration of 0021. This attachment
|'f ,|,i' ' [If? if Iff- ^ •'.;. - ,. ,. „ ;,. .ji r :,„ " v °^ I ,
S3:,ij'ls' to be used in conjunction with (1) the Product Specific Data Call-In Notice, (2) the Product Specific
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Data Call-In Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form
If ' li,!!!':1'; ii.iOli111;1' SfV 'lllli::: 1I.1EIEI '•' llllllH^^ ' Jlllilp , ,i. - ,n.r .2i in.,.. - mi 5
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Requir^ instructions
.i!ill.,..-and guidance accompany each form.
1.._, ,;;ft .jii,, ji;:
DATA REQUIRED BY THIS NOTICE
Ilill siii!!,,.,"!!... ,, •' !• iilliSTSi ft, •-:"!, ,1 '!! '.', B I
I IIIVT liinydiiiini ixi'tii
The additional data requirements needed to complete the database for TPTH are contained in the
" ''J'~ -1;;* RequirernenteStatos^ Attachment 3. The Agency has concluded that additional
;: „;,:',, :r; ^^t.pn;ii^iltjre,ji^^e!ij|.^:^pecific products. These data are required to be submitted to the Agency
"",;;;;; ^; ...'Vyn^^t.^ timejBame listed. These data are needed tpLfully complete the reregislration of all eligible TPTH
II 'PT, II'T !!!;,! TI'iiilHI:
IU Ji:i'" ' "!>i .''" BBIBliiJilB B,r fl'iiihiBlljk vB Ji in ' BilllBB'M "iii, IJBil» - ':. Ji1 1 ^ ' ' !»i Ji.li' , „ .• !i: • ....... : ...... iiui: , ..... ' .» < • «i , ' .......... 4n '! '• "»
i1 iiiMJ' • "Hi L It
AU responses to this Notice for the Product Specific data requirements should be submitted to:
:-i:' 'U«. ' Jane Mitchell
,' „ ,,,;;;" ;,Cjiemc^Reviewiji]Manager
Product Reregistration JBranch
Special Review and Reregistration Branch 7508C
E iliriljFI! III! r ',„ ' , r,';:r ,, „'„„
-------
TPTH DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
TPTH.
You have been sent this Generic Data Call-In Notice because you have produces) containing
This Generic Data Call-In Chemical Status Sheet, contains an overview of data required by this
notice, and point of contact for inquiries pertaining to the reregistration of TPTH. This attachment is to be
used in conjunction with (1) the Generic Data Call-in Notice, (2) the Generic Data Call-in Response Form
(Attachment 2), (3) the Requirements Status and Registrant's Form (Attachment 3), and (4) a list of
registrants receiving this DCI (Attachment 5). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for TPTH are contained
in the Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded that
additional product chemistry data on TPTH are needed. These data are needed to fully complete the
reregistration of all eligible TPTH products.
INQUIRIES
| RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures established by
this Notice, please contact Loan Phan at (703) 308-8008.
All responses to this Notice for the generic data requirements should be submitted to:
Loan Phan, Chemical Review Manager
Special Review Branch
Special Review and Registration Division (H7508C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: TPTH
147
-------
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2. Combined Generic and Product Specific DCI Response Forms (Insert A)
Plus Instructions
149
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•I
(I 111
Instructions For Completing The "Data Call-In Response Forms" For The Generic And Product
i;i :'i Specffic Data Call-In
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duct Specific "Data Call-In Response Forms" (Insert A)
duct specific Data Call-ins as part of
EPA's Reregistration Program under the Federal Insecticide, Fungicide, and Rodenticide Act If you
are an end-use product registrant only and have been sent this DCI letter as part of a RED document
you have been sent just the product specific "Data Call-in Response Forms." (Insert A) Only
III1,,! '' " III;,I ill IB'IlllJt ;
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registrants responsible for generic data have been sent the generic data response form. The type of
=!,_; Data Call-In (generic or product specific] is indicated in item number 3 ("Date and Type of
=^ DCI") on" each form.
Although the form is the same for both generic and product specific data, instructions for completing
I K!'TtfafiSe forms are different Please read these instructions carefully before filling out the forms.
I I;,!!, I'1 ii|ii|» ''I I1 niirj" .iii!'1 n" < i ipi iiiiiiiiiini mi 11 i i ii 'in nil ^
EPA has developed these forms individually for each registrant, and has preprinted these forms with a
I ri"'^r."..'" " , I.," *. PBWber.Qf items. DO NOT use these forms for any other active ingredient
IHtiJ Ili',!1. lit'''
h,rv. Sii"!1"::11:
I lilll'i: ^'t:'! I t ill1
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^--"7- : sgp-o-14 have been preprinted on the form. Items 5 through 7 must be completed by the
^stFa5! *? ^IffiE1:^!?- Ite™ 8 through 11 must be completed by the registrant before submitting a
response to the Agency.
i for this collection of information is estimated to average 15 minutes per
response, including time for renewing instoctions, searching existing data sources, gathering and
|h t""' ...rnamtaining the data neededj^and rompleting and reviewing the collection of information. Send
coriments reg^raing the burden estimate or any other aspect of this collection of information, including
111 ij, ii-s^^estions^ for reducin^this burden, to Chief, Information Policy Branc^ Mail Code 2137, U.S.
Environmental Protection Agency, 401 M sCs.W.,' Washington, Di.Q 20460; and to the Office of
Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
I r ii i ' i
150
,(; ;: • „
-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
(INSERT A)
Generic and Product Specific Data
Item 1 . ON BOTH FORMS: This item identifies your company name, number and address.
Item 2. ON BOTH FORMS: This item identifies the case number, case name, EPA chemical
number and chemical name.
ItemS. ON BOTH FORMS: This item identifies the type of Data Call-in. The date of
issuance is date stamped.
Item 4. ON BOTH FORMS: 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.
ItemS.
ON BOTH FORMS: Check 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. Since this
Data Call-in requires both generic and product specific data, you must complete item 5
on both Data Call-In response forms. You do not need to complete any item on the
Requirements Status and Registrant's Response Ff>rms (Insert B)
Item 6a. ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and 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 Genetic Data Exemption as explained in the
Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA registration
Number of each registered source of that active ingredient that you use in your product.
Typically, if you purchase an EPA-registered product from one or more other producers
(who, with respect to the incorporated product, are in compliance with this and any
other outstanding Data Call-In Notice), and incorporate that product into all your
products, you may complete this item for all products listed on this form. If, however,
you produce the active ingredient yourself, or use any unregistered product (regardless
of the fact that some of your sources are registered), you may not claim a Generic Data
Exemption and you may not select this item.
151
-------
Item 8. ON BOTH FORMS: This certification statement must be signed by an authorized
representative of your company and the person signing must include his/her title.
Additional pages used in your response must be initialed and dated in the space
provided for the certification.
Item 9. ' ON BOTH FORMS: Enter the date of signature.
Item 10. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information that does not fit on this form in a signed letter
that accompanies your response. 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.
153
-------
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3. Generic and Product Specific Requirements Status and Registrants'
Response Forms (Insert B) and Instructions
157
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Instructions For Completing The "Requirements Status and Registrant's Response Forms"
(Insert B) For The Generic and Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used by registrants to respond to generic and product
specific Data Call-in's as part of EPA's reregistration program under the Federal Insecticide, Fungicide,
and Rodenticide Act. If you are an end-use product registrant only and have been sent this DCI letter
as part of a RED document you have been sent just the product specific "Requirements Status and
Registrant's Response Forms." Only registrants responsible for generic data have been sent the generic
data response forms. The type of Data Call-In (generic or product specific) is indicated in item
number 3 ("Date and Type of DCI") on each form.
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS" (Insert B)
Generic and Product Specific Data Call-in
Item 1. ON BOTH FORMS: This item identifies your company name, number and address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the case number,
name, EPA chemical number and chemical name.
case
Item 3.
Item 4.
Item 5.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the case
number, case name, and the EPA Registration Number of the product for which the
Agency is requesting product specific data.
ON THE GENERIC DATA FORM: This item identifies the type of Data CaflJh.
The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type of
Data Call-in. The date of issuance is also date stamped. Note the unique identifier
number (E)#) assigned by the Agency. This ID number must be used in the transmittal
document for any data submissions in response to this Data Call-In Notice.
ON BOTH FORMS: This item identifies the guideline reference number of studies
required. These guidelines, in addition to the requirements specified in the Data Call-in
Notice, govern the conduct of the required studies. Note that series 61 and 62 in
product chemistry are now listed under 40 CFR 158.155 through 158.180, Subpart c.
ON BOTH FORMS: This item identifies the study title associated with the guideline
reference number and whether protocols and 1,2, or 3-year progress reports are
required to be submitted in connection with the study. As noted in Section ffl of the
Data Call-In Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this guideline
reference number to the Requirements Stafns ?nH Entrant's RespnnsP fojmflnsert
B).
159
-------
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Item 6. ON BOTH FORMS: This item identifies the code associated with the use pattern of
the pesticide. In the case of efficacy data (product specific
ii j IIP i i
requirement),, the required study only pertains to products which have the use sites
and/or pests indicated. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic; non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H • Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
.."'IK1' '!" ,ki: f!"1 I'M , 'i.. ','„' i ', i'1!!""
L Indopr food
M Indoor non-food
N Indoor medical
O Indoor residential
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ON BOTH FORMS: This item identifies the code assigned to the substance that must
Be used for testing. A brief description of each code follows:
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Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active Ingredient Radiolabelled
i
Pure Active Ingredient Radiolabelled
ii 11 i i in i °^ -
Pure Active 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
Typical End-Use Product or Pure Active Ingredient and Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active Ingredient
1"': I'Wi d',, :'i" - ,„;!, I1.'i'''' ' ilf'li, III '" * ,:,„!:",,„! '"'iliillr i " si I'1, ' Iff'''li'flii,1' iliilifil' h!ii|, 11 .' : i I,,!/:,'": ' I „,„ ill!!'!!!! i if, iliif EH'!! lir In, III Iii11 III! I , ii,:, ' r III,; E'l i, • , ,,. ' ,J ll,l,,,llii, I,,,
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pSadiolabefled
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IMP Impurities
DEGR Degradates
* See: guideline comment
Item 8. This item completed by the Agency identifies the time frame allowed for submission of
the study or protocol identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the date of your
receipt of the Data Call-In notice.
ON THE PRODUCT SPECIFIC DATA FORM: The due date for submission of
product specific studies begins from the date stamped on the letter transmitting the
Reregistration Eligibility Decision document, and not from the date of receipt. However,
your response to the Data Call-in itself is due 90 days from the date of receipt.
Item 9. ON BOTH FORMS: 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.
Option 1. ON BOTH FORMS: (Devslo^in^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 protocols and progress reports
required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Shane) T have enter^ ™tn an
agreement with one or more registrants to develop data jointly. By indicating that
I have chosen this option, I certify that I will comply with all the requirements
pertaining to sharing in the cost of developing data as outlined in the Data Call-in
Notice.
However, for Product Specific Data, I understand that this option is available
for acute toxicity or certain efficacy data ONLY if the Agency indicates in an
attachment to this notice that my product is similar enough to another product to qualify
for this option. I certify that another party in the agreement is committing to submit or
provide the required data; if the required study is not submitted on time, my product
may be subject to suspension.
Option 3. ON BOTH FORMS: (Offer to Cost Shared I have made an offer to enter into
an agreement with one or more registrants to develop data jointly. I am also
submitting a completed "Certification of offer to Cost Share in the Development
of Data" form. I am submitting evidence that I have made an offer to another
161
-------
FOR THE GENERIC DATA FORM ONLY: The following three options (Numbers 7,
8, and 9) are responses that apply only to the "Requirements Status and Registrant's
Response Form" (Insert B) for generic data.
Option 7. (Deleting Uses^ I am attaching an application for amendment to my registration
deleting the uses for which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice and I
request a low-volume minor use waiver of the data requirement. I am attaching a
detailed justification to support this waiver request including, among other things,
all information required to support the request. I understand that, unless modified
by the Agency in writing, me data requirement as stated in the Notice governs.
Option 9. ("Request for Waiver of Data) I have read the statements concerning data
waivers other than lowvolume minor-use data waivers in the Data Call-In Notice
and I request a waiver of the data requirement. I am attaching a rationale
explaining why I believe the data requirements do not apply. I am also submitting
a copy of my current labels. (You must also submit a copy of your Confidential
Statement of Formula if not already on file with EPA). I understand that, unless
modified by the Agency in writing, the data requirement as stated in the Notice
governs.
FOR PRODUCT SPECIFIC DATA; The following option (number 7) is a response that
applies to the "Requirements Status and Registrant's Response Form" (Insert B) for
product specific data.
7. (Waiver Request) I request a waiver for this study because it is inappropriate
for my product. I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted in the format required
by P.R. Notice 86-5]. I understand that this is my only opportunity to state the
reasons or provide information in support of my request. If the Agency approves
my waiver request, I will not be required to supply the data pursuant to Section
3(c) (2) (B) of FIFRA. If the Agency denies my waiver request, I must choose a
method of meeting the data requirements of this Notice by the due date stated
by this Notice, hi this case, I must, within 30 days-of my receipt of the Agency's
written decision, submit a revised "Requirements Status" form specifying the
option chosen. I also understand that the deadline for submission of data as
specified by the original Data Call-in notice will not change.
163
-------
Ill III
III" II Ill
Item 10. ON BOTH,,,FORMS:,i'rhisiitem rnust be, signed by an authorized representative ofyour
company. The'person signing must include Ms/her title, and mustinitial and date all other
pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with questions
regarding your response.
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Item 13. ON BOTH FORMS:Enter the phone number of your company contact.
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NOTE: You may provide additional information that does not fit on this form in a signed letter
that accompanies this your response. For example, you may wish to report that your
product has already been transferred to another company or that you have already
SOluntarily canceled this product. For these cases, please supply all relevant details so
that the Agency can ensure that its records are correct.
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Form Approved
OMB Bo. 2070-0107
2070-OOS7
Approval Expires 03-31-99
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
n^v^wras «•««• cype Or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet (s) if necessary.
3. Date and Type of DCI
PRODUCT SPECIFIC
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4. EPA's Batching of TPTH Products iFor Meeting Acute Toxicity Data
Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicily data requirements for reregistration of products containing TPTH as the active ingredient, the
Agency has1 batched products which can be considered similar for purposes of acute toxicity. Factors
considered in the sorting process include each product's active and inert ingredients (identity, percent
composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol,
wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary
labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since
some products within 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 lexicological studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute toxicological
studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she
must use one of the products within the batch as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided that the data base is complete and
valid by today's standards (see acceptance criteria attached), the formulation tested is considered by
EPA to be similar for acute toxicity, and the formulation has not been significantly altered since
submission and acceptance of the acute toxicity data. Regardless of whether new data is generated or
existing data is referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product, the registrant
must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days of
receipt. The first form, "Data Call-in Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response,"
lists the product specific data required for each product, including the standard six acute toxicity tests.
A registrant who wishes to participate in a batch must decide whether he/she will provide the data or
depend on someone else to do so. If a registrant supplies the data to support a batch of products,
he/she must select one of the following options: Developing Data (Option 1), Submitting an Existing
Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a
175
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'"lii" >;„,!?;,„!',*;,i ,inii, n a1 ,7 -u^' si^lf...'1 .•;* .r^fl Jill! I!'11'.' ;;i JI!'1": ,1 ni,
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registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to
Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to
participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that
choosing not to participate in a batch does not preclude other registrants in the batch from citing his/her
studies and offering to cost share (Option 3) those studies.
Ten products were found which contain TPTH as the active ingredient. These products have
been placed into three batches and a "no batch" category in accordance with the active and inert
ingredients and type of formulation.
Due to the high acute toxicity and corrosive potential of TPTH, the acute inhalation and primary
eye irritation guidelines for all products listed below, with the exception of 1812-351, may be waived
and classified as category I.
•• The technical acute toxicity values included jn this document are for inforrnational purposes
only- Tie data supporting these values may or may not meet the current acceptance criteria.
r r| ,, :[ .. ' : : i : :
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Batch
1
EPA Reg. No.
1812-279
45639-171
5204-86
55146-71
% Active Ingredient
TPTH...96%
TPTH...96%
TPTH...96%
TPTH...96%
Formulation Type
liquid
liquid
liquid
liquid
' I < i!,;'!!' ill' ' itlR,, 'T i Ilillillllllli;!''! ' .Zill ,' liMil IlilillH1:"1! llliilliiV^^ 1 Jilllllil , I il|li»;,::il«^ ilif! • ill ii: ' liliil'l : • ' illiili'!: H" Kill! T I', IK*:!];! • ji 'I ill, ' '; ! ', ttmJi |l:ial I1' Ity'liS^^^^^^^^ ,.':!!!> 11 'liTi'liii1: '! ' :i * 'i: .mxiiaPT.'iK* 'fit" ••' L, iiiJWWili1 '"MPf'ft,1.", ',l'i!":i: :••'. ,:
;: iiUllBt!,:, ilii'Ei" ., id ' IllllIK I1'"1'* •lili All ^fTllllllB , .i'llf'i Bill!, ll'VlillilO^^^^ !', •"•,' /'i!1! ' 'JliRT I*- " lillii):,1' ''"i-iUl! ,ii::!i!l !'K; i':' "11 Illlllll ' f iiin'ILr "i:1 .'>;; il i" ft' i"! *', II f ,.- "iililiii'illliii": ,:»:"/: "ii'l'ilil'.!'!'!!
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2
EPA Reg. No.
1812-350
55146-72
% Active Ingredient
TPTH...80%
TPTH...80%
Formulation Type
solid
-------
Batch
3
EPA Reg. No.
1812-244
45639-186
% Active Ingredient
TPTH...40%
TPTH...40.4%
Formulation Type
liquid
liquid
No Batch
EPA Reg. No.
1812-351
45639-170
% Active Ingredient
TPTH...4.72%
Maneb...32.63%
TPTH...47.5%
Formulation Type
liquid
liquid
177
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Appendix E. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet
site:
http://www.epa. gov/oppridOO 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 Information1 or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at
(703) 308-5551 or by e-mail at wiUiams.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
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
httD://www.eDa.sov/opDrd001/forms/8570-l.pdf.
htto://www.eDa.sov/or>Drd001 /forms/8570-4 pdf
httD://www.eoa.sov/ODord001 /forms/8570-5 pdf
htto ://www.epa. gov/oonrdOO 1 /forms/8570- 1 7 pdf
181
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Ill II lllllll'l
111'ill "I III11
8570-25
8570-27
8570-28
8570-30
8570-32
%
8570-34
8570-35
8570-36
8570-37
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee
Filing
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of
Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical
Properties (in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
httD://www.eoa.eov/oDt>rd001 /forms/8570-25, pdf.
httD://www.eoa.Eov/opDrd001/forms/8570-27.pdf.
htto://www.eDa.eov/ooDrd001/forms/8570-28.pdf.
http://www.epa. aov/oocrdOOl /forms/8570-30 pdf
httD://www.eDa.aov/opprd001 /forms/8570-32 pdf
httD://www.eoa.eov/opDDmsdl/PR Notices/pr98-5.ndf.
http://www.epa. gov/opppmsdl/PR_Notices/pr98-5. pdf.
httD://www.er>a.eov/oDDDmsdl/PR Notices/pr98-l pdf
httD://www.eoa.eov/oDDDmsd1/PR Notices/nr98-l.pdf.
182
ill
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Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
(FQPA)ofl996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/6Dppmsdl /PR Notices.
3.
Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat reader.)
a.
b.
c.
d.
e.
EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
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
183
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Ill I II 111 Illllll
4. General Pesticide Information (Some of these forms are in PDF fqrmat and will require the
Acrobat reader.)
i i *
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention..Division. (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
• d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f.. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
n. iiicijii!!;;" ; v vcu i..." •':--n^^A~:8^&?w^yv^*^A&ftion. fPr registration, you may wish to consult some additional sources
SB.L/T..H.V.I a;:.!:: as <;•.;:. bfi^or^tion. These include;
|r :''!;|:" ;^'£r" j|s ,:",:'' 1',/Us, _. .The Office of Pesticide Programs' Web Site
fe'tHWjilfK'';1'•' 'fliii1'!'^1 iii V1**'' "SI;"111'11/ i1""",, """l " " ' " "" """ ""
;:,.;,,lr fe
grates", PB92-221811, available through the National Technical Information Service
HIS, i ,,"i s, ."aiiiiF ! EI". ill1 ; ,'ii;;••,:;:• ; ..«•. j.Mw-i (NTIS) at the following address:
liiJirilin''!.,!1.,!1! ' iliiiliii "'i| lihii'i'l'IIIK^ ,i""Hii'• «! ' ,'! ,' • ', I'!'1'!!!!' Ill, Hl'IIIIHIillljl i I'1'1 i. "'
in,':!!; I'liiiilni'! 12 unci. •. i1 JiiMri;. t^ui' iEih'-1 lyiifciii"* "iii|!ni:ii, . i .u,,,, \ n n in i i n i inn n inn in i i n n i i i HI in
i •:••:" - ',' • ..: ' i, r : .,. ,, t;;: „';,.;,. ;..;.:'" National Technical Information Service (NTIS)
:: : 5285 Port Royal Road
i;;,™~' ». i"1.' "«r,:: :«;; :;,'« i:;;;;;; ;=",.,v:'Springfield, VA22161
'/IJhs^lephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
&e 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
PpSi?11?^;W.® E1!!??3^! tolhis publication \^ become avaUabledurmg the Fall of 1998.
"] ' ' ' ' ' '", ' '" '" ' '! i
3- The Natiorial Pesticide information Retrieval System (NPIRS) of Purdue University's
;;:;;;: :.;' '.,'~' •; ;;£,,, ;.,,,,,,;;,:::';::lEI,,'';Sr^^^L^3^Wl^^§H4£!Bgulatoiy Information Systems. This service does charge a
;'„ •";[:;;;,;:,;: ' ,; !=:;;,;"'' ',";::,"!;" '"JJJ". ;|ES,|^ll^2crip_tions ^d .ci8,*01!!, searches. You can contact NPIRS by telephone at (765)
'•"• '".••-•- : • • - -""" •-'.'•"• - 494-6614 or through their Web site.
,;;,„„; ,„. „;::::;; ;;,:;;;,;, ~ ~,,™ ;, ~-rt^ 2§!?ye .mgredientSj^uses, toxicology, and chemistry of pesticides. You can contact NPTN by
;;; , -,;,; ,';^;'. ,',, • ^i;; ".'^'.r, .iii^'.I^^PS® #• $2°) §5§:Z378 .OT.tiirough their Web site: ace.orst.edu/info/npta.
, i,, , ., .. ., t , i;i,, ,,,. ,„ ,. Sw ^i^S.^.E!?™ a ^p? of receipt of an apphcation for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or
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petitioner encloses with his submission a stamped, self-addressed postcard. The postcard
must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the acknowledgment
of receipt to the specific application submitted. EPA will stamp the date of receipt and
provide the EPA identifying File Symbol or petition number for the new submission. The
identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded
and assigned to your company, please include a list of all synonyms, common and trade
names, company experimental codes, and other names which identify the chemical
(including "blind" codes used when a sample was submitted for testing by commercial or
academic facilities). Please provide a CAS number'if one has been assigned.
Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical
Status Sheet.
a.
b.
Health and Environmental Effects Science Chapters.
Detailed Label Usage Information System (LUIS) Report.
185
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